9 Replies Latest reply: Aug 1, 2013 6:20 AM by odie_63 RSS

    How to import xml file to oracle database

    ff4dac86-43ce-4b32-8ea5-8b05fce972ee

      Hi Experts,

      I have xml file and need to import it in oracle database. I tried couple of times but didnt succeed.

       

       

       

      
      

        <?xml version="1.0" encoding="ISO-8859-1" ?>

      - <ODM xmlns="http://www.cdisc.org/ns/odm/v1.2" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:def="http://www.cdisc.org/ns/def/v1.0" xsi:schemaLocation="http://www.cdisc.org/ns/odm/v1.2 define1-0-0.xsd" FileOID="DefineXML" ODMVersion="1.2" FileType="Snapshot" CreationDateTime="2012-10-12T19:41:16">

      - <Study OID="ESKETIVTRD2001">

      - <GlobalVariables>

        <StudyName>ESKETIVTRD2001</StudyName>

        <StudyDescription>ESKETIVTRD2001</StudyDescription>

        <ProtocolName>ESKETIVTRD2001</ProtocolName>

        </GlobalVariables>

      - <MetaDataVersion OID="CDISC.SDTM.3.1.2" Name="Study ESKETIVTRD2001, Data Definitions" Description="Study ESKETIVTRD2001, Data Definitions" def:DefineVersion="1.0.0" def:StandardName="CDISC SDTM" def:StandardVersion="3.1.1">

      - <def:AnnotatedCRF>

        <def:DocumentRef leafID="blankcrf" />

        </def:AnnotatedCRF>

      - <def:leaf ID="blankcrf" xlink:href="blankcrf.pdf">

        <def:title>Annotated Case Report Form</def:title>

        </def:leaf>

      + <def:ValueListDef OID="ValueList.EG.EGTESTCD">

        <ItemRef ItemOID="EG.EGTESTCD.HR" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.PR" OrderNumber="002" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.RR" OrderNumber="003" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.QRS" OrderNumber="004" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.QT" OrderNumber="005" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.QTCB" OrderNumber="006" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.QTCF" OrderNumber="007" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.QTCLD" OrderNumber="008" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.QTCL" OrderNumber="009" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.TWAVE" OrderNumber="010" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.UWAVE" OrderNumber="011" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.STWAVE" OrderNumber="012" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.CONDUCT" OrderNumber="013" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.MORPH" OrderNumber="014" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.RHYTHM" OrderNumber="015" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.OTHFIND" OrderNumber="016" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.TCHFIND" OrderNumber="017" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.CLINARTS" OrderNumber="018" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.INTP" OrderNumber="019" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.EGCLSIG1" OrderNumber="020" Mandatory="No" />

        <ItemRef ItemOID="EG.EGTESTCD.EGABNOR" OrderNumber="021" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.IE.IECAT">

        <ItemRef ItemOID="IE.IECAT.INCLUSION" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION" OrderNumber="002" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.IE.IECAT.EXCLUSION.IETESTCD">

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX01" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX02" OrderNumber="002" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX03" OrderNumber="003" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX04" OrderNumber="004" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX05" OrderNumber="005" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX06" OrderNumber="006" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX07" OrderNumber="007" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX08" OrderNumber="008" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX09" OrderNumber="009" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX10" OrderNumber="010" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX11" OrderNumber="011" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX12" OrderNumber="012" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX13" OrderNumber="013" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX14" OrderNumber="014" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX15" OrderNumber="015" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX16" OrderNumber="016" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX17" OrderNumber="017" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX18" OrderNumber="018" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX19" OrderNumber="019" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX20" OrderNumber="020" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX21" OrderNumber="021" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.EXCLUSION.IETESTCD.EX22" OrderNumber="022" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.IE.IECAT.INCLUSION.IETESTCD">

        <ItemRef ItemOID="IE.IECAT.INCLUSION.IETESTCD.IN01" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.INCLUSION.IETESTCD.IN02" OrderNumber="002" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.INCLUSION.IETESTCD.IN03" OrderNumber="003" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.INCLUSION.IETESTCD.IN04" OrderNumber="004" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.INCLUSION.IETESTCD.IN05" OrderNumber="005" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.INCLUSION.IETESTCD.IN06" OrderNumber="006" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.INCLUSION.IETESTCD.IN07" OrderNumber="007" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.INCLUSION.IETESTCD.IN08" OrderNumber="008" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.INCLUSION.IETESTCD.IN09" OrderNumber="009" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.INCLUSION.IETESTCD.IN10" OrderNumber="010" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.INCLUSION.IETESTCD.IN11" OrderNumber="011" Mandatory="No" />

        <ItemRef ItemOID="IE.IECAT.INCLUSION.IETESTCD.IN12" OrderNumber="012" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.LB.LBCAT">

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.HEMATOLOGY" OrderNumber="002" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.IMMUNOLOGY" OrderNumber="003" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS" OrderNumber="004" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.LB.LBCAT.CHEMISTRY.LBSPEC">

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.SERUM" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.BREATH" OrderNumber="002" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED)" OrderNumber="003" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD">

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED)" OrderNumber="003" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD">

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.ALT" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.ALP" OrderNumber="002" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.AST" OrderNumber="003" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.BICARB" OrderNumber="004" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.BUN" OrderNumber="005" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CA" OrderNumber="006" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CL" OrderNumber="007" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CK" OrderNumber="008" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CREAT" OrderNumber="009" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.GGT" OrderNumber="010" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.LDH" OrderNumber="011" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.PHOS" OrderNumber="012" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.K" OrderNumber="013" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.SODIUM" OrderNumber="014" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.TSH" OrderNumber="015" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.BILI" OrderNumber="016" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.PROT" OrderNumber="017" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.ALB" OrderNumber="018" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.LB.LBCAT.CHEMISTRY.LBSPEC.BREATH.LBMETHOD">

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.BREATH.LBMETHOD.(NO VALUE RECORDED)" OrderNumber="002" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.LB.LBCAT.CHEMISTRY.LBSPEC.BREATH.LBMETHOD.(NO VALUE RECORDED).LBTESTCD">

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.BREATH.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.ETHANOL" OrderNumber="001" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.LB.LBCAT.CHEMISTRY.LBSPEC.SERUM.LBMETHOD">

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.SERUM.LBMETHOD.(NO VALUE RECORDED)" OrderNumber="001" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.LB.LBCAT.CHEMISTRY.LBSPEC.SERUM.LBMETHOD.(NO VALUE RECORDED).LBTESTCD">

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.SERUM.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.GLUC" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.SERUM.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.URATE" OrderNumber="002" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.CHEMISTRY.LBSPEC.SERUM.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.HCG" OrderNumber="003" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.LB.LBCAT.HEMATOLOGY.LBSPEC">

        <ItemRef ItemOID="LB.LBCAT.HEMATOLOGY.LBSPEC.(NO VALUE RECORDED)" OrderNumber="001" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.LB.LBCAT.IMMUNOLOGY.LBSPEC">

        <ItemRef ItemOID="LB.LBCAT.IMMUNOLOGY.LBSPEC.(NO VALUE RECORDED)" OrderNumber="001" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.LB.LBCAT.IMMUNOLOGY.LBSPEC.(NO VALUE RECORDED).LBMETHOD">

        <ItemRef ItemOID="LB.LBCAT.IMMUNOLOGY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.WESTERN BLOT" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.IMMUNOLOGY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED)" OrderNumber="002" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.LB.LBCAT.IMMUNOLOGY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD">

        <ItemRef ItemOID="LB.LBCAT.IMMUNOLOGY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.HBSAG" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.IMMUNOLOGY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.HCAB" OrderNumber="002" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.IMMUNOLOGY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.HIV12AB" OrderNumber="003" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.LB.LBCAT.IMMUNOLOGY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.WESTERN BLOT.LBTESTCD">

        <ItemRef ItemOID="LB.LBCAT.IMMUNOLOGY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.WESTERN BLOT.LBTESTCD.HIV1AB" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.IMMUNOLOGY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.WESTERN BLOT.LBTESTCD.HIV2AB" OrderNumber="002" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.LB.LBCAT.URINALYSIS.LBSPEC">

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE" OrderNumber="001" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD">

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.LPF MICROSCOPY" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.HPF MICROSCOPY" OrderNumber="002" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED)" OrderNumber="003" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD">

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.Ethanol" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.AMPHET" OrderNumber="002" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.BACT" OrderNumber="003" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.BARB" OrderNumber="004" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.BILI" OrderNumber="005" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.BLOOD" OrderNumber="006" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CASTS" OrderNumber="007" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.COCAINE" OrderNumber="008" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.GLUC" OrderNumber="009" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.KETONES" OrderNumber="010" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.LEUKASE" OrderNumber="011" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.METHDN" OrderNumber="012" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.NITRITE" OrderNumber="013" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.OPIATE" OrderNumber="014" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.pH" OrderNumber="015" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.PROT" OrderNumber="016" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.RBC" OrderNumber="017" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.SPGRAV" OrderNumber="018" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.WBC" OrderNumber="019" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CYAMMBIU" OrderNumber="020" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CYAMORPH" OrderNumber="021" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.COLOR" OrderNumber="022" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.FAT" OrderNumber="023" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.APPEAR" OrderNumber="024" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CYBILI" OrderNumber="025" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CYCACAR" OrderNumber="026" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CYCAOXA" OrderNumber="027" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CYCAPHOS" OrderNumber="028" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CYCYSTIN" OrderNumber="029" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CYLEUC" OrderNumber="030" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.MUCTHR" OrderNumber="031" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.FATBODOV" OrderNumber="032" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.RBCCLMP" OrderNumber="033" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CYTRPHOS" OrderNumber="034" Mandatory="No" />

        <ItemRef ItemOID="LB.LBCAT.URINALYSIS.LBSPEC.URINE.LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CYURIAC" OrderNumber="035" Mandatory="No" />

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        <ItemRef ItemOID="QS.QSCAT.SCI_V2008.QSTESTCD.CTNIMGH" OrderNumber="022" Mandatory="No" />

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      - <def:ValueListDef OID="ValueList.SUPPAE.QNAM">

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        <ItemRef ItemOID="SUPPAE.QNAM.AEHLGT" OrderNumber="007" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.SUPPCM.QNAM">

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        <ItemRef ItemOID="SUPPCM.QNAM.CMLVL4CD" OrderNumber="020" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.SUPPDM.QNAM">

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      - <def:ValueListDef OID="ValueList.SUPPDS.QNAM">

        <ItemRef ItemOID="SUPPDS.QNAM.RANUM" OrderNumber="001" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.SUPPEG.QNAM">

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        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.SUPPEX.QNAM">

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        <ItemRef ItemOID="SUPPEX.QNAM.EXEDOST" OrderNumber="003" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.SUPPLB.QNAM">

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        <ItemRef ItemOID="SUPPLB.QNAM.AUX1" OrderNumber="003" Mandatory="No" />

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        <ItemRef ItemOID="SUPPLB.QNAM.AUX3" OrderNumber="005" Mandatory="No" />

        <ItemRef ItemOID="SUPPLB.QNAM.AUX4" OrderNumber="006" Mandatory="No" />

        <ItemRef ItemOID="SUPPLB.QNAM.AUX5" OrderNumber="007" Mandatory="No" />

        <ItemRef ItemOID="SUPPLB.QNAM.AUX6" OrderNumber="008" Mandatory="No" />

        <ItemRef ItemOID="SUPPLB.QNAM.AUX7" OrderNumber="009" Mandatory="No" />

        <ItemRef ItemOID="SUPPLB.QNAM.AUX8" OrderNumber="010" Mandatory="No" />

        <ItemRef ItemOID="SUPPLB.QNAM.AUX9" OrderNumber="011" Mandatory="No" />

        <ItemRef ItemOID="SUPPLB.QNAM.AUX10" OrderNumber="012" Mandatory="No" />

        <ItemRef ItemOID="SUPPLB.QNAM.LBNONCOM" OrderNumber="013" Mandatory="No" />

        <ItemRef ItemOID="SUPPLB.QNAM.RRNGDESC" OrderNumber="014" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.SUPPMH.QNAM">

        <ItemRef ItemOID="SUPPMH.QNAM.MHONGO" OrderNumber="001" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.SUPPQS.QNAM">

        <ItemRef ItemOID="SUPPQS.QNAM.QSTSCORE" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="SUPPQS.QNAM.QSTIMEFR" OrderNumber="002" Mandatory="No" />

        <ItemRef ItemOID="SUPPQS.QNAM.QSMTSCRT" OrderNumber="003" Mandatory="No" />

        <ItemRef ItemOID="SUPPQS.QNAM.QSPRIDX" OrderNumber="004" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.SUPPSG.QNAM">

        <ItemRef ItemOID="SUPPSG.QNAM.SGPLNDTC" OrderNumber="001" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.SUPPSV.QNAM">

        <ItemRef ItemOID="SUPPSV.QNAM.SVCONTYP" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="SUPPSV.QNAM.SVSTAT" OrderNumber="002" Mandatory="No" />

        <ItemRef ItemOID="SUPPSV.QNAM.SVREASND" OrderNumber="003" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.SUPPVS.QNAM">

        <ItemRef ItemOID="SUPPVS.QNAM.VSENDTC" OrderNumber="001" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.SUPPXZ.QNAM">

        <ItemRef ItemOID="SUPPXZ.QNAM.XZREAS" OrderNumber="001" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.VS.VSTESTCD">

        <ItemRef ItemOID="VS.VSTESTCD.WEIGHT" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="VS.VSTESTCD.HEIGHT" OrderNumber="002" Mandatory="No" />

        <ItemRef ItemOID="VS.VSTESTCD.HR" OrderNumber="003" Mandatory="No" />

        <ItemRef ItemOID="VS.VSTESTCD.SYSBP" OrderNumber="004" Mandatory="No" />

        <ItemRef ItemOID="VS.VSTESTCD.DIABP" OrderNumber="005" Mandatory="No" />

        <ItemRef ItemOID="VS.VSTESTCD.BMI" OrderNumber="006" Mandatory="No" />

        <ItemRef ItemOID="VS.VSTESTCD.TEMP" OrderNumber="007" Mandatory="No" />

        <ItemRef ItemOID="VS.VSTESTCD.RESP" OrderNumber="008" Mandatory="No" />

        <ItemRef ItemOID="VS.VSTESTCD.VSABNOR" OrderNumber="009" Mandatory="No" />

        <ItemRef ItemOID="VS.VSTESTCD.VSCLSIG" OrderNumber="010" Mandatory="No" />

        <ItemRef ItemOID="VS.VSTESTCD.VSPULABR" OrderNumber="011" Mandatory="No" />

        <ItemRef ItemOID="VS.VSTESTCD.VSCLSIG1" OrderNumber="012" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.XZ.XZCAT">

        <ItemRef ItemOID="XZ.XZCAT.BIOMARKER MAP" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="XZ.XZCAT.BIOMARKER MTB" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="XZ.XZCAT.DNA SAMPLE" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="XZ.XZCAT.DNA SAMPLE CONSENT MODIFICATION" OrderNumber="002" Mandatory="No" />

        <ItemRef ItemOID="XZ.XZCAT.DNA SAMPLE REPLACEMENT" OrderNumber="003" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.XZ.XZCAT.BIOMARKER MAP.XZTESTCD">

        <ItemRef ItemOID="XZ.XZCAT.BIOMARKER MAP.XZTESTCD.SAMPOBT" OrderNumber="001" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.XZ.XZCAT.BIOMARKER MTB.XZTESTCD">

        <ItemRef ItemOID="XZ.XZCAT.BIOMARKER MTB.XZTESTCD.SAMPOBT" OrderNumber="001" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.XZ.XZCAT.DNA SAMPLE CONSENT MODIFICATION.XZTESTCD">

        <ItemRef ItemOID="XZ.XZCAT.DNA SAMPLE CONSENT MODIFICATION.XZTESTCD.STUDYTST" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="XZ.XZCAT.DNA SAMPLE CONSENT MODIFICATION.XZTESTCD.FUTURTST" OrderNumber="002" Mandatory="No" />

        <ItemRef ItemOID="XZ.XZCAT.DNA SAMPLE CONSENT MODIFICATION.XZTESTCD.SAMPOBT" OrderNumber="003" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.XZ.XZCAT.DNA SAMPLE REPLACEMENT.XZTESTCD">

        <ItemRef ItemOID="XZ.XZCAT.DNA SAMPLE REPLACEMENT.XZTESTCD.SAMPOBT" OrderNumber="001" Mandatory="No" />

        </def:ValueListDef>

      - <def:ValueListDef OID="ValueList.XZ.XZCAT.DNA SAMPLE.XZTESTCD">

        <ItemRef ItemOID="XZ.XZCAT.DNA SAMPLE.XZTESTCD.STORLIMT" OrderNumber="001" Mandatory="No" />

        <ItemRef ItemOID="XZ.XZCAT.DNA SAMPLE.XZTESTCD.STORLEN" OrderNumber="002" Mandatory="No" />

        <ItemRef ItemOID="XZ.XZCAT.DNA SAMPLE.XZTESTCD.STUDYTST" OrderNumber="003" Mandatory="No" />

        <ItemRef ItemOID="XZ.XZCAT.DNA SAMPLE.XZTESTCD.FUTURTST" OrderNumber="004" Mandatory="No" />

        <ItemRef ItemOID="XZ.XZCAT.DNA SAMPLE.XZTESTCD.SAMPOBT" OrderNumber="005" Mandatory="No" />

        </def:ValueListDef>

        <ItemDef OID="EG.EGTESTCD.HR" Name="HR" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="Heart rate" />

        <ItemDef OID="EG.EGTESTCD.PR" Name="PR" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="PR interval" />

        <ItemDef OID="EG.EGTESTCD.RR" Name="RR" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="RR interval" />

        <ItemDef OID="EG.EGTESTCD.QRS" Name="QRS" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="QRS Interval" />

        <ItemDef OID="EG.EGTESTCD.QT" Name="QT" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="QT interval" />

        <ItemDef OID="EG.EGTESTCD.QTCB" Name="QTCB" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="QTC Interval Bazett" />

        <ItemDef OID="EG.EGTESTCD.QTCF" Name="QTCF" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="QTC Interval Fridericia" />

        <ItemDef OID="EG.EGTESTCD.QTCLD" Name="QTCLD" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="QTC Interval Linear Derived" />

        <ItemDef OID="EG.EGTESTCD.QTCL" Name="QTCL" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="QTC Interval Framingham" />

        <ItemDef OID="EG.EGTESTCD.TWAVE" Name="TWAVE" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="T Wave" />

        <ItemDef OID="EG.EGTESTCD.UWAVE" Name="UWAVE" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="U Wave" />

        <ItemDef OID="EG.EGTESTCD.STWAVE" Name="STWAVE" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="ST Wave" />

        <ItemDef OID="EG.EGTESTCD.CONDUCT" Name="CONDUCT" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="Conduction" />

        <ItemDef OID="EG.EGTESTCD.MORPH" Name="MORPH" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="Morphology" />

        <ItemDef OID="EG.EGTESTCD.RHYTHM" Name="RHYTHM" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="Rhythm" />

        <ItemDef OID="EG.EGTESTCD.OTHFIND" Name="OTHFIND" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="Other Finding" />

        <ItemDef OID="EG.EGTESTCD.TCHFIND" Name="TCHFIND" DataType="text" Length="12" Origin="CRF" Comment="" def:Label="Technical Findings" />

        <ItemDef OID="EG.EGTESTCD.CLINARTS" Name="CLINARTS" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="Clinical Alerts" />

      - <ItemDef OID="EG.EGTESTCD.INTP" Name="INTP" DataType="text" Length="8" Origin="CRF" Comment="" def:Label="ECG Interpretation">

        <CodeListRef CodeListOID="EGINTP" />

        </ItemDef>

        <ItemDef OID="EG.EGTESTCD.EGCLSIG1" Name="EGCLSIG1" DataType="text" Length="8" Origin="CRF" Comment="" def:Label="CLINICAL SIGNIFICANCE" />

      - <ItemDef OID="EG.EGTESTCD.EGABNOR" Name="EGABNOR" DataType="text" Length="1" Origin="CRF" Comment="" def:Label="Abnormalities observed in ECG">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

      - <ItemDef OID="IE.IECAT.INCLUSION" Name="INCLUSION" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Inclusion">

        <def:ValueListRef ValueListOID="ValueList.IE.IECAT.INCLUSION.IETESTCD" />

        </ItemDef>

      - <ItemDef OID="IE.IECAT.EXCLUSION" Name="EXCLUSION" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Exclusion">

        <def:ValueListRef ValueListOID="ValueList.IE.IECAT.EXCLUSION.IETESTCD" />

        </ItemDef>

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX01" Name="EX01" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Has a history of, or current signs and symptoms of, liver or renal insufficiency; hypothyroidism or hyperthyroidism (a normal thyroid-stimulating hormone [TSH] is required at screening);" />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX02" Name="EX02" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Has uncontrolled hypertension (SBP> 160mmHg or DBP > 90mmHg despite diet, exercise or a stable dose of an allowed anti-hypertensive tmt) at Screening; or any past history of hypertensive crisis." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX03" Name="EX03" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Has known HIV, hepatitis B, or hepatitis C infection, or have positive results at screening." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX04" Name="EX04" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix)." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX05" Name="EX05" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Has known allergies, hypersensitivity, or intolerance to esketamine or its excipients (SPC, 2003)." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX06" Name="EX06" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Has a history of previous non-response of depressive symptoms to ketamine/esketamine." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX07" Name="EX07" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Has any contraindication to the use of esketamine, per local prescribing information." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX08" Name="EX08" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Has not responded to previous treatment with electroconvulsive therapy (ECT)." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX09" Name="EX09" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Has had psychological treatments , other than psycho-education, within 1 week prior to Day 1." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX10" Name="EX10" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="10. Has a primary DSM-IV diagnosis of current (active) generalized anxiety disorder, panicdisorder, obsessive compulsive disorder, posttraumatic stress disorder, anorexia nervosa, or bulimia nervosa." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX11" Name="EX11" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="History or current diagnosis of a psychotic disorder, bipolar disorder, mentalretardation, mood disorder with postpartum onset, somatoform disorders, Fatigue syndrome." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX12" Name="EX12" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Is acutely suicidal or homicidal (in imminent danger with plan, urges and intent to harm oneself or others) including any serious attempts/those requiring hospitalization in the past 12 months." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX13" Name="EX13" DataType="text" Length="13" Origin="Protocol" Comment="" def:Label="Has any significant primary sleep disorder. Must have score of less than 25 on the Modified Berlin Questionnaire at Screening to rule out possible obstructive sleep apnea." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX14" Name="EX14" DataType="text" Length="14" Origin="Protocol" Comment="" def:Label="Has a history of substance abuse (drug or alcohol) or dependence (except nicotine or caffeine) within the previous 1 year of screening visit." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX15" Name="EX15" DataType="text" Length="15" Origin="Protocol" Comment="" def:Label="Has a positive urine drug screen for opiates, cocaine, barbiturates, methadone, and amphetamine/methamphetamine or positive alcohol screen at Screening or Day -1." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX16" Name="EX16" DataType="text" Length="16" Origin="Protocol" Comment="" def:Label="Disallowed therapy: Has used a disallowed therapy, Any change in psychotropic medication type, Tmt with any MAO-I currently, ECT in past 3 months before screening, Receipt of potent inhibitor" />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX17" Name="EX17" DataType="text" Length="17" Origin="Protocol" Comment="" def:Label="Received investigational drug (investigational vaccine) or used an invasive investigational medical device within 60 days before the planned first dose of study drug, or participated in 2 studies" />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX18" Name="EX18" DataType="text" Length="18" Origin="Protocol" Comment="" def:Label="Is unwilling or unable to undergo multiple venipunctures because of poor tolerability or lack of easy access." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX19" Name="EX19" DataType="text" Length="19" Origin="Protocol" Comment="" def:Label="Is unable to read and understand the consent forms and patient reported outcomes, complete study-related procedures, and/or communicate with the study staff." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX20" Name="EX20" DataType="text" Length="20" Origin="Protocol" Comment="" def:Label="Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the subject or that could prevent, limit." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX21" Name="EX21" DataType="text" Length="21" Origin="Protocol" Comment="" def:Label="Had major surgery, (requiring anesthesia) within 4 weeks before screening, or will not have fully recovered from surgery, or planned surgery during the time the subject is expected participate." />

        <ItemDef OID="IE.IECAT.EXCLUSION.IETESTCD.EX22" Name="EX22" DataType="text" Length="22" Origin="Protocol" Comment="" def:Label="Employee of the investigator or study site, with direct involvement in the study or other studies under the direction of that investigator, as well as family members of the employees." />

        <ItemDef OID="IE.IECAT.INCLUSION.IETESTCD.IN01" Name="IN01" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Be a man or woman, 18 to 64 years of age, inclusive." />

        <ItemDef OID="IE.IECAT.INCLUSION.IETESTCD.IN02" Name="IN02" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Be medically stable on the basis of clinical laboratory tests performed at screening." />

        <ItemDef OID="IE.IECAT.INCLUSION.IETESTCD.IN03" Name="IN03" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Meet Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria for Recurrent MDD, without psychotic features" />

        <ItemDef OID="IE.IECAT.INCLUSION.IETESTCD.IN04" Name="IN04" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Have an inadequate response to at least 1 antidepressant in the current episode of depression and at least one other inadequate treatment response to an antidepressant" />

        <ItemDef OID="IE.IECAT.INCLUSION.IETESTCD.IN05" Name="IN05" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Have an IDS-C30 total score ? 34 at Screening and Day -1." />

        <ItemDef OID="IE.IECAT.INCLUSION.IETESTCD.IN06" Name="IN06" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Hospitalized or agreed to be hospitalized from Day -1 through the completion of study procedures" />

        <ItemDef OID="IE.IECAT.INCLUSION.IETESTCD.IN07" Name="IN07" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="If a woman, before entry she must be: Postmenopausal, Surgically sterile, etc" />

        <ItemDef OID="IE.IECAT.INCLUSION.IETESTCD.IN08" Name="IN08" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="If a woman of childbearing potential, she must have a negative serum -human chorionic gonadotropin (hCG) pregnancy test at screening" />

        <ItemDef OID="IE.IECAT.INCLUSION.IETESTCD.IN09" Name="IN09" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="If a man and heterosexually active with a woman of childbearing potential, he must agree to use a double barrier method of birth control" />

        <ItemDef OID="IE.IECAT.INCLUSION.IETESTCD.IN10" Name="IN10" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Be willing and able to adhere to the prohibitions and restrictions specified in this protocol." />

        <ItemDef OID="IE.IECAT.INCLUSION.IETESTCD.IN11" Name="IN11" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study." />

        <ItemDef OID="IE.IECAT.INCLUSION.IETESTCD.IN12" Name="IN12" DataType="text" Length="1" Origin="Protocol" Comment="" def:Label="Sign the informed consent form for pharmacogenomic research in order to participate in the optional pharmacogenomic component of this study - where local regulations permit." />

      - <ItemDef OID="LB.LBCAT.CHEMISTRY" Name="CHEMISTRY" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Chemistry">

        <def:ValueListRef ValueListOID="ValueList.LB.LBCAT.CHEMISTRY.LBSPEC" />

        </ItemDef>

      - <ItemDef OID="LB.LBCAT.HEMATOLOGY" Name="HEMATOLOGY" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Hematology">

        <def:ValueListRef ValueListOID="ValueList.LB.LBCAT.HEMATOLOGY.LBSPEC" />

        </ItemDef>

      - <ItemDef OID="LB.LBCAT.IMMUNOLOGY" Name="IMMUNOLOGY" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Immunology">

        <def:ValueListRef ValueListOID="ValueList.LB.LBCAT.IMMUNOLOGY.LBSPEC" />

        </ItemDef>

      - <ItemDef OID="LB.LBCAT.URINALYSIS" Name="URINALYSIS" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Urinalysis">

        <def:ValueListRef ValueListOID="ValueList.LB.LBCAT.URINALYSIS.LBSPEC" />

        </ItemDef>

      - <ItemDef OID="LB.LBCAT.CHEMISTRY.LBSPEC.SERUM" Name="SERUM" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Serum">

        <def:ValueListRef ValueListOID="ValueList.LB.LBCAT.CHEMISTRY.LBSPEC.SERUM.LBMETHOD" />

        </ItemDef>

      - <ItemDef OID="LB.LBCAT.CHEMISTRY.LBSPEC.BREATH" Name="BREATH" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Breath">

        <def:ValueListRef ValueListOID="ValueList.LB.LBCAT.CHEMISTRY.LBSPEC.BREATH.LBMETHOD" />

        </ItemDef>

      - <ItemDef OID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED)" Name="(NO VALUE RECORDED)" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="(NO VALUE RECORDED)">

        <def:ValueListRef ValueListOID="ValueList.LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD" />

        </ItemDef>

      - <ItemDef OID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED)" Name="(NO VALUE RECORDED)" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="(NO VALUE RECORDED)">

        <def:ValueListRef ValueListOID="ValueList.LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD" />

        </ItemDef>

        <ItemDef OID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.ALT" Name="ALT" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Alanine Aminotransferase" />

        <ItemDef OID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.ALP" Name="ALP" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Alkaline Phosphatase" />

        <ItemDef OID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.AST" Name="AST" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Aspartate Aminotransferase" />

        <ItemDef OID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.BICARB" Name="BICARB" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Bicarbonate" />

        <ItemDef OID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.BUN" Name="BUN" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Blood Urea Nitrogen" />

        <ItemDef OID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CA" Name="CA" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Calcium" />

        <ItemDef OID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CL" Name="CL" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Chloride" />

        <ItemDef OID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CK" Name="CK" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Creatine Kinase" />

        <ItemDef OID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.CREAT" Name="CREAT" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Creatinine" />

        <ItemDef OID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.GGT" Name="GGT" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Gamma Glutamyl Transferase" />

        <ItemDef OID="LB.LBCAT.CHEMISTRY.LBSPEC.(NO VALUE RECORDED).LBMETHOD.(NO VALUE RECORDED).LBTESTCD.LDH" Name="LDH" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Lactate Dehydrogenase" />

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        <CodeListRef CodeListOID="CADSSL" />

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      - <ItemDef OID="QS.QSCAT.CGII_V1976.QSTESTCD.CGI02" Name="CGI02" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Global improvement">

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        <ItemDef OID="QS.QSCAT.CSSRS_B_V20080719.QSSCAT.OTHER SUICIDAL BEHAVIOR INFORMATION.QSTESTCD.CSSBF01" Name="CSSBF01" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Initial/first attempt date (dd- MMM- yyyy)" />

      - <ItemDef OID="QS.QSCAT.CSSRS_B_V20080719.QSSCAT.OTHER SUICIDAL BEHAVIOR INFORMATION.QSTESTCD.CSSBF02" Name="CSSBF02" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Actual lethality/medical damage">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC06" Name="IDSC06" DataType="text" Length="52" Origin="CRF" Comment="" def:Label="Mood (Irritable)">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC07" Name="IDSC07" DataType="text" Length="56" Origin="CRF" Comment="" def:Label="Mood (Anxious)">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC08" Name="IDSC08" DataType="text" Length="78" Origin="CRF" Comment="" def:Label="Reactivity of Mood">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC10" Name="IDSC10" DataType="text" Length="136" Origin="CRF" Comment="" def:Label="Quality of Mood">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC11" Name="IDSC11" DataType="text" Length="104" Origin="CRF" Comment="" def:Label="Appetite (Decreased)">

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        </ItemDef>

      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC12" Name="IDSC12" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Appetite (Increased)">

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        </ItemDef>

      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC13" Name="IDSC13" DataType="text" Length="45" Origin="CRF" Comment="" def:Label="Weight (Decrease) Last Two Weeks">

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        </ItemDef>

      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC14" Name="IDSC14" DataType="text" Length="49" Origin="CRF" Comment="" def:Label="Weight (Increase) Last Two Weeks">

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        </ItemDef>

      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC15" Name="IDSC15" DataType="text" Length="75" Origin="CRF" Comment="" def:Label="Concentration/Decision Making">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC16" Name="IDSC16" DataType="text" Length="56" Origin="CRF" Comment="" def:Label="Outlook (Self)">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC17" Name="IDSC17" DataType="text" Length="79" Origin="CRF" Comment="" def:Label="Outlook (Future)">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC18" Name="IDSC18" DataType="text" Length="103" Origin="CRF" Comment="" def:Label="Suicidal Ideation">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC19" Name="IDSC19" DataType="text" Length="70" Origin="CRF" Comment="" def:Label="Involvement">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC20" Name="IDSC20" DataType="text" Length="81" Origin="CRF" Comment="" def:Label="Energy/Fatiguability">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC21" Name="IDSC21" DataType="text" Length="81" Origin="CRF" Comment="" def:Label="Pleasure/Enjoyment">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC22" Name="IDSC22" DataType="text" Length="62" Origin="CRF" Comment="" def:Label="Sexual Interest">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC23" Name="IDSC23" DataType="text" Length="76" Origin="CRF" Comment="" def:Label="Psychomotor Slowing">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC24" Name="IDSC24" DataType="text" Length="64" Origin="CRF" Comment="" def:Label="Psychomotor Agitation">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC25" Name="IDSC25" DataType="text" Length="95" Origin="CRF" Comment="" def:Label="Somatic Complaints">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC26" Name="IDSC26" DataType="text" Length="124" Origin="CRF" Comment="" def:Label="Sympathetic Arousal">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC27" Name="IDSC27" DataType="text" Length="126" Origin="CRF" Comment="" def:Label="Panic/Phobic Symptoms">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC28" Name="IDSC28" DataType="text" Length="114" Origin="CRF" Comment="" def:Label="Gastrointestinal">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC29" Name="IDSC29" DataType="text" Length="126" Origin="CRF" Comment="" def:Label="Interpersonal Sensitivity">

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      - <ItemDef OID="QS.QSCAT.IDSC_V1988.QSTESTCD.IDSC30" Name="IDSC30" DataType="text" Length="163" Origin="CRF" Comment="" def:Label="Leaden Paralysis/Physical Energy">

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      - <ItemDef OID="QS.QSCAT.MADRS_V1979.QSTESTCD.MADRS04" Name="MADRS04" DataType="text" Length="82" Origin="CRF" Comment="" def:Label="Reduced Sleep">

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      - <ItemDef OID="QS.QSCAT.MADRS_V1979.QSTESTCD.MADRS08" Name="MADRS08" DataType="text" Length="169" Origin="CRF" Comment="" def:Label="Inability to Feel">

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      - <ItemDef OID="QS.QSCAT.MADRS_V1979.QSTESTCD.MADRS09" Name="MADRS09" DataType="text" Length="125" Origin="CRF" Comment="" def:Label="Pessimistic Thoughts">

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      - <ItemDef OID="QS.QSCAT.MADRS_V1979.QSTESTCD.MADRS10" Name="MADRS10" DataType="text" Length="146" Origin="CRF" Comment="" def:Label="Suicidal Thoughts">

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      - <ItemDef OID="QS.QSCAT.MADRS_WSAA_V1979.QSTESTCD.MADRS01" Name="MADRS01" DataType="text" Length="57" Origin="CRF" Comment="" def:Label="Apparent Sadness">

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      - <ItemDef OID="QS.QSCAT.MADRS_WSAA_V1979.QSTESTCD.MADRS02" Name="MADRS02" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Reported Sadness">

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      - <ItemDef OID="QS.QSCAT.MADRS_WSAA_V1979.QSTESTCD.MADRS03" Name="MADRS03" DataType="text" Length="114" Origin="CRF" Comment="" def:Label="Inner Tension">

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        </ItemDef>

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        <CodeListRef CodeListOID="PGIIMP" />

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        <CodeListRef CodeListOID="QIDSRL5" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR10_V2003.QSSCAT.QIDSSR10.QSTESTCD.QIDSSR06" Name="QIDSSR06" DataType="text" Length="110" Origin="CRF" Comment="" def:Label="Decreased appetite">

        <CodeListRef CodeListOID="QIDSRL6" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR10_V2003.QSSCAT.QIDSSR10.QSTESTCD.QIDSSR07" Name="QIDSSR07" DataType="text" Length="103" Origin="CRF" Comment="" def:Label="Increased appetite">

        <CodeListRef CodeListOID="QIDSRL7" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR10_V2003.QSSCAT.QIDSSR10.QSTESTCD.QIDSSR10" Name="QIDSSR10" DataType="text" Length="77" Origin="CRF" Comment="" def:Label="Concentration/decision making">

        <CodeListRef CodeListOID="QIDRL10" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR10_V2003.QSSCAT.QIDSSR10.QSTESTCD.QIDSSR11" Name="QIDSSR11" DataType="text" Length="66" Origin="CRF" Comment="" def:Label="View of myself">

        <CodeListRef CodeListOID="QIDRL11" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR10_V2003.QSSCAT.QIDSSR10.QSTESTCD.QIDSSR12" Name="QIDSSR12" DataType="text" Length="145" Origin="CRF" Comment="" def:Label="Thoughts of death or suicide">

        <CodeListRef CodeListOID="QIDRL12" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR10_V2003.QSSCAT.QIDSSR10.QSTESTCD.QIDSSR13" Name="QIDSSR13" DataType="text" Length="83" Origin="CRF" Comment="" def:Label="General interest">

        <CodeListRef CodeListOID="QIDRL13" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR10_V2003.QSSCAT.QIDSSR10.QSTESTCD.QIDSSR14" Name="QIDSSR14" DataType="text" Length="133" Origin="CRF" Comment="" def:Label="Energy level">

        <CodeListRef CodeListOID="QIDRL14" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR10_V2003.QSSCAT.QIDSSR10.QSTESTCD.QIDSSR15" Name="QIDSSR15" DataType="text" Length="92" Origin="CRF" Comment="" def:Label="Feeling slowed down">

        <CodeListRef CodeListOID="QIDRL15" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR10_V2003.QSSCAT.QIDSSR10.QSTESTCD.QIDSSR16" Name="QIDSSR16" DataType="text" Length="69" Origin="CRF" Comment="" def:Label="Feeling restless">

        <CodeListRef CodeListOID="QIDRL16" />

        </ItemDef>

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        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR14_V2003.QSSCAT.QIDSSR14.QSTESTCD.QIDSSR01" Name="QIDSSR01" DataType="text" Length="68" Origin="CRF" Comment="" def:Label="Falling asleep">

        <CodeListRef CodeListOID="QIDSRL1" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR14_V2003.QSSCAT.QIDSSR14.QSTESTCD.QIDSSR02" Name="QIDSSR02" DataType="text" Length="95" Origin="CRF" Comment="" def:Label="Sleep during the night">

        <CodeListRef CodeListOID="QIDSRL2" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR14_V2003.QSSCAT.QIDSSR14.QSTESTCD.QIDSSR03" Name="QIDSSR03" DataType="text" Length="99" Origin="CRF" Comment="" def:Label="Waking up too early">

        <CodeListRef CodeListOID="QIDSRL3" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR14_V2003.QSSCAT.QIDSSR14.QSTESTCD.QIDSSR04" Name="QIDSSR04" DataType="text" Length="71" Origin="CRF" Comment="" def:Label="Sleeping too much">

        <CodeListRef CodeListOID="QIDSRL4" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR14_V2003.QSSCAT.QIDSSR14.QSTESTCD.QIDSSR05" Name="QIDSSR05" DataType="text" Length="35" Origin="CRF" Comment="" def:Label="Feeling sad">

        <CodeListRef CodeListOID="QIDSRL5" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR14_V2003.QSSCAT.QIDSSR14.QSTESTCD.QIDSSR06" Name="QIDSSR06" DataType="text" Length="110" Origin="CRF" Comment="" def:Label="Decreased appetite">

        <CodeListRef CodeListOID="QIDSRL6" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR14_V2003.QSSCAT.QIDSSR14.QSTESTCD.QIDSSR07" Name="QIDSSR07" DataType="text" Length="103" Origin="CRF" Comment="" def:Label="Increased appetite">

        <CodeListRef CodeListOID="QIDSRL7" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR14_V2003.QSSCAT.QIDSSR14.QSTESTCD.QIDSSR10" Name="QIDSSR10" DataType="text" Length="77" Origin="CRF" Comment="" def:Label="Concentration/decision making">

        <CodeListRef CodeListOID="QIDRL10" />

        </ItemDef>

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        <CodeListRef CodeListOID="QIDRL11" />

        </ItemDef>

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        <CodeListRef CodeListOID="QIDRL12" />

        </ItemDef>

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        <CodeListRef CodeListOID="QIDRL13" />

        </ItemDef>

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        </ItemDef>

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        <CodeListRef CodeListOID="QIDRL15" />

        </ItemDef>

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        <CodeListRef CodeListOID="QIDRL16" />

        </ItemDef>

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        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR16_V2003.QSSCAT.QIDSSR16.QSTESTCD.QIDSSR01" Name="QIDSSR01" DataType="text" Length="68" Origin="CRF" Comment="" def:Label="Falling asleep">

        <CodeListRef CodeListOID="QIDSRL1" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR16_V2003.QSSCAT.QIDSSR16.QSTESTCD.QIDSSR02" Name="QIDSSR02" DataType="text" Length="95" Origin="CRF" Comment="" def:Label="Sleep during the night">

        <CodeListRef CodeListOID="QIDSRL2" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR16_V2003.QSSCAT.QIDSSR16.QSTESTCD.QIDSSR03" Name="QIDSSR03" DataType="text" Length="99" Origin="CRF" Comment="" def:Label="Waking up too early">

        <CodeListRef CodeListOID="QIDSRL3" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR16_V2003.QSSCAT.QIDSSR16.QSTESTCD.QIDSSR04" Name="QIDSSR04" DataType="text" Length="71" Origin="CRF" Comment="" def:Label="Sleeping too much">

        <CodeListRef CodeListOID="QIDSRL4" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR16_V2003.QSSCAT.QIDSSR16.QSTESTCD.QIDSSR05" Name="QIDSSR05" DataType="text" Length="35" Origin="CRF" Comment="" def:Label="Feeling sad">

        <CodeListRef CodeListOID="QIDSRL5" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR16_V2003.QSSCAT.QIDSSR16.QSTESTCD.QIDSSR06" Name="QIDSSR06" DataType="text" Length="110" Origin="CRF" Comment="" def:Label="Decreased appetite">

        <CodeListRef CodeListOID="QIDSRL6" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR16_V2003.QSSCAT.QIDSSR16.QSTESTCD.QIDSSR07" Name="QIDSSR07" DataType="text" Length="103" Origin="CRF" Comment="" def:Label="Increased appetite">

        <CodeListRef CodeListOID="QIDSRL7" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR16_V2003.QSSCAT.QIDSSR16.QSTESTCD.QIDSSR08" Name="QIDSSR08" DataType="text" Length="43" Origin="CRF" Comment="" def:Label="Decreased weight (within last two weeks)">

        <CodeListRef CodeListOID="QIDSRL8" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR16_V2003.QSSCAT.QIDSSR16.QSTESTCD.QIDSSR09" Name="QIDSSR09" DataType="text" Length="43" Origin="CRF" Comment="" def:Label="Increased weight (within the last two weeks)">

        <CodeListRef CodeListOID="QIDSRL9" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR16_V2003.QSSCAT.QIDSSR16.QSTESTCD.QIDSSR10" Name="QIDSSR10" DataType="text" Length="77" Origin="CRF" Comment="" def:Label="Concentration/decision making">

        <CodeListRef CodeListOID="QIDRL10" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR16_V2003.QSSCAT.QIDSSR16.QSTESTCD.QIDSSR11" Name="QIDSSR11" DataType="text" Length="66" Origin="CRF" Comment="" def:Label="View of myself">

        <CodeListRef CodeListOID="QIDRL11" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR16_V2003.QSSCAT.QIDSSR16.QSTESTCD.QIDSSR12" Name="QIDSSR12" DataType="text" Length="145" Origin="CRF" Comment="" def:Label="Thoughts of death or suicide">

        <CodeListRef CodeListOID="QIDRL12" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR16_V2003.QSSCAT.QIDSSR16.QSTESTCD.QIDSSR13" Name="QIDSSR13" DataType="text" Length="83" Origin="CRF" Comment="" def:Label="General interest">

        <CodeListRef CodeListOID="QIDRL13" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR16_V2003.QSSCAT.QIDSSR16.QSTESTCD.QIDSSR14" Name="QIDSSR14" DataType="text" Length="133" Origin="CRF" Comment="" def:Label="Energy level">

        <CodeListRef CodeListOID="QIDRL14" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.QIDSSR16_V2003.QSSCAT.QIDSSR16.QSTESTCD.QIDSSR15" Name="QIDSSR15" DataType="text" Length="92" Origin="CRF" Comment="" def:Label="Feeling slowed down">

        <CodeListRef CodeListOID="QIDRL15" />

        </ItemDef>

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        </ItemDef>

      - <ItemDef OID="QS.QSCAT.SCI_V2008.QSTESTCD.SCI06" Name="SCI06" DataType="text" Length="110" Origin="CRF" Comment="" def:Label="Specificity of Symptoms">

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        </ItemDef>

      - <ItemDef OID="QS.QSCAT.SCI_V2008.QSTESTCD.SCI07" Name="SCI07" DataType="text" Length="103" Origin="CRF" Comment="" def:Label="Ecologically Valid Symptoms">

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      - <ItemDef OID="QS.QSCAT.SCI_V2008.QSTESTCD.SCI08" Name="SCI08" DataType="text" Length="43" Origin="CRF" Comment="" def:Label="Assessable Symptoms">

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        </ItemDef>

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        </ItemDef>

      - <ItemDef OID="QS.QSCAT.SCI_V2008.QSTESTCD.SCI11" Name="SCI11" DataType="text" Length="66" Origin="CRF" Comment="" def:Label="Valid Patient (meets all SAFER clinical trial criteria)">

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        </ItemDef>

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        </ItemDef>

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        <ItemDef OID="QS.QSCAT.SCI_V2008.QSTESTCD.MASCORE2" Name="MASCORE2" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Reported Sadness" />

        <ItemDef OID="QS.QSCAT.SCI_V2008.QSTESTCD.MASCORE3" Name="MASCORE3" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Inner Tension" />

        <ItemDef OID="QS.QSCAT.SCI_V2008.QSTESTCD.MASCORE4" Name="MASCORE4" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Reduced Sleep" />

        <ItemDef OID="QS.QSCAT.SCI_V2008.QSTESTCD.MASCORE5" Name="MASCORE5" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Reduced Appetite" />

        <ItemDef OID="QS.QSCAT.SCI_V2008.QSTESTCD.MASCORE6" Name="MASCORE6" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Concentration Difficulties" />

        <ItemDef OID="QS.QSCAT.SCI_V2008.QSTESTCD.MASCORE7" Name="MASCORE7" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Lassitude" />

        <ItemDef OID="QS.QSCAT.SCI_V2008.QSTESTCD.MASCORE8" Name="MASCORE8" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Inability to Feel" />

        <ItemDef OID="QS.QSCAT.SCI_V2008.QSTESTCD.MASCORE9" Name="MASCORE9" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Pessimistic Thoughts" />

        <ItemDef OID="QS.QSCAT.SCI_V2008.QSTESTCD.MASCORE10" Name="MASCORE10" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Suicidal Thoughts" />

      - <ItemDef OID="QS.QSCAT.SCI_V2008.QSTESTCD.CTNIMGH" Name="CTNIMGH" DataType="text" Length="83" Origin="CRF" Comment="" def:Label="CTNI- MGH Antidepressant Treatment History Questionnaire (MGH ATRQ)">

        <CodeListRef CodeListOID="SCICD3" />

        </ItemDef>

        <ItemDef OID="QS.QSCAT.STEP.QSTESTCD.STEP01" Name="STEP01" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Health change" />

      - <ItemDef OID="QS.QSCAT.STEP.QSTESTCD.STEP02" Name="STEP02" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Importance of health change">

        <CodeListRef CodeListOID="STEPIC" />

        </ItemDef>

      - <ItemDef OID="QS.QSCAT.STEP.QSTESTCD.STEP03" Name="STEP03" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Positive/negative impact">

        <CodeListRef CodeListOID="STEPPN" />

        </ItemDef>

        <ItemDef OID="QS.QSCAT.STEP.QSTESTCD.STEP04" Name="STEP04" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Days from start to notice health change" />

        <ItemDef OID="QS.QSCAT.STEP.QSTESTCD.STEP05A" Name="STEP05A" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="How long health change lasts" />

        <ItemDef OID="QS.QSCAT.STEP.QSTESTCD.STEP05B" Name="STEP05B" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="On-going" />

      - <ItemDef OID="QS.QSCAT.STEP.QSTESTCD.STEP06" Name="STEP06" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Interest in continuing study medication if needed">

        <CodeListRef CodeListOID="STEPINT" />

        </ItemDef>

        <ItemDef OID="QS.QSCAT.STEP.QSTESTCD.STEP07" Name="STEP07" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Reasons for your response in continuing study medication" />

        <ItemDef OID="QS.QSCAT.STEP.QSTESTCD.STEP08" Name="STEP08" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Comments about the study medication that you would like to share" />

      - <ItemDef OID="SUPPAE.QNAM.AESHOSPP" Name="AESHOSPP" DataType="text" Length="25" Origin="CRF" Comment="" def:Label="PROLONGS HOSPITALIZATION">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

      - <ItemDef OID="SUPPAE.QNAM.AESHOSPR" Name="AESHOSPR" DataType="text" Length="25" Origin="CRF" Comment="" def:Label="REQUIRES HOSPITALIZATION">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

      - <ItemDef OID="SUPPAE.QNAM.AETRLPRC" Name="AETRLPRC" DataType="text" Length="25" Origin="CRF" Comment="" def:Label="RELATED TO TRIAL PROCEDURE">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

      - <ItemDef OID="SUPPAE.QNAM.AELLT" Name="AELLT" DataType="text" Length="100" Origin="Assigned" Comment="" def:Label="LOWER LEVEL TERM">

        <CodeListRef CodeListOID="MedDRA" />

        </ItemDef>

      - <ItemDef OID="SUPPAE.QNAM.AELLTCD" Name="AELLTCD" DataType="text" Length="25" Origin="Assigned" Comment="" def:Label="LOWER LEVEL TERM CODE">

        <CodeListRef CodeListOID="MedDRA" />

        </ItemDef>

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        <CodeListRef CodeListOID="MedDRA" />

        </ItemDef>

      - <ItemDef OID="SUPPAE.QNAM.AEHLGT" Name="AEHLGT" DataType="text" Length="100" Origin="Assigned" Comment="" def:Label="HIGH LEVEL GROUP TERM">

        <CodeListRef CodeListOID="MedDRA" />

        </ItemDef>

        <ItemDef OID="SUPPCM.QNAM.CMINDOTH" Name="CMINDOTH" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="OTHER INDICATION" />

      - <ItemDef OID="SUPPCM.QNAM.CMONGO" Name="CMONGO" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="TREATMENT ONGOING AT END OF STUDY">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

      - <ItemDef OID="SUPPCM.QNAM.CMPRIOR" Name="CMPRIOR" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="TREATMENT BEGAN PRIOR TO ENTRY">

        <CodeListRef CodeListOID="NY" />

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      - <ItemDef OID="SUPPCM.QNAM.CMTRTRVD" Name="CMTRTRVD" DataType="text" Length="1" Origin="CRF" Comment="" def:Label="TREATMENT MEDICATION">

        <CodeListRef CodeListOID="NY" />

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      - <ItemDef OID="SUPPCM.QNAM.CMPREVEP" Name="CMPREVEP" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="DEPRESSION EPISODE">

        <CodeListRef CodeListOID="CMPRV" />

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      - <ItemDef OID="SUPPCM.QNAM.CMCURTK" Name="CMCURTK" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="CURRENTLY TAKEN">

        <CodeListRef CodeListOID="NY" />

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      - <ItemDef OID="SUPPCM.QNAM.CMMINMAX" Name="CMMINMAX" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="MEDICATION DOSAGE">

        <CodeListRef CodeListOID="CMMINMA" />

        </ItemDef>

      - <ItemDef OID="SUPPCM.QNAM.CMAUGMT" Name="CMAUGMT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="AUGMENT EFFECT">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

      - <ItemDef OID="SUPPCM.QNAM.CMIMPROV" Name="CMIMPROV" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="IMPROVEMENT">

        <CodeListRef CodeListOID="CMIMPR" />

        </ItemDef>

      - <ItemDef OID="SUPPCM.QNAM.CMECT" Name="CMECT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="ECT TREATMENT">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

      - <ItemDef OID="SUPPCM.QNAM.CMTMS" Name="CMTMS" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="TMS TREATMENT">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

      - <ItemDef OID="SUPPCM.QNAM.CMLVL1" Name="CMLVL1" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Preferred ATC Text for ATC Level 1">

        <CodeListRef CodeListOID="WHODRUG" />

        </ItemDef>

      - <ItemDef OID="SUPPCM.QNAM.CMLVL1CD" Name="CMLVL1CD" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Preferred ATC Code for ATC Level 1">

        <CodeListRef CodeListOID="WHODRUG" />

        </ItemDef>

      - <ItemDef OID="SUPPCM.QNAM.CMLVL2" Name="CMLVL2" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Preferred ATC Text for ATC Level 2">

        <CodeListRef CodeListOID="WHODRUG" />

        </ItemDef>

      - <ItemDef OID="SUPPCM.QNAM.CMLVL2CD" Name="CMLVL2CD" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Preferred ATC Code for ATC Level 2">

        <CodeListRef CodeListOID="WHODRUG" />

        </ItemDef>

      - <ItemDef OID="SUPPCM.QNAM.CMLVL3" Name="CMLVL3" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Preferred ATC Text for ATC Level 3">

        <CodeListRef CodeListOID="WHODRUG" />

        </ItemDef>

      - <ItemDef OID="SUPPCM.QNAM.CMLVL3CD" Name="CMLVL3CD" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Preferred ATC Code for ATC Level 3">

        <CodeListRef CodeListOID="WHODRUG" />

        </ItemDef>

      - <ItemDef OID="SUPPCM.QNAM.CMLVL4" Name="CMLVL4" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Preferred ATC Text for ATC Level 4">

        <CodeListRef CodeListOID="WHODRUG" />

        </ItemDef>

      - <ItemDef OID="SUPPCM.QNAM.CMLVL4CD" Name="CMLVL4CD" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Preferred ATC Code for ATC Level 4">

        <CodeListRef CodeListOID="WHODRUG" />

        </ItemDef>

        <ItemDef OID="SUPPDM.QNAM.RACEA" Name="RACEA" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="ASIAN RACE" />

        <ItemDef OID="SUPPDM.QNAM.RACEAIAN" Name="RACEAIAN" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="AMERICAN INDIAN OR ALASKA NATIVE RACE" />

        <ItemDef OID="SUPPDM.QNAM.RACEBA" Name="RACEBA" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="BLACK OR AFRICAN AMERICAN RACE" />

        <ItemDef OID="SUPPDM.QNAM.RACENHOP" Name="RACENHOP" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="NATIVE HAWAIIAN/OTHER PAC. ISLANDER RACE" />

        <ItemDef OID="SUPPDM.QNAM.RACEOTH" Name="RACEOTH" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="RACE, OTHER" />

        <ItemDef OID="SUPPDM.QNAM.RACEOTHR" Name="RACEOTHR" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="OTHER RACE" />

        <ItemDef OID="SUPPDM.QNAM.RACEW" Name="RACEW" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="WHITE RACE" />

        <ItemDef OID="SUPPDS.QNAM.RANUM" Name="RANUM" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="RANDOMIZATION NUMBER" />

        <ItemDef OID="SUPPEG.QNAM.EGENDTC" Name="EGENDTC" DataType="text" Length="8" Origin="CRF" Comment="" def:Label="EG END DATE" />

        <ItemDef OID="SUPPEG.QNAM.EGCLSIG" Name="EGCLSIG" DataType="text" Length="8" Origin="CRF" Comment="" def:Label="CLINICAL SIGNIFICANCE" />

        <ItemDef OID="SUPPEX.QNAM.EXAMONT" Name="EXAMONT" DataType="text" Length="8" Origin="CRF" Comment="" def:Label="AMOUNT" />

        <ItemDef OID="SUPPEX.QNAM.EXAMONTU" Name="EXAMONTU" DataType="text" Length="8" Origin="CRF" Comment="" def:Label="AMOUNT UNITS" />

        <ItemDef OID="SUPPEX.QNAM.EXEDOST" Name="EXEDOST" DataType="text" Length="8" Origin="CRF" Comment="" def:Label="DOSE OTHERS" />

        <ItemDef OID="SUPPLB.QNAM.LBRESDTC" Name="LBRESDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="DATE/TIME OF REPORTING" />

        <ItemDef OID="SUPPLB.QNAM.LBCONF" Name="LBCONF" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="CONFIRMATORY TESTS RESULT" />

        <ItemDef OID="SUPPLB.QNAM.AUX1" Name="AUX1" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="AUXILIARY FIELD 1" />

        <ItemDef OID="SUPPLB.QNAM.AUX2" Name="AUX2" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="AUXILIARY FIELD 2" />

        <ItemDef OID="SUPPLB.QNAM.AUX3" Name="AUX3" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="AUXILIARY FIELD 3" />

        <ItemDef OID="SUPPLB.QNAM.AUX4" Name="AUX4" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="AUXILIARY FIELD 4" />

        <ItemDef OID="SUPPLB.QNAM.AUX5" Name="AUX5" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="AUXILIARY FIELD 5" />

        <ItemDef OID="SUPPLB.QNAM.AUX6" Name="AUX6" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="AUXILIARY FIELD 6" />

        <ItemDef OID="SUPPLB.QNAM.AUX7" Name="AUX7" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="AUXILIARY FIELD 7" />

        <ItemDef OID="SUPPLB.QNAM.AUX8" Name="AUX8" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="AUXILIARY FIELD 8" />

        <ItemDef OID="SUPPLB.QNAM.AUX9" Name="AUX9" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="AUXILIARY FIELD 9" />

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        <ItemDef OID="SUPPLB.QNAM.RRNGDESC" Name="RRNGDESC" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="DESCRIPTIVE REFERENCE RANGE" />

      - <ItemDef OID="SUPPMH.QNAM.MHONGO" Name="MHONGO" DataType="text" Length="1" Origin="CRF" Comment="" def:Label="ABNORMALITY ONGOING AT STUDY ENTRY">

        <CodeListRef CodeListOID="NY" />

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        <ItemDef OID="SUPPQS.QNAM.QSTIMEFR" Name="QSTIMEFR" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="TIME FRAME" />

        <ItemDef OID="SUPPQS.QNAM.QSMTSCRT" Name="QSMTSCRT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="MEETS CRITERIA" />

        <ItemDef OID="SUPPQS.QNAM.QSPRIDX" Name="QSPRIDX" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="PRIMARY DIAGNOSIS" />

        <ItemDef OID="SUPPSG.QNAM.SGPLNDTC" Name="SGPLNDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="PLANNED DATE/TIME OF SURGERY/PROCEDURE" />

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      - <ItemDef OID="SUPPSV.QNAM.SVSTAT" Name="SVSTAT" DataType="text" Length="30" Origin="CRF" Comment="" def:Label="SUBJECT CONTACT STATUS">

        <CodeListRef CodeListOID="ND" />

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        <ItemDef OID="SUPPSV.QNAM.SVREASND" Name="SVREASND" DataType="text" Length="30" Origin="CRF" Comment="" def:Label="SUBJECT VISIT REASON NOT DONE" />

        <ItemDef OID="SUPPVS.QNAM.VSENDTC" Name="VSENDTC" DataType="text" Length="8" Origin="CRF" Comment="" def:Label="VS END DATE" />

        <ItemDef OID="SUPPXZ.QNAM.XZREAS" Name="XZREAS" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="ADDITIONAL SAMPLE" />

        <ItemDef OID="VS.VSTESTCD.WEIGHT" Name="WEIGHT" DataType="float" Length="8" Origin="CRF" Comment="" def:Label="Weight" />

        <ItemDef OID="VS.VSTESTCD.HEIGHT" Name="HEIGHT" DataType="float" Length="8" Origin="CRF" Comment="" def:Label="Height" />

        <ItemDef OID="VS.VSTESTCD.HR" Name="HR" DataType="float" Length="8" Origin="CRF" Comment="" def:Label="Heart rate" />

        <ItemDef OID="VS.VSTESTCD.SYSBP" Name="SYSBP" DataType="float" Length="8" Origin="CRF" Comment="" def:Label="Systolic Blood Pressure" />

        <ItemDef OID="VS.VSTESTCD.DIABP" Name="DIABP" DataType="float" Length="8" Origin="CRF" Comment="" def:Label="Diastolic Blood Pressure" />

        <ItemDef OID="VS.VSTESTCD.BMI" Name="BMI" DataType="float" Length="8" Origin="CRF" Comment="" def:Label="Body Mass Index" />

        <ItemDef OID="VS.VSTESTCD.TEMP" Name="TEMP" DataType="float" Length="8" Origin="CRF" Comment="" def:Label="Temperature" />

        <ItemDef OID="VS.VSTESTCD.RESP" Name="RESP" DataType="float" Length="8" Origin="CRF" Comment="" def:Label="Respiratory rate" />

        <ItemDef OID="VS.VSTESTCD.VSABNOR" Name="VSABNOR" DataType="text" Length="30" Origin="CRF" Comment="" def:Label="Abnormalities observed in Vital Signs" />

        <ItemDef OID="VS.VSTESTCD.VSCLSIG" Name="VSCLSIG" DataType="text" Length="30" Origin="CRF" Comment="" def:Label="SIGNIFICANCE OF ABNORMALITY" />

        <ItemDef OID="VS.VSTESTCD.VSPULABR" Name="VSPULABR" DataType="text" Length="30" Origin="CRF" Comment="" def:Label="ABNORMALITIES OBSERVED IN PULSE OXIMETRY" />

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      - <ItemDef OID="XZ.XZCAT.BIOMARKER MAP" Name="BIOMARKER MAP" DataType="text" Length="200" Origin="CRF" Comment="J. Douglas Bremner, Carolyn Mazure, Frank W. Putnam, Journal of Traumatic Stress, Vol. 11, No. 1, 1998. Modified by author, 9/24/2008." def:Label="Biomarker - Multi-Analyte Panel">

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      - <ItemDef OID="XZ.XZCAT.BIOMARKER MTB" Name="BIOMARKER MTB" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Biomarker - Metabolomics">

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      - <ItemDef OID="XZ.XZCAT.DNA SAMPLE" Name="DNA SAMPLE" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Dna Sample">

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      - <ItemDef OID="XZ.XZCAT.DNA SAMPLE CONSENT MODIFICATION" Name="DNA SAMPLE CONSENT MODIFICATION" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Dna Sample Consent Modification">

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      - <ItemDef OID="XZ.XZCAT.DNA SAMPLE REPLACEMENT" Name="DNA SAMPLE REPLACEMENT" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Dna Sample Replacement">

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        </ItemDef>

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        </ItemDef>

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      - <def:leaf ID="Location.AE" xlink:href="AE.xpt">

        <def:title>AE.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

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        <ItemRef ItemOID="BE.BEENDY" OrderNumber="015" Mandatory="" Role="Timing" />

      - <def:leaf ID="Location.BE" xlink:href="BE.xpt">

        <def:title>BE.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

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      - <def:leaf ID="Location.CM" xlink:href="CM.xpt">

        <def:title>CM.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

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      - <def:leaf ID="Location.CO" xlink:href="CO.xpt">

        <def:title>CO.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="DM" Name="DM" SASDatasetName="DM" Repeating="No" IsReferenceData="No" Purpose="Tabulation" def:Label="Demographics" def:Structure="One record per subject" def:DomainKeys="STUDYID, USUBJID" def:Class="Special Purpose" def:ArchiveLocationID="Location.DM">

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        <ItemRef ItemOID="DM.SEX" OrderNumber="013" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="DM.RACE" OrderNumber="014" Mandatory="" Role="Qualifier" />

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      - <def:leaf ID="Location.DM" xlink:href="DM.xpt">

        <def:title>DM.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

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      - <def:leaf ID="Location.DS" xlink:href="DS.xpt">

        <def:title>DS.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

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      - <def:leaf ID="Location.DV" xlink:href="DV.xpt">

        <def:title>DV.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

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        <ItemRef ItemOID="EG.EGSTRESC" OrderNumber="012" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="EG.EGSTRESN" OrderNumber="013" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="EG.EGSTRESU" OrderNumber="014" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="EG.EGBLFL" OrderNumber="015" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="EG.EGEVAL" OrderNumber="016" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="EG.VISITNUM" OrderNumber="017" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="EG.VISIT" OrderNumber="018" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="EG.EPOCH" OrderNumber="019" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="EG.EGDTC" OrderNumber="020" Mandatory="" Role="Timing" />

      - <def:leaf ID="Location.EG" xlink:href="EG.xpt">

        <def:title>EG.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

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        <ItemRef ItemOID="EX.DOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

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        <ItemRef ItemOID="EX.EXSEQ" OrderNumber="004" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="EX.EXSPID" OrderNumber="005" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="EX.EXTRT" OrderNumber="006" Mandatory="" Role="Topic" />

        <ItemRef ItemOID="EX.EXDOSE" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="EX.EXDOSU" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="EX.EXDOSFRM" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="EX.VISITNUM" OrderNumber="010" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="EX.VISIT" OrderNumber="011" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="EX.EPOCH" OrderNumber="012" Mandatory="" Role="Timing" />

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        <ItemRef ItemOID="EX.EXENDTC" OrderNumber="014" Mandatory="" Role="Timing" />

      - <def:leaf ID="Location.EX" xlink:href="EX.xpt">

        <def:title>EX.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

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        <ItemRef ItemOID="HO.DOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="HO.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="HO.HOSEQ" OrderNumber="004" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="HO.HOSPID" OrderNumber="005" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="HO.HOTERM" OrderNumber="006" Mandatory="" Role="Topic" />

        <ItemRef ItemOID="HO.VISITNUM" OrderNumber="007" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="HO.VISIT" OrderNumber="008" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="HO.VISITDY" OrderNumber="009" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="HO.EPOCH" OrderNumber="010" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="HO.HOSTDTC" OrderNumber="011" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="HO.HODY" OrderNumber="012" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="HO.HOSTDY" OrderNumber="013" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="HO.HOENDY" OrderNumber="014" Mandatory="" Role="Timing" />

      - <def:leaf ID="Location.HO" xlink:href="HO.xpt">

        <def:title>HO.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

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        <ItemRef ItemOID="IE.DOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="IE.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="IE.IESEQ" OrderNumber="004" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="IE.IESPID" OrderNumber="005" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="IE.IETESTCD" OrderNumber="006" Mandatory="" Role="Topic" />

        <ItemRef ItemOID="IE.IETEST" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="IE.IECAT" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="IE.IEORRES" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="IE.IESTRESC" OrderNumber="010" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="IE.VISITNUM" OrderNumber="011" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="IE.VISIT" OrderNumber="012" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="IE.IEDTC" OrderNumber="013" Mandatory="" Role="Timing" />

      - <def:leaf ID="Location.IE" xlink:href="IE.xpt">

        <def:title>IE.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="LB" Name="LB" SASDatasetName="LB" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Laboratory Test Results" def:Structure="One record per lab test per method per specimen per category per timepoint per visit per subject" def:DomainKeys="STUDYID, USUBJID, LBTESTCD, LBMETHOD, LBSPEC, LBCAT, VISITNUM, LBTPTNUM" def:Class="Findings" def:ArchiveLocationID="Location.LB">

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        <ItemRef ItemOID="LB.DOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="LB.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="LB.LBSEQ" OrderNumber="004" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="LB.LBGRPID" OrderNumber="005" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="LB.LBREFID" OrderNumber="006" Mandatory="" Role="Identifier" />

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        <ItemRef ItemOID="LB.LBSCAT" OrderNumber="011" Mandatory="" Role="Qualifier" />

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        <ItemRef ItemOID="LB.LBORRESU" OrderNumber="013" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="LB.LBORNRLO" OrderNumber="014" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="LB.LBORNRHI" OrderNumber="015" Mandatory="" Role="Qualifier" />

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        <ItemRef ItemOID="LB.LBSTNRC" OrderNumber="017" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="LB.LBSTRESN" OrderNumber="018" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="LB.LBSTRESU" OrderNumber="019" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="LB.LBSTNRLO" OrderNumber="020" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="LB.LBSTNRHI" OrderNumber="021" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="LB.LBNRIND" OrderNumber="022" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="LB.LBSTAT" OrderNumber="023" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="LB.LBREASND" OrderNumber="024" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="LB.LBNAM" OrderNumber="025" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="LB.LBSPEC" OrderNumber="026" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="LB.LBSPCCND" OrderNumber="027" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="LB.LBMETHOD" OrderNumber="028" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="LB.LBBLFL" OrderNumber="029" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="LB.LBFAST" OrderNumber="030" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="LB.VISITNUM" OrderNumber="031" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="LB.VISIT" OrderNumber="032" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="LB.VISITDY" OrderNumber="033" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="LB.EPOCH" OrderNumber="034" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="LB.LBDTC" OrderNumber="035" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="LB.LBENDTC" OrderNumber="036" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="LB.LBENDY" OrderNumber="037" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="LB.LBDY" OrderNumber="038" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="LB.LBTPT" OrderNumber="039" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="LB.LBTPTNUM" OrderNumber="040" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="LB.LBELTM" OrderNumber="041" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="LB.LBTPTREF" OrderNumber="042" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="LB.LBTOX" OrderNumber="043" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="LB.LBTOXGR" OrderNumber="044" Mandatory="" Role="Timing" />

      - <def:leaf ID="Location.LB" xlink:href="LB.xpt">

        <def:title>LB.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="MH" Name="MH" SASDatasetName="MH" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Medical History" def:Structure="One record per subject" def:DomainKeys="STUDYID, USUBJID" def:Class="Events" def:ArchiveLocationID="Location.MH">

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        <ItemRef ItemOID="MH.DOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="MH.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="MH.MHSEQ" OrderNumber="004" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="MH.MHSPID" OrderNumber="005" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="MH.MHTERM" OrderNumber="006" Mandatory="" Role="Topic" />

        <ItemRef ItemOID="MH.MHCAT" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="MH.MHSCAT" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="MH.VISITNUM" OrderNumber="009" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="MH.VISIT" OrderNumber="010" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="MH.EPOCH" OrderNumber="011" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="MH.MHDTC" OrderNumber="012" Mandatory="" Role="Timing" />

      - <def:leaf ID="Location.MH" xlink:href="MH.xpt">

        <def:title>MH.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="PC" Name="PC" SASDatasetName="PC" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Pharmacokinetic Concentrations" def:Structure="One record per test per specimen per timepoint per visit per subject" def:DomainKeys="STUDYID, USUBJID, PCTESTCD, PCSPEC, VISITNUM, PCTPTNUM" def:Class="Findings" def:ArchiveLocationID="Location.PC">

        <ItemRef ItemOID="PC.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="PC.DOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="PC.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="PC.PCSEQ" OrderNumber="004" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="PC.PCSPID" OrderNumber="005" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="PC.PCTESTCD" OrderNumber="006" Mandatory="" Role="Topic" />

        <ItemRef ItemOID="PC.PCTEST" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PC.PCCAT" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PC.PCORRES" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PC.PCORRESU" OrderNumber="010" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PC.PCSTRESC" OrderNumber="011" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PC.PCSTRESN" OrderNumber="012" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PC.PCSTRESU" OrderNumber="013" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PC.PCSTAT" OrderNumber="014" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PC.PCREASND" OrderNumber="015" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PC.PCNAM" OrderNumber="016" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PC.PCSPEC" OrderNumber="017" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PC.VISITNUM" OrderNumber="018" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="PC.VISIT" OrderNumber="019" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="PC.PCDTC" OrderNumber="020" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="PC.PCTPT" OrderNumber="021" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="PC.PCTPTNUM" OrderNumber="022" Mandatory="" Role="Timing" />

      - <def:leaf ID="Location.PC" xlink:href="PC.xpt">

        <def:title>PC.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="PE" Name="PE" SASDatasetName="PE" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Physical Examinations" def:Structure="One record per body system or abnormality per visit per subject" def:DomainKeys="STUDYID, USUBJID, PETESTCD, VISITNUM" def:Class="Findings" def:ArchiveLocationID="Location.PE">

        <ItemRef ItemOID="PE.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="PE.DOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="PE.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="PE.PESEQ" OrderNumber="004" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="PE.PEGRPID" OrderNumber="005" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="PE.PESPID" OrderNumber="006" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="PE.PETESTCD" OrderNumber="007" Mandatory="" Role="Topic" />

        <ItemRef ItemOID="PE.PETEST" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PE.PECAT" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PE.PEORRES" OrderNumber="010" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PE.PESTRESC" OrderNumber="011" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PE.PESTRESN" OrderNumber="012" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PE.PESTRESU" OrderNumber="013" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PE.PESTAT" OrderNumber="014" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PE.PEBLFL" OrderNumber="015" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="PE.VISITNUM" OrderNumber="016" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="PE.VISIT" OrderNumber="017" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="PE.EPOCH" OrderNumber="018" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="PE.PEDTC" OrderNumber="019" Mandatory="" Role="Timing" />

      - <def:leaf ID="Location.PE" xlink:href="PE.xpt">

        <def:title>PE.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="QS" Name="QS" SASDatasetName="QS" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Questionnaires" def:Structure="One record per question per Questionnaire per visit per subject" def:DomainKeys="STUDYID, USUBJID, QSTESTCD, QSCAT, VISITNUM" def:Class="Findings" def:ArchiveLocationID="Location.QS">

        <ItemRef ItemOID="QS.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="QS.DOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="QS.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="QS.QSSEQ" OrderNumber="004" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="QS.QSSPID" OrderNumber="005" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="QS.QSTESTCD" OrderNumber="006" Mandatory="" Role="Topic" />

        <ItemRef ItemOID="QS.QSTEST" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="QS.QSCAT" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="QS.QSSCAT" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="QS.QSORRES" OrderNumber="010" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="QS.QSSTRESC" OrderNumber="011" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="QS.QSSTRESN" OrderNumber="012" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="QS.QSBLFL" OrderNumber="013" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="QS.VISITNUM" OrderNumber="014" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="QS.VISIT" OrderNumber="015" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="QS.EPOCH" OrderNumber="016" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="QS.QSDTC" OrderNumber="017" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="QS.QSTPT" OrderNumber="018" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="QS.QSTPTNUM" OrderNumber="019" Mandatory="" Role="Timing" />

      - <def:leaf ID="Location.QS" xlink:href="QS.xpt">

        <def:title>QS.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="RA" Name="RA" SASDatasetName="RA" Repeating="Yes" IsReferenceData="No" Purpose="Not Submit" def:Label="Randomization" def:Structure="One record per randomization per subject" def:DomainKeys="STUDYID, USUBJID, EPOCH" def:Class="Operational" def:ArchiveLocationID="Location.RA">

        <ItemRef ItemOID="RA.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="RA.DOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="RA.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="RA.SUBJID" OrderNumber="004" Mandatory="" Role="Topic" />

        <ItemRef ItemOID="RA.SITEID" OrderNumber="005" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="RA.RASEQ" OrderNumber="006" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="RA.RASPID" OrderNumber="007" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="RA.ARMCD" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="RA.ARM" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="RA.RANUM" OrderNumber="010" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="RA.COHORT" OrderNumber="011" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="RA.RAORIG" OrderNumber="012" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="RA.RASTDTC" OrderNumber="013" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="RA.VISITNUM" OrderNumber="014" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="RA.VISIT" OrderNumber="015" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="RA.EPOCH" OrderNumber="016" Mandatory="" Role="Timing" />

      - <def:leaf ID="Location.RA" xlink:href="RA.xpt">

        <def:title>RA.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="RELREC" Name="RELREC" SASDatasetName="RELREC" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Related Records" def:Structure="One record per record or domain relationship" def:DomainKeys="STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELID" def:Class="Relationships" def:ArchiveLocationID="Location.RELREC">

        <ItemRef ItemOID="RELREC.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="RELREC.RDOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="RELREC.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="RELREC.IDVAR" OrderNumber="004" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="RELREC.IDVARVAL" OrderNumber="005" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="RELREC.RELTYPE" OrderNumber="006" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="RELREC.RELID" OrderNumber="007" Mandatory="" Role="Qualifier" />

      - <def:leaf ID="Location.RELREC" xlink:href="RELREC.xpt">

        <def:title>RELREC.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="SG" Name="SG" SASDatasetName="SG" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Surgery" def:Structure="One record per surgery per subject" def:DomainKeys="STUDYID, USUBJID, SGTRT" def:Class="Interventions" def:ArchiveLocationID="Location.SG">

        <ItemRef ItemOID="SG.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SG.DOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SG.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SG.SGSEQ" OrderNumber="004" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SG.SGSPID" OrderNumber="005" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SG.SGTRT" OrderNumber="006" Mandatory="" Role="Topic" />

        <ItemRef ItemOID="SG.SGDECOD" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SG.SGCAT" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SG.SGSCAT" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SG.SGINDC" OrderNumber="010" Mandatory="" Role="Qualifier" />

      - <def:leaf ID="Location.SG" xlink:href="SG.xpt">

        <def:title>SG.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="SUPPAE" Name="SUPPAE" SASDatasetName="SUPPAE" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Supplemental Qualifiers for AE" def:Structure="One record per IDVAR, IDVARVAL, QNAM per subject" def:DomainKeys="STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM" def:Class="Relationships" def:ArchiveLocationID="Location.SUPPAE">

        <ItemRef ItemOID="SUPPAE.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPAE.RDOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPAE.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPAE.IDVAR" OrderNumber="004" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPAE.IDVARVAL" OrderNumber="005" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPAE.QNAM" OrderNumber="006" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPAE.QLABEL" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPAE.QVAL" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPAE.QORIG" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPAE.QEVAL" OrderNumber="010" Mandatory="" Role="Qualifier" />

      - <def:leaf ID="Location.SUPPAE" xlink:href="SUPPAE.xpt">

        <def:title>SUPPAE.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="SUPPCM" Name="SUPPCM" SASDatasetName="SUPPCM" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Supplemental Qualifiers for CM" def:Structure="One record per IDVAR, IDVARVAL, QNAM per subject" def:DomainKeys="STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM" def:Class="Relationships" def:ArchiveLocationID="Location.SUPPCM">

        <ItemRef ItemOID="SUPPCM.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPCM.RDOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPCM.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPCM.IDVAR" OrderNumber="004" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPCM.IDVARVAL" OrderNumber="005" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPCM.QNAM" OrderNumber="006" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPCM.QLABEL" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPCM.QVAL" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPCM.QORIG" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPCM.QEVAL" OrderNumber="010" Mandatory="" Role="Qualifier" />

      - <def:leaf ID="Location.SUPPCM" xlink:href="SUPPCM.xpt">

        <def:title>SUPPCM.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="SUPPDM" Name="SUPPDM" SASDatasetName="SUPPDM" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Supplemental Qualifiers for DM" def:Structure="One record per IDVAR, IDVARVAL, QNAM per subject" def:DomainKeys="STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM" def:Class="Relationships" def:ArchiveLocationID="Location.SUPPDM">

        <ItemRef ItemOID="SUPPDM.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPDM.RDOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPDM.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPDM.IDVAR" OrderNumber="004" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPDM.IDVARVAL" OrderNumber="005" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPDM.QNAM" OrderNumber="006" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPDM.QLABEL" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPDM.QVAL" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPDM.QORIG" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPDM.QEVAL" OrderNumber="010" Mandatory="" Role="Qualifier" />

      - <def:leaf ID="Location.SUPPDM" xlink:href="SUPPDM.xpt">

        <def:title>SUPPDM.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="SUPPDS" Name="SUPPDS" SASDatasetName="SUPPDS" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Supplemental Qualifiers for DS" def:Structure="One record per IDVAR, IDVARVAL, QNAM per subject" def:DomainKeys="STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM" def:Class="Relationships" def:ArchiveLocationID="Location.SUPPDS">

        <ItemRef ItemOID="SUPPDS.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPDS.RDOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPDS.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPDS.IDVAR" OrderNumber="004" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPDS.IDVARVAL" OrderNumber="005" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPDS.QNAM" OrderNumber="006" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPDS.QLABEL" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPDS.QVAL" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPDS.QORIG" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPDS.QEVAL" OrderNumber="010" Mandatory="" Role="Qualifier" />

      - <def:leaf ID="Location.SUPPDS" xlink:href="SUPPDS.xpt">

        <def:title>SUPPDS.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="SUPPEG" Name="SUPPEG" SASDatasetName="SUPPEG" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Supplemental Qualifiers for EG" def:Structure="One record per IDVAR, IDVARVAL, QNAM per subject" def:DomainKeys="STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM" def:Class="Relationships" def:ArchiveLocationID="Location.SUPPEG">

        <ItemRef ItemOID="SUPPEG.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPEG.RDOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPEG.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPEG.IDVAR" OrderNumber="004" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPEG.IDVARVAL" OrderNumber="005" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPEG.QNAM" OrderNumber="006" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPEG.QLABEL" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPEG.QVAL" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPEG.QORIG" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPEG.QEVAL" OrderNumber="010" Mandatory="" Role="Qualifier" />

      - <def:leaf ID="Location.SUPPEG" xlink:href="SUPPEG.xpt">

        <def:title>SUPPEG.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="SUPPEX" Name="SUPPEX" SASDatasetName="SUPPEX" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Supplemental Qualifiers for EX" def:Structure="One record per IDVAR, IDVARVAL, QNAM per subject" def:DomainKeys="STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM" def:Class="Relationships" def:ArchiveLocationID="Location.SUPPEX">

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        <ItemRef ItemOID="SUPPEX.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPEX.IDVAR" OrderNumber="004" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPEX.IDVARVAL" OrderNumber="005" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPEX.QNAM" OrderNumber="006" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPEX.QLABEL" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPEX.QVAL" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPEX.QORIG" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPEX.QEVAL" OrderNumber="010" Mandatory="" Role="Qualifier" />

      - <def:leaf ID="Location.SUPPEX" xlink:href="SUPPEX.xpt">

        <def:title>SUPPEX.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="SUPPLB" Name="SUPPLB" SASDatasetName="SUPPLB" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Supplemental Qualifiers for LB" def:Structure="One record per IDVAR, IDVARVAL, QNAM per subject" def:DomainKeys="STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM" def:Class="Relationships" def:ArchiveLocationID="Location.SUPPLB">

        <ItemRef ItemOID="SUPPLB.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPLB.RDOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPLB.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPLB.IDVAR" OrderNumber="004" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPLB.IDVARVAL" OrderNumber="005" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPLB.QNAM" OrderNumber="006" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPLB.QLABEL" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPLB.QVAL" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPLB.QORIG" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPLB.QEVAL" OrderNumber="010" Mandatory="" Role="Qualifier" />

      - <def:leaf ID="Location.SUPPLB" xlink:href="SUPPLB.xpt">

        <def:title>SUPPLB.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="SUPPMH" Name="SUPPMH" SASDatasetName="SUPPMH" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Supplemental Qualifiers for MH" def:Structure="One record per IDVAR, IDVARVAL, QNAM per subject" def:DomainKeys="STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM" def:Class="Relationships" def:ArchiveLocationID="Location.SUPPMH">

        <ItemRef ItemOID="SUPPMH.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPMH.RDOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPMH.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPMH.IDVAR" OrderNumber="004" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPMH.IDVARVAL" OrderNumber="005" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPMH.QNAM" OrderNumber="006" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPMH.QLABEL" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPMH.QVAL" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPMH.QORIG" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPMH.QEVAL" OrderNumber="010" Mandatory="" Role="Qualifier" />

      - <def:leaf ID="Location.SUPPMH" xlink:href="SUPPMH.xpt">

        <def:title>SUPPMH.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="SUPPQS" Name="SUPPQS" SASDatasetName="SUPPQS" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Supplemental Qualifiers for QS" def:Structure="One record per IDVAR, IDVARVAL, QNAM per subject" def:DomainKeys="STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM" def:Class="Relationships" def:ArchiveLocationID="Location.SUPPQS">

        <ItemRef ItemOID="SUPPQS.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPQS.RDOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPQS.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPQS.IDVAR" OrderNumber="004" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPQS.IDVARVAL" OrderNumber="005" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPQS.QNAM" OrderNumber="006" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPQS.QLABEL" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPQS.QVAL" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPQS.QORIG" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPQS.QEVAL" OrderNumber="010" Mandatory="" Role="Qualifier" />

      - <def:leaf ID="Location.SUPPQS" xlink:href="SUPPQS.xpt">

        <def:title>SUPPQS.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="SUPPSG" Name="SUPPSG" SASDatasetName="SUPPSG" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Supplemental Qualifiers for SG" def:Structure="One record per IDVAR, IDVARVAL, QNAM per subject" def:DomainKeys="STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM" def:Class="Relationships" def:ArchiveLocationID="Location.SUPPSG">

        <ItemRef ItemOID="SUPPSG.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPSG.RDOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPSG.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPSG.IDVAR" OrderNumber="004" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPSG.IDVARVAL" OrderNumber="005" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPSG.QNAM" OrderNumber="006" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPSG.QLABEL" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPSG.QVAL" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPSG.QORIG" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPSG.QEVAL" OrderNumber="010" Mandatory="" Role="Qualifier" />

      - <def:leaf ID="Location.SUPPSG" xlink:href="SUPPSG.xpt">

        <def:title>SUPPSG.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="SUPPSV" Name="SUPPSV" SASDatasetName="SUPPSV" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Supplemental Qualifiers for SV" def:Structure="One record per IDVAR, IDVARVAL, QNAM per subject" def:DomainKeys="STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM" def:Class="Relationships" def:ArchiveLocationID="Location.SUPPSV">

        <ItemRef ItemOID="SUPPSV.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPSV.RDOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPSV.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPSV.IDVAR" OrderNumber="004" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPSV.IDVARVAL" OrderNumber="005" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPSV.QNAM" OrderNumber="006" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPSV.QLABEL" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPSV.QVAL" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPSV.QORIG" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPSV.QEVAL" OrderNumber="010" Mandatory="" Role="Qualifier" />

      - <def:leaf ID="Location.SUPPSV" xlink:href="SUPPSV.xpt">

        <def:title>SUPPSV.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="SUPPVS" Name="SUPPVS" SASDatasetName="SUPPVS" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Supplemental Qualifiers for VS" def:Structure="One record per IDVAR, IDVARVAL, QNAM per subject" def:DomainKeys="STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM" def:Class="Relationships" def:ArchiveLocationID="Location.SUPPVS">

        <ItemRef ItemOID="SUPPVS.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPVS.RDOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPVS.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPVS.IDVAR" OrderNumber="004" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPVS.IDVARVAL" OrderNumber="005" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPVS.QNAM" OrderNumber="006" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPVS.QLABEL" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPVS.QVAL" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPVS.QORIG" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPVS.QEVAL" OrderNumber="010" Mandatory="" Role="Qualifier" />

      - <def:leaf ID="Location.SUPPVS" xlink:href="SUPPVS.xpt">

        <def:title>SUPPVS.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="SUPPXZ" Name="SUPPXZ" SASDatasetName="SUPPXZ" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Supplemental Qualifiers for XZ" def:Structure="One record per IDVAR, IDVARVAL, QNAM per subject" def:DomainKeys="STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM" def:Class="Relationships" def:ArchiveLocationID="Location.SUPPXZ">

        <ItemRef ItemOID="SUPPXZ.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPXZ.RDOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPXZ.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SUPPXZ.IDVAR" OrderNumber="004" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPXZ.IDVARVAL" OrderNumber="005" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPXZ.QNAM" OrderNumber="006" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPXZ.QLABEL" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPXZ.QVAL" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPXZ.QORIG" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SUPPXZ.QEVAL" OrderNumber="010" Mandatory="" Role="Qualifier" />

      - <def:leaf ID="Location.SUPPXZ" xlink:href="SUPPXZ.xpt">

        <def:title>SUPPXZ.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="SV" Name="SV" SASDatasetName="SV" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Subject Visits" def:Structure="One record per subject per actual visit" def:DomainKeys="STUDYID, USUBJID, VISITNUM" def:Class="Special Purpose" def:ArchiveLocationID="Location.SV">

        <ItemRef ItemOID="SV.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SV.DOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SV.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="SV.VISITNUM" OrderNumber="004" Mandatory="" Role="Topic" />

        <ItemRef ItemOID="SV.VISIT" OrderNumber="005" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="SV.SVSTDTC" OrderNumber="006" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="SV.SVENDTC" OrderNumber="007" Mandatory="" Role="Timing" />

      - <def:leaf ID="Location.SV" xlink:href="SV.xpt">

        <def:title>SV.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="TI" Name="TI" SASDatasetName="TI" Repeating="Yes" IsReferenceData="Yes" Purpose="Tabulation" def:Label="Trial Inclusion/Exclusion Criteria" def:Structure="One record per I/E criterion" def:DomainKeys="STUDYID, IETESTCD" def:Class="Trial Design" def:ArchiveLocationID="Location.TI">

        <ItemRef ItemOID="TI.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="TI.DOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="TI.IETESTCD" OrderNumber="003" Mandatory="" Role="Topic" />

        <ItemRef ItemOID="TI.IETEST" OrderNumber="004" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="TI.IECAT" OrderNumber="005" Mandatory="" Role="Qualifier" />

      - <def:leaf ID="Location.TI" xlink:href="TI.xpt">

        <def:title>TI.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="VS" Name="VS" SASDatasetName="VS" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Vital Signs" def:Structure="One record per vital sign measurement per visit per subject" def:DomainKeys="STUDYID, USUBJID, VSTESTCD, VISITNUM" def:Class="Findings" def:ArchiveLocationID="Location.VS">

        <ItemRef ItemOID="VS.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="VS.DOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="VS.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="VS.VSSEQ" OrderNumber="004" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="VS.VSSPID" OrderNumber="005" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="VS.VSTESTCD" OrderNumber="006" Mandatory="" Role="Topic" />

        <ItemRef ItemOID="VS.VSTEST" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="VS.VSPOS" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="VS.VSORRES" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="VS.VSORRESU" OrderNumber="010" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="VS.VSSTRESC" OrderNumber="011" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="VS.VSSTRESN" OrderNumber="012" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="VS.VSSTRESU" OrderNumber="013" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="VS.VSBLFL" OrderNumber="014" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="VS.VISITNUM" OrderNumber="015" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="VS.VISIT" OrderNumber="016" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="VS.EPOCH" OrderNumber="017" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="VS.VSDTC" OrderNumber="018" Mandatory="" Role="Timing" />

      - <def:leaf ID="Location.VS" xlink:href="VS.xpt">

        <def:title>VS.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

      - <ItemGroupDef OID="XZ" Name="XZ" SASDatasetName="XZ" Repeating="Yes" IsReferenceData="No" Purpose="Tabulation" def:Label="Sample Handling" def:Structure="One record per test per category per subject" def:DomainKeys="STUDYID, USUBJID, XZTESTCD, XZCAT" def:Class="Findings" def:ArchiveLocationID="Location.XZ">

        <ItemRef ItemOID="XZ.STUDYID" OrderNumber="001" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="XZ.DOMAIN" OrderNumber="002" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="XZ.USUBJID" OrderNumber="003" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="XZ.XZSEQ" OrderNumber="004" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="XZ.XZSPID" OrderNumber="005" Mandatory="" Role="Identifier" />

        <ItemRef ItemOID="XZ.XZTESTCD" OrderNumber="006" Mandatory="" Role="Topic" />

        <ItemRef ItemOID="XZ.XZTEST" OrderNumber="007" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="XZ.XZCAT" OrderNumber="008" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="XZ.XZORRES" OrderNumber="009" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="XZ.XZORRESU" OrderNumber="010" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="XZ.XZSTRESC" OrderNumber="011" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="XZ.XZSTRESN" OrderNumber="012" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="XZ.XZSTRESU" OrderNumber="013" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="XZ.XZBLFL" OrderNumber="014" Mandatory="" Role="Qualifier" />

        <ItemRef ItemOID="XZ.VISITNUM" OrderNumber="015" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="XZ.VISIT" OrderNumber="016" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="XZ.EPOCH" OrderNumber="017" Mandatory="" Role="Timing" />

        <ItemRef ItemOID="XZ.XZDTC" OrderNumber="018" Mandatory="" Role="Timing" />

      - <def:leaf ID="Location.XZ" xlink:href="XZ.xpt">

        <def:title>XZ.xpt</def:title>

        </def:leaf>

        </ItemGroupDef>

        <ItemDef OID="AE.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="AE.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="AE.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="AE.AESEQ" Name="AESEQ" DataType="integer" Length="8" Origin="Derived" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="AE.AESPID" Name="AESPID" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Sponsor-Defined Identifier" />

        <ItemDef OID="AE.AETERM" Name="AETERM" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Reported Term for the Adverse Event" />

        <ItemDef OID="AE.AEMODIFY" Name="AEMODIFY" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Modified Reported Term" />

      - <ItemDef OID="AE.AEDECOD" Name="AEDECOD" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Dictionary-Derived Term">

        <CodeListRef CodeListOID="MEDDRA" />

        </ItemDef>

      - <ItemDef OID="AE.AEBODSYS" Name="AEBODSYS" DataType="text" Length="100" Origin="Assigned" Comment="" def:Label="Body System or Organ Class">

        <CodeListRef CodeListOID="MEDDRA" />

        </ItemDef>

      - <ItemDef OID="AE.AESEV" Name="AESEV" DataType="text" Length="8" Origin="CRF" Comment="" def:Label="Severity/Intensity">

        <CodeListRef CodeListOID="AESEV" />

        </ItemDef>

      - <ItemDef OID="AE.AESER" Name="AESER" DataType="text" Length="1" Origin="CRF" Comment="" def:Label="Serious Event">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

      - <ItemDef OID="AE.AEACN" Name="AEACN" DataType="text" Length="25" Origin="CRF" Comment="" def:Label="Action Taken with Study Treatment">

        <CodeListRef CodeListOID="ACN" />

        </ItemDef>

      - <ItemDef OID="AE.AEREL" Name="AEREL" DataType="text" Length="16" Origin="CRF" Comment="" def:Label="Causality">

        <CodeListRef CodeListOID="REL" />

        </ItemDef>

      - <ItemDef OID="AE.AEOUT" Name="AEOUT" DataType="text" Length="35" Origin="CRF" Comment="" def:Label="Outcome of Adverse Event">

        <CodeListRef CodeListOID="OUT" />

        </ItemDef>

      - <ItemDef OID="AE.AESCONG" Name="AESCONG" DataType="text" Length="1" Origin="CRF" Comment="" def:Label="Congenital Anomaly or Birth Defect">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

      - <ItemDef OID="AE.AESDISAB" Name="AESDISAB" DataType="text" Length="1" Origin="CRF" Comment="" def:Label="Persist or Signif Disability/Incapacity">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

      - <ItemDef OID="AE.AESDTH" Name="AESDTH" DataType="text" Length="1" Origin="CRF" Comment="" def:Label="Results in Death">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

      - <ItemDef OID="AE.AESHOSP" Name="AESHOSP" DataType="text" Length="1" Origin="Derived" Comment="Derived from AESHOSPP and AESHOSPR" def:Label="Requires or Prolongs Hospitalization">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

      - <ItemDef OID="AE.AESLIFE" Name="AESLIFE" DataType="text" Length="1" Origin="CRF" Comment="" def:Label="Is Life Threatening">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

      - <ItemDef OID="AE.AESMIE" Name="AESMIE" DataType="text" Length="1" Origin="CRF" Comment="" def:Label="Other Medically Important Serious Event">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

      - <ItemDef OID="AE.AECONTRT" Name="AECONTRT" DataType="text" Length="1" Origin="CRF" Comment="" def:Label="Concomitant or Additional Trtmnt Given">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

        <ItemDef OID="AE.AESTDTC" Name="AESTDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Start Date/Time of Adverse Event" />

        <ItemDef OID="AE.AEENDTC" Name="AEENDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="End Date/Time of Adverse Event" />

        <ItemDef OID="AE.AESTDY" Name="AESTDY" DataType="integer" Length="8" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Study Day of Start of Adverse Event" />

        <ItemDef OID="AE.AEENDY" Name="AEENDY" DataType="integer" Length="8" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Study Day of End of Adverse Event" />

        <ItemDef OID="BE.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="BE.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="BE.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="BE.BESEQ" Name="BESEQ" DataType="integer" Length="8" Origin="Derived" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="BE.BESPID" Name="BESPID" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Sponsor-Defined Identifier" />

        <ItemDef OID="BE.BETERM" Name="BETERM" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Reported Term for the Bio-Specimen Event" />

        <ItemDef OID="BE.BEDECOD" Name="BEDECOD" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Dictionary-Derived Term" />

        <ItemDef OID="BE.BECAT" Name="BECAT" DataType="text" Length="40" Origin="CRF" Comment="" def:Label="Category for Bio-Specimen Event" />

        <ItemDef OID="BE.BEBODSYS" Name="BEBODSYS" DataType="text" Length="100" Origin="Assigned" Comment="" def:Label="Body System or Organ Class" />

        <ItemDef OID="BE.VISITNUM" Name="VISITNUM" DataType="float" Length="8" SignificantDigits="3" Origin="Assigned" Comment="" def:Label="Visit Number" />

        <ItemDef OID="BE.VISIT" Name="VISIT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Visit Name" />

        <ItemDef OID="BE.BEDTC" Name="BEDTC" DataType="text" Length="19" Origin="Assigned" Comment="" def:Label="Date/Time of Specimen Collection" />

        <ItemDef OID="BE.BESTDTC" Name="BESTDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Start Date/Time of Bio-Specimen Event" />

        <ItemDef OID="BE.BESTDY" Name="BESTDY" DataType="integer" Length="8" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Study Day of Start of Bio-Specimen Event" />

        <ItemDef OID="BE.BEENDY" Name="BEENDY" DataType="integer" Length="8" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Study Day of End of Bio-Specimen Event" />

        <ItemDef OID="CM.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="CM.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="CM.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="CM.CMSEQ" Name="CMSEQ" DataType="integer" Length="8" Origin="Derived" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="CM.CMSPID" Name="CMSPID" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Sponsor-Defined Identifier" />

        <ItemDef OID="CM.CMTRT" Name="CMTRT" DataType="text" Length="100" Origin="CRF" Comment="" def:Label="Reported Name of Drug, Med, or Therapy" />

        <ItemDef OID="CM.CMMODIFY" Name="CMMODIFY" DataType="text" Length="100" Origin="Assigned" Comment="" def:Label="Modified Reported Name" />

      - <ItemDef OID="CM.CMDECOD" Name="CMDECOD" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Standardized Medication Name">

        <CodeListRef CodeListOID="WHODRUG" />

        </ItemDef>

        <ItemDef OID="CM.CMCAT" Name="CMCAT" DataType="text" Length="40" Origin="CRF" Comment="" def:Label="Category for Medication" />

      - <ItemDef OID="CM.CMINDC" Name="CMINDC" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Indication">

        <CodeListRef CodeListOID="INDC" />

        </ItemDef>

      - <ItemDef OID="CM.CMCLAS" Name="CMCLAS" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Medication Class">

        <CodeListRef CodeListOID="WHODRUG" />

        </ItemDef>

      - <ItemDef OID="CM.CMCLASCD" Name="CMCLASCD" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Medication Class Code">

        <CodeListRef CodeListOID="WHODRUG" />

        </ItemDef>

        <ItemDef OID="CM.CMDOSTXT" Name="CMDOSTXT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Dose Description" />

      - <ItemDef OID="CM.CMDOSU" Name="CMDOSU" DataType="text" Length="25" Origin="CRF" Comment="" def:Label="Dose Units">

        <CodeListRef CodeListOID="DOSU" />

        </ItemDef>

      - <ItemDef OID="CM.CMDOSFRQ" Name="CMDOSFRQ" DataType="text" Length="40" Origin="CRF" Comment="" def:Label="Dosing Frequency per Interval">

        <CodeListRef CodeListOID="FRQ" />

        </ItemDef>

      - <ItemDef OID="CM.CMROUTE" Name="CMROUTE" DataType="text" Length="40" Origin="CRF" Comment="" def:Label="Route of Administration">

        <CodeListRef CodeListOID="ROUTE" />

        </ItemDef>

        <ItemDef OID="CM.CMSTDTC" Name="CMSTDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Start Date/Time of Medication" />

        <ItemDef OID="CM.CMENDTC" Name="CMENDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="End Date/Time of Medication" />

        <ItemDef OID="CM.CMSTDY" Name="CMSTDY" DataType="integer" Length="8" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Study Day of Start of Medication" />

        <ItemDef OID="CM.CMENDY" Name="CMENDY" DataType="integer" Length="8" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Study Day of End of Medication" />

        <ItemDef OID="CM.CMDUR" Name="CMDUR" DataType="text" Length="15" Origin="CRF" Comment="" def:Label="Duration of Medication" />

        <ItemDef OID="CO.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="CO.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

      - <ItemDef OID="CO.RDOMAIN" Name="RDOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Related Domain Abbreviation">

        <CodeListRef CodeListOID="FRMNM" />

        </ItemDef>

        <ItemDef OID="CO.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="CO.COSEQ" Name="COSEQ" DataType="integer" Length="8" Origin="Derived" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="CO.IDVAR" Name="IDVAR" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Identifying Variable" />

        <ItemDef OID="CO.IDVARVAL" Name="IDVARVAL" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Identifying Variable Value" />

        <ItemDef OID="CO.COREF" Name="COREF" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Comment Reference" />

        <ItemDef OID="CO.COVAL" Name="COVAL" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Comment" />

      - <ItemDef OID="CO.COEVAL" Name="COEVAL" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Evaluator">

        <CodeListRef CodeListOID="COEVAL" />

        </ItemDef>

        <ItemDef OID="DM.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="DM.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="DM.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="DM.SUBJID" Name="SUBJID" DataType="text" Length="20" Origin="CRF" Comment="" def:Label="Subject Identifier for the Study" />

        <ItemDef OID="DM.RFSTDTC" Name="RFSTDTC" DataType="text" Length="19" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Subject Reference Start Date/Time" />

        <ItemDef OID="DM.RFENDTC" Name="RFENDTC" DataType="text" Length="19" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Subject Reference End Date/Time" />

        <ItemDef OID="DM.SITEID" Name="SITEID" DataType="text" Length="10" Origin="Assigned" Comment="" def:Label="Study Site Identifier" />

        <ItemDef OID="DM.INVID" Name="INVID" DataType="text" Length="20" Origin="Assigned" Comment="" def:Label="Investigator Identifier" />

        <ItemDef OID="DM.INVNAM" Name="INVNAM" DataType="text" Length="120" Origin="Assigned" Comment="" def:Label="Investigator Name" />

        <ItemDef OID="DM.BRTHDTC" Name="BRTHDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Date/Time of Birth" />

        <ItemDef OID="DM.AGE" Name="AGE" DataType="integer" Length="8" Origin="CRF" Comment="" def:Label="Age" />

      - <ItemDef OID="DM.AGEU" Name="AGEU" DataType="text" Length="6" Origin="CRF" Comment="" def:Label="Age Units">

        <CodeListRef CodeListOID="AGEU" />

        </ItemDef>

      - <ItemDef OID="DM.SEX" Name="SEX" DataType="text" Length="2" Origin="CRF" Comment="" def:Label="Sex">

        <CodeListRef CodeListOID="SEX" />

        </ItemDef>

      - <ItemDef OID="DM.RACE" Name="RACE" DataType="text" Length="41" Origin="CRF" Comment="" def:Label="Race">

        <CodeListRef CodeListOID="RACE" />

        </ItemDef>

      - <ItemDef OID="DM.ETHNIC" Name="ETHNIC" DataType="text" Length="22" Origin="CRF" Comment="" def:Label="Ethnicity">

        <CodeListRef CodeListOID="ETHNIC" />

        </ItemDef>

        <ItemDef OID="DM.ARMCD" Name="ARMCD" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Planned Arm Code" />

        <ItemDef OID="DM.ARM" Name="ARM" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Description of Planned Arm" />

      - <ItemDef OID="DM.COUNTRY" Name="COUNTRY" DataType="text" Length="3" Origin="Assigned" Comment="" def:Label="Country">

        <CodeListRef CodeListOID="COUNTRY" />

        </ItemDef>

        <ItemDef OID="DS.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="DS.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="DS.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="DS.DSSEQ" Name="DSSEQ" DataType="integer" Length="8" Origin="Derived" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="DS.DSGRPID" Name="DSGRPID" DataType="text" Length="30" Origin="Assigned" Comment="" def:Label="Group ID" />

        <ItemDef OID="DS.DSSPID" Name="DSSPID" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Sponsor-Defined Identifier" />

        <ItemDef OID="DS.DSTERM" Name="DSTERM" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Reported Term for the Disposition Event" />

      - <ItemDef OID="DS.DSDECOD" Name="DSDECOD" DataType="text" Length="30" Origin="CRF" Comment="" def:Label="Standardized Disposition Term">

        <CodeListRef CodeListOID="REAS" />

        </ItemDef>

      - <ItemDef OID="DS.DSCAT" Name="DSCAT" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Category for Disposition Event">

        <CodeListRef CodeListOID="DSCAT" />

        </ItemDef>

        <ItemDef OID="DS.VISITNUM" Name="VISITNUM" DataType="float" Length="8" SignificantDigits="3" Origin="Assigned" Comment="" def:Label="Visit Number" />

        <ItemDef OID="DS.VISIT" Name="VISIT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Visit Name" />

        <ItemDef OID="DS.VISITDY" Name="VISITDY" DataType="integer" Length="8" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Planned Study Day of Visit" />

        <ItemDef OID="DS.DSDY" Name="DSDY" DataType="integer" Length="8" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Study Day of Disposition Event" />

      - <ItemDef OID="DS.EPOCH" Name="EPOCH" DataType="text" Length="40" Origin="Derived" Comment="EPOCH variable is populated based on the Phase or Period of the trial." def:Label="Trial Epoch">

        <CodeListRef CodeListOID="EPCH" />

        </ItemDef>

        <ItemDef OID="DS.DSSTDTC" Name="DSSTDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Start Date/Time of Disposition Event" />

        <ItemDef OID="DS.DSSTDY" Name="DSSTDY" DataType="integer" Length="8" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Study Day of Start of Disposition Event" />

        <ItemDef OID="DV.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="DV.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="DV.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="DV.DVSEQ" Name="DVSEQ" DataType="integer" Length="8" Origin="Derived" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="DV.DVSPID" Name="DVSPID" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Sponsor-Defined Identifier" />

        <ItemDef OID="DV.DVTERM" Name="DVTERM" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Protocol Deviation Term" />

        <ItemDef OID="DV.DVDECOD" Name="DVDECOD" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Protocol Deviation Coded Term" />

        <ItemDef OID="DV.DVSTDTC" Name="DVSTDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Start Date/Time of Protocol Deviation" />

        <ItemDef OID="DV.DVENDTC" Name="DVENDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="End Date/Time of Protocol Deviation" />

        <ItemDef OID="EG.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="EG.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="EG.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="EG.EGSEQ" Name="EGSEQ" DataType="integer" Length="8" Origin="Assigned" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="EG.EGGRPID" Name="EGGRPID" DataType="text" Length="30" Origin="Assigned" Comment="" def:Label="Group ID" />

        <ItemDef OID="EG.EGSPID" Name="EGSPID" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Sponsor-Defined Identifier" />

      - <ItemDef OID="EG.EGTESTCD" Name="EGTESTCD" DataType="text" Length="8" Origin="CRF" Comment="" def:Label="ECG Test or Examination Short Name">

        <def:ValueListRef ValueListOID="ValueList.EG.EGTESTCD" />

        </ItemDef>

        <ItemDef OID="EG.EGTEST" Name="EGTEST" DataType="text" Length="40" Origin="CRF" Comment="" def:Label="ECG Test or Examination Name" />

      - <ItemDef OID="EG.EGPOS" Name="EGPOS" DataType="text" Length="20" Origin="CRF" Comment="" def:Label="ECG Position of Subject">

        <CodeListRef CodeListOID="EGPOS" />

        </ItemDef>

        <ItemDef OID="EG.EGORRES" Name="EGORRES" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Result or Finding in Original Units" />

      - <ItemDef OID="EG.EGORRESU" Name="EGORRESU" DataType="text" Length="20" Origin="CRF" Comment="" def:Label="Original Units">

        <CodeListRef CodeListOID="EGRESU" />

        </ItemDef>

        <ItemDef OID="EG.EGSTRESC" Name="EGSTRESC" DataType="text" Length="200" Origin="eDT" Comment="Copied or derived from --ORRES in a standard format or standard units." def:Label="Character Result/Finding in Std Format" />

        <ItemDef OID="EG.EGSTRESN" Name="EGSTRESN" DataType="float" Length="8" SignificantDigits="4" Origin="eDT" Comment="Copied in numeric format from --STRESC" def:Label="Numeric Result/Finding in Standard Units" />

      - <ItemDef OID="EG.EGSTRESU" Name="EGSTRESU" DataType="text" Length="20" Origin="eDT" Comment="Standardized unit used for --STRESC or --STRESN." def:Label="Standard Units">

        <CodeListRef CodeListOID="EGSRESU" />

        </ItemDef>

      - <ItemDef OID="EG.EGBLFL" Name="EGBLFL" DataType="text" Length="1" Origin="eDT" Comment="The algorithm becomes available in Q2, 2011" def:Label="Baseline Flag">

        <CodeListRef CodeListOID="YES" />

        </ItemDef>

      - <ItemDef OID="EG.EGEVAL" Name="EGEVAL" DataType="text" Length="60" Origin="eDT" Comment="" def:Label="Evaluator">

        <CodeListRef CodeListOID="EGEVAL" />

        </ItemDef>

        <ItemDef OID="EG.VISITNUM" Name="VISITNUM" DataType="float" Length="8" SignificantDigits="3" Origin="Assigned" Comment="" def:Label="Visit Number" />

        <ItemDef OID="EG.VISIT" Name="VISIT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Visit Name" />

      - <ItemDef OID="EG.EPOCH" Name="EPOCH" DataType="text" Length="40" Origin="Assigned" Comment="EPOCH variable is populated based on the Phase or Period of the trial." def:Label="Trial Epoch">

        <CodeListRef CodeListOID="EPCH" />

        </ItemDef>

        <ItemDef OID="EG.EGDTC" Name="EGDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Date/Time of ECG" />

        <ItemDef OID="EX.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="EX.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="EX.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="EX.EXSEQ" Name="EXSEQ" DataType="integer" Length="8" Origin="Derived" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="EX.EXSPID" Name="EXSPID" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Sponsor-Defined Identifier" />

        <ItemDef OID="EX.EXTRT" Name="EXTRT" DataType="text" Length="60" Origin="Derived" Comment="" def:Label="Name of Actual Treatment" />

        <ItemDef OID="EX.EXDOSE" Name="EXDOSE" DataType="float" Length="8" SignificantDigits="4" Origin="CRF" Comment="The derivation is assumed to be performed by B&P for non open-label studies" def:Label="Dose per Administration" />

      - <ItemDef OID="EX.EXDOSU" Name="EXDOSU" DataType="text" Length="25" Origin="CRF" Comment="" def:Label="Dose Units">

        <CodeListRef CodeListOID="EXDOSU" />

        </ItemDef>

      - <ItemDef OID="EX.EXDOSFRM" Name="EXDOSFRM" DataType="text" Length="65" Origin="Derived" Comment="" def:Label="Dose Form">

        <CodeListRef CodeListOID="EXFRM" />

        </ItemDef>

        <ItemDef OID="EX.VISITNUM" Name="VISITNUM" DataType="float" Length="8" SignificantDigits="3" Origin="Assigned" Comment="" def:Label="Visit Number" />

        <ItemDef OID="EX.VISIT" Name="VISIT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Visit Name" />

      - <ItemDef OID="EX.EPOCH" Name="EPOCH" DataType="text" Length="40" Origin="Derived" Comment="EPOCH variable is populated based on the Phase or Period of the trial." def:Label="Trial Epoch">

        <CodeListRef CodeListOID="EPCH" />

        </ItemDef>

        <ItemDef OID="EX.EXSTDTC" Name="EXSTDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Start Date/Time of Treatment" />

        <ItemDef OID="EX.EXENDTC" Name="EXENDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="End Date/Time of Treatment" />

        <ItemDef OID="HO.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="HO.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="HO.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="HO.HOSEQ" Name="HOSEQ" DataType="integer" Length="8" Origin="Derived" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="HO.HOSPID" Name="HOSPID" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Sponsor-Defined Identifier" />

        <ItemDef OID="HO.HOTERM" Name="HOTERM" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Reported Term for the Hospitalization" />

        <ItemDef OID="HO.VISITNUM" Name="VISITNUM" DataType="float" Length="8" SignificantDigits="3" Origin="Assigned" Comment="" def:Label="Visit Number" />

        <ItemDef OID="HO.VISIT" Name="VISIT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Visit Name" />

        <ItemDef OID="HO.VISITDY" Name="VISITDY" DataType="integer" Length="8" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Planned Study Day of Visit" />

      - <ItemDef OID="HO.EPOCH" Name="EPOCH" DataType="text" Length="40" Origin="Derived" Comment="EPOCH variable is populated based on the Phase or Period of the trial." def:Label="Trial Epoch">

        <CodeListRef CodeListOID="EPCH" />

        </ItemDef>

        <ItemDef OID="HO.HOSTDTC" Name="HOSTDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Start Date/Time of Hospitalization" />

        <ItemDef OID="HO.HODY" Name="HODY" DataType="integer" Length="8" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Study Day of Hospitalization Collection" />

        <ItemDef OID="HO.HOSTDY" Name="HOSTDY" DataType="integer" Length="8" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Study Day of Start of Hospitalization" />

        <ItemDef OID="HO.HOENDY" Name="HOENDY" DataType="integer" Length="8" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Study Day of End of Hospitalization" />

        <ItemDef OID="IE.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="IE.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="IE.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="IE.IESEQ" Name="IESEQ" DataType="integer" Length="8" Origin="Derived" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="IE.IESPID" Name="IESPID" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Sponsor-Defined Identifier" />

        <ItemDef OID="IE.IETESTCD" Name="IETESTCD" DataType="text" Length="8" Origin="CRF" Comment="" def:Label="Inclusion/Exclusion Criterion Short Name" />

        <ItemDef OID="IE.IETEST" Name="IETEST" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Inclusion/Exclusion Criterion" />

      - <ItemDef OID="IE.IECAT" Name="IECAT" DataType="text" Length="9" Origin="CRF" Comment="" def:Label="Inclusion/Exclusion Category">

        <def:ValueListRef ValueListOID="ValueList.IE.IECAT" />

        </ItemDef>

      - <ItemDef OID="IE.IEORRES" Name="IEORRES" DataType="text" Length="1" Origin="Assigned" Comment="" def:Label="I/E Criterion Original Result">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

      - <ItemDef OID="IE.IESTRESC" Name="IESTRESC" DataType="text" Length="1" Origin="Derived" Comment="Copied or derived from --ORRES in a standard format or standard units." def:Label="I/E Criterion Result in Std Format">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

        <ItemDef OID="IE.VISITNUM" Name="VISITNUM" DataType="float" Length="8" SignificantDigits="3" Origin="Assigned" Comment="" def:Label="Visit Number" />

        <ItemDef OID="IE.VISIT" Name="VISIT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Visit Name" />

        <ItemDef OID="IE.IEDTC" Name="IEDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Date/Time of Collection" />

        <ItemDef OID="LB.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="LB.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="eDT" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="LB.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="LB.LBSEQ" Name="LBSEQ" DataType="integer" Length="8" Origin="eDT" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="LB.LBGRPID" Name="LBGRPID" DataType="text" Length="30" Origin="eDT" Comment="" def:Label="Group ID" />

        <ItemDef OID="LB.LBREFID" Name="LBREFID" DataType="text" Length="25" Origin="eDT" Comment="" def:Label="Specimen ID" />

        <ItemDef OID="LB.LBSPID" Name="LBSPID" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Sponsor-Defined Identifier" />

        <ItemDef OID="LB.LBTESTCD" Name="LBTESTCD" DataType="text" Length="8" Origin="eDT" Comment="Per sponsor defined dictionary" def:Label="LAB Test or Examination Short Name" />

        <ItemDef OID="LB.LBTEST" Name="LBTEST" DataType="text" Length="40" Origin="eDT" Comment="Per sponsor defined dictionary" def:Label="LAB Test or Examination Name" />

      - <ItemDef OID="LB.LBCAT" Name="LBCAT" DataType="text" Length="30" Origin="eDT" Comment="" def:Label="Category for Lab Test">

        <def:ValueListRef ValueListOID="ValueList.LB.LBCAT" />

        </ItemDef>

        <ItemDef OID="LB.LBSCAT" Name="LBSCAT" DataType="text" Length="40" Origin="eDT" Comment="" def:Label="Subcategory for Lab Test" />

      - <ItemDef OID="LB.LBORRES" Name="LBORRES" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Result or Finding in Original Units">

        <CodeListRef CodeListOID="POSNEG" />

        </ItemDef>

        <ItemDef OID="LB.LBORRESU" Name="LBORRESU" DataType="text" Length="20" Origin="eDT" Comment="" def:Label="Original Units" />

        <ItemDef OID="LB.LBORNRLO" Name="LBORNRLO" DataType="text" Length="20" Origin="eDT" Comment="" def:Label="Reference Range Lower Limit in Orig Unit" />

        <ItemDef OID="LB.LBORNRHI" Name="LBORNRHI" DataType="text" Length="20" Origin="eDT" Comment="" def:Label="Reference Range Upper Limit in Orig Unit" />

        <ItemDef OID="LB.LBSTRESC" Name="LBSTRESC" DataType="text" Length="200" Origin="eDT" Comment="Copied or derived from --ORRES in a standard format or standard units." def:Label="Character Result/Finding in Std Format" />

        <ItemDef OID="LB.LBSTNRC" Name="LBSTNRC" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Reference Range for Char Rslt-Std Units" />

        <ItemDef OID="LB.LBSTRESN" Name="LBSTRESN" DataType="float" Length="8" SignificantDigits="3" Origin="eDT" Comment="Copied in numeric format from --STRESC" def:Label="Numeric Result/Finding in Standard Units" />

        <ItemDef OID="LB.LBSTRESU" Name="LBSTRESU" DataType="text" Length="20" Origin="eDT" Comment="Standardized unit used for --STRESC or --STRESN." def:Label="Standard Units" />

        <ItemDef OID="LB.LBSTNRLO" Name="LBSTNRLO" DataType="float" Length="8" SignificantDigits="3" Origin="eDT" Comment="LBORNRLO multiplied by conversion factor" def:Label="Reference Range Lower Limit-Std Units" />

        <ItemDef OID="LB.LBSTNRHI" Name="LBSTNRHI" DataType="float" Length="8" SignificantDigits="3" Origin="eDT" Comment="LBORNRHI multiplied by conversion factor" def:Label="Reference Range Upper Limit-Std Units" />

      - <ItemDef OID="LB.LBNRIND" Name="LBNRIND" DataType="text" Length="8" Origin="eDT" Comment="The algorithm becomes available in Q2, 2011" def:Label="Reference Range Indicator">

        <CodeListRef CodeListOID="LNHFLG" />

        </ItemDef>

      - <ItemDef OID="LB.LBSTAT" Name="LBSTAT" DataType="text" Length="8" Origin="eDT" Comment="" def:Label="Lab Status">

        <CodeListRef CodeListOID="ND" />

        </ItemDef>

        <ItemDef OID="LB.LBREASND" Name="LBREASND" DataType="text" Length="200" Origin="eDT" Comment="" def:Label="Reason Test Not Done" />

        <ItemDef OID="LB.LBNAM" Name="LBNAM" DataType="text" Length="80" Origin="eDT" Comment="" def:Label="Vendor Name" />

      - <ItemDef OID="LB.LBSPEC" Name="LBSPEC" DataType="text" Length="20" Origin="eDT" Comment="" def:Label="Specimen Type">

        <CodeListRef CodeListOID="SPEC" />

        </ItemDef>

      - <ItemDef OID="LB.LBSPCCND" Name="LBSPCCND" DataType="text" Length="100" Origin="eDT" Comment="" def:Label="Specimen Condition">

        <CodeListRef CodeListOID="SPCCND" />

        </ItemDef>

        <ItemDef OID="LB.LBMETHOD" Name="LBMETHOD" DataType="text" Length="100" Origin="eDT" Comment="" def:Label="Method of Test or Examination" />

      - <ItemDef OID="LB.LBBLFL" Name="LBBLFL" DataType="text" Length="1" Origin="eDT" Comment="The algorithm becomes available in Q2, 2011" def:Label="Baseline Flag">

        <CodeListRef CodeListOID="YES" />

        </ItemDef>

      - <ItemDef OID="LB.LBFAST" Name="LBFAST" DataType="text" Length="1" Origin="eDT" Comment="" def:Label="Fasting Status">

        <CodeListRef CodeListOID="NY" />

        </ItemDef>

        <ItemDef OID="LB.VISITNUM" Name="VISITNUM" DataType="float" Length="8" SignificantDigits="3" Origin="Assigned" Comment="" def:Label="Visit Number" />

        <ItemDef OID="LB.VISIT" Name="VISIT" DataType="text" Length="60" Origin="eDT" Comment="" def:Label="Visit Name" />

        <ItemDef OID="LB.VISITDY" Name="VISITDY" DataType="integer" Length="8" Origin="eDT" Comment="The algorithm becomes available in Q2, 2011" def:Label="Planned Study Day of Visit" />

      - <ItemDef OID="LB.EPOCH" Name="EPOCH" DataType="text" Length="40" Origin="eDT" Comment="EPOCH variable is populated based on the Phase or Period of the trial." def:Label="Trial Epoch">

        <CodeListRef CodeListOID="EPCH" />

        </ItemDef>

        <ItemDef OID="LB.LBDTC" Name="LBDTC" DataType="text" Length="19" Origin="eDT" Comment="" def:Label="Date/Time of Specimen Collection" />

        <ItemDef OID="LB.LBENDTC" Name="LBENDTC" DataType="text" Length="19" Origin="eDT" Comment="" def:Label="End Date/Time of Specimen Collection" />

        <ItemDef OID="LB.LBENDY" Name="LBENDY" DataType="integer" Length="8" Origin="eDT" Comment="The algorithm becomes available in Q2, 2011" def:Label="Study Day of End of Specimen Collection" />

        <ItemDef OID="LB.LBDY" Name="LBDY" DataType="integer" Length="8" Origin="eDT" Comment="The algorithm becomes available in Q2, 2011" def:Label="Study Day of Specimen Collection" />

        <ItemDef OID="LB.LBTPT" Name="LBTPT" DataType="text" Length="40" Origin="eDT" Comment="" def:Label="Planned Time Point Name" />

        <ItemDef OID="LB.LBTPTNUM" Name="LBTPTNUM" DataType="float" Length="8" SignificantDigits="3" Origin="eDT" Comment="" def:Label="Planned Time Point Number" />

        <ItemDef OID="LB.LBELTM" Name="LBELTM" DataType="text" Length="40" Origin="eDT" Comment="The algorithm becomes available in Q2, 2011" def:Label="Elapsed Time from Reference Point" />

      - <ItemDef OID="LB.LBTPTREF" Name="LBTPTREF" DataType="text" Length="40" Origin="eDT" Comment="The algorithm becomes available in Q2, 2011" def:Label="Time Point Reference">

        <CodeListRef CodeListOID="TPNTRF" />

        </ItemDef>

        <ItemDef OID="LB.LBTOX" Name="LBTOX" DataType="text" Length="40" Origin="eDT" Comment="" def:Label="Toxicity" />

        <ItemDef OID="LB.LBTOXGR" Name="LBTOXGR" DataType="text" Length="40" Origin="eDT" Comment="" def:Label="Standard Toxicity Grade" />

        <ItemDef OID="MH.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="MH.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="MH.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="MH.MHSEQ" Name="MHSEQ" DataType="integer" Length="8" Origin="Derived" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="MH.MHSPID" Name="MHSPID" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Sponsor-Defined Identifier" />

        <ItemDef OID="MH.MHTERM" Name="MHTERM" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Reported Term for the Medical History" />

        <ItemDef OID="MH.MHCAT" Name="MHCAT" DataType="text" Length="40" Origin="CRF" Comment="" def:Label="Category for Medical History" />

      - <ItemDef OID="MH.MHSCAT" Name="MHSCAT" DataType="text" Length="40" Origin="CRF" Comment="" def:Label="Subcategory for Medical History">

        <CodeListRef CodeListOID="MHSCAT" />

        </ItemDef>

        <ItemDef OID="MH.VISITNUM" Name="VISITNUM" DataType="float" Length="8" SignificantDigits="3" Origin="Assigned" Comment="" def:Label="Visit Number" />

        <ItemDef OID="MH.VISIT" Name="VISIT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Visit Name" />

      - <ItemDef OID="MH.EPOCH" Name="EPOCH" DataType="text" Length="40" Origin="Derived" Comment="EPOCH variable is populated based on the Phase or Period of the trial." def:Label="Trial Epoch">

        <CodeListRef CodeListOID="EPCH" />

        </ItemDef>

        <ItemDef OID="MH.MHDTC" Name="MHDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Date/Time of History Collection" />

        <ItemDef OID="PC.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="PC.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="PC.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="PC.PCSEQ" Name="PCSEQ" DataType="integer" Length="8" Origin="Derived" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="PC.PCSPID" Name="PCSPID" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Sponsor-Defined Identifier" />

        <ItemDef OID="PC.PCTESTCD" Name="PCTESTCD" DataType="text" Length="8" Origin="eDT" Comment="" def:Label="Pharmacokinetic Test Short Name" />

        <ItemDef OID="PC.PCTEST" Name="PCTEST" DataType="text" Length="40" Origin="eDT" Comment="" def:Label="Pharmacokinetic Test Name" />

        <ItemDef OID="PC.PCCAT" Name="PCCAT" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Test Category" />

        <ItemDef OID="PC.PCORRES" Name="PCORRES" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Result or Finding in Original Units" />

        <ItemDef OID="PC.PCORRESU" Name="PCORRESU" DataType="text" Length="20" Origin="Derived" Comment="" def:Label="Original Units" />

        <ItemDef OID="PC.PCSTRESC" Name="PCSTRESC" DataType="text" Length="200" Origin="eDT" Comment="Copied or derived from --ORRES in a standard format or standard units." def:Label="Character Result/Finding in Std Format" />

        <ItemDef OID="PC.PCSTRESN" Name="PCSTRESN" DataType="float" Length="8" SignificantDigits="4" Origin="eDT" Comment="Copied in numeric format from --STRESC" def:Label="Numeric Result/Finding in Standard Units" />

        <ItemDef OID="PC.PCSTRESU" Name="PCSTRESU" DataType="text" Length="20" Origin="eDT" Comment="Standardized unit used for --STRESC or --STRESN." def:Label="Standard Units" />

      - <ItemDef OID="PC.PCSTAT" Name="PCSTAT" DataType="text" Length="8" Origin="CRF" Comment="" def:Label="Completion Status">

        <CodeListRef CodeListOID="ND" />

        </ItemDef>

        <ItemDef OID="PC.PCREASND" Name="PCREASND" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Reason Test Not Done" />

        <ItemDef OID="PC.PCNAM" Name="PCNAM" DataType="text" Length="80" Origin="eDT" Comment="" def:Label="Vendor Name" />

        <ItemDef OID="PC.PCSPEC" Name="PCSPEC" DataType="text" Length="20" Origin="CRF" Comment="" def:Label="Specimen Type" />

        <ItemDef OID="PC.VISITNUM" Name="VISITNUM" DataType="float" Length="8" SignificantDigits="3" Origin="Assigned" Comment="" def:Label="Visit Number" />

        <ItemDef OID="PC.VISIT" Name="VISIT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Visit Name" />

        <ItemDef OID="PC.PCDTC" Name="PCDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Start Date/Time of Specimen Collection" />

        <ItemDef OID="PC.PCTPT" Name="PCTPT" DataType="text" Length="40" Origin="CRF" Comment="" def:Label="Planned Time Point Name" />

        <ItemDef OID="PC.PCTPTNUM" Name="PCTPTNUM" DataType="float" Length="8" SignificantDigits="3" Origin="Assigned" Comment="" def:Label="Planned Time Point Number" />

        <ItemDef OID="PE.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="PE.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="PE.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="PE.PESEQ" Name="PESEQ" DataType="integer" Length="8" Origin="Derived" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="PE.PEGRPID" Name="PEGRPID" DataType="text" Length="30" Origin="Assigned" Comment="" def:Label="Group ID" />

        <ItemDef OID="PE.PESPID" Name="PESPID" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Sponsor-Defined Identifier" />

      - <ItemDef OID="PE.PETESTCD" Name="PETESTCD" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Body System Examined Short Name">

        <def:ValueListRef ValueListOID="ValueList.PE.PETESTCD" />

        </ItemDef>

        <ItemDef OID="PE.PETEST" Name="PETEST" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Body System Examined" />

        <ItemDef OID="PE.PECAT" Name="PECAT" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Category for Examination" />

        <ItemDef OID="PE.PEORRES" Name="PEORRES" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Verbatim Examination Finding" />

        <ItemDef OID="PE.PESTRESC" Name="PESTRESC" DataType="text" Length="200" Origin="Derived" Comment="Copied or derived from --ORRES in a standard format or standard units." def:Label="Character Result/Finding in Std Format" />

        <ItemDef OID="PE.PESTRESN" Name="PESTRESN" DataType="float" Length="8" SignificantDigits="4" Origin="Derived" Comment="Copied in numeric format from --STRESC" def:Label="Numeric Result/Finding in Standard Units" />

        <ItemDef OID="PE.PESTRESU" Name="PESTRESU" DataType="text" Length="15" Origin="Derived" Comment="Standardized unit used for --STRESC or --STRESN." def:Label="Standard Units" />

      - <ItemDef OID="PE.PESTAT" Name="PESTAT" DataType="text" Length="8" Origin="CRF" Comment="" def:Label="Examination Status">

        <CodeListRef CodeListOID="ND" />

        </ItemDef>

      - <ItemDef OID="PE.PEBLFL" Name="PEBLFL" DataType="text" Length="1" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Baseline Flag">

        <CodeListRef CodeListOID="YES" />

        </ItemDef>

        <ItemDef OID="PE.VISITNUM" Name="VISITNUM" DataType="float" Length="8" SignificantDigits="3" Origin="Assigned" Comment="" def:Label="Visit Number" />

        <ItemDef OID="PE.VISIT" Name="VISIT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Visit Name" />

      - <ItemDef OID="PE.EPOCH" Name="EPOCH" DataType="text" Length="40" Origin="Derived" Comment="EPOCH variable is populated based on the Phase or Period of the trial." def:Label="Trial Epoch">

        <CodeListRef CodeListOID="EPCH" />

        </ItemDef>

        <ItemDef OID="PE.PEDTC" Name="PEDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Date/Time of Examination" />

        <ItemDef OID="QS.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="QS.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="QS.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="QS.QSSEQ" Name="QSSEQ" DataType="integer" Length="8" Origin="Derived" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="QS.QSSPID" Name="QSSPID" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Sponsor-Defined Identifier" />

        <ItemDef OID="QS.QSTESTCD" Name="QSTESTCD" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Question Short Name" />

        <ItemDef OID="QS.QSTEST" Name="QSTEST" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Question Name" />

      - <ItemDef OID="QS.QSCAT" Name="QSCAT" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Category of Question">

        <def:ValueListRef ValueListOID="ValueList.QS.QSCAT" />

        </ItemDef>

        <ItemDef OID="QS.QSSCAT" Name="QSSCAT" DataType="text" Length="40" Origin="CRF" Comment="" def:Label="Subcategory for Question" />

        <ItemDef OID="QS.QSORRES" Name="QSORRES" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Finding in Original Units" />

        <ItemDef OID="QS.QSSTRESC" Name="QSSTRESC" DataType="text" Length="200" Origin="Derived" Comment="Copied or derived from --ORRES in a standard format or standard units." def:Label="Character Result/Finding in Std Format" />

        <ItemDef OID="QS.QSSTRESN" Name="QSSTRESN" DataType="float" Length="8" SignificantDigits="4" Origin="Derived" Comment="Copied in numeric format from --STRESC" def:Label="Numeric Result/Finding in Standard Units" />

      - <ItemDef OID="QS.QSBLFL" Name="QSBLFL" DataType="text" Length="1" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Baseline Flag">

        <CodeListRef CodeListOID="YES" />

        </ItemDef>

        <ItemDef OID="QS.VISITNUM" Name="VISITNUM" DataType="float" Length="8" SignificantDigits="3" Origin="Assigned" Comment="" def:Label="Visit Number" />

        <ItemDef OID="QS.VISIT" Name="VISIT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Visit Name" />

      - <ItemDef OID="QS.EPOCH" Name="EPOCH" DataType="text" Length="40" Origin="Derived" Comment="EPOCH variable is populated based on the Phase or Period of the trial." def:Label="Trial Epoch">

        <CodeListRef CodeListOID="EPCH" />

        </ItemDef>

        <ItemDef OID="QS.QSDTC" Name="QSDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Date/Time of Finding" />

        <ItemDef OID="QS.QSTPT" Name="QSTPT" DataType="text" Length="40" Origin="CRF" Comment="" def:Label="Planned Time Point Name" />

        <ItemDef OID="QS.QSTPTNUM" Name="QSTPTNUM" DataType="float" Length="8" SignificantDigits="3" Origin="Assigned" Comment="" def:Label="Planned Time Point Number" />

        <ItemDef OID="RA.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="RA.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="RA.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="RA.SUBJID" Name="SUBJID" DataType="text" Length="20" Origin="CRF" Comment="" def:Label="Subject Identifier for the Study" />

        <ItemDef OID="RA.SITEID" Name="SITEID" DataType="text" Length="10" Origin="Assigned" Comment="" def:Label="Study Site Identifier" />

        <ItemDef OID="RA.RASEQ" Name="RASEQ" DataType="integer" Length="8" Origin="Derived" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="RA.RASPID" Name="RASPID" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Sponsor-Defined Identifier" />

        <ItemDef OID="RA.ARMCD" Name="ARMCD" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Planned Arm Code" />

        <ItemDef OID="RA.ARM" Name="ARM" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Description of Planned Arm" />

        <ItemDef OID="RA.RANUM" Name="RANUM" DataType="text" Length="10" Origin="CRF" Comment="" def:Label="Randomization Number" />

        <ItemDef OID="RA.COHORT" Name="COHORT" DataType="text" Length="20" Origin="Assigned" Comment="" def:Label="Cohort Description" />

        <ItemDef OID="RA.RAORIG" Name="RAORIG" DataType="text" Length="10" Origin="Assigned" Comment="" def:Label="Origin of Randomization Data" />

        <ItemDef OID="RA.RASTDTC" Name="RASTDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Date/Time of Randomization" />

        <ItemDef OID="RA.VISITNUM" Name="VISITNUM" DataType="float" Length="8" SignificantDigits="3" Origin="Assigned" Comment="" def:Label="Visit Number" />

        <ItemDef OID="RA.VISIT" Name="VISIT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Visit Name" />

      - <ItemDef OID="RA.EPOCH" Name="EPOCH" DataType="text" Length="40" Origin="Derived" Comment="EPOCH variable is populated based on the Phase or Period of the trial." def:Label="Trial Epoch">

        <CodeListRef CodeListOID="EPCH" />

        </ItemDef>

        <ItemDef OID="RELREC.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

      - <ItemDef OID="RELREC.RDOMAIN" Name="RDOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Related Domain Abbreviation">

        <CodeListRef CodeListOID="FRMNM" />

        </ItemDef>

        <ItemDef OID="RELREC.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="RELREC.IDVAR" Name="IDVAR" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Identifying Variable" />

        <ItemDef OID="RELREC.IDVARVAL" Name="IDVARVAL" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Identifying Variable Value" />

        <ItemDef OID="RELREC.RELTYPE" Name="RELTYPE" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Relationship Type" />

        <ItemDef OID="RELREC.RELID" Name="RELID" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Relationship Identifier" />

        <ItemDef OID="SG.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="SG.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="SG.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="SG.SGSEQ" Name="SGSEQ" DataType="integer" Length="8" Origin="Derived" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="SG.SGSPID" Name="SGSPID" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Sponsor-Defined Identifier" />

        <ItemDef OID="SG.SGTRT" Name="SGTRT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Reported Name of Surgery/Procedure" />

        <ItemDef OID="SG.SGDECOD" Name="SGDECOD" DataType="text" Length="45" Origin="Derived" Comment="" def:Label="Standardized Surgery/Procedure Name" />

        <ItemDef OID="SG.SGCAT" Name="SGCAT" DataType="text" Length="40" Origin="CRF" Comment="" def:Label="Category for Surgery/Procedure" />

      - <ItemDef OID="SG.SGSCAT" Name="SGSCAT" DataType="text" Length="40" Origin="CRF" Comment="" def:Label="Subcategory for Surgery/Procedure">

        <CodeListRef CodeListOID="SGSCAT" />

        </ItemDef>

        <ItemDef OID="SG.SGINDC" Name="SGINDC" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Indication" />

        <ItemDef OID="SUPPAE.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="SUPPAE.RDOMAIN" Name="RDOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Related Domain Abbreviation" />

        <ItemDef OID="SUPPAE.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="SUPPAE.IDVAR" Name="IDVAR" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Identifying Variable" />

        <ItemDef OID="SUPPAE.IDVARVAL" Name="IDVARVAL" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Identifying Variable Value" />

      - <ItemDef OID="SUPPAE.QNAM" Name="QNAM" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Qualifier Variable Name">

        <def:ValueListRef ValueListOID="ValueList.SUPPAE.QNAM" />

        </ItemDef>

        <ItemDef OID="SUPPAE.QLABEL" Name="QLABEL" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Qualifier Variable Label" />

        <ItemDef OID="SUPPAE.QVAL" Name="QVAL" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Data Value" />

        <ItemDef OID="SUPPAE.QORIG" Name="QORIG" DataType="text" Length="30" Origin="Assigned" Comment="" def:Label="Origin" />

        <ItemDef OID="SUPPAE.QEVAL" Name="QEVAL" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Evaluator" />

        <ItemDef OID="SUPPCM.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="SUPPCM.RDOMAIN" Name="RDOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Related Domain Abbreviation" />

        <ItemDef OID="SUPPCM.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="SUPPCM.IDVAR" Name="IDVAR" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Identifying Variable" />

        <ItemDef OID="SUPPCM.IDVARVAL" Name="IDVARVAL" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Identifying Variable Value" />

      - <ItemDef OID="SUPPCM.QNAM" Name="QNAM" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Qualifier Variable Name">

        <def:ValueListRef ValueListOID="ValueList.SUPPCM.QNAM" />

        </ItemDef>

        <ItemDef OID="SUPPCM.QLABEL" Name="QLABEL" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Qualifier Variable Label" />

        <ItemDef OID="SUPPCM.QVAL" Name="QVAL" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Data Value" />

        <ItemDef OID="SUPPCM.QORIG" Name="QORIG" DataType="text" Length="30" Origin="Assigned" Comment="" def:Label="Origin" />

        <ItemDef OID="SUPPCM.QEVAL" Name="QEVAL" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Evaluator" />

        <ItemDef OID="SUPPDM.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="SUPPDM.RDOMAIN" Name="RDOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Related Domain Abbreviation" />

        <ItemDef OID="SUPPDM.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="SUPPDM.IDVAR" Name="IDVAR" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Identifying Variable" />

        <ItemDef OID="SUPPDM.IDVARVAL" Name="IDVARVAL" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Identifying Variable Value" />

      - <ItemDef OID="SUPPDM.QNAM" Name="QNAM" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Qualifier Variable Name">

        <def:ValueListRef ValueListOID="ValueList.SUPPDM.QNAM" />

        </ItemDef>

        <ItemDef OID="SUPPDM.QLABEL" Name="QLABEL" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Qualifier Variable Label" />

        <ItemDef OID="SUPPDM.QVAL" Name="QVAL" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Data Value" />

        <ItemDef OID="SUPPDM.QORIG" Name="QORIG" DataType="text" Length="30" Origin="Assigned" Comment="" def:Label="Origin" />

        <ItemDef OID="SUPPDM.QEVAL" Name="QEVAL" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Evaluator" />

        <ItemDef OID="SUPPDS.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="SUPPDS.RDOMAIN" Name="RDOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Related Domain Abbreviation" />

        <ItemDef OID="SUPPDS.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="SUPPDS.IDVAR" Name="IDVAR" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Identifying Variable" />

        <ItemDef OID="SUPPDS.IDVARVAL" Name="IDVARVAL" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Identifying Variable Value" />

      - <ItemDef OID="SUPPDS.QNAM" Name="QNAM" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Qualifier Variable Name">

        <def:ValueListRef ValueListOID="ValueList.SUPPDS.QNAM" />

        </ItemDef>

        <ItemDef OID="SUPPDS.QLABEL" Name="QLABEL" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Qualifier Variable Label" />

        <ItemDef OID="SUPPDS.QVAL" Name="QVAL" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Data Value" />

        <ItemDef OID="SUPPDS.QORIG" Name="QORIG" DataType="text" Length="30" Origin="Assigned" Comment="" def:Label="Origin" />

        <ItemDef OID="SUPPDS.QEVAL" Name="QEVAL" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Evaluator" />

        <ItemDef OID="SUPPEG.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="SUPPEG.RDOMAIN" Name="RDOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Related Domain Abbreviation" />

        <ItemDef OID="SUPPEG.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="SUPPEG.IDVAR" Name="IDVAR" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Identifying Variable" />

        <ItemDef OID="SUPPEG.IDVARVAL" Name="IDVARVAL" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Identifying Variable Value" />

      - <ItemDef OID="SUPPEG.QNAM" Name="QNAM" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Qualifier Variable Name">

        <def:ValueListRef ValueListOID="ValueList.SUPPEG.QNAM" />

        </ItemDef>

        <ItemDef OID="SUPPEG.QLABEL" Name="QLABEL" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Qualifier Variable Label" />

        <ItemDef OID="SUPPEG.QVAL" Name="QVAL" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Data Value" />

        <ItemDef OID="SUPPEG.QORIG" Name="QORIG" DataType="text" Length="30" Origin="Assigned" Comment="" def:Label="Origin" />

        <ItemDef OID="SUPPEG.QEVAL" Name="QEVAL" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Evaluator" />

        <ItemDef OID="SUPPEX.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="SUPPEX.RDOMAIN" Name="RDOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Related Domain Abbreviation" />

        <ItemDef OID="SUPPEX.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="SUPPEX.IDVAR" Name="IDVAR" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Identifying Variable" />

        <ItemDef OID="SUPPEX.IDVARVAL" Name="IDVARVAL" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Identifying Variable Value" />

      - <ItemDef OID="SUPPEX.QNAM" Name="QNAM" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Qualifier Variable Name">

        <def:ValueListRef ValueListOID="ValueList.SUPPEX.QNAM" />

        </ItemDef>

        <ItemDef OID="SUPPEX.QLABEL" Name="QLABEL" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Qualifier Variable Label" />

        <ItemDef OID="SUPPEX.QVAL" Name="QVAL" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Data Value" />

        <ItemDef OID="SUPPEX.QORIG" Name="QORIG" DataType="text" Length="30" Origin="Assigned" Comment="" def:Label="Origin" />

        <ItemDef OID="SUPPEX.QEVAL" Name="QEVAL" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Evaluator" />

        <ItemDef OID="SUPPLB.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="SUPPLB.RDOMAIN" Name="RDOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Related Domain Abbreviation" />

        <ItemDef OID="SUPPLB.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="SUPPLB.IDVAR" Name="IDVAR" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Identifying Variable" />

        <ItemDef OID="SUPPLB.IDVARVAL" Name="IDVARVAL" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Identifying Variable Value" />

      - <ItemDef OID="SUPPLB.QNAM" Name="QNAM" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Qualifier Variable Name">

        <def:ValueListRef ValueListOID="ValueList.SUPPLB.QNAM" />

        </ItemDef>

        <ItemDef OID="SUPPLB.QLABEL" Name="QLABEL" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Qualifier Variable Label" />

        <ItemDef OID="SUPPLB.QVAL" Name="QVAL" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Data Value" />

        <ItemDef OID="SUPPLB.QORIG" Name="QORIG" DataType="text" Length="30" Origin="Assigned" Comment="" def:Label="Origin" />

        <ItemDef OID="SUPPLB.QEVAL" Name="QEVAL" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Evaluator" />

        <ItemDef OID="SUPPMH.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="SUPPMH.RDOMAIN" Name="RDOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Related Domain Abbreviation" />

        <ItemDef OID="SUPPMH.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="SUPPMH.IDVAR" Name="IDVAR" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Identifying Variable" />

        <ItemDef OID="SUPPMH.IDVARVAL" Name="IDVARVAL" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Identifying Variable Value" />

      - <ItemDef OID="SUPPMH.QNAM" Name="QNAM" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Qualifier Variable Name">

        <def:ValueListRef ValueListOID="ValueList.SUPPMH.QNAM" />

        </ItemDef>

        <ItemDef OID="SUPPMH.QLABEL" Name="QLABEL" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Qualifier Variable Label" />

        <ItemDef OID="SUPPMH.QVAL" Name="QVAL" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Data Value" />

        <ItemDef OID="SUPPMH.QORIG" Name="QORIG" DataType="text" Length="30" Origin="Assigned" Comment="" def:Label="Origin" />

        <ItemDef OID="SUPPMH.QEVAL" Name="QEVAL" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Evaluator" />

        <ItemDef OID="SUPPQS.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="SUPPQS.RDOMAIN" Name="RDOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Related Domain Abbreviation" />

        <ItemDef OID="SUPPQS.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="SUPPQS.IDVAR" Name="IDVAR" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Identifying Variable" />

        <ItemDef OID="SUPPQS.IDVARVAL" Name="IDVARVAL" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Identifying Variable Value" />

      - <ItemDef OID="SUPPQS.QNAM" Name="QNAM" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Qualifier Variable Name">

        <def:ValueListRef ValueListOID="ValueList.SUPPQS.QNAM" />

        </ItemDef>

        <ItemDef OID="SUPPQS.QLABEL" Name="QLABEL" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Qualifier Variable Label" />

        <ItemDef OID="SUPPQS.QVAL" Name="QVAL" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Data Value" />

        <ItemDef OID="SUPPQS.QORIG" Name="QORIG" DataType="text" Length="30" Origin="Assigned" Comment="" def:Label="Origin" />

        <ItemDef OID="SUPPQS.QEVAL" Name="QEVAL" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Evaluator" />

        <ItemDef OID="SUPPSG.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="SUPPSG.RDOMAIN" Name="RDOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Related Domain Abbreviation" />

        <ItemDef OID="SUPPSG.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="SUPPSG.IDVAR" Name="IDVAR" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Identifying Variable" />

        <ItemDef OID="SUPPSG.IDVARVAL" Name="IDVARVAL" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Identifying Variable Value" />

      - <ItemDef OID="SUPPSG.QNAM" Name="QNAM" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Qualifier Variable Name">

        <def:ValueListRef ValueListOID="ValueList.SUPPSG.QNAM" />

        </ItemDef>

        <ItemDef OID="SUPPSG.QLABEL" Name="QLABEL" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Qualifier Variable Label" />

        <ItemDef OID="SUPPSG.QVAL" Name="QVAL" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Data Value" />

        <ItemDef OID="SUPPSG.QORIG" Name="QORIG" DataType="text" Length="30" Origin="Assigned" Comment="" def:Label="Origin" />

        <ItemDef OID="SUPPSG.QEVAL" Name="QEVAL" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Evaluator" />

        <ItemDef OID="SUPPSV.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="SUPPSV.RDOMAIN" Name="RDOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Related Domain Abbreviation" />

        <ItemDef OID="SUPPSV.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="SUPPSV.IDVAR" Name="IDVAR" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Identifying Variable" />

        <ItemDef OID="SUPPSV.IDVARVAL" Name="IDVARVAL" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Identifying Variable Value" />

      - <ItemDef OID="SUPPSV.QNAM" Name="QNAM" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Qualifier Variable Name">

        <def:ValueListRef ValueListOID="ValueList.SUPPSV.QNAM" />

        </ItemDef>

        <ItemDef OID="SUPPSV.QLABEL" Name="QLABEL" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Qualifier Variable Label" />

        <ItemDef OID="SUPPSV.QVAL" Name="QVAL" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Data Value" />

        <ItemDef OID="SUPPSV.QORIG" Name="QORIG" DataType="text" Length="30" Origin="Assigned" Comment="" def:Label="Origin" />

        <ItemDef OID="SUPPSV.QEVAL" Name="QEVAL" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Evaluator" />

        <ItemDef OID="SUPPVS.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="SUPPVS.RDOMAIN" Name="RDOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Related Domain Abbreviation" />

        <ItemDef OID="SUPPVS.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="SUPPVS.IDVAR" Name="IDVAR" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Identifying Variable" />

        <ItemDef OID="SUPPVS.IDVARVAL" Name="IDVARVAL" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Identifying Variable Value" />

      - <ItemDef OID="SUPPVS.QNAM" Name="QNAM" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Qualifier Variable Name">

        <def:ValueListRef ValueListOID="ValueList.SUPPVS.QNAM" />

        </ItemDef>

        <ItemDef OID="SUPPVS.QLABEL" Name="QLABEL" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Qualifier Variable Label" />

        <ItemDef OID="SUPPVS.QVAL" Name="QVAL" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Data Value" />

        <ItemDef OID="SUPPVS.QORIG" Name="QORIG" DataType="text" Length="30" Origin="Assigned" Comment="" def:Label="Origin" />

        <ItemDef OID="SUPPVS.QEVAL" Name="QEVAL" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Evaluator" />

        <ItemDef OID="SUPPXZ.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="SUPPXZ.RDOMAIN" Name="RDOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Related Domain Abbreviation" />

        <ItemDef OID="SUPPXZ.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="SUPPXZ.IDVAR" Name="IDVAR" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Identifying Variable" />

        <ItemDef OID="SUPPXZ.IDVARVAL" Name="IDVARVAL" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Identifying Variable Value" />

      - <ItemDef OID="SUPPXZ.QNAM" Name="QNAM" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Qualifier Variable Name">

        <def:ValueListRef ValueListOID="ValueList.SUPPXZ.QNAM" />

        </ItemDef>

        <ItemDef OID="SUPPXZ.QLABEL" Name="QLABEL" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Qualifier Variable Label" />

        <ItemDef OID="SUPPXZ.QVAL" Name="QVAL" DataType="text" Length="200" Origin="CRF" Comment="" def:Label="Data Value" />

        <ItemDef OID="SUPPXZ.QORIG" Name="QORIG" DataType="text" Length="30" Origin="Assigned" Comment="" def:Label="Origin" />

        <ItemDef OID="SUPPXZ.QEVAL" Name="QEVAL" DataType="text" Length="60" Origin="Assigned" Comment="" def:Label="Evaluator" />

        <ItemDef OID="SV.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="SV.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="SV.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="SV.VISITNUM" Name="VISITNUM" DataType="float" Length="8" SignificantDigits="3" Origin="Assigned" Comment="" def:Label="Visit Number" />

        <ItemDef OID="SV.VISIT" Name="VISIT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Visit Name" />

        <ItemDef OID="SV.SVSTDTC" Name="SVSTDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Start Date/Time of Visit" />

        <ItemDef OID="SV.SVENDTC" Name="SVENDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="End Date/Time of Visit" />

        <ItemDef OID="TI.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="TI.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="TI.IETESTCD" Name="IETESTCD" DataType="text" Length="8" Origin="Protocol" Comment="" def:Label="Inclusion/Exclusion Criterion Short Name" />

        <ItemDef OID="TI.IETEST" Name="IETEST" DataType="text" Length="200" Origin="Protocol" Comment="" def:Label="Inclusion/Exclusion Criterion" />

      - <ItemDef OID="TI.IECAT" Name="IECAT" DataType="text" Length="9" Origin="Protocol" Comment="" def:Label="Inclusion/Exclusion Category">

        <def:ValueListRef ValueListOID="ValueList.IE.IECAT" />

        </ItemDef>

        <ItemDef OID="VS.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="VS.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="VS.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="VS.VSSEQ" Name="VSSEQ" DataType="integer" Length="8" Origin="Derived" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="VS.VSSPID" Name="VSSPID" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Sponsor-Defined Identifier" />

      - <ItemDef OID="VS.VSTESTCD" Name="VSTESTCD" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Vital Signs Test Short Name">

        <def:ValueListRef ValueListOID="ValueList.VS.VSTESTCD" />

        </ItemDef>

        <ItemDef OID="VS.VSTEST" Name="VSTEST" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Vital Signs Test Name" />

      - <ItemDef OID="VS.VSPOS" Name="VSPOS" DataType="text" Length="20" Origin="CRF" Comment="" def:Label="Vital Signs Position of Subject">

        <CodeListRef CodeListOID="VSPOS" />

        </ItemDef>

        <ItemDef OID="VS.VSORRES" Name="VSORRES" DataType="text" Length="40" Origin="CRF" Comment="" def:Label="Result or Finding in Original Units" />

      - <ItemDef OID="VS.VSORRESU" Name="VSORRESU" DataType="text" Length="20" Origin="CRF" Comment="" def:Label="Original Units">

        <CodeListRef CodeListOID="VSRESU" />

        </ItemDef>

        <ItemDef OID="VS.VSSTRESC" Name="VSSTRESC" DataType="text" Length="40" Origin="Derived" Comment="Copied or derived from --ORRES in a standard format or standard units." def:Label="Character Result/Finding in Std Format" />

        <ItemDef OID="VS.VSSTRESN" Name="VSSTRESN" DataType="float" Length="8" SignificantDigits="4" Origin="Derived" Comment="Copied in numeric format from --STRESC" def:Label="Numeric Result/Finding in Standard Units" />

      - <ItemDef OID="VS.VSSTRESU" Name="VSSTRESU" DataType="text" Length="20" Origin="Derived" Comment="Standardized unit used for --STRESC or --STRESN." def:Label="Standard Units">

        <CodeListRef CodeListOID="VSTRESU" />

        </ItemDef>

      - <ItemDef OID="VS.VSBLFL" Name="VSBLFL" DataType="text" Length="1" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Baseline Flag">

        <CodeListRef CodeListOID="YES" />

        </ItemDef>

        <ItemDef OID="VS.VISITNUM" Name="VISITNUM" DataType="float" Length="8" SignificantDigits="3" Origin="Assigned" Comment="" def:Label="Visit Number" />

        <ItemDef OID="VS.VISIT" Name="VISIT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Visit Name" />

      - <ItemDef OID="VS.EPOCH" Name="EPOCH" DataType="text" Length="40" Origin="Derived" Comment="EPOCH variable is populated based on the Phase or Period of the trial." def:Label="Trial Epoch">

        <CodeListRef CodeListOID="EPCH" />

        </ItemDef>

        <ItemDef OID="VS.VSDTC" Name="VSDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Date/Time of Measurements" />

        <ItemDef OID="XZ.STUDYID" Name="STUDYID" DataType="text" Length="40" Origin="Protocol" Comment="" def:Label="Study Identifier" />

        <ItemDef OID="XZ.DOMAIN" Name="DOMAIN" DataType="text" Length="2" Origin="Assigned" Comment="" def:Label="Domain Abbreviation" />

        <ItemDef OID="XZ.USUBJID" Name="USUBJID" DataType="text" Length="70" Origin="Derived" Comment="Concatenation of STUDYID, SITEID, SUBJID" def:Label="Unique Subject Identifier" />

        <ItemDef OID="XZ.XZSEQ" Name="XZSEQ" DataType="integer" Length="8" Origin="Derived" Comment="Sequence number given to ensure uniqueness within a dataset for a subject" def:Label="Sequence Number" />

        <ItemDef OID="XZ.XZSPID" Name="XZSPID" DataType="text" Length="200" Origin="Assigned" Comment="" def:Label="Sponsor-Defined Identifier" />

        <ItemDef OID="XZ.XZTESTCD" Name="XZTESTCD" DataType="text" Length="8" Origin="Assigned" Comment="" def:Label="Sample Handling Test Short Name" />

        <ItemDef OID="XZ.XZTEST" Name="XZTEST" DataType="text" Length="40" Origin="Assigned" Comment="" def:Label="Sample Handling Test Name" />

      - <ItemDef OID="XZ.XZCAT" Name="XZCAT" DataType="text" Length="40" Origin="CRF" Comment="" def:Label="Category for Sample Handling">

        <def:ValueListRef ValueListOID="ValueList.XZ.XZCAT" />

        </ItemDef>

        <ItemDef OID="XZ.XZORRES" Name="XZORRES" DataType="text" Length="40" Origin="CRF" Comment="" def:Label="Result or Finding in Original Units" />

        <ItemDef OID="XZ.XZORRESU" Name="XZORRESU" DataType="text" Length="20" Origin="CRF" Comment="" def:Label="Original Units" />

        <ItemDef OID="XZ.XZSTRESC" Name="XZSTRESC" DataType="text" Length="40" Origin="Derived" Comment="Copied or derived from --ORRES in a standard format or standard units." def:Label="Character Result/Finding in Std Format" />

        <ItemDef OID="XZ.XZSTRESN" Name="XZSTRESN" DataType="float" Length="8" SignificantDigits="4" Origin="Derived" Comment="Copied in numeric format from --STRESC" def:Label="Numeric Result/Finding in Standard Units" />

        <ItemDef OID="XZ.XZSTRESU" Name="XZSTRESU" DataType="text" Length="20" Origin="Derived" Comment="Standardized unit used for --STRESC or --STRESN." def:Label="Standard Units" />

      - <ItemDef OID="XZ.XZBLFL" Name="XZBLFL" DataType="text" Length="1" Origin="Derived" Comment="The algorithm becomes available in Q2, 2011" def:Label="Baseline Flag">

        <CodeListRef CodeListOID="YES" />

        </ItemDef>

        <ItemDef OID="XZ.VISITNUM" Name="VISITNUM" DataType="float" Length="8" SignificantDigits="3" Origin="Assigned" Comment="" def:Label="Visit Number" />

        <ItemDef OID="XZ.VISIT" Name="VISIT" DataType="text" Length="60" Origin="CRF" Comment="" def:Label="Visit Name" />

      - <ItemDef OID="XZ.EPOCH" Name="EPOCH" DataType="text" Length="40" Origin="Derived" Comment="EPOCH variable is populated based on the Phase or Period of the trial." def:Label="Trial Epoch">

        <CodeListRef CodeListOID="EPCH" />

        </ItemDef>

        <ItemDef OID="XZ.XZDTC" Name="XZDTC" DataType="text" Length="19" Origin="CRF" Comment="" def:Label="Date/Time of Sample Handling" />

      - <CodeList OID="ACN" Name="ACN" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DOSE INCREASED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DOSE NOT CHANGED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DOSE REDUCED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DRUG INTERRUPTED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DRUG WITHDRAWN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NOT APPLICABLE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="7" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UNKNOWN</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="AESEV" Name="AESEV" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MILD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MODERATE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SEVERE</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="AGEU" Name="AGEU" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HOURS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DAYS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">WEEKS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MONTHS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">YEARS</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="BMK1" Name="BMK1" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">YES</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="BPRSL" Name="BPRSL" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NOT ASSESSED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NOT PRESENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">VERY MILD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MILD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MODERATE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MODERATELY SEVERE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SEVERE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="7" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">EXTREMELY SEVERE</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="CADSSL" Name="CADSSL" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NOT AT ALL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MILD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MODERATE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SEVERE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">EXTREME</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="CGI1" Name="CGI1" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">0</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">2</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">4</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">5</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">6</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="7" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">7</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="CMIMPR" Name="CMIMPR" DataType="C">

      - <CodeListItem CodedValue="A" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">A= Less than 25% improved</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="B" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">B= Between 25% and 49% improved</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="C" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">C= Between 50% and 75% improved</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="D" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">D= More than 75% improved</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="CMMINMA" Name="CMMINMA" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Equal or greater than Minimum Dose</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Equal or greater than Maximum Dose</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="CMPRV" Name="CMPRV" DataType="C">

      - <CodeListItem CodedValue="C" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Current</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="P" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Previous</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="COEVAL" Name="COEVAL" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ADJUDICATION COMMITTEE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">STATISTICIAN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CLINICAL COORDINATOR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PRIMARY INVESTIGATOR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">VENDOR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="7" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CARDIOLOGIST</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="COUNTRY" Name="COUNTRY" DataType="C">

      - <CodeListItem CodedValue="AFGHANISTAN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AFG</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ALAND ISLANDS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ALA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ALBANIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ALB</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ALGERIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DZA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="AMERICAN SAMOA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ASM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ANDORRA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AND</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ANGOLA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AGO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ANGUILLA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AIA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ANTARCTICA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ATA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ANTIGUA AND BARBUDA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ATG</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ARGENTINA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ARG</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ARMENIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ARM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ARUBA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ABW</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="AUSTRALIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AUS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="AUSTRIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AUT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="AZERBAIJAN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AZE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BAHAMAS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BHS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BAHRAIN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BHR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BANGLADESH" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BGD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BARBADOS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BRB</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BELARUS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BLR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BELGIUM" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BEL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BELIZE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BLZ</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BENIN REPUBLIC" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BEN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BERMUDA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BMU</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BHUTAN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BTN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BOLIVIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BOL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BOSNIA-HERZEGOVINA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BIH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BOTSWANA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BWA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BOUVET ISLAND" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BVT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BRAZIL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BRA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BRITISH INDIAN OCEAN TERRITORY" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">IOT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BRUNEI" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BRN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BULGARIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BGR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BURKINA FASO" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BFA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BURUNDI" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BDI</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CAMBODIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">KHM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CAMEROON" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CMR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CANADA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CAN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CAPE VERDE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CPV</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CAYMAN ISLANDS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CYM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CENTRAL AFRICAN REPUBLIC" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CAF</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CHAD" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TCD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CHILE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CHL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CHINA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CHN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CHRISTMAS ISLAND" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CXR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="COCOS (KEELING) ISLANDS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CCK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="COLOMBIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">COL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="COMOROS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">COM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CONGO" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">COG</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="COOK ISLANDS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">COK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="COSTA RICA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CRI</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="COTE D'IVOIRE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CIV</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CROATIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HRV</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CUBA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CUB</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CYPRUS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CYP</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CZECH REPUBLIC" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CZE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="DEMOCRATIC REPUBLIC OF THE CONGO" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">COD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="DENMARK" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DNK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="DJIBOUTI" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DJI</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="DOMINICA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DMA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="DOMINICAN REPUBLIC" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DOM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ECUADOR" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ECU</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="EGYPT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">EGY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="EL SALVADOR" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SLV</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="EQUATORIAL GUINEA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GNQ</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ERITREA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ERI</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ESTONIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">EST</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ETHIOPIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ETH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FALKLAND ISLANDS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FLK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FAROE ISLANDS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FRO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FIJI" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FJI</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FINLAND" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FIN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FRANCE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FRA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FRENCH GUIANA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GUF</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FRENCH POLYNESIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PYF</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FRENCH SOUTHERN TERRITORIES" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ATF</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GABON" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GAB</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GAMBIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GMB</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GEORGIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GEO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GERMANY" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DEU</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GHANA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GHA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GIBRALTAR" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GIB</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GREECE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GRC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GREENLAND" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GRL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GRENADA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GRD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GUADELOUPE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GLP</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GUAM" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GUM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GUATEMALA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GTM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GUERNSEY" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GGY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GUINEA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GIN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GUINEA-BISSAU" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GNB</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GUYANA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GUY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="HAITI" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HTI</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="HEARD ISLAND AND MCDONALD ISLANDS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HMD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="HKG; HONG KONG" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HKG</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="HONDURAS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HND</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="HUNGARY" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HUN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ICELAND" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ISL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INDIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">IND</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INDONESIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">IDN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="IRAN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">IRN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="IRAQ" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">IRQ</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="IRELAND" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">IRL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ISRAEL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ISR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ITALY" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ITA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="JAMAICA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">JAM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="JAPAN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">JPN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="JERSEY" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">JRE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="JORDAN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">JOR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="KAZAKHSTAN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">KAZ</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="KENYA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">KEN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="KIRIBATI" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">KIR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="KUWAIT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">KWT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="KYRGYZSTAN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">KGZ</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LAO PEOPLE'S DEMOCRATIC REPUBLIC" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LAO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LATVIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LVA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LEBANON" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LBN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LESOTHO" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LSO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LIBERIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LBR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LIBYAN ARAB JAMAHIRIYA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LBY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LIECHTENSTEIN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LIE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LITHUANIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LTU</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LUXEMBOURG" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LUX</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MACAO" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MAC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MADAGASCAR" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MDG</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MALAWI" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MWI</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MALAYSIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MYS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MALDIVES" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MDV</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MALI" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MLI</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MALTA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MLT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MARSHALL ISLANDS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MHL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MARTINIQUE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MTQ</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MAURITANIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MRT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MAURITIUS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MUS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MAYOTTE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MYT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MEXICO" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MEX</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MICRONESIA, FEDERATED STATES OF" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FSM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MOLDOVA, REPUBLIC OF" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MDA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MONACO" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MCO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MONGOLIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MNG</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MONTENEGRO" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MNE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MONTSERRAT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MSR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MOROCCO" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MAR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MOZAMBIQUE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MOZ</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MYANMAR" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MMR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NAMIBIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NAM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NAURU" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NRU</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NEPAL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NPL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NETHERLANDS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NLD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NETHERLANDS ANTILLES" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ANT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NEW CALEDONIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NCL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NEW ZEALAND" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NZL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NICARAGUA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NIC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NIGER" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NER</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NIGERIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NGA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NIUE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NIU</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NORFOLK ISLAND" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NFK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NORTH KOREA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PRK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NORTHERN MARIANA ISLANDS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MNP</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NORWAY" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NOR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="OMAN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OMN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PAKISTAN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PAK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PALAU" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PLW</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PALESTINIAN TERRITORY, OCCUPIED" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PSE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PANAMA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PAN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PAPUA NEW GUINEA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PNG</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PARAGUAY" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PRY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PERU" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PER</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PHILIPPINES" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PHL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PITCAIRN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PCN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="POLAND" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">POL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PORTUGAL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PRT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PUERTO RICO" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PRI</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="QATAR" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">QAT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="REPUBLIC OF MACEDONIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MKD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="REUNION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">REU</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ROMANIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ROU</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="RUSSIAN FEDERATION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">RUS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="RWANDA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">RWA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SAINT HELENA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SHN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SAINT KITTS AND NEVIS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">KNA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SAINT LUCIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LCA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SAINT PIERRE AND MIQUELON" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SPM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SAINT VINCENT AND THE GRENADINES" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">VCT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SAMOA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">WSM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SAN MARINO" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SMR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SAO TOME AND PRINCIPE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">STP</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SAUDI ARABIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SAU</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SENEGAL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SEN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SERBIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SCG</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SEYCHELLES" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SYC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SIERRA LEONE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SLE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SINGAPORE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SGP</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SLOVAKIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SVK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SLOVENIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SVN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SOLOMON ISLANDS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SLB</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SOMALIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SOM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SOUTH AFRICA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ZAF</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SOUTH GEORGIA AND THE SOUTH SANDWICH ISLANDS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SGS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SOUTH KOREA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">KOR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SPAIN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ESP</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SRI LANKA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LKA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SUDAN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SDN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SURINAME" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SUR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SVALBARD AND JAN MAYEN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SJM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SWAZILAND" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SWZ</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SWEDEN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SWE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SWITZERLAND" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CHE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SYRIAN ARAB REPUBLIC" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SYR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TAIWAN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TWN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TAJIKISTAN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TJK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TANZANIA, UNITED REPUBLIC OF" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TZA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="THAILAND" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">THA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TIMOR-LESTE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TLS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TOGO" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TGO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TOKELAU" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TKL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TONGA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TON</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TRINIDAD AND TOBAGO" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TTO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TUNISIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TUN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TURKEY" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TUR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TURKMENISTAN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TKM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TURKS AND CAICOS ISLANDS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TCA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TUVALU" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TUV</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="UGANDA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UGA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="UKRAINE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UKR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="UNITED ARAB EMIRATES" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ARE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="UNITED KINGDOM" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GBR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="UNITED STATES" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">USA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="UNITED STATES MINOR OUTLYING ISLANDS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UMI</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="URUGUAY" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">URY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="UZBEKISTAN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UZB</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="VANUATU" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">VUT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="VATICAN CITY STATE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">VAT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="VENEZUELA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">VEN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="VIETNAM" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">VNM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="VIRGIN ISLANDS, BRITISH" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">VGB</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="VIRGIN ISLANDS, U.S." def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">VIR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="WALLIS AND FUTUNA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">WLF</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="WESTERN SAHARA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ESH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="YEMEN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">YEM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ZAMBIA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ZMB</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ZIMBABWE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ZWE</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="CPFQLK" Name="CPFQLK" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GREATER THAN NORMAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NORMAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MINIMALLY DIMINISHED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MODERATELY DIMINISHED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MARKEDLY DIMINISHED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TOTALLY ABSENT</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="CSSCD1" Name="CSSCD1" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">YES</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="CSSCD2" Name="CSSCD2" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">2</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">4</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">5</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="CSSCD3" Name="CSSCD3" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">6</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">2</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">4</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">5</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="CSSCD4" Name="CSSCD4" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">2</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="DNST1" Name="DNST1" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">YES</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="DNST2" Name="DNST2" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3 years</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">5 years</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">10 years</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">15 years</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">20 years</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="99" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Other</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="DOSU" Name="DOSU" DataType="C">

      - <CodeListItem CodedValue="CAPSULE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CAPSULE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="DROPS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DROPS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="L" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">L</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="OINTMENT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OINTMENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="OTHER" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OTHER</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PATCH" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PATCH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PILL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PILL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PUFF" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PUFF</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLESPOON" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLESPOON</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TEASPOON" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TEASPOON</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="UNITS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UNITS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="g" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">g</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="mL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">mL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="mcL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">mcL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="mcg" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">mcg</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="meq" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">meq</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="mg" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">mg</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="DSCAT" Name="DSCAT" DataType="C">

      - <CodeListItem CodedValue="DISPOSITION EVENT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DISPOSITION EVENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="OTHER EVENT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OTHER EVENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PROTOCOL MILESTONE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PROTOCOL MILESTONE</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="EGEVAL" Name="EGEVAL" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ADJUDICATION COMMITTEE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">STATISTICIAN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DATABASE ADMINISTRATOR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CLINICAL COORDINATOR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PRIMARY INVESTIGATOR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">VENDOR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="7" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CARDIOLOGIST</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="EGINTP" Name="EGINTP" DataType="C">

      - <CodeListItem CodedValue="ABNORMAL, CLINICALLY INSIGNIFICANT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ABNORMAL, CLINICALLY INSIGNIFICANT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ABNORMAL, CLINICALLY SIGNIFICANT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ABNORMAL, CLINICALLY SIGNIFICANT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="WITHIN NORMAL LIMITS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">WITHIN NORMAL LIMITS</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="EGPOS" Name="EGPOS" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SUPINE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">STANDING</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SITTING</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="EGRESU" Name="EGRESU" DataType="C">

      - <CodeListItem CodedValue="BEATS/MIN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BEATS/MIN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="beats/min" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">beats/min</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="degrees" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">degrees</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="mm" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">mm</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ms" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ms</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="msec" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">msec</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="sec" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">sec</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="EGSRESU" Name="EGSRESU" DataType="C">

      - <CodeListItem CodedValue="BEATS/MIN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BEATS/MIN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="beats/min" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">beats/min</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="degrees" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">degrees</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="mm" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">mm</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ms" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ms</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="msec" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">msec</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="sec" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">sec</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="EPCH" Name="EPCH" DataType="C">

      - <CodeListItem CodedValue="DOUBLE BLIND" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DOUBLE BLIND</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="END OF TRIAL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">END OF TRIAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="EXTENSION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">EXTENSION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FOLLOW-UP" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FOLLOW-UP</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MAINTENANCE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MAINTENANCE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="OPEN LABEL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OPEN LABEL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PERIOD 1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PERIOD 1</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PERIOD 2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PERIOD 2</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="POSTTREATMENT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">POSTTREATMENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PRE TREATMENT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PRE TREATMENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="RUN-IN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">RUN-IN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SCREENING" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SCREENING</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TAPER" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TAPER</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TITRATION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TITRATION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TREATMENT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TREATMENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TREATMENT1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TREATMENT1</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TREATMENT2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TREATMENT2</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="WASH-OUT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">WASH-OUT</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="ETHNIC" Name="ETHNIC" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HISPANIC OR LATINO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NOT HISPANIC OR LATINO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UNKNOWN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NOT REPORTED</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="EXDOSU" Name="EXDOSU" DataType="C">

      - <CodeListItem CodedValue="CAPSULE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CAPSULE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="DROPS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DROPS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="L" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">L</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="OINTMENT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OINTMENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="OTHER" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OTHER</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PATCH" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PATCH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PILL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PILL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PUFF" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PUFF</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLESPOON" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLESPOON</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TEASPOON" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TEASPOON</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="UNITS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UNITS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="g" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">g</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="mL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">mL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="mcL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">mcL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="mcg" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">mcg</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="meq" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">meq</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="mg" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">mg</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="mg/kg" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">mg/kg</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="EXFRM" Name="EXFRM" DataType="C">

      - <CodeListItem CodedValue="AEROSOL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AEROSOL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="AEROSOL, FOAM" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AEROSOL, FOAM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="AEROSOL, METERED" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AEROSOL, METERED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="AEROSOL, POWDER" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AEROSOL, POWDER</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="AEROSOL, SPRAY" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AEROSOL, SPRAY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BAR, CHEWABLE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BAR, CHEWABLE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BEAD" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BEAD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BEAD, IMPLANT, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BEAD, IMPLANT, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BLOCK" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BLOCK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CAPSULE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CAPSULE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CAPSULE, COATED" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CAPSULE, COATED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CAPSULE, COATED PELLETS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CAPSULE, COATED PELLETS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CAPSULE, COATED, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CAPSULE, COATED, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CAPSULE, DELAYED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CAPSULE, DELAYED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CAPSULE, DELAYED RELEASE PELLETS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CAPSULE, DELAYED RELEASE PELLETS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CAPSULE, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CAPSULE, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CAPSULE, FILM COATED, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CAPSULE, FILM COATED, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CAPSULE, GELATIN COATED" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CAPSULE, GELATIN COATED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CAPSULE, LIQUID FILLED" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CAPSULE, LIQUID FILLED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CEMENT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CEMENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CIGARETTE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CIGARETTE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CLOTH" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CLOTH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="COATED PARTICLES" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">COATED PARTICLES</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CONCENTRATE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CONCENTRATE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CONE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CONE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CORE, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CORE, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CREAM" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CREAM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CREAM, AUGMENTED" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CREAM, AUGMENTED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CRYSTAL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CRYSTAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CULTURE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CULTURE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="DIAPHRAGM" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DIAPHRAGM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="DISC" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DISC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="DOUCHE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DOUCHE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="DRESSING" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DRESSING</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="DRUG DELIVERY SYSTEM" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DRUG DELIVERY SYSTEM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ELIXIR" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ELIXIR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="EMULSION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">EMULSION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ENEMA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ENEMA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="EXTRACT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">EXTRACT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FIBER, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FIBER, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FILM" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FILM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FILM, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FILM, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FILM, SOLUBLE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FILM, SOLUBLE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FOR SOLUTION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FOR SOLUTION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FOR SUSPENSION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FOR SUSPENSION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FOR SUSPENSION, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FOR SUSPENSION, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GAS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GAS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GEL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GEL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GEL, DENTIFRICE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GEL, DENTIFRICE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GEL, METERED" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GEL, METERED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GENERATOR" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GENERATOR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GLOBULE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GLOBULE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GRAFT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GRAFT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GRANULE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GRANULE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GRANULE, DELAYED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GRANULE, DELAYED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GRANULE, EFFERVESCENT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GRANULE, EFFERVESCENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GRANULE, FOR SOLUTION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GRANULE, FOR SOLUTION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GRANULE, FOR SUSPENSION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GRANULE, FOR SUSPENSION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GRANULE, FOR SUSPENSION, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GRANULE, FOR SUSPENSION, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GUM" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GUM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GUM, CHEWING" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GUM, CHEWING</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="GUM, RESIN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GUM, RESIN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="IMPLANT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">IMPLANT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INHALANT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INHALANT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INJECTABLE, LIPOSOMAL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INJECTABLE, LIPOSOMAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INJECTION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INJECTION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INJECTION, EMULSION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INJECTION, EMULSION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INJECTION, LIPID COMPLEX" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INJECTION, LIPID COMPLEX</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INJECTION, POWDER, FOR SOLUTION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INJECTION, POWDER, FOR SOLUTION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INJECTION, POWDER, FOR SUSPENSION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INJECTION, POWDER, FOR SUSPENSION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INJECTION, SOLUTION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INJECTION, SOLUTION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INJECTION, SOLUTION, CONCENTRATE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INJECTION, SOLUTION, CONCENTRATE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INJECTION, SUSPENSION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INJECTION, SUSPENSION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INJECTION, SUSPENSION, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INJECTION, SUSPENSION, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INJECTION, SUSPENSION, LIPOSOMAL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INJECTION, SUSPENSION, LIPOSOMAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INJECTION, SUSPENSION, SONICATED" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INJECTION, SUSPENSION, SONICATED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INSERT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INSERT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INSERT, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INSERT, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INTRAUTERINE DEVICE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INTRAUTERINE DEVICE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="IRRIGANT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">IRRIGANT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="JELLY" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">JELLY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="KIT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">KIT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LINER, DENTAL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LINER, DENTAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LINIMENT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LINIMENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LIPSTICK" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LIPSTICK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LIQUID" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LIQUID</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LIQUID," def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LIQUID,</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LOTION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LOTION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LOTION, AUGMENTED" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LOTION, AUGMENTED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LOTION/SHAMPOO" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LOTION/SHAMPOO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LOZENGE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LOZENGE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MOUTHWASH" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MOUTHWASH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NOT APPLICABLE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NOT APPLICABLE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="OIL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OIL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="OINTMENT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OINTMENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="OINTMENT, AUGMENTED" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OINTMENT, AUGMENTED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PACKING" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PACKING</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PASTE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PASTE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PASTE, DENTIFRICE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PASTE, DENTIFRICE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PASTILLE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PASTILLE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PATCH" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PATCH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PATCH, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PATCH, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLED" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PELLET" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PELLET</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PELLET, IMPLANTABLE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PELLET, IMPLANTABLE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PELLETS, COATED, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PELLETS, COATED, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PILL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PILL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PLASTER" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PLASTER</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="POULTICE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">POULTICE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="POWDER" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">POWDER</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="POWDER, DENTIFRICE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">POWDER, DENTIFRICE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="POWDER, FOR SOLUTION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">POWDER, FOR SOLUTION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="POWDER, FOR SUSPENSION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">POWDER, FOR SUSPENSION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="POWDER, METERED" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">POWDER, METERED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="RING" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">RING</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="RINSE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">RINSE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SALVE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SALVE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SHAMPOO" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SHAMPOO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SHAMPOO, SUSPENSION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SHAMPOO, SUSPENSION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SOAP" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SOAP</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SOLUTION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SOLUTION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SOLUTION, CONCENTRATE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SOLUTION, CONCENTRATE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SOLUTION, FOR SLUSH" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SOLUTION, FOR SLUSH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SOLUTION, GEL FORMING / DROPS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SOLUTION, GEL FORMING / DROPS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SOLUTION, GEL FORMING, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SOLUTION, GEL FORMING, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SOLUTION/ DROPS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SOLUTION/ DROPS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SPONGE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SPONGE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SPRAY" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SPRAY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SPRAY, METERED" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SPRAY, METERED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SPRAY, SUSPENSION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SPRAY, SUSPENSION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="STICK" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">STICK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="STRIP" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">STRIP</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SUPPOSITORY" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SUPPOSITORY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SUPPOSITORY, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SUPPOSITORY, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SUSPENSION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SUSPENSION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SUSPENSION, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SUSPENSION, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SUSPENSION/ DROPS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SUSPENSION/ DROPS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SUTURE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SUTURE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SWAB" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SWAB</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SYRUP" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SYRUP</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET," def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET,</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET, CHEWABLE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET, CHEWABLE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET, COATED" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET, COATED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET, DELAYED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET, DELAYED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET, DELAYED RELEASE PARTICLES" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET, DELAYED RELEASE PARTICLES</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET, DISPERSIBLE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET, DISPERSIBLE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET, EFFERVESCENT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET, EFFERVESCENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET, FILM COATED" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET, FILM COATED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET, FILM COATED, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET, FILM COATED, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET, FOR SOLUTION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET, FOR SOLUTION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET, FOR SUSPENSION" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET, FOR SUSPENSION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET, MULTILAYER" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET, MULTILAYER</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET, MULTILAYER, EXTENDED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET, MULTILAYER, EXTENDED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET, ORALLY DISINTEGRATING" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET, ORALLY DISINTEGRATING</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET, SOLUBLE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET, SOLUBLE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TABLET, SUGAR COATED" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TABLET, SUGAR COATED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TAMPON" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TAMPON</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TAPE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TAPE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TINCTURE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TINCTURE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TROCHE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TROCHE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="UNASSIGNED" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UNASSIGNED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="WAFER" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">WAFER</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="FRMNM" Name="FRMNM" DataType="C">

      - <CodeListItem CodedValue="AE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CM" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CO" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="DM" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="DS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="EG" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">EG</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="EX" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">EX</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="IE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">IE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LB" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LB</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MH" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ML" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ML</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PC" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="QS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">QS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SC" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SG" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SG</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SV" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SV</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="VS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">VS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="XZ" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">XZ</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="FRQ" Name="FRQ" DataType="C">

      - <CodeListItem CodedValue="2XAM" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">2XAM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2XPM" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">2XPM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="AC" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BID" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BID</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BIW" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BIW</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="CONT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CONT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="DAILY" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DAILY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="FID" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FID</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="HS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MONTHLY" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MONTHLY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ONCE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ONCE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="OTHER" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OTHER</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PC" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PCA" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PCA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="PRN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PRN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="Q1-2H" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Q1-2H</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="Q10H" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Q10H</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="Q11H" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Q11H</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="Q12H" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Q12H</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="Q4W" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Q4W</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="QAM" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">QAM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="QD" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">QD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="QH" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">QH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="QID" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">QID</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="QIW" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">QIW</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="QOD" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">QOD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="QPM" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">QPM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="QW" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">QW</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="STAT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">STAT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TID" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TID</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TIW" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TIW</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="UNK" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UNK</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL1" Name="IDSCL1" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NEVER TAKES LONGER THAN 30 MINUTES TO FALL ASLEEP.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TAKES AT LEAST 30 MINUTES TO FALL ASLEEP, LESS THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TAKES AT LEAST 30 MINUTES TO FALL ASLEEP, MORE THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TAKES MORE THAN 60 MINUTES TO FALL ASLEEP, MORE THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL10" Name="IDSCL10" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MOOD IS VIRTUALLY IDENTICAL TO FEELINGS ASSOCIATED WITH BEREAVEMENT OR IS UNDISTURBED.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MOOD IS LARGELY LIKE SADNESS IN BEREAVEMENT, ALTHOUGH IT MAY LACK EXPLANATION, BE ASSOCIATED WITH MORE ANXIETY, OR BE MUCH MORE INTENSE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LESS THAN HALF THE TIME, MOOD IS QUALITATIVELY DISTINCT FROM GRIEF AND THEREFORE DIFFICULT TO EXPLAIN TO OTHERS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MOOD IS QUALITATIVELY DISTINCT FROM GRIEF NEARLY ALL OF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL11" Name="IDSCL11" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NO CHANGE FROM USUAL APPETITE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">EATS SOMEWHAT LESS OFTEN AND/OR LESSER AMOUNTS THAN USUAL.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">EATS MUCH LESS THAN USUAL AND ONLY WITH PERSONAL EFFORT.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">EATS RARELY WITHIN A 24-HOUR PERIOD, AND ONLY WITH EXTREME PERSONAL EFFORT OR WITH PERSUASION BY OTHERS.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL12" Name="IDSCL12" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NO CHANGE FROM USUAL APPETITE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MORE FREQUENTLY FEELS A NEED TO EAT THAN USUAL.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">REGULARLY EATS MORE OFTEN AND/OR GREATER AMOUNTS THAN USUAL.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FEELS DRIVEN TO OVEREAT AT AND BETWEEN MEALS</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL13" Name="IDSCL13" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS EXPERIENCED NO WEIGHT CHANGE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FEELS AS IF SOME SLIGHT WEIGHT LOSS OCCURRED.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS LOST 2 POUNDS OR MORE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS LOST 5 POUNDS OR MORE.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL14" Name="IDSCL14" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS EXPERIENCED NO WEIGHT CHANGE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FEELS AS IF SOME SLIGHT WEIGHT GAIN HAS OCCURRED.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS GAINED 2 POUNDS OR MORE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS GAINED 5 POUNDS OR MORE.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL15" Name="IDSCL15" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NO CHANGE IN USUAL CAPACITY TO CONCENTRATE AND DECIDE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OCCASIONALLY FEELS INDECISIVE OR NOTES THAT ATTENTION OFTEN WANDERS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MOST OF THE TIME STRUGGLES TO FOCUS ATTENTION OR MAKE DECISIONS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CANNOT CONCENTRATE WELL ENOUGH TO READ OR CANNOT MAKE EVEN MINOR DECISIONS.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL16" Name="IDSCL16" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SEES SELF AS EQUALLY WORTHWHILE AND DESERVING AS OTHERS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">IS MORE SELF-BLAMING THAN USUAL.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LARGELY BELIEVES THAT HE/SHE CAUSES PROBLEMS FOR OTHERS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">RUMINATES OVER MAJOR AND MINOR DEFECTS IN SELF.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL17" Name="IDSCL17" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">VIEWS FUTURE WITH USUAL OPTIMISM.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OCCASIONALLY HAS PESSIMISTIC OUTLOOK THAT CAN BE DISPELLED BY OTHERS OR EVENTS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LARGELY PESSIMISTIC FOR THE NEAR FUTURE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SEES NO HOPE FOR SELF/SITUATION ANYTIME IN THE FUTURE.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL18" Name="IDSCL18" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DOES NOT THINK OF SUICIDE OR DEATH.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FEELS LIFE IS EMPTY OR IS NOT WORTH LIVING.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">THINKS OF SUICIDE/DEATH SEVERAL TIMES A WEEK FOR SEVERAL MINUTES.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">THINKS OF SUICIDE/DEATH SEVERAL TIMES A DAY IN DEPTH, OR HAS MADE SPECIFIC PLANS, OR ATTEMPTED SUICIDE.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL19" Name="IDSCL19" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NO CHANGE FROM USUAL LEVEL OF INTEREST IN OTHER PEOPLE AND ACTIVITIES.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NOTICES A REDUCTION IN FORMER INTERESTS/ ACTIVITIES.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FINDS ONLY ONE OR TWO FORMER INTERESTS REMAIN.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS VIRTUALLY NO INTEREST IN FORMERLY PURSUED ACTIVITIES.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL2" Name="IDSCL2" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DOES NOT WAKE UP AT NIGHT.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">RESTLESS, LIGHT SLEEP WITH FEW AWAKENINGS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">WAKES UP AT LEAST ONCE A NIGHT, BUT GOES BACK TO SLEEP EASILY.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AWAKENS MORE THAN ONCE A NIGHT AND STAYS AWAKE FOR 20 MINUTES OR MORE, MORE THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL20" Name="IDSCL20" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NO CHANGE IN USUAL LEVEL OF ENERGY.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TIRES MORE EASILY THAN USUAL.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MAKES SIGNIFICANT PERSONAL EFFORT TO INITIATE OR MAINTAIN USUAL DAILY ACTIVITIES.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UNABLE TO CARRY OUT MOST OF USUAL DAILY ACTIVITIES DUE TO LACK OF ENERGY.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL21" Name="IDSCL21" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PARTICIPATES IN AND DERIVES USUAL SENSE OF ENJOYMENT FROM PLEASURABLE ACTIVITIES.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DOES NOT FEEL USUAL ENJOYMENT FROM PLEASURABLE ACTIVITIES.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">RARELY DERIVES PLEASURE FROM ANY ACTIVITIES.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">IS UNABLE TO REGISTER ANY SENSE OF PLEASURE/ ENJOYMENT FROM ANYTHING.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL22" Name="IDSCL22" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS USUAL INTEREST IN OR DERIVES USUAL PLEASURE FROM SEX.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS NEAR USUAL INTEREST IN OR DERIVES SOME PLEASURE FROM SEX.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS LITTLE DESIRE FOR OR RARELY DERIVES PLEASURE FROM SEX.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS ABSOLUTELY NO INTEREST IN OR DERIVES NO PLEASURE FROM SEX.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL23" Name="IDSCL23" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NORMAL SPEED OF THINKING, GESTURING, AND SPEAKING.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PATIENT NOTES SLOWED THINKING, AND VOICE MODULATION IS REDUCED.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TAKES SEVERAL SECONDS TO RESPOND TO MOST QUESTIONS; REPORTS SLOWED THINKING.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">IS LARGELY UNRESPONSIVE TO MOST QUESTIONS WITHOUT STRONG ENCOURAGEMENT.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL24" Name="IDSCL24" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NO INCREASED SPEED OR DISORGANIZATION IN THINKING OR GESTURING.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FIDGETS, WRINGS HANDS AND SHIFTS POSITIONS OFTEN.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DESCRIBES IMPULSE TO MOVE ABOUT AND DISPLAYS MOTOR RESTLESSNESS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UNABLE TO STAY SEATED. PACES ABOUT WITH OR WITHOUT PERMISSION.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL25" Name="IDSCL25" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">STATES THERE IS NO FEELING OF LIMB HEAVINESS OR PAINS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">COMPLAINS OF HEADACHES, ABDOMINAL, BACK OR JOINT PAINS THAT ARE INTERMITTENT AND NOT DISABLING.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">COMPLAINS THAT THE ABOVE PAINS ARE PRESENT MOST OF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FUNCTIONAL IMPAIRMENT RESULTS FROM THE ABOVE PAINS.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL26" Name="IDSCL26" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">REPORTS NO PALPITATIONS, TREMORS, BLURRED VISION, TINNITUS OR INCREASED SWEATING, DYSPNEA, HOT AND COLD FLASHES, CHEST PAIN.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">THE ABOVE ARE MILD AND ONLY INTERMITTENTLY PRESENT.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">THE ABOVE ARE MODERATE AND PRESENT MORE THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">THE ABOVE RESULT IN FUNCTIONAL IMPAIRMENT.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL27" Name="IDSCL27" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS NEITHER PANIC EPISODES NOR PHOBIC SYMPTOMS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS MILD PANIC EPISODES OR PHOBIAS THAT DO NOT USUALLY ALTER BEHAVIOR OR INCAPACITATE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS SIGNIFICANT PANIC EPISODES OR PHOBIAS THAT MODIFY BEHAVIOR BUT DO NOT INCAPACITATE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS INCAPACITATING PANIC EPISODES AT LEAST ONCE A WEEK OR SEVERE PHOBIAS THAT LEAD TO COMPLETE AND REGULAR AVOIDANCE BEHAVIOR.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL28" Name="IDSCL28" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS NO CHANGE IN USUAL BOWEL HABITS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS INTERMITTENT CONSTIPATION AND/OR DIARRHEA THAT IS MILD.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS DIARRHEA AND/OR CONSTIPATION MOST OF THE TIME THAT DOES NOT IMPAIR FUNCTIONING.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS INTERMITTENT PRESENCE OF CONSTIPATION AND/OR DIARRHEA THAT REQUIRES TREATMENT OR CAUSES FUNCTIONAL IMPAIRMENT.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL29" Name="IDSCL29" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAS NOT FELT EASILY REJECTED, SLIGHTED, CRITICIZED OR HURT BY OTHERS AT ALL.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OCCASIONALLY FEELS REJECTED, SLIGHTED, CRITICIZED OR HURT BY OTHERS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OFTEN FEELS REJECTED, SLIGHTED, CRITICIZED OR HURT BY OTHERS, BUT WITH ONLY SLIGHT EFFECTS ON SOCIAL/OCCUPATIONAL FUNCTIONING.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OFTEN FEELS REJECTED, SLIGHTED, CRITICIZED OR HURT BY OTHERS THAT RESULTS IN IMPAIRED SOCIAL/OCCUPATIONAL FUNCTIONING.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL3" Name="IDSCL3" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LESS THAN HALF THE TIME, AWAKENS NO MORE THAN 30 MINUTES BEFORE NECESSARY.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MORE THAN HALF THE TIME, AWAKENS MORE THAN 30 MINUTES BEFORE NEED BE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AWAKENS AT LEAST ONE HOUR BEFORE NEED BE, MORE THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AWAKENS AT LEAST TWO HOURS BEFORE NEED BE, MORE THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL30" Name="IDSCL30" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DOES NOT EXPERIENCE THE PHYSICAL SENSATION OF FEELING WEIGHTED DOWN AND WITHOUT PHYSICAL ENERGY.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OCCASIONALLY EXPERIENCES PERIODS OF FEELING PHYSICALLY WEIGHTED DOWN AND WITHOUT PHYSICAL ENERGY, BUT WITHOUT A NEGATIVE EFFECT ON WORK, SCHOOL, OR ACTIVITY LEVEL.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FEELS PHYSICALLY WEIGHTED DOWN (WITHOUT PHYSICAL ENERGY) MORE THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FEELS PHYSICALLY WEIGHTED DOWN (WITHOUT PHYSICAL ENERGY) MOST OF THE TIME, SEVERAL HOURS PER DAY, SEVERAL DAYS PER WEEK.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL4" Name="IDSCL4" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SLEEPS NO LONGER THAN 7-8 HOURS/NIGHT, WITHOUT NAPS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SLEEPS NO LONGER THAN 10 HOURS IN A 24 HOUR PERIOD (INCLUDE NAPS).</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SLEEPS NO LONGER THAN 12 HOURS IN A 24 HOUR PERIOD (INCLUDE NAPS).</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SLEEPS LONGER THAN 12 HOURS IN A 24 HOUR PERIOD (INCLUDE NAPS).</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL5" Name="IDSCL5" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DOES NOT FEEL SAD.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FEELS SAD LESS THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FEELS SAD MORE THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FEELS INTENSELY SAD VIRTUALLY ALL OF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL6" Name="IDSCL6" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DOES NOT FEEL IRRITABLE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FEELS IRRITABLE LESS THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FEELS IRRITABLE MORE THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FEELS EXTREMELY IRRITABLE VIRTUALLY ALL OF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL7" Name="IDSCL7" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DOES NOT FEEL ANXIOUS OR TENSE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FEELS ANXIOUS/TENSE LESS THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FEELS ANXIOUS/TENSE MORE THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FEELS EXTREMELY ANXIOUS/TENSE VIRTUALLY ALL OF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL8" Name="IDSCL8" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MOOD BRIGHTENS TO NORMAL LEVEL AND LASTS SEVERAL HOURS WHEN GOOD EVENTS OCCUR.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MOOD BRIGHTENS BUT DOES NOT FEEL LIKE NORMAL SELF WHEN GOOD EVENTS OCCUR.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MOOD BRIGHTENS ONLY SOMEWHAT WITH FEW SELECTED, EXTREMELY DESIRED EVENTS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MOOD DOES NOT BRIGHTEN AT ALL, EVEN WHEN VERY GOOD OR DESIRED EVENTS OCCUR.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL9" Name="IDSCL9" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NOTES NO REGULAR RELATIONSHIP BETWEEN MOOD AND TIME OF DAY.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MOOD OFTEN RELATES TO TIME OF DAY DUE TO ENVIRONMENTAL CIRCUMSTANCES.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FOR MOST OF WEEK, MOOD APPEARS MORE RELATED TO TIME OF DAY THAN TO EVENTS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MOOD IS CLEARLY, PREDICTABLY, BETTER OR WORSE AT A FIXED TIME EACH DAY.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL9A" Name="IDSCL9A" DataType="C">

      - <CodeListItem CodedValue="AFTERNOON" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AFTERNOON</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MORNING" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MORNING</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NIGHT" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NIGHT</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="IDSCL9B" Name="IDSCL9B" DataType="C">

      - <CodeListItem CodedValue="NO" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="YES" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">YES</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="INDC" Name="INDC" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ADVERSE EVENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="99" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OTHER</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="LNHFLG" Name="LNHFLG" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HIGH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LOW</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NORMAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ABNORMAL</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MADRL01" Name="MADRL01" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NO SADNESS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LOOKS DISPIRITED BUT DOES BRIGHTEN UP WITHOUT DIFFICULTY.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">APPEARS SAD AND UNHAPPY MOST OF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">5</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LOOKS MISERABLE ALL THE TIME EXTREMELY DESPONDENT.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MADRL02" Name="MADRL02" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OCCASIONAL SADNESS IN KEEPING WITH THE CIRCUMSTANCES.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SAD OR LOW BUT BRIGHTENS UP WITHOUT DIFFICULTY.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PERVASIVE FEELINGS OF SADNESS OR GLOOMINESS. THE MOOD IS STILL INFLUENCED BY EXTERNAL CIRCUMSTANCES.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">5</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CONTINUOUS OR UNVARYING SADNESS, MISERY OR DESPONDENCY.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MADRL03" Name="MADRL03" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PLACID. ONLY REFLECTING INNER TENSION.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OCCASIONAL FEELINGS OF EDGINESS AND ILL-DEFINED DISCOMFORT.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CONTINUOUS FEELINGS OF INNER TENSION OR INTERMITTENT PANIC WHICH THE PATIENT CAN ONLY MASTER WITH SOME DIFFICULTY.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">5</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UNRELENTING DREAD OR ANGUISH. OVERWHELMING PANIC.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MADRL04" Name="MADRL04" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SLEEPS AS USUAL.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SLIGHT DIFFICULTY DROPPING OFF TO SLEEP OR SLIGHTLY REDUCED LIGHT OR FITFUL SLEEP.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SLEEP REDUCED OR BROKEN BY AT LEAST TWO HOURS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">5</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LESS THAN TWO OR THREE HOURS SLEEP.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MADRL05" Name="MADRL05" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NORMAL OR INCREASED APPETITE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SLIGHTLY REDUCED APPETITE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NO APPETITE. FOOD IS TASTELESS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">5</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NEEDS PERSUASION TO EAT.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MADRL06" Name="MADRL06" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NO DIFFICULTIES IN CONCENTRATING.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OCCASIONAL DIFFICULTIES IN COLLECTING ONE&#146;S THOUGHTS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DIFFICULTIES IN CONCENTRATING AND SUSTAINING THOUGHT WHICH REDUCES ABILITY TO READ OR HOLD A CONVERSATION.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">5</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UNABLE TO READ OR CONVERSE WITHOUT GREAT INITIATIVE.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MADRL07" Name="MADRL07" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HARDLY ANY DIFFICULTY IN GETTING STARTED. NO SLUGGISHNESS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DIFFICULTIES IN STARTING ACTIVITIES.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DIFFICULTIES IN STARTING SIMPLE ROUTINE ACTIVITIES WHICH ARE CARRIED OUT WITH EFFORT.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">5</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">COMPLETE LASSITUDE. UNABLE TO DO ANYTHING WITHOUT HELP.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MADRL08" Name="MADRL08" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NORMAL INTEREST IN THE SURROUNDINGS AND IN OTHER PEOPLE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">REDUCED ABILITY TO ENJOY USUAL INTEREST.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LOSS OF INTEREST IN SURROUNDINGS. LOSS OF FEELINGS FOR FRIENDS AND ACQUAINTANCES.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">5</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">THE EXPERIENCE OF BEING EMOTIONALLY PARALYZED, INABILITY TO FEEL ANGER, GRIEF OR PLEASURE AND A COMPLETE OR EVEN PAINFUL FAILURE TO FEEL FOR CLOSE RELATIVES AND FRIENDS.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MADRL09" Name="MADRL09" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NO PESSIMISTIC THOUGHTS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FLUCTUATING IDEAS OF FAILURE, SELF-REPROACH OR SELF-DEPRECIATION.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PERSISTENT SELF-ACCUSATIONS, OR DEFINITE BUT STILL RATIONAL IDEAS OF GUILT OR SIN. INCREASINGLY PESSIMISTIC ABOUT THE FUTURE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">5</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DELUSIONS OF RUIN, REMORSE OR UNREDEEMABLE SIN. SELF-ACCUSATIONS WHICH ARE ABSURD AND UNSHAKABLE.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MADRL10" Name="MADRL10" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ENJOYS LIFE OR TAKES IT AS IT COMES.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">WEARY OF LIFE. ONLY FLEETING SUICIDAL THOUGHTS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PROBABLY BETTER OFF DEAD. SUICIDAL THOUGHTS ARE COMMON, AND SUICIDE IS CONSIDERED AS A POSSIBLE SOLUTION, BUT WITHOUT SPECIFIC PLANS OR INTENTION.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">5</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">EXPLICIT PLANS FOR SUICIDE WHEN THERE IS AN OPPORTUNITY. ACTIVE PREPARATIONS FOR SUICIDE.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MBQ1L" Name="MBQ1L" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">YES</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MBQ2L" Name="MBQ2L" DataType="C">

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LOUD AS BREATHING</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LOUD AS TALKING</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LOUDER THAN TALKING</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">VERY LOUD</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MBQ3L" Name="MBQ3L" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ALMOST NEVER</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1 - 2 TIMES PER MONTH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1 - 2 TIMES PER WEEK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3 - 4 TIMES PER WEEK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ALMOST EVERY DAY</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MBQ4L" Name="MBQ4L" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NEVER</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ALMOST NEVER</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1 - 2 TIMES PER MONTH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1 - 2 TIMES PER WEEK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3 - 4 TIMES PER WEEK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ALMOST EVERY DAY</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MBQ5L" Name="MBQ5L" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ALMOST NEVER</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1 - 2 TIMES PER MONTH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1 - 2 TIMES PER WEEK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3 - 4 TIMES PER WEEK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ALMOST EVERY DAY</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MBQ6L" Name="MBQ6L" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ALMOST NEVER</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1 - 2 TIMES PER MONTH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">1 - 2 TIMES PER WEEK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">3 - 4 TIMES PER WEEK</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ALMOST EVERY DAY</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MBQ7L" Name="MBQ7L" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NO</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="10" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">YES</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MBQ8L" Name="MBQ8L" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LESS THAN 30</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="10" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GREATER THAN 30</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MEDDRA" Name="MEDDRA" DataType="C">

        <ExternalCodeList Dictionary="MedDRA" Version="15.0" />

      - <Referenc>

        <TranslatedText>MedDRA</TranslatedText>

        </Referenc>

        </CodeList>

      - <CodeList OID="MHSCAT" Name="MHSCAT" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">EYES, EARS, NOSE & THROAT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="10" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DERMATOLOGIC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="11" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PSYCHIATRIC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="12" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ALLERGIC/ IMMUNOLOGIC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="13" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">REPRODUCTIVE/BREAST</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">RESPIRATORY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CARDIOVASCULAR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GASTROINTESTINAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GENITOURINARY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MUSCULOSKELETAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="7" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NEUROLOGIC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="8" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ENDOCRINE & METABOLIC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="9" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HEMATOPOIETIC/LYMPHATIC</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MINIFND" Name="MINIFND" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">No</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Yes</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Uncertain</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MININEX" Name="MININEX" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Not Explored</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="MINISTG" Name="MINISTG" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Low</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Moderate</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">High</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="ND" Name="ND" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NOT DONE</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="NY" Name="NY" DataType="C">

      - <CodeListItem CodedValue="N" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">N</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="Y" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Y</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="OUT" Name="OUT" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">RECOVERED/RESOLVED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">RECOVERING/RESOLVING</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NOT RECOVERED/NOT RESOLVED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">RECOVERED/RESOLVED WITH SEQUELAE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FATAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UNKNOWN</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="PGIIMP" Name="PGIIMP" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">VERY MUCH IMPROVED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MUCH IMPROVED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">IMPROVED (JUST ENOUGH TO MAKE A DIFFERENCE)</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NO CHANGE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">WORSE (JUST ENOUGH TO MAKE A DIFFERENCE)</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MUCH WORSE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="7" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">VERY MUCH WORSE</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="PGISEV" Name="PGISEV" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NONE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MILD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MODERATE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SEVERE</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="POSNEG" Name="POSNEG" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NEGATIVE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">POSITIVE</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="QIDRL10" Name="QIDRL10" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">THERE IS NO CHANGE IN MY USUAL CAPACITY TO CONCENTRATE OR MAKE DECISIONS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I OCCASIONALLY FEEL INDECISIVE OR FIND THAT MY ATTENTION WANDERS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MOST OF THE TIME, I STRUGGLE TO FOCUS MY ATTENTION OR TO MAKE DECISIONS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I CANNOT CONCENTRATE WELL ENOUGH TO READ OR CANNOT MAKE EVEN MINOR DECISIONS.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="QIDRL11" Name="QIDRL11" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I SEE MYSELF AS EQUALLY WORTHWHILE AND DESERVING AS OTHER PEOPLE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I AM MORE SELF-BLAMING THAN USUAL.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I LARGELY BELIEVE THAT I CAUSE PROBLEMS FOR OTHERS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I THINK ALMOST CONSTANTLY ABOUT MAJOR AND MINOR DEFECTS IN MYSELF.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="QIDRL12" Name="QIDRL12" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I DO NOT THINK OF SUICIDE OR DEATH.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I FEEL THAT LIFE IS EMPTY OR WONDER IF IT'S WORTH LIVING.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I THINK OF SUICIDE OR DEATH SEVERAL TIMES A WEEK FOR SEVERAL MINUTES.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I THINK OF SUICIDE OR DEATH SEVERAL TIMES A DAY IN SOME DETAIL, OR I HAVE MADE SPECIFIC PLANS FOR SUICIDE OR HAVE ACTUALLY TRIED TO TAKE MY LIFE.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="QIDRL13" Name="QIDRL13" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">THERE IS NO CHANGE FROM USUAL IN HOW INTERESTED I AM IN OTHER PEOPLE OR ACTIVITIES.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I NOTICE THAT I AM LESS INTERESTED IN PEOPLE OR ACTIVITIES.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I FIND I HAVE INTEREST IN ONLY ONE OR TWO OF MY FORMERLY PURSUED ACTIVITIES.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I HAVE VIRTUALLY NO INTEREST IN FORMERLY PURSUED ACTIVITIES.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="QIDRL14" Name="QIDRL14" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">THERE IS NO CHANGE IN MY USUAL LEVEL OF ENERGY.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I GET TIRED MORE EASILY THAN USUAL.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I HAVE TO MAKE A BIG EFFORT TO START OR FINISH MY USUAL DAILY ACTIVITIES (FOR EXAMPLE, SHOPPING, HOMEWORK, COOKING OR GOING TO WORK).</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I REALLY CANNOT CARRY OUT MOST OF MY USUAL DAILY ACTIVITIES BECAUSE I JUST DON'T HAVE THE ENERGY.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="QIDRL15" Name="QIDRL15" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I THINK, SPEAK, AND MOVE AT MY USUAL RATE OF SPEED.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I FIND THAT MY THINKING IS SLOWED DOWN OR MY VOICE SOUNDS DULL OR FLAT.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">IT TAKES ME SEVERAL SECONDS TO RESPOND TO MOST QUESTIONS AND I'M SURE MY THINKING IS SLOWED.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I AM OFTEN UNABLE TO RESPOND TO QUESTIONS WITHOUT EXTREME EFFORT.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="QIDRL16" Name="QIDRL16" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I DO NOT FEEL RESTLESS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I'M OFTEN FIDGETY, WRING MY HANDS, OR NEED TO SHIFT HOW I AM SITTING.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I HAVE IMPULSES TO MOVE ABOUT AND AM QUITE RESTLESS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AT TIMES, I AM UNABLE TO STAY SEATED AND NEED TO PACE AROUND.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="QIDSRL1" Name="QIDSRL1" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I NEVER TAKE LONGER THAN 30 MINUTES TO FALL ASLEEP.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I TAKE AT LEAST 30 MINUTES TO FALL ASLEEP, LESS THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I TAKE AT LEAST 30 MINUTES TO FALL ASLEEP, MORE THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I TAKE MORE THAN 60 MINUTES TO FALL ASLEEP, MORE THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="QIDSRL2" Name="QIDSRL2" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I DO NOT WAKE UP AT NIGHT.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I HAVE A RESTLESS, LIGHT SLEEP WITH A FEW BRIEF AWAKENINGS EACH NIGHT.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I WAKE UP AT LEAST ONCE A NIGHT, BUT I GO BACK TO SLEEP EASILY.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I AWAKEN MORE THAN ONCE A NIGHT AND STAY AWAKE FOR 20 MINUTES OR MORE, MORE THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="QIDSRL3" Name="QIDSRL3" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MOST OF THE TIME, I AWAKEN NO MORE THAN 30 MINUTES BEFORE I NEED TO GET UP.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MORE THAN HALF THE TIME, I AWAKEN MORE THAN 30 MINUTES BEFORE I NEED TO GET UP.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I ALMOST ALWAYS AWAKEN AT LEAST ONE HOUR OR SO BEFORE I NEED TO, BUT I GO BACK TO SLEEP EVENTUALLY.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I AWAKEN AT LEAST ONE HOUR BEFORE I NEED TO, AND CAN'T GO BACK TO SLEEP.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="QIDSRL4" Name="QIDSRL4" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I SLEEP NO LONGER THAN 7-8 HOURS/NIGHT, WITHOUT NAPPING DURING THE DAY.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I SLEEP NO LONGER THAN 10 HOURS IN A 24-HOUR PERIOD INCLUDING NAPS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I SLEEP NO LONGER THAN 12 HOURS IN A 24-HOUR PERIOD INCLUDING NAPS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I SLEEP LONGER THAN 12 HOURS IN A 24-HOUR PERIOD INCLUDING NAPS.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="QIDSRL5" Name="QIDSRL5" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I DO NOT FEEL SAD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I FEEL SAD LESS THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I FEEL SAD MORE THAN HALF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I FEEL SAD NEARLY ALL OF THE TIME.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="QIDSRL6" Name="QIDSRL6" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">THERE IS NO CHANGE IN MY USUAL APPETITE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I EAT SOMEWHAT LESS OFTEN OR LESSER AMOUNTS OF FOOD THAN USUAL.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I EAT MUCH LESS THAN USUAL AND ONLY WITH PERSONAL EFFORT.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I RARELY EAT WITHIN A 24-HOUR PERIOD, AND ONLY WITH EXTREME PERSONAL EFFORT OR WHEN OTHERS PERSUADE ME TO EAT.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="QIDSRL7" Name="QIDSRL7" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">THERE IS NO CHANGE FROM MY USUAL APPETITE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I FEEL A NEED TO EAT MORE FREQUENTLY THAN USUAL.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I REGULARLY EAT MORE OFTEN AND/OR GREATER AMOUNTS OF FOOD THAN USUAL.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I FEEL DRIVEN TO OVEREAT BOTH AT MEALTIME AND BETWEEN MEALS. PLEASE COMPLETE EITHER 13 OR 14 (NOT BOTH)</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="QIDSRL8" Name="QIDSRL8" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I HAVE NOT HAD A CHANGE IN MY WEIGHT.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I FEEL AS IF I'VE HAD A SLIGHT WEIGHT LOSS.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I HAVE LOST 2 POUNDS OR MORE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I HAVE LOST 5 POUNDS OR MORE.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="QIDSRL9" Name="QIDSRL9" DataType="C">

      - <CodeListItem CodedValue="0" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I HAVE NOT HAD A CHANGE IN MY WEIGHT.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I FEEL AS IF I'VE HAD A SLIGHT WEIGHT GAIN.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I HAVE GAINED 2 POUNDS OR MORE.</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">I HAVE GAINED 5 POUNDS OR MORE.</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="RACE" Name="RACE" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">WHITE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BLACK OR AFRICAN AMERICAN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ASIAN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AMERICAN INDIAN OR ALASKA NATIVE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NOT REPORTED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="7" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UNKNOWN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="8" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MULTIPLE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="99" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OTHER</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="REAS" Name="REAS" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ADVERSE EVENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="10" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PROTOCOL VIOLATION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="11" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">RECOVERY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="12" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SCREEN FAILURE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="13" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">STUDY TERMINATED BY SPONSOR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="14" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TECHNICAL PROBLEMS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="15" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">WITHDRAWAL OF CONSENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="16" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INFORMED CONSENT OBTAINED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="17" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">RANDOMIZED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="18" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TREATMENT UNBLINDED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="19" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PRODUCT QUALITY COMPLAINT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">COMPLETED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DEATH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LACK OF EFFICACY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LOST TO FOLLOW-UP</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NONCOMPLIANCE WITH STUDY DRUG</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="7" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PHYSICIAN DECISION</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="8" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PREGNANCY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="9" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PROGRESSIVE DISEASE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="99" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OTHER</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="REL" Name="REL" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NOT RELATED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DOUBTFUL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">POSSIBLE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PROBABLE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">VERY LIKELY</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="ROUTE" Name="ROUTE" DataType="C">

      - <CodeListItem CodedValue="INTRA-ABDOMINAL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INTRA-ABDOMINAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INTRA-ARTICULAR" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INTRA-ARTICULAR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INTRALESIONAL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INTRALESIONAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INTRAMUSCULAR" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INTRAMUSCULAR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INTRAVENOUS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INTRAVENOUS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INTRAVENOUS BOLUS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INTRAVENOUS BOLUS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INTRAVENOUS DRIP" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INTRAVENOUS DRIP</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NASAL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NASAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="NASOGASTRIC" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NASOGASTRIC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="OPHTHALMIC" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OPHTHALMIC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ORAL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ORAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="OTHER" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">OTHER</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="RECTAL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">RECTAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="RESPIRATORY (INHALATION)" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">RESPIRATORY (INHALATION)</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SUBCUTANEOUS" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SUBCUTANEOUS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SUBLINGUAL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SUBLINGUAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TOPICAL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TOPICAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="TRANSDERMAL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TRANSDERMAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="UNKNOWN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UNKNOWN</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="SCICD1" Name="SCICD1" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DEFINITELY/YES</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">POSSIBLY/PROBABLY YES</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UNLIKELY/NO</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="SCICD2" Name="SCICD2" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DEFINITELY/YES</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UNLIKELY/NO</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="SCICD3" Name="SCICD3" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PASS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FAIL</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="SEX" Name="SEX" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">M</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">F</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">U</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UN</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="SGSCAT" Name="SGSCAT" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">EYES, EARS, NOSE & THROAT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="10" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DERMATOLOGIC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="11" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PSYCHIATRIC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="12" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ALLERGIC/IMMUNOLOGIC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="13" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">REPRODUCTIVE/BREAST</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">RESPIRATORY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CARDIOVASCULAR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GASTROINTESTINAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">GENITOURINARY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MUSCULOSKELETAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="7" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">NEUROLOGIC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="8" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ENDOCRINE & METABOLIC</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="9" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HEMATOPOIETIC/LYMPHATIC</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="SPCCND" Name="SPCCND" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CELLS PRESENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="10" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INHIBITING SUBSTANCE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="11" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LAB ACCIDENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="12" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LIPEMIA, MODERATE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="13" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LIPEMIA, SEVERE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="14" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LIPEMIA, SLIGHT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="15" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LIPEMIA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="16" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LIPEMIC, PARTIALLY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="17" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">QUANTITY NOT SUFFICIENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="18" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">QUESTIONABLE RESULT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="19" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SERUM SEPARATION INADEQUATE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CLOTTED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="20" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TEST TUBE BROKEN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="21" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">THAWED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="22" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UNSPUN, PARTIALLY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="23" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">UNSPUN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="24" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AMBIENT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="25" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FROZEN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="26" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">REFRIGRITATED</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HEMOLYSIS, MODERATE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HEMOLYSIS, SEVERE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HEMOLYSIS, SLIGHT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HEMOLYSIS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="7" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HEMOLYZED, PARTIALLY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="8" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ICTERIC, PARTIALLY</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="9" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INCORRECT SAMPLE</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="SPEC" Name="SPEC" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BLOOD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="10" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">PLASMA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="11" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SERUM</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="12" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">WHOLE BLOOD</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="13" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">CS FLUID</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="14" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SYNOVIAL FLUID</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="15" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">TEARS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="16" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SWEAT</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="17" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">AMNIOTIC FLUID</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FINGERNAILS</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">HAIR</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SALIVA</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SKIN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="6" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">URINE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="7" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">STOOL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="8" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BREATH</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="9" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">FECES</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="STEPIC" Name="STEPIC" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Not at all important</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Slightly important</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Moderately important</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Very important</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Extremely important</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="STEPINT" Name="STEPINT" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Not at all interested</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">A little interested</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Moderately interested</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="4" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Very interested</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="5" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Extremely interesting</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="STEPPN" Name="STEPPN" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Positive impact</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Negative impact</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">No impact</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="TPNTRF" Name="TPNTRF" DataType="C">

      - <CodeListItem CodedValue="DOSE" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">DOSE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INFUSION END" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INFUSION END</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="INFUSION START" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">INFUSION START</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="MEAL" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">MEAL</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="SURGERY" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SURGERY</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="VSPOS" Name="VSPOS" DataType="C">

      - <CodeListItem CodedValue="1" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SUPINE</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">STANDING</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="3" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">SITTING</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="VSRESU" Name="VSRESU" DataType="C">

      - <CodeListItem CodedValue="%" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">%</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BEATS/MIN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BEATS/MIN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BREATHS/MIN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BREATHS/MIN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="C" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">C</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="F" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">F</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="IN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">IN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="LB" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">LB</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="cm" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">cm</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="g" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">g</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="kg" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">kg</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="kg/m2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">kg/m2</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="m2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">m2</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="mmHg" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">mmHg</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="ohm" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">ohm</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="VSTRESU" Name="VSTRESU" DataType="C">

      - <CodeListItem CodedValue="BEATS/MIN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BEATS/MIN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="BREATHS/MIN" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">BREATHS/MIN</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="C" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">C</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="cm" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">cm</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="g" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">g</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="kg" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">kg</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="kg/m2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">kg/m2</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="m2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">m2</TranslatedText>

        </Decode>

        </CodeListItem>

      - <CodeListItem CodedValue="mmHg" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">mmHg</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

      - <CodeList OID="WHODRUG" Name="WHODRUG" DataType="C">

        <ExternalCodeList Dictionary="WHODRUG" Version="June2010" />

      - <Referenc>

        <TranslatedText>WHO</TranslatedText>

        </Referenc>

        </CodeList>

      - <CodeList OID="YES" Name="YES" DataType="C">

      - <CodeListItem CodedValue="2" def:Rank="">

      - <Decode>

        <TranslatedText xml:lang="en">Y</TranslatedText>

        </Decode>

        </CodeListItem>

        </CodeList>

        </MetaDataVersion>

        </Study>

        </ODM>