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<!-- ******************************************************************************* -->
<!-- File: define.xml                                                                -->
<!-- Date: 14FEB2016                                                                -->
<!-- Description: Define.xml file for XYZ123                          -->
<!-- Created by the %make_define2 SAS macro                                          -->
<!-- ******************************************************************************* -->
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  CreationDateTime="2016-02-14T20:56:52">
<Study OID="123">
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    <StudyDescription>A PHASE IIB, DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED, PARALLEL GROUP TRIAL OF ANALGEZIA HCL FOR THE TREATMENT OF CHRONIC PAIN</StudyDescription>
    <ProtocolName>XYZ123</ProtocolName>
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        Mandatory="No"
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        RoleCodeListOID="CodeList.rolecode"/>
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        RoleCodeListOID="CodeList.rolecode"/>
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        RoleCodeListOID="CodeList.rolecode"/>
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        Mandatory="No"
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        Mandatory="No"
        KeySequence="5"
        Role="Timing"
        RoleCodeListOID="CodeList.rolecode"/>
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        Mandatory="No"
        Role="Timing"
        RoleCodeListOID="CodeList.rolecode"/>
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        Mandatory="No"
        MethodOID="LB.EPOCH"
        Role="Timing"
        RoleCodeListOID="CodeList.rolecode"/>
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        Mandatory="No"
        Role="Timing"
        RoleCodeListOID="CodeList.rolecode"/>
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        OrderNumber="23"
        Mandatory="No"
        MethodOID="STUDYDAYS"
        Role="Timing"
        RoleCodeListOID="CodeList.rolecode"/>
      <!-- **************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset   -->
      <!-- **************************************************** -->
      <def:leaf ID="Location.LB" xlink:href="lb.xpt">
        <def:title>lb.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
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    <!-- SUPPDM         ItemGroupDef INFORMATION *** -->
    <!-- ******************************************* -->
    <ItemGroupDef OID="SUPPDM"
      Domain="SUPPDM"
      Name="SUPPDM"
      Repeating="Yes"
      Purpose="Tabulation"
      IsReferenceData="No"
      SASDatasetName="SUPPDM"
      def:Structure="Supplemental Qualifier - One record per qualifier"
      def:Class="Relationship"
      def:ArchiveLocationID="Location.SUPPDM">
      <Description>
        <TranslatedText xml:lang="en">DM - Supplemental Qualifiers</TranslatedText>
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        Mandatory="Yes"
        KeySequence="1"
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        Mandatory="Yes"
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        Mandatory="No"
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        Mandatory="Yes"
        KeySequence="6"
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      <ItemRef ItemOID="SUPPDM.QVAL"
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        Mandatory="Yes"
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      <ItemRef ItemOID="SUPPDM.QORIG"
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        Mandatory="Yes"
        MethodOID="SETNULL"
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      <ItemRef ItemOID="SUPPDM.QEVAL"
        OrderNumber="10"
        Mandatory="No"
        MethodOID="SETNULL"
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      <!-- **************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset   -->
      <!-- **************************************************** -->
      <def:leaf ID="Location.SUPPDM" xlink:href="suppdm.xpt">
        <def:title>suppdm.xpt </def:title>
      </def:leaf>
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    <!-- ******************************************* -->
    <!-- TA             ItemGroupDef INFORMATION *** -->
    <!-- ******************************************* -->
    <ItemGroupDef OID="TA"
      Domain="TA"
      Name="TA"
      Repeating="Yes"
      Purpose="Tabulation"
      IsReferenceData="Yes"
      SASDatasetName="TA"
      def:Structure="One record per planned Element per Arm"
      def:Class="Trial Design"
      def:ArchiveLocationID="Location.TA">
      <Description>
        <TranslatedText xml:lang="en">Trial Arms</TranslatedText>
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        Mandatory="Yes"
        KeySequence="1"
        Role="Identifier"
        RoleCodeListOID="CodeList.rolecode"/>
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        MethodOID="METADATAENTRY"
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        RoleCodeListOID="CodeList.rolecode"/>
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        Mandatory="Yes"
        MethodOID="METADATAENTRY"
        Role="Record Qualifier"
        RoleCodeListOID="CodeList.rolecode"/>
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        Mandatory="No"
        MethodOID="METADATAENTRY"
        Role="Synonym Qualifier"
        RoleCodeListOID="CodeList.rolecode"/>
      <ItemRef ItemOID="TA.TABRANCH"
        OrderNumber="8"
        Mandatory="No"
        MethodOID="METADATAENTRY"
        Role="Rule"
        RoleCodeListOID="CodeList.rolecode"/>
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        MethodOID="METADATAENTRY"
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        OrderNumber="10"
        Mandatory="No"
        MethodOID="METADATAENTRY"
        Role="Timing"
        RoleCodeListOID="CodeList.rolecode"/>
      <!-- **************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset   -->
      <!-- **************************************************** -->
      <def:leaf ID="Location.TA" xlink:href="ta.xpt">
        <def:title>ta.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
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    <!-- TD             ItemGroupDef INFORMATION *** -->
    <!-- ******************************************* -->
    <ItemGroupDef OID="TD"
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      Name="TD"
      Repeating="Yes"
      Purpose="Tabulation"
      IsReferenceData="Yes"
      SASDatasetName="TD"
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      def:Class="Trial Design"
      def:ArchiveLocationID="Location.TD">
      <Description>
        <TranslatedText xml:lang="en">Trial Disease Assessments</TranslatedText>
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        Mandatory="Yes"
        KeySequence="1"
        Role="Identifier"
        RoleCodeListOID="CodeList.rolecode"/>
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        Mandatory="Yes"
        MethodOID="METADATAENTRY"
        Role="Record Qualifier"
        RoleCodeListOID="CodeList.rolecode"/>
      <!-- **************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset   -->
      <!-- **************************************************** -->
      <def:leaf ID="Location.TD" xlink:href="td.xpt">
        <def:title>td.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <!-- ******************************************* -->
    <!-- TE             ItemGroupDef INFORMATION *** -->
    <!-- ******************************************* -->
    <ItemGroupDef OID="TE"
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      Name="TE"
      Repeating="Yes"
      Purpose="Tabulation"
      IsReferenceData="Yes"
      SASDatasetName="TE"
      def:Structure="One record per planned Element"
      def:Class="Trial Design"
      def:ArchiveLocationID="Location.TE">
      <Description>
        <TranslatedText xml:lang="en">Trial Elements</TranslatedText>
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        Mandatory="Yes"
        KeySequence="1"
        Role="Identifier"
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        MethodOID="SETDOMAIN"
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        Mandatory="Yes"
        MethodOID="METADATAENTRY"
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        Mandatory="Yes"
        MethodOID="METADATAENTRY"
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        Mandatory="No"
        MethodOID="METADATAENTRY"
        Role="Timing"
        RoleCodeListOID="CodeList.rolecode"/>
      <!-- **************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset   -->
      <!-- **************************************************** -->
      <def:leaf ID="Location.TE" xlink:href="te.xpt">
        <def:title>te.xpt </def:title>
      </def:leaf>
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    <!-- TI             ItemGroupDef INFORMATION *** -->
    <!-- ******************************************* -->
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      Name="TI"
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      Purpose="Tabulation"
      IsReferenceData="Yes"
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      def:Class="Trial Design"
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        <TranslatedText xml:lang="en">Trial Inclusion/Exclusion Criteria</TranslatedText>
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        MethodOID="METADATAENTRY"
        Role="Grouping Qualifier"
        RoleCodeListOID="CodeList.rolecode"/>
      <!-- **************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset   -->
      <!-- **************************************************** -->
      <def:leaf ID="Location.TI" xlink:href="ti.xpt">
        <def:title>ti.xpt </def:title>
      </def:leaf>
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    <!-- TS             ItemGroupDef INFORMATION *** -->
    <!-- ******************************************* -->
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      Purpose="Tabulation"
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      SASDatasetName="TS"
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      def:Class="Trial Design"
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      <Description>
        <TranslatedText xml:lang="en">Trial Summary</TranslatedText>
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        Mandatory="Yes"
        KeySequence="1"
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        MethodOID="SETDOMAIN"
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        MethodOID="METADATAENTRY"
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        RoleCodeListOID="CodeList.rolecode"/>
      <!-- **************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset   -->
      <!-- **************************************************** -->
      <def:leaf ID="Location.TS" xlink:href="ts.xpt">
        <def:title>ts.xpt </def:title>
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    <!-- TV             ItemGroupDef INFORMATION *** -->
    <!-- ******************************************* -->
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      Purpose="Tabulation"
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      SASDatasetName="TV"
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      def:Class="Trial Design"
      def:ArchiveLocationID="Location.TV">
      <Description>
        <TranslatedText xml:lang="en">Trial Visits</TranslatedText>
      </Description>
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        KeySequence="1"
        Role="Identifier"
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        Mandatory="No"
        MethodOID="METADATAENTRY"
        Role="Rule"
        RoleCodeListOID="CodeList.rolecode"/>
      <!-- **************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset   -->
      <!-- **************************************************** -->
      <def:leaf ID="Location.TV" xlink:href="tv.xpt">
        <def:title>tv.xpt </def:title>
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    <!-- ******************************************* -->
    <!-- XP             ItemGroupDef INFORMATION *** -->
    <!-- ******************************************* -->
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      SASDatasetName="XP"
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      <Description>
        <TranslatedText xml:lang="en">Pain Scores</TranslatedText>
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        Role="Timing"
        RoleCodeListOID="CodeList.rolecode"/>
      <!-- **************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset   -->
      <!-- **************************************************** -->
      <def:leaf ID="Location.XP" xlink:href="xp.xpt">
        <def:title>xp.xpt </def:title>
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    <!-- ************************************************************ -->
    <!-- The details of each variable is here for all domains         -->
    <!-- ************************************************************ -->
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      def:DisplayFormat="15"
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    </ItemDef>
    <ItemDef OID="AE.AETERM"
      Name="AETERM"
      SASFieldName="AETERM"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Reported Term for the Adverse Event</TranslatedText>
      </Description>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="6" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AELLT"
      Name="AELLT"
      SASFieldName="AELLT"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Lowest Level Term</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AELLTCD"
      Name="AELLTCD"
      SASFieldName="AELLTCD"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Lowest Level Term Code</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AEDECOD"
      Name="AEDECOD"
      SASFieldName="AEDECOD"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Dictionary-Derived Term</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.AEDECOD"/>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AEPTCD"
      Name="AEPTCD"
      SASFieldName="AEPTCD"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Preferred Term Code</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AEHLT"
      Name="AEHLT"
      SASFieldName="AEHLT"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">High Level Term</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AEHLTCD"
      Name="AEHLTCD"
      SASFieldName="AEHLTCD"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">High Level Term Code</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AEHLGT"
      Name="AEHLGT"
      SASFieldName="AEHLGT"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">High Level Group Term</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AEHLGTCD"
      Name="AEHLGTCD"
      SASFieldName="AEHLGTCD"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">High Level Group Term Code</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AEBODSYS"
      Name="AEBODSYS"
      SASFieldName="AEBODSYS"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Body System or Organ Class</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.AEBODSYS"/>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AEBDSYCD"
      Name="AEBDSYCD"
      SASFieldName="AEBDSYCD"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Body System or Organ Class Code</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AESOC"
      Name="AESOC"
      SASFieldName="AESOC"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Primary System Organ Class</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AESOCCD"
      Name="AESOCCD"
      SASFieldName="AESOCCD"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Primary System Organ Class Code</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AESEV"
      Name="AESEV"
      SASFieldName="AESEV"
      DataType="text"
      Length="20"
      def:DisplayFormat="20"
      >
      <Description>
          <TranslatedText xml:lang="en">Severity</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.AESEV"/>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="6" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AESER"
      Name="AESER"
      SASFieldName="AESER"
      DataType="text"
      Length="2"
      def:DisplayFormat="2"
      >
      <Description>
          <TranslatedText xml:lang="en">Serious Event</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.NY"/>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="6" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AEACN"
      Name="AEACN"
      SASFieldName="AEACN"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Action Taken with Study Treatment</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ACN"/>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="6" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AEREL"
      Name="AEREL"
      SASFieldName="AEREL"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Causality</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.AEREL"/>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="6" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AESLIFE"
      Name="AESLIFE"
      SASFieldName="AESLIFE"
      DataType="text"
      Length="2"
      def:DisplayFormat="2"
      >
      <Description>
          <TranslatedText xml:lang="en">Is Life Threatening</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.NY"/>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="6" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.EPOCH"
      Name="EPOCH"
      SASFieldName="EPOCH"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Epoch</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.EPOCH"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AESTDTC"
      Name="AESTDTC"
      SASFieldName="AESTDTC"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">Start Date/Time of Adverse Event</TranslatedText>
      </Description>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="6" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AEENDTC"
      Name="AEENDTC"
      SASFieldName="AEENDTC"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">End Date/Time of Adverse Event</TranslatedText>
      </Description>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="6" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AESTDY"
      Name="AESTDY"
      SASFieldName="AESTDY"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Day of Start of Adverse Event</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="AE.AEENDY"
      Name="AEENDY"
      SASFieldName="AEENDY"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Day of End of Adverse Event</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.STUDYID"
      Name="STUDYID"
      SASFieldName="STUDYID"
      DataType="text"
      Length="15"
      def:DisplayFormat="15"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.DOMAIN"
      Name="DOMAIN"
      SASFieldName="DOMAIN"
      DataType="text"
      Length="2"
      def:DisplayFormat="2"
      >
      <Description>
          <TranslatedText xml:lang="en">Domain Abbreviation</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.USUBJID"
      Name="USUBJID"
      SASFieldName="USUBJID"
      DataType="text"
      Length="25"
      def:DisplayFormat="25"
      >
      <Description>
          <TranslatedText xml:lang="en">Unique Subject Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.SUBJID"
      Name="SUBJID"
      SASFieldName="SUBJID"
      DataType="text"
      Length="7"
      def:DisplayFormat="7"
      >
      <Description>
          <TranslatedText xml:lang="en">Subject Identifier for the Study</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.RFSTDTC"
      Name="RFSTDTC"
      SASFieldName="RFSTDTC"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">Subject Reference Start Date/Time</TranslatedText>
      </Description>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="1" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.RFENDTC"
      Name="RFENDTC"
      SASFieldName="RFENDTC"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">Subject Reference End Date/Time</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.RFXSTDTC"
      Name="RFXSTDTC"
      SASFieldName="RFXSTDTC"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">Date/Time of First Study Treatment</TranslatedText>
      </Description>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="4" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.RFXENDTC"
      Name="RFXENDTC"
      SASFieldName="RFXENDTC"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">Date/Time of Last Study Treatment</TranslatedText>
      </Description>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="4" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.RFICDTC"
      Name="RFICDTC"
      SASFieldName="RFICDTC"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">Date/Time of Informed Consent</TranslatedText>
      </Description>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="1" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.RFPENDTC"
      Name="RFPENDTC"
      SASFieldName="RFPENDTC"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">Date/Time of End of Participation</TranslatedText>
      </Description>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="30" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.DTHDTC"
      Name="DTHDTC"
      SASFieldName="DTHDTC"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">Date/Time of Death</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.DTHFL"
      Name="DTHFL"
      SASFieldName="DTHFL"
      DataType="text"
      Length="2"
      def:DisplayFormat="2"
      >
      <Description>
          <TranslatedText xml:lang="en">Subject Death Flag</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.SITEID"
      Name="SITEID"
      SASFieldName="SITEID"
      DataType="text"
      Length="7"
      def:DisplayFormat="7"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Site Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.BRTHDTC"
      Name="BRTHDTC"
      SASFieldName="BRTHDTC"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">Date/Time of Birth</TranslatedText>
      </Description>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="1" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.AGE"
      Name="AGE"
      SASFieldName="AGE"
      DataType="integer"
      Length="8"
      def:DisplayFormat="3.0"
      >
      <Description>
          <TranslatedText xml:lang="en">Age</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.AGEU"
      Name="AGEU"
      SASFieldName="AGEU"
      DataType="text"
      Length="10"
      def:DisplayFormat="10"
      >
      <Description>
          <TranslatedText xml:lang="en">Age Units</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.AGEU"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.SEX"
      Name="SEX"
      SASFieldName="SEX"
      DataType="text"
      Length="2"
      def:DisplayFormat="2"
      >
      <Description>
          <TranslatedText xml:lang="en">Sex</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.SEX"/>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="1" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.RACE"
      Name="RACE"
      SASFieldName="RACE"
      DataType="text"
      Length="80"
      def:DisplayFormat="80"
      >
      <Description>
          <TranslatedText xml:lang="en">Race</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.RACE"/>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="1" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.ARMCD"
      Name="ARMCD"
      SASFieldName="ARMCD"
      DataType="text"
      Length="8"
      def:DisplayFormat="8"
      def:CommentOID="COM.ARMCD"
      >
      <Description>
          <TranslatedText xml:lang="en">Planned Arm Code</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ARMCD"/>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.ARM"
      Name="ARM"
      SASFieldName="ARM"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Description of Planned Arm</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ARM"/>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.ACTARMCD"
      Name="ACTARMCD"
      SASFieldName="ACTARMCD"
      DataType="text"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Actual Arm Code</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ARMCD"/>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.ACTARM"
      Name="ACTARM"
      SASFieldName="ACTARM"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Description of Actual Arm</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ARM"/>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="DM.COUNTRY"
      Name="COUNTRY"
      SASFieldName="COUNTRY"
      DataType="text"
      Length="3"
      def:DisplayFormat="3"
      >
      <Description>
          <TranslatedText xml:lang="en">Country</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.COUNTRY"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="EX.STUDYID"
      Name="STUDYID"
      SASFieldName="STUDYID"
      DataType="text"
      Length="15"
      def:DisplayFormat="15"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="EX.DOMAIN"
      Name="DOMAIN"
      SASFieldName="DOMAIN"
      DataType="text"
      Length="2"
      def:DisplayFormat="2"
      >
      <Description>
          <TranslatedText xml:lang="en">Domain Abbreviation</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="EX.USUBJID"
      Name="USUBJID"
      SASFieldName="USUBJID"
      DataType="text"
      Length="25"
      def:DisplayFormat="25"
      >
      <Description>
          <TranslatedText xml:lang="en">Unique Subject Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="EX.EXSEQ"
      Name="EXSEQ"
      SASFieldName="EXSEQ"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Sequence Number</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="EX.EXTRT"
      Name="EXTRT"
      SASFieldName="EXTRT"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Name of Actual Treatment</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="EX.EXDOSE"
      Name="EXDOSE"
      SASFieldName="EXDOSE"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Dose</TranslatedText>
      </Description>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="4" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="EX.EXDOSU"
      Name="EXDOSU"
      SASFieldName="EXDOSU"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Dose Units</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.UNIT"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="EX.EXDOSFRM"
      Name="EXDOSFRM"
      SASFieldName="EXDOSFRM"
      DataType="text"
      Length="80"
      def:DisplayFormat="80"
      >
      <Description>
          <TranslatedText xml:lang="en">Dose Form</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.FRM"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="EX.EPOCH"
      Name="EPOCH"
      SASFieldName="EPOCH"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Epoch</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.EPOCH"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="EX.EXSTDTC"
      Name="EXSTDTC"
      SASFieldName="EXSTDTC"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">Start Date/Time of Treatment</TranslatedText>
      </Description>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="4" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="EX.EXENDTC"
      Name="EXENDTC"
      SASFieldName="EXENDTC"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">End Date/Time of Treatment</TranslatedText>
      </Description>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="4" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="EX.EXSTDY"
      Name="EXSTDY"
      SASFieldName="EXSTDY"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Day of Start of Treatment</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="EX.EXENDY"
      Name="EXENDY"
      SASFieldName="EXENDY"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Day of End of Treatment</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.STUDYID"
      Name="STUDYID"
      SASFieldName="STUDYID"
      DataType="text"
      Length="15"
      def:DisplayFormat="15"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.DOMAIN"
      Name="DOMAIN"
      SASFieldName="DOMAIN"
      DataType="text"
      Length="2"
      def:DisplayFormat="2"
      >
      <Description>
          <TranslatedText xml:lang="en">Domain Abbreviation</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.USUBJID"
      Name="USUBJID"
      SASFieldName="USUBJID"
      DataType="text"
      Length="25"
      def:DisplayFormat="25"
      >
      <Description>
          <TranslatedText xml:lang="en">Unique Subject Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.LBSEQ"
      Name="LBSEQ"
      SASFieldName="LBSEQ"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Sequence Number</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.LBTESTCD"
      Name="LBTESTCD"
      SASFieldName="LBTESTCD"
      DataType="text"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Lab Test or Examination Short Name</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.LBTESTCD"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.LBTEST"
      Name="LBTEST"
      SASFieldName="LBTEST"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Lab Test or Examination Name</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.LBTEST"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.LBCAT"
      Name="LBCAT"
      SASFieldName="LBCAT"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Category for Lab Test</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.LBCAT"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.LBORRES"
      Name="LBORRES"
      SASFieldName="LBORRES"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Result or Finding in Original Units</TranslatedText>
      </Description>
      <def:Origin Type="eDT">
      </def:Origin>
      <def:ValueListRef ValueListOID="VL.LB.LBORRES"/>
    </ItemDef>
    <ItemDef OID="LB.LBORRESU"
      Name="LBORRESU"
      SASFieldName="LBORRESU"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Original Units</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.UNIT"/>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.LBORNRLO"
      Name="LBORNRLO"
      SASFieldName="LBORNRLO"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Reference Range Lower Limit in Orig Unit</TranslatedText>
      </Description>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.LBORNRHI"
      Name="LBORNRHI"
      SASFieldName="LBORNRHI"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Reference Range Upper Limit in Orig Unit</TranslatedText>
      </Description>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.LBSTRESC"
      Name="LBSTRESC"
      SASFieldName="LBSTRESC"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Character Result/Finding in Std Format</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.LBSTRESN"
      Name="LBSTRESN"
      SASFieldName="LBSTRESN"
      DataType="float"
      Length="8"
      SignificantDigits="2"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Numeric Result/Finding in Standard Units</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.LBSTRESU"
      Name="LBSTRESU"
      SASFieldName="LBSTRESU"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Standard Units</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.UNIT"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.LBSTNRLO"
      Name="LBSTNRLO"
      SASFieldName="LBSTNRLO"
      DataType="float"
      Length="8"
      SignificantDigits="2"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Reference Range Lower Limit-Std Units</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.LBSTNRHI"
      Name="LBSTNRHI"
      SASFieldName="LBSTNRHI"
      DataType="float"
      Length="8"
      SignificantDigits="2"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Reference Range Upper Limit-Std Units</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.LBNRIND"
      Name="LBNRIND"
      SASFieldName="LBNRIND"
      DataType="text"
      Length="20"
      def:DisplayFormat="20"
      >
      <Description>
          <TranslatedText xml:lang="en">Reference Range Indicator</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.LBNRIND"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.LBBLFL"
      Name="LBBLFL"
      SASFieldName="LBBLFL"
      DataType="text"
      Length="2"
      def:DisplayFormat="2"
      >
      <Description>
          <TranslatedText xml:lang="en">Baseline Flag</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.NY"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.VISITNUM"
      Name="VISITNUM"
      SASFieldName="VISITNUM"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Visit Number</TranslatedText>
      </Description>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.VISIT"
      Name="VISIT"
      SASFieldName="VISIT"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Visit Name</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.VISIT"/>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.EPOCH"
      Name="EPOCH"
      SASFieldName="EPOCH"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Epoch</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.EPOCH"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.LBDTC"
      Name="LBDTC"
      SASFieldName="LBDTC"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">Date/Time of Specimen Collection</TranslatedText>
      </Description>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="LB.LBDY"
      Name="LBDY"
      SASFieldName="LBDY"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Day of Specimen Collection</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="SUPPDM.STUDYID"
      Name="STUDYID"
      SASFieldName="STUDYID"
      DataType="text"
      Length="15"
      def:DisplayFormat="15"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="SUPPDM.RDOMAIN"
      Name="RDOMAIN"
      SASFieldName="RDOMAIN"
      DataType="text"
      Length="2"
      def:DisplayFormat="2"
      >
      <Description>
          <TranslatedText xml:lang="en">Related Domain Abbreviation</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="SUPPDM.USUBJID"
      Name="USUBJID"
      SASFieldName="USUBJID"
      DataType="text"
      Length="25"
      def:DisplayFormat="25"
      >
      <Description>
          <TranslatedText xml:lang="en">Unique Subject Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="SUPPDM.IDVAR"
      Name="IDVAR"
      SASFieldName="IDVAR"
      DataType="text"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Identifying Variable</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="SUPPDM.IDVARVAL"
      Name="IDVARVAL"
      SASFieldName="IDVARVAL"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Identifying Variable Value</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="SUPPDM.QNAM"
      Name="QNAM"
      SASFieldName="QNAM"
      DataType="text"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Qualifier Variable Name</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="SUPPDM.QLABEL"
      Name="QLABEL"
      SASFieldName="QLABEL"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Qualifier Variable Label</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="SUPPDM.QVAL"
      Name="QVAL"
      SASFieldName="QVAL"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Data Value</TranslatedText>
      </Description>
      <def:Origin Type=" ">
      </def:Origin>
      <def:ValueListRef ValueListOID="VL.SUPPDM.QVAL"/>
    </ItemDef>
    <ItemDef OID="SUPPDM.QORIG"
      Name="QORIG"
      SASFieldName="QORIG"
      DataType="text"
      Length="20"
      def:DisplayFormat="20"
      >
      <Description>
          <TranslatedText xml:lang="en">Origin</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="SUPPDM.QEVAL"
      Name="QEVAL"
      SASFieldName="QEVAL"
      DataType="text"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Evaluator</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TA.STUDYID"
      Name="STUDYID"
      SASFieldName="STUDYID"
      DataType="text"
      Length="15"
      def:DisplayFormat="15"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TA.DOMAIN"
      Name="DOMAIN"
      SASFieldName="DOMAIN"
      DataType="text"
      Length="2"
      def:DisplayFormat="2"
      >
      <Description>
          <TranslatedText xml:lang="en">Domain Abbreviation</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TA.ARMCD"
      Name="ARMCD"
      SASFieldName="ARMCD"
      DataType="text"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Planned Arm Code</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ARMCD"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TA.ARM"
      Name="ARM"
      SASFieldName="ARM"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Description of Planned Arm</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ARM"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TA.TAETORD"
      Name="TAETORD"
      SASFieldName="TAETORD"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Planned Order of Element within Arm</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TA.ETCD"
      Name="ETCD"
      SASFieldName="ETCD"
      DataType="text"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Element Code</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TA.ELEMENT"
      Name="ELEMENT"
      SASFieldName="ELEMENT"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Description of Element</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TA.TABRANCH"
      Name="TABRANCH"
      SASFieldName="TABRANCH"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Branch</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TA.TATRANS"
      Name="TATRANS"
      SASFieldName="TATRANS"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Transition Rule</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TA.EPOCH"
      Name="EPOCH"
      SASFieldName="EPOCH"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Epoch</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.EPOCH"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TD.STUDYID"
      Name="STUDYID"
      SASFieldName="STUDYID"
      DataType="text"
      Length="15"
      def:DisplayFormat="15"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TD.DOMAIN"
      Name="DOMAIN"
      SASFieldName="DOMAIN"
      DataType="text"
      Length="2"
      def:DisplayFormat="2"
      >
      <Description>
          <TranslatedText xml:lang="en">Domain Abbreviation</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TD.TDORDER"
      Name="TDORDER"
      SASFieldName="TDORDER"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Sequence of Planned Assessment Schedule</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TD.TDANCVAR"
      Name="TDANCVAR"
      SASFieldName="TDANCVAR"
      DataType="text"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Anchor Variable Name</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TD.TDSTOFF"
      Name="TDSTOFF"
      SASFieldName="TDSTOFF"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">Offset from the Anchor</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TD.TDTGTPAI"
      Name="TDTGTPAI"
      SASFieldName="TDTGTPAI"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">Planned Assessment Interval</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TD.TDMINPAI"
      Name="TDMINPAI"
      SASFieldName="TDMINPAI"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">Planned Assessment Interval Minimum</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TD.TDMAXPAI"
      Name="TDMAXPAI"
      SASFieldName="TDMAXPAI"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">Planned Assessment Interval Maximum</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TD.TDNUMRPT"
      Name="TDNUMRPT"
      SASFieldName="TDNUMRPT"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Maximum Number of Actual Assessments</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TE.STUDYID"
      Name="STUDYID"
      SASFieldName="STUDYID"
      DataType="text"
      Length="15"
      def:DisplayFormat="15"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TE.DOMAIN"
      Name="DOMAIN"
      SASFieldName="DOMAIN"
      DataType="text"
      Length="2"
      def:DisplayFormat="2"
      >
      <Description>
          <TranslatedText xml:lang="en">Domain Abbreviation</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TE.ETCD"
      Name="ETCD"
      SASFieldName="ETCD"
      DataType="text"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Element Code</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TE.ELEMENT"
      Name="ELEMENT"
      SASFieldName="ELEMENT"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Description of Element</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TE.TESTRL"
      Name="TESTRL"
      SASFieldName="TESTRL"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Rule for Start of Element</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TE.TEENRL"
      Name="TEENRL"
      SASFieldName="TEENRL"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Rule for End of Element</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TE.TEDUR"
      Name="TEDUR"
      SASFieldName="TEDUR"
      DataType="text"
      Length="64"
      def:DisplayFormat="64"
      >
      <Description>
          <TranslatedText xml:lang="en">Planned Duration of Element</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TI.STUDYID"
      Name="STUDYID"
      SASFieldName="STUDYID"
      DataType="text"
      Length="15"
      def:DisplayFormat="15"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TI.DOMAIN"
      Name="DOMAIN"
      SASFieldName="DOMAIN"
      DataType="text"
      Length="2"
      def:DisplayFormat="2"
      >
      <Description>
          <TranslatedText xml:lang="en">Domain Abbreviation</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TI.IETESTCD"
      Name="IETESTCD"
      SASFieldName="IETESTCD"
      DataType="text"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Inclusion/Exclusion Criterion Short Name</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TI.IETEST"
      Name="IETEST"
      SASFieldName="IETEST"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Inclusion/Exclusion Criterion</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TI.IECAT"
      Name="IECAT"
      SASFieldName="IECAT"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Inclusion/Exclusion Category</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.IECAT"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TS.STUDYID"
      Name="STUDYID"
      SASFieldName="STUDYID"
      DataType="text"
      Length="15"
      def:DisplayFormat="15"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TS.DOMAIN"
      Name="DOMAIN"
      SASFieldName="DOMAIN"
      DataType="text"
      Length="2"
      def:DisplayFormat="2"
      >
      <Description>
          <TranslatedText xml:lang="en">Domain Abbreviation</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TS.TSSEQ"
      Name="TSSEQ"
      SASFieldName="TSSEQ"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Sequence Number</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TS.TSPARMCD"
      Name="TSPARMCD"
      SASFieldName="TSPARMCD"
      DataType="text"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Trial Summary Parameter Short Name</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.TSPARMCD"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TS.TSPARM"
      Name="TSPARM"
      SASFieldName="TSPARM"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Trial Summary Parameter</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.TSPARM"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TS.TSVAL"
      Name="TSVAL"
      SASFieldName="TSVAL"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Parameter Value</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TS.TSVALCD"
      Name="TSVALCD"
      SASFieldName="TSVALCD"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Parameter Value Code</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TS.TSVCDREF"
      Name="TSVCDREF"
      SASFieldName="TSVCDREF"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Name of the Reference Terminology</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TS.TSVCDVER"
      Name="TSVCDVER"
      SASFieldName="TSVCDVER"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Version of the Reference Terminology</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TV.STUDYID"
      Name="STUDYID"
      SASFieldName="STUDYID"
      DataType="text"
      Length="15"
      def:DisplayFormat="15"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TV.DOMAIN"
      Name="DOMAIN"
      SASFieldName="DOMAIN"
      DataType="text"
      Length="2"
      def:DisplayFormat="2"
      >
      <Description>
          <TranslatedText xml:lang="en">Domain Abbreviation</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TV.VISITNUM"
      Name="VISITNUM"
      SASFieldName="VISITNUM"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Visit Number</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TV.VISIT"
      Name="VISIT"
      SASFieldName="VISIT"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Visit Name</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TV.ARMCD"
      Name="ARMCD"
      SASFieldName="ARMCD"
      DataType="text"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Planned Arm Code</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ARMCD"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TV.ARM"
      Name="ARM"
      SASFieldName="ARM"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Description of Planned Arm</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ARM"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TV.TVSTRL"
      Name="TVSTRL"
      SASFieldName="TVSTRL"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Visit Start Rule</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="TV.TVENRL"
      Name="TVENRL"
      SASFieldName="TVENRL"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Visit End Rule</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="XP.STUDYID"
      Name="STUDYID"
      SASFieldName="STUDYID"
      DataType="text"
      Length="15"
      def:DisplayFormat="15"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="XP.DOMAIN"
      Name="DOMAIN"
      SASFieldName="DOMAIN"
      DataType="text"
      Length="2"
      def:DisplayFormat="2"
      >
      <Description>
          <TranslatedText xml:lang="en">Domain Abbreviation</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="XP.USUBJID"
      Name="USUBJID"
      SASFieldName="USUBJID"
      DataType="text"
      Length="25"
      def:DisplayFormat="25"
      >
      <Description>
          <TranslatedText xml:lang="en">Unique Subject Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="XP.XPSEQ"
      Name="XPSEQ"
      SASFieldName="XPSEQ"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Sequence Number</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="XP.XPTESTCD"
      Name="XPTESTCD"
      SASFieldName="XPTESTCD"
      DataType="text"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Pain Test Short Name</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.XPTESTCD"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="XP.XPTEST"
      Name="XPTEST"
      SASFieldName="XPTEST"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Pain Test Name</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.XPTEST"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="XP.XPORRES"
      Name="XPORRES"
      SASFieldName="XPORRES"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Result or Finding in Original Units</TranslatedText>
      </Description>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="5" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="XP.XPSTRESC"
      Name="XPSTRESC"
      SASFieldName="XPSTRESC"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Character Result/Finding in Std Format</TranslatedText>
      </Description>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="5" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="XP.XPSTRESN"
      Name="XPSTRESN"
      SASFieldName="XPSTRESN"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Numeric Result/Finding in Std Format</TranslatedText>
      </Description>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="5" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="XP.EPOCH"
      Name="EPOCH"
      SASFieldName="EPOCH"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Epoch</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.EPOCH"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="XP.VISITNUM"
      Name="VISITNUM"
      SASFieldName="VISITNUM"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Visit Number</TranslatedText>
      </Description>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="XP.VISIT"
      Name="VISIT"
      SASFieldName="VISIT"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Visit Name</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.VISIT"/>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="5" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="XP.XPBLFL"
      Name="XPBLFL"
      SASFieldName="XPBLFL"
      DataType="text"
      Length="2"
      def:DisplayFormat="2"
      >
      <Description>
          <TranslatedText xml:lang="en">Baseline Flag</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.NY"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="XP.XPDTC"
      Name="XPDTC"
      SASFieldName="XPDTC"
      DataType="date"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">Date/Time of  Collection</TranslatedText>
      </Description>
      <def:Origin Type="CRF">
        <def:DocumentRef leafID="blankcrf">
          <def:PDFPageRef PageRefs="5" Type="PhysicalRef"/>
        </def:DocumentRef>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="XP.XPDY"
      Name="XPDY"
      SASFieldName="XPDY"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Day of  Collection</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <!-- ************************************************************ -->
    <!-- The details of value level items are here                    -->
    <!-- ************************************************************ -->
    <ItemDef OID="VL.LB.LBORRES.ALB"
      Name="ALB"
      DataType="float"
      SASFieldName="ALB"
      Length="8"
      SignificantDigits="2"
      def:DisplayFormat="4.2"
      >
      <Description>
        <TranslatedText xml:lang="en">Albumin; Microalbumin</TranslatedText>
      </Description>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.LB.LBORRES.ALP"
      Name="ALP"
      DataType="float"
      SASFieldName="ALP"
      Length="8"
      SignificantDigits="0"
      def:DisplayFormat="3."
      >
      <Description>
        <TranslatedText xml:lang="en">Alkaline Phosphatase</TranslatedText>
      </Description>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.LB.LBORRES.ALT"
      Name="ALT"
      DataType="float"
      SASFieldName="ALT"
      Length="8"
      SignificantDigits="0"
      def:DisplayFormat="3."
      >
      <Description>
        <TranslatedText xml:lang="en">Alanine Aminotransferase; SGPT</TranslatedText>
      </Description>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.LB.LBORRES.AST"
      Name="AST"
      DataType="float"
      SASFieldName="AST"
      Length="8"
      SignificantDigits="0"
      def:DisplayFormat="3."
      >
      <Description>
        <TranslatedText xml:lang="en">Aspartate Aminotransferase; SGOT</TranslatedText>
      </Description>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.LB.LBORRES.BILDIR"
      Name="BILDIR"
      DataType="float"
      SASFieldName="BILDIR"
      Length="8"
      SignificantDigits="2"
      def:DisplayFormat="4.2"
      >
      <Description>
        <TranslatedText xml:lang="en">Direct Bilirubin</TranslatedText>
      </Description>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.LB.LBORRES.BILI"
      Name="BILI"
      DataType="float"
      SASFieldName="BILI"
      Length="8"
      SignificantDigits="2"
      def:DisplayFormat="4.2"
      >
      <Description>
        <TranslatedText xml:lang="en">Bilirubin; Total Bilirubin</TranslatedText>
      </Description>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.LB.LBORRES.GGT"
      Name="GGT"
      DataType="float"
      SASFieldName="GGT"
      Length="8"
      SignificantDigits="0"
      def:DisplayFormat="3."
      >
      <Description>
        <TranslatedText xml:lang="en">Gamma Glutamyl Transferase</TranslatedText>
      </Description>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.LB.LBORRES.GLUC.1"
      Name="GLUC"
      DataType="float"
      SASFieldName="GLUC"
      Length="8"
      SignificantDigits="2"
      def:DisplayFormat="4.2"
      >
      <Description>
        <TranslatedText xml:lang="en">Glucose</TranslatedText>
      </Description>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.LB.LBORRES.GLUC.2"
      Name="GLUC"
      DataType="text"
      SASFieldName="GLUC"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
        <TranslatedText xml:lang="en">Glucose</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.URINGLUC"/>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.LB.LBORRES.HCT"
      Name="HCT"
      DataType="float"
      SASFieldName="HCT"
      Length="8"
      SignificantDigits="0"
      def:DisplayFormat="3."
      >
      <Description>
        <TranslatedText xml:lang="en">Hematocrit</TranslatedText>
      </Description>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.LB.LBORRES.HGB"
      Name="HGB"
      DataType="float"
      SASFieldName="HGB"
      Length="8"
      SignificantDigits="2"
      def:DisplayFormat="5.2"
      >
      <Description>
        <TranslatedText xml:lang="en">Hemoglobin</TranslatedText>
      </Description>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.LB.LBORRES.PROT"
      Name="PROT"
      DataType="float"
      SASFieldName="PROT"
      Length="8"
      SignificantDigits="2"
      def:DisplayFormat="4.2"
      >
      <Description>
        <TranslatedText xml:lang="en">Protein</TranslatedText>
      </Description>
      <def:Origin Type="eDT">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.SUPPDM.QVAL.RACEOTH"
      Name="RACEOTH"
      DataType="text"
      SASFieldName="RACEOTH"
      Length="20"
      def:DisplayFormat="20"
      >
      <Description>
        <TranslatedText xml:lang="en">Race, Other</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.SUPPDM.QVAL.RANDDTC"
      Name="RANDDTC"
      DataType="text"
      SASFieldName="RANDDTC"
      Length="10"
      def:DisplayFormat="10"
      >
      <Description>
        <TranslatedText xml:lang="en">Randomization Date</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <!-- ************************************************************ -->
    <!-- Codelists are presented below                                -->
    <!-- ************************************************************ -->
    <CodeList OID="CodeList.ACN"
      Name="ACN"
      DataType="text">
      <CodeListItem CodedValue="DOSE INCREASED" Rank="1">
        <Decode>
          <TranslatedText>DOSE INCREASED</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="DOSE NOT CHANGED" Rank="2">
        <Decode>
          <TranslatedText>DOSE NOT CHANGED</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="DOSE REDUCED" Rank="3">
        <Decode>
          <TranslatedText>DOSE REDUCED</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="DRUG INTERRUPTED" Rank="4">
        <Decode>
          <TranslatedText>DRUG INTERRUPTED</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="DRUG WITHDRAWN" Rank="5">
        <Decode>
          <TranslatedText>DRUG WITHDRAWN</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="NOT APPLICABLE" Rank="6">
        <Decode>
          <TranslatedText>NA</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="UNKNOWN" Rank="7">
        <Decode>
          <TranslatedText>U; Unknown</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.AEBODSYS"
      Name="AEBODSYS"
      DataType="text">
      <ExternalCodeList Dictionary="MedDRA" Version="18.0"/>
    </CodeList>
    <CodeList OID="CodeList.AEDECOD"
      Name="AEDECOD"
      DataType="text">
      <ExternalCodeList Dictionary="MedDRA" Version="18.0"/>
    </CodeList>
    <CodeList OID="CodeList.AEREL"
      Name="AEREL"
      DataType="text">
      <CodeListItem CodedValue="NOT RELATED" Rank="1">
        <Decode>
          <TranslatedText>NOT RELATED</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="POSSIBLY RELATED" Rank="2">
        <Decode>
          <TranslatedText>POSSIBLY RELATED</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="PROBABLY RELATED" Rank="3">
        <Decode>
          <TranslatedText>PROBABLY RELATED</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.AESEV"
      Name="AESEV"
      DataType="text">
      <CodeListItem CodedValue="MILD" Rank="1">
        <Decode>
          <TranslatedText>Grade 1; 1</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="MODERATE" Rank="2">
        <Decode>
          <TranslatedText>Grade 2; 2</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="SEVERE" Rank="3">
        <Decode>
          <TranslatedText>Grade 3; 3</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.AGEU"
      Name="AGEU"
      DataType="text">
      <CodeListItem CodedValue="YEARS" Rank="1">
        <Decode>
          <TranslatedText>YEARS</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.ARM"
      Name="ARM"
      DataType="text">
      <CodeListItem CodedValue="Analgezia HCL 30 mg" Rank="1">
        <Decode>
          <TranslatedText>Analgezia HCL 30 mg</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Placebo" Rank="2">
        <Decode>
          <TranslatedText>Placebo</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.ARMCD"
      Name="ARMCD"
      DataType="text">
      <CodeListItem CodedValue="ALG123" Rank="1">
        <Decode>
          <TranslatedText>Analgezia HCL 30 mg</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="PLACEBO" Rank="2">
        <Decode>
          <TranslatedText>Placebo</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.COUNTRY"
      Name="COUNTRY"
      DataType="text">
      <CodeListItem CodedValue="USA" Rank="1">
        <Decode>
          <TranslatedText>UNITED STATES</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.EPOCH"
      Name="EPOCH"
      DataType="text">
      <CodeListItem CodedValue="SCREENING" Rank="1">
        <Decode>
          <TranslatedText>SCREENING</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="TREATMENT" Rank="2">
        <Decode>
          <TranslatedText>TREATMENT</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.FRM"
      Name="FRM"
      DataType="text">
      <CodeListItem CodedValue="TABLET, COATED" Rank="1">
        <Decode>
          <TranslatedText>TABLET, COATED</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.IECAT"
      Name="IECAT"
      DataType="text">
      <CodeListItem CodedValue="INCLUSION" Rank="1">
        <Decode>
          <TranslatedText>INCLUSION</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="EXCLUSION" Rank="2">
        <Decode>
          <TranslatedText>EXCLUSION</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.LBCAT"
      Name="LBCAT"
      DataType="text">
      <CodeListItem CodedValue="CHEMISTRY" Rank="1">
        <Decode>
          <TranslatedText>CHEMISTRY</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="HEMATOLOGY" Rank="2">
        <Decode>
          <TranslatedText>HEMATOLOGY</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="URINALYSIS" Rank="3">
        <Decode>
          <TranslatedText>URINALYSIS</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.LBNRIND"
      Name="LBNRIND"
      DataType="text">
      <CodeListItem CodedValue="HIGH" Rank="1">
        <Decode>
          <TranslatedText>HIGH</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="LOW" Rank="2">
        <Decode>
          <TranslatedText>LOW</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="NORMAL" Rank="3">
        <Decode>
          <TranslatedText>NORMAL</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.LBTEST"
      Name="LBTEST"
      DataType="text">
      <CodeListItem CodedValue="Albumin; Microalbumin" Rank="1">
        <Decode>
          <TranslatedText>Albumin; Microalbumin</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Protein" Rank="10">
        <Decode>
          <TranslatedText>Protein</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Glucose" Rank="11">
        <Decode>
          <TranslatedText>Glucose</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Alkaline Phosphatase" Rank="2">
        <Decode>
          <TranslatedText>Alkaline Phosphatase</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Alanine Aminotransferase; SGPT" Rank="3">
        <Decode>
          <TranslatedText>Alanine Aminotransferase; SGPT</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Aspartate Aminotransferase; SGOT" Rank="4">
        <Decode>
          <TranslatedText>Aspartate Aminotransferase; SGOT</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Direct Bilirubin" Rank="5">
        <Decode>
          <TranslatedText>Direct Bilirubin</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Bilirubin; Total Bilirubin" Rank="6">
        <Decode>
          <TranslatedText>Bilirubin; Total Bilirubin</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Gamma Glutamyl Transferase" Rank="7">
        <Decode>
          <TranslatedText>Gamma Glutamyl Transferase</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="EVF; Erythrocyte Volume Fraction; Hematocrit; PCV; Packed Cell Volume" Rank="8">
        <Decode>
          <TranslatedText>EVF; Erythrocyte Volume Fraction; Hematocrit; PCV; Packed Cell Volume</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="FHGB; Free Hemoglobin; Hemoglobin" Rank="9">
        <Decode>
          <TranslatedText>FHGB; Free Hemoglobin; Hemoglobin</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.LBTESTCD"
      Name="LBTESTCD"
      DataType="text">
      <CodeListItem CodedValue="ALB" Rank="1">
        <Decode>
          <TranslatedText>Albumin; Microalbumin</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="PROT" Rank="10">
        <Decode>
          <TranslatedText>Protein</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="GLUC" Rank="11">
        <Decode>
          <TranslatedText>Glucose</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="ALP" Rank="2">
        <Decode>
          <TranslatedText>Alkaline Phosphatase</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="ALT" Rank="3">
        <Decode>
          <TranslatedText>Alanine Aminotransferase; SGPT</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="AST" Rank="4">
        <Decode>
          <TranslatedText>Aspartate Aminotransferase; SGOT</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="BILDIR" Rank="5">
        <Decode>
          <TranslatedText>Direct Bilirubin</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="BILI" Rank="6">
        <Decode>
          <TranslatedText>Bilirubin; Total Bilirubin</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="GGT" Rank="7">
        <Decode>
          <TranslatedText>Gamma Glutamyl Transferase</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="HCT" Rank="8">
        <Decode>
          <TranslatedText>EVF; Erythrocyte Volume Fraction; Hematocrit; PCV; Packed Cell Volume</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="HGB" Rank="9">
        <Decode>
          <TranslatedText>FHGB; Free Hemoglobin; Hemoglobin</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.NY"
      Name="NY"
      DataType="text">
      <CodeListItem CodedValue="N" Rank="1">
        <Decode>
          <TranslatedText>No</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="NA" Rank="2">
        <Decode>
          <TranslatedText>NA</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="U" Rank="3">
        <Decode>
          <TranslatedText>U; Unknown</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Y" Rank="4">
        <Decode>
          <TranslatedText>Yes</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.RACE"
      Name="RACE"
      DataType="text">
      <CodeListItem CodedValue="BLACK OR AFRICAN AMERICAN" Rank="1">
        <Decode>
          <TranslatedText>BLACK OR AFRICAN AMERICAN</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="ASIAN" Rank="2">
        <Decode>
          <TranslatedText>ASIAN</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="WHITE" Rank="3">
        <Decode>
          <TranslatedText>WHITE</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.SEX"
      Name="SEX"
      DataType="text">
      <CodeListItem CodedValue="F" Rank="1">
        <Decode>
          <TranslatedText>FEMALE</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="M" Rank="2">
        <Decode>
          <TranslatedText>MALE</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="U" Rank="3">
        <Decode>
          <TranslatedText>UNKNOWN</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.TSPARM"
      Name="TSPARM"
      DataType="text">
      <CodeListItem CodedValue="Added on to Existing Treatments" Rank="1">
        <Decode>
          <TranslatedText>Added on to Existing Treatments</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Control Type" Rank="10">
        <Decode>
          <TranslatedText>Control Type</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Diagnosis Group" Rank="11">
        <Decode>
          <TranslatedText>Diagnosis Group</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Trial Indication Type" Rank="12">
        <Decode>
          <TranslatedText>Trial Indication Type</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Trial Title" Rank="13">
        <Decode>
          <TranslatedText>Trial Title</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Trial Phase Classification" Rank="14">
        <Decode>
          <TranslatedText>Trial Phase Classification</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Trial Type" Rank="15">
        <Decode>
          <TranslatedText>Trial Type</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Current Therapy or Treatment" Rank="16">
        <Decode>
          <TranslatedText>Current Therapy or Treatment</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Trial Primary Objective" Rank="17">
        <Decode>
          <TranslatedText>Trial Primary Objective</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Trial Secondary Objective" Rank="18">
        <Decode>
          <TranslatedText>Trial Secondary Objective</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Clinical Study Sponsor" Rank="19">
        <Decode>
          <TranslatedText>Clinical Study Sponsor</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Planned Maximum Age of Subjects" Rank="2">
        <Decode>
          <TranslatedText>Planned Maximum Age of Subjects</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Trial Indication" Rank="20">
        <Decode>
          <TranslatedText>Trial Indication</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Investigational Therapy or Treatment" Rank="21">
        <Decode>
          <TranslatedText>Investigational Therapy or Treatment</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Randomization Quotient" Rank="22">
        <Decode>
          <TranslatedText>Randomization Quotient</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Registry Identifier" Rank="23">
        <Decode>
          <TranslatedText>Registry Identifier</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Primary Outcome Measure" Rank="24">
        <Decode>
          <TranslatedText>Primary Outcome Measure</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Secondary Outcome Measure" Rank="25">
        <Decode>
          <TranslatedText>Secondary Outcome Measure</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Exploratory Outcome Measure" Rank="26">
        <Decode>
          <TranslatedText>Exploratory Outcome Measure</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Pharmacological Class of Investigational Therapy" Rank="27">
        <Decode>
          <TranslatedText>Pharmacological Class of Investigational Therapy</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Planned Country of Investigational Site(s)" Rank="28">
        <Decode>
          <TranslatedText>Planned Country of Investigational Site(s)</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Adaptive Design" Rank="29">
        <Decode>
          <TranslatedText>Adaptive Design</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Planned Minimum Age of Subjects" Rank="3">
        <Decode>
          <TranslatedText>Planned Minimum Age of Subjects</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Data Cutoff Date" Rank="30">
        <Decode>
          <TranslatedText>Data Cutoff Date</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Data Cutoff Description" Rank="31">
        <Decode>
          <TranslatedText>Data Cutoff Description</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Intervention Model" Rank="32">
        <Decode>
          <TranslatedText>Intervention Model</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Planned Number of Arms" Rank="33">
        <Decode>
          <TranslatedText>Planned Number of Arms</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Study Type" Rank="34">
        <Decode>
          <TranslatedText>Study Type</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Intervention Type" Rank="35">
        <Decode>
          <TranslatedText>Intervention Type</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Study Start Date" Rank="36">
        <Decode>
          <TranslatedText>Study Start Date</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Study End Date" Rank="37">
        <Decode>
          <TranslatedText>Study End Date</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Actual Number of Subjects" Rank="38">
        <Decode>
          <TranslatedText>Actual Number of Subjects</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Healthy Subject" Rank="39">
        <Decode>
          <TranslatedText>Healthy Subject</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Planned Trial Length" Rank="4">
        <Decode>
          <TranslatedText>Planned Trial Length</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Stable Disease Minimum Duration" Rank="40">
        <Decode>
          <TranslatedText>Stable Disease Minimum Duration</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Confirmed Response Minimum Duration" Rank="41">
        <Decode>
          <TranslatedText>Confirmed Response Minimum Duration</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Planned Number of Subjects" Rank="5">
        <Decode>
          <TranslatedText>Planned Number of Subjects</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Trial is Randomized" Rank="6">
        <Decode>
          <TranslatedText>Trial is Randomized</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Sex of Participants" Rank="7">
        <Decode>
          <TranslatedText>Sex of Participants</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Study Stop Rules" Rank="8">
        <Decode>
          <TranslatedText>Study Stop Rules</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Trial Blinding Schema" Rank="9">
        <Decode>
          <TranslatedText>Trial Blinding Schema</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.TSPARMCD"
      Name="TSPARMCD"
      DataType="text">
      <CodeListItem CodedValue="ADDON" Rank="1">
        <Decode>
          <TranslatedText>Added on to Existing Treatments</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="TCNTRL" Rank="10">
        <Decode>
          <TranslatedText>Control Type</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="TDIGRP" Rank="11">
        <Decode>
          <TranslatedText>Diagnosis Group</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="TINDTP" Rank="12">
        <Decode>
          <TranslatedText>Trial Indication Type</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="TITLE" Rank="13">
        <Decode>
          <TranslatedText>Trial Title</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="TPHASE" Rank="14">
        <Decode>
          <TranslatedText>Trial Phase Classification</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="TTYPE" Rank="15">
        <Decode>
          <TranslatedText>Trial Type</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="CURTRT" Rank="16">
        <Decode>
          <TranslatedText>Current Therapy or Treatment</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="OBJPRIM" Rank="17">
        <Decode>
          <TranslatedText>Trial Primary Objective</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="OBJSEC" Rank="18">
        <Decode>
          <TranslatedText>Trial Secondary Objective</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="SPONSOR" Rank="19">
        <Decode>
          <TranslatedText>Clinical Study Sponsor</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="AGEMAX" Rank="2">
        <Decode>
          <TranslatedText>Planned Maximum Age of Subjects</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="INDIC" Rank="20">
        <Decode>
          <TranslatedText>Trial Indication</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="TRT" Rank="21">
        <Decode>
          <TranslatedText>Investigational Therapy or Treatment</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="RANDQT" Rank="22">
        <Decode>
          <TranslatedText>Randomization Quotient</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="REGID" Rank="23">
        <Decode>
          <TranslatedText>Registry Identifier</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="OUTMSPRI" Rank="24">
        <Decode>
          <TranslatedText>Primary Outcome Measure</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="OUTMSSEC" Rank="25">
        <Decode>
          <TranslatedText>Secondary Outcome Measure</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="OUTMSEXP" Rank="26">
        <Decode>
          <TranslatedText>Exploratory Outcome Measure</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="PCLAS" Rank="27">
        <Decode>
          <TranslatedText>Pharmacological Class of Investigational Therapy</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="FCNTRY" Rank="28">
        <Decode>
          <TranslatedText>Planned Country of Investigational Site(s)</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="ADAPT" Rank="29">
        <Decode>
          <TranslatedText>Adaptive Design</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="AGEMIN" Rank="3">
        <Decode>
          <TranslatedText>Planned Minimum Age of Subjects</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="DCUTDTC" Rank="30">
        <Decode>
          <TranslatedText>Data Cutoff Date</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="DCUTDESC" Rank="31">
        <Decode>
          <TranslatedText>Data Cutoff Description</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="INTMODEL" Rank="32">
        <Decode>
          <TranslatedText>Intervention Model</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="NARMS" Rank="33">
        <Decode>
          <TranslatedText>Planned Number of Arms</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="STYPE" Rank="34">
        <Decode>
          <TranslatedText>Study Type</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="INTTYPE" Rank="35">
        <Decode>
          <TranslatedText>Intervention Type</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="SSTDTC" Rank="36">
        <Decode>
          <TranslatedText>Study Start Date</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="SENDTC" Rank="37">
        <Decode>
          <TranslatedText>Study End Date</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="ACTSUB" Rank="38">
        <Decode>
          <TranslatedText>Actual Number of Subjects</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="HLTSUBJI" Rank="39">
        <Decode>
          <TranslatedText>Healthy Subject</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="LENGTH" Rank="4">
        <Decode>
          <TranslatedText>Planned Trial Length</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="SDMDUR" Rank="40">
        <Decode>
          <TranslatedText>Stable Disease Minimum Duration</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="CRMDUR" Rank="41">
        <Decode>
          <TranslatedText>Confirmed Response Minimum Duration</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="PLANSUB" Rank="5">
        <Decode>
          <TranslatedText>Planned Number of Subjects</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="RANDOM" Rank="6">
        <Decode>
          <TranslatedText>Trial is Randomized</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="SEXPOP" Rank="7">
        <Decode>
          <TranslatedText>Sex of Participants</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="STOPRULE" Rank="8">
        <Decode>
          <TranslatedText>Study Stop Rules</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="TBLIND" Rank="9">
        <Decode>
          <TranslatedText>Trial Blinding Schema</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.UNIT"
      Name="UNIT"
      DataType="text">
      <CodeListItem CodedValue="%" Rank="1">
        <Decode>
          <TranslatedText>Percentage</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="g/dL" Rank="2">
        <Decode>
          <TranslatedText>Gram per Deciliter</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="IU/L" Rank="3">
        <Decode>
          <TranslatedText>International Unit per Liter</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="mg/dL" Rank="4">
        <Decode>
          <TranslatedText>Milligram per Deciliter</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="mg" Rank="5">
        <Decode>
          <TranslatedText>Milligram</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.URINGLUC"
      Name="URINGLUC"
      DataType="text">
      <CodeListItem CodedValue="NEGATIVE" Rank="1">
        <Decode>
          <TranslatedText>Negative</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="POSITIVE" Rank="2">
        <Decode>
          <TranslatedText>Positive</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.VISIT"
      Name="VISIT"
      DataType="text">
      <CodeListItem CodedValue="Baseline" Rank="1">
        <Decode>
          <TranslatedText>Baseline</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Month 3" Rank="2">
        <Decode>
          <TranslatedText>Month 3</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Month 6" Rank="3">
        <Decode>
          <TranslatedText>Month 6</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.XPTEST"
      Name="XPTEST"
      DataType="text">
      <CodeListItem CodedValue="Pain Score" Rank="1">
        <Decode>
          <TranslatedText>Pain Score</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.XPTESTCD"
      Name="XPTESTCD"
      DataType="text">
      <CodeListItem CodedValue="XPPAIN" Rank="1">
        <Decode>
          <TranslatedText>XPPAIN</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>

    <!-- ******************************************* -->
    <!-- COMPUTATIONAL METHOD INFORMATION        *** -->
    <!-- ******************************************* -->
    <MethodDef OID="SETDOMAIN" Name="Hardcode to assign domain" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Hardcode to the name of the SDTM domain</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="STUDYDAYS" Name="--DY derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">If the date is before RFSTDTC, then --DY = this date minus RFSTDTC. Otherwise, --DY = this date minus RFSTDTC plus 1.</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="SETNULL" Name="Null Value" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Set to null</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="AE.AESEQ" Name="AESEQ derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Unique sequence based on sort order of studyid usubjid aedecod aestdtc aeendtc</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="AE.EPOCH" Name="EPOCH hardcode" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Hardcoded to TREATMENT</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="DM.RFENDTC" Name="RFENDTC derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">RFENDTC is the last date of dosing from the source dosing dataset</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="DM.DTHDTC" Name="DTHDTC derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">DTHDTC is set to null as no subjects died</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="DM.DTHFL" Name="DTHFL derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">DTHFL='N' since no subjects died</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="DM.AGE" Name="Algorithm to compute age" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">integer value of (BRTHDT - RFSTDTC)/365.25</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="DM.AGEU" Name="Age units hardcode" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Hardcoded to YEARS</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="DM.COUNTRY" Name="Country hardcode" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Hardcoded to USA</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="EX.EXSEQ" Name="EXSEQ derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Unique sequence based on sort order of studyid usubjid extrt exstdtc</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="EX.EXTRT" Name="EXTRT derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">All subjects were dosed with what they were randomized to, so EXTRT=DM.ARM</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="EX.EXDOSU" Name="EXDOSU hardcode" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Hardcoded to mg</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="EX.EXDOSFRM" Name="EXDOSFRM hardcode" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Hardcoded to TABLET, COATED</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="EX.EPOCH" Name="EPOCH hardcode" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Hardcoded to TREATMENT</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="LB.LBSEQ" Name="LBSEQ derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Unique sequence based on sort order of studyid usubjid lbcat lbtestcd visitnum</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="LB.LBTESTCD" Name="LBTESTCD derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Source labs.labtest variable mapped to LBTESTCD controlled terminology</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="LB.LBTEST" Name="LBTEST derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Source labs.labtest variable mapped to LBTEST controlled terminology</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="LB.LBCAT" Name="LBCAT derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Source labs.labcat variable mapped to LBCAT controlled terminology</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="LB.LBSTRESC" Name="LBSTRESC derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Copied directly (and unrealistically) from LBORRES</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="LB.LBSTRESN" Name="LBSTRESN derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Copied directly (and unrealistically) from LBORRES</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="LB.LBSTRESU" Name="LBSTRESN derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Copied directly (and unrealistically) from LBORRESU</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="LB.LBSTNRLO" Name="LBSTNRLO derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Set equal to (and unrealistically) from the soucre labs.lownorm</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="LB.LBSTNRHI" Name="LBSTNRHI derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Set equal to (and unrealistically) from the soucre labs.highnorm</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="LB.LBNRIND" Name="LBNRIND derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">if lbtestcd = 'GLUC' and lbcat = 'URINALYSIS' and lborres = 'POSITIVE' then
   lbnrind = 'HIGH';
 else if lbtestcd = 'GLUC' and lbcat = 'URINALYSIS' and lborres = 'NEGATIVE' then
   lbnrind = 'NORMAL';
 else if lbstnrlo ne . and lbstresn ne . and 
</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="LB.LBBLFL" Name="LBBLFL derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">If visit=Baseline then Y, else blank</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="LB.EPOCH" Name="EPOCH derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">If VISITNUM &lt; 0 then SCREENING and otherwise TREATMENT</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="METADATAENTRY" Name="Manual entry" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">This variable consists of study level metadata that was manually entered</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="XP.XPSEQ" Name="XPSEQ derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Unique sequence based on sort order of studyid usubjid xptestcd visitnum</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="XP.XPTESTCD" Name="XPTESTCD hardcode" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Set to XPAIN</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="XP.XPTEST" Name="XPTEST hardcode" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Set to Pain Score</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="XP.EPOCH" Name="EPOCH hardcode" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Hardcoded to TREATMENT</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="XP.XPBLFL" Name="XPBLFL derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">If visit=Baseline then Y, else blank</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="SUPPDM.RACEOTH" Name="RACEOTH derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Set to other race from source demographics file</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="SUPPDM.RANDDT" Name="RANDDT derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Set equal to the randomization date from the source demographics file</TranslatedText>
      </Description>
    </MethodDef>

    <!-- ******************************** -->
    <!-- COMMENTS DEFINITION SECTION      -->
    <!-- ******************************** -->
    <def:CommentDef OID="COM.ARMCD">
      <Description>
        <TranslatedText xml:lang="en">Assigned based on Randomization Number.</TranslatedText>
      </Description>
    </def:CommentDef>

    <!-- ******************************************* -->
    <!-- LEAF DEFINITION SECTION                 *** -->
    <!-- ******************************************* -->
    <def:leaf ID="blankcrf"
      xlink:href="blankcrf.pdf">
      <def:title>Annotated Case Report Form </def:title>
    </def:leaf>

    <def:leaf ID="CRTRG"
      xlink:href="reviewersguide.pdf">
      <def:title>CRT Reviewer's Guide </def:title>
    </def:leaf>

  </MetaDataVersion>
</Study>
</ODM>
