<?xml version="1.0" encoding="ISO-8859-1"?>
<!-- ****************************************************************************** -->
<!-- File: defineexample1.xml                                                       -->
<!-- Date: 28-01-2005                                                               -->
<!-- Author: Clinical Data Interchange Standards Consortium (CDISC)                 -->
<!-- Description: This is an example define.xml document which implements the Case  --> 
<!--   Report Tabulation Data Definition Specification Version 1.0.0.               -->
<!-- ****************************************************************************** -->
<ODM 
  xmlns="http://www.cdisc.org/ns/odm/v1.2"
  xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
  xmlns:xlink="http://www.w3.org/1999/xlink" 
  xmlns:def="http://www.cdisc.org/ns/def/v1.0"
  xsi:schemaLocation="http://www.cdisc.org/ns/odm/v1.2 define1-0-0.xsd"  
  FileOID="Study1234" 
  ODMVersion="1.2" 
  FileType="Snapshot" 
  CreationDateTime="2004-07-28T12:34:13-06:00">
<Study OID="1234">
  <GlobalVariables>
    <StudyName>1234</StudyName>
    <StudyDescription>1234 Data Definition</StudyDescription>
    <ProtocolName>1234</ProtocolName>
  </GlobalVariables>
  <MetaDataVersion OID="CDISC.SDTM.3.1.0"
    Name="Study 1234, Data Definitions"
    Description="Study 1234, Data Definitions"
    def:DefineVersion="1.0.0"
    def:StandardName="CDISC SDTM"
    def:StandardVersion="3.1.0">
    <def:AnnotatedCRF>
      <def:DocumentRef leafID="blankcrf"/>
    </def:AnnotatedCRF>
    <def:leaf ID="blankcrf" xlink:href="blankcrf.pdf">
      <def:title>Annotated Case Report Form</def:title>
    </def:leaf>
    <def:SupplementalDoc>
	<def:DocumentRef leafID="SupplementalDataDefinitions"/>
    </def:SupplementalDoc>
    <def:leaf ID="SupplementalDataDefinitions"
	 xlink:href="supplementaldatadefinitions.pdf">
	<def:title>Supplemental Data Definitions Document</def:title>
    </def:leaf>
    <def:ComputationMethod OID="COMPMETHOD.MEANBP">Sum all mean blood pressure readings for visits 0, 1, and 2 and divide by the total number of readings</def:ComputationMethod>
    <def:ValueListDef OID="ValueList.SC.SCTESTCD">
      <ItemRef ItemOID="SC.SCTESTCD.ALLERGY" OrderNumber="1" Mandatory="No"/>
      <ItemRef ItemOID="SC.SCTESTCD.EDLEVLN" OrderNumber="2" Mandatory="No"/>
      <ItemRef ItemOID="SC.SCTESTCD.EXCLSN" OrderNumber="3" Mandatory="No"/>
      <ItemRef ItemOID="SC.SCTESTCD.RACEOTH" OrderNumber="4" Mandatory="No"/>
    </def:ValueListDef>
    <def:ValueListDef OID="ValueList.SU.SUTRT">
      <ItemRef ItemOID="SU.SUTRT.ALCBEERA" OrderNumber="5" Mandatory="No"/>
      <ItemRef ItemOID="SU.SUTRT.ALCHIST2" OrderNumber="6" Mandatory="No"/>
      <ItemRef ItemOID="SU.SUTRT.ALCOTHA" OrderNumber="7" Mandatory="No"/>
      <ItemRef ItemOID="SU.SUTRT.ALCWINEA" OrderNumber="8" Mandatory="No"/>
      <ItemRef ItemOID="SU.SUTRT.SMKCLASS" OrderNumber="9" Mandatory="No"/>
    </def:ValueListDef>
    <def:ValueListDef OID="ValueList.VS.VSTESTCD">
      <ItemRef ItemOID="VS.VSTESTCD.FRAME" OrderNumber="10" Mandatory="No"/>
      <ItemRef ItemOID="VS.VSTESTCD.HTRAW" OrderNumber="11" Mandatory="No"/>
      <ItemRef ItemOID="VS.VSTESTCD.WTRAW" OrderNumber="12" Mandatory="No"/>
      <ItemRef ItemOID="VS.VSTESTCD.MEANBP" OrderNumber="13" Mandatory="No"/>
    </def:ValueListDef>
    <!-- ************************************************************** -->
    <!-- ItemGroupDef (domain) information Section                      -->
    <!-- ************************************************************** -->
    <ItemGroupDef OID="DM"
      Name="DM"
      Repeating="No"
      IsReferenceData="No"
      Purpose="Tabulation"
      def:Label="Demographics"
      def:Structure="One record per event per subject"
      def:DomainKeys="STUDYID, USUBJID"
      def:Class="Special Purpose"
      def:ArchiveLocationID="Location.DM">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="1"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="2"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="USUBJID"
        OrderNumber="3"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="SUBJID"
        OrderNumber="4"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="DM.RFSTDTC"
        OrderNumber="5"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="DM.RFENDTC"
        OrderNumber="6"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="DM.SITEID"
        OrderNumber="7"
        Mandatory="Yes"
        Role="Record Qualifier"/>
      <ItemRef ItemOID="DM.INVID"
        OrderNumber="8"
        Mandatory="Yes"
        Role="Record Qualifier"/>
      <ItemRef ItemOID="DM.BRTHDTC"
        OrderNumber="10"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="DM.AGE"
        OrderNumber="11"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="DM.AGEU"
        OrderNumber="12"
        Mandatory="Yes"
        Role="Variable Qualifier"/>
      <ItemRef ItemOID="DM.SEX"
        OrderNumber="13"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="DM.RACE"
        OrderNumber="14"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="DM.ARMCD"
        OrderNumber="16"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="DM.ARM"
        OrderNumber="17"
        Mandatory="Yes"
        Role="Synonym Qualifier"/>
      <ItemRef ItemOID="DM.COUNTRY"
        OrderNumber="18"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="DM.DMDTC"
        OrderNumber="19"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="DM.DMDY"
        OrderNumber="20"
        Mandatory="Yes"
        Role="Timing"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.DM" xlink:href="dm.xpt">
        <def:title>crt/datasets/1234/dm.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="TE"
      Name="TE"
      Repeating="No"
      IsReferenceData="Yes"
      Purpose="Tabulation"
      def:Label="Trial Elements"
      def:Structure="One Record Per Element"
      def:DomainKeys="STUDYID, ELEMENT"
      def:Class="Trial Design"
      def:ArchiveLocationID="Location.TE">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="1"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="2"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="TE.ETCD"
        OrderNumber="3"
        Mandatory="Yes"
        Role="Record Qualifier"/>
      <ItemRef ItemOID="TE.ELEMENT"
        OrderNumber="4"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="TE.TESTRL"
        OrderNumber="5"
        Mandatory="Yes"
        Role="Rule"/>
      <ItemRef ItemOID="TE.TEENRL"
        OrderNumber="6"
        Mandatory="Yes"
        Role="Rule"/>
      <ItemRef ItemOID="TE.TEDUR"
        OrderNumber="7"
        Mandatory="Yes"
        Role="Timing"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.TE" xlink:href="te.xpt">
        <def:title>crt/datasets/1234/te.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="TA"
      Name="TA"
      Repeating="No"
      IsReferenceData="Yes"
      Purpose="Tabulation"
      def:Label="Trial Arms"
      def:Structure="One Record per Element for each Arm"
      def:DomainKeys="STUDYID, ARM"
      def:Class="Trial Design"
      def:ArchiveLocationID="Location.TA">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="1"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="2"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="TA.ARMCD"
        OrderNumber="3"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="TA.ARM"
        OrderNumber="4"
        Mandatory="Yes"
        Role="Synonym Qualifier"/>
      <ItemRef ItemOID="TA.TAETORD"
        OrderNumber="5"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="TA.ETCD"
        OrderNumber="6"
        Mandatory="Yes"
        Role="Record Qualifier"/>
      <ItemRef ItemOID="TA.ELEMENT"
        OrderNumber="7"
        Mandatory="Yes"
        Role="Synonym Qualifier"/>
      <ItemRef ItemOID="TA.TABRANCH"
        OrderNumber="8"
        Mandatory="Yes"
        Role="Rule"/>
      <ItemRef ItemOID="TA.TATRANS"
        OrderNumber="9"
        Mandatory="Yes"
        Role="Rule"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.TA" xlink:href="ta.xpt">
        <def:title>crt/datasets/1234/ta.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="TV"
      Name="TV"
      Repeating="No"
      IsReferenceData="Yes"
      Purpose="Tabulation"
      def:Label="Trial Visits"
      def:Structure="One Record per Visit per Arm"
      def:DomainKeys="STUDYID, VISIT"
      def:Class="Trial Design"
      def:ArchiveLocationID="Location.TV">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="1"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="2"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="TV.VISIT"
        OrderNumber="3"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="TV.VISITNUM"
        OrderNumber="4"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="TV.ARMCD"
        OrderNumber="6"
        Mandatory="Yes"
        Role="Record Qualifier"/>
      <ItemRef ItemOID="TV.ARM"
        OrderNumber="7"
        Mandatory="Yes"
        Role="Synonym Qualifier"/>
      <ItemRef ItemOID="TV.TVSTRL"
        OrderNumber="8"
        Mandatory="Yes"
        Role="Rule"/>
      <ItemRef ItemOID="TV.TVENRL"
        OrderNumber="9"
        Mandatory="Yes"
        Role="Rule"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.TV" xlink:href="tv.xpt">
        <def:title>crt/datasets/1234/tv.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="SE"
      Name="SE"
      Repeating="No"
      IsReferenceData="Yes"
      Purpose="Tabulation"
      def:Label="Subject Elements"
      def:Structure="One Record Per Subject Element"
      def:DomainKeys="STUDYID, ELEMENT"
      def:Class="Study Design"
      def:ArchiveLocationID="Location.SE">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="1"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="2"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="USUBJID"
        OrderNumber="3"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="SE.ETCD"
        OrderNumber="4"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="SE.ELEMENT"
        OrderNumber="5"
        Mandatory="Yes"
        Role="Synonym Qualifier"/>
      <ItemRef ItemOID="SE.SESTDTC"
        OrderNumber="6"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="SE.SEENDTC"
        OrderNumber="7"
        Mandatory="Yes"
        Role="Timing"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.SE" xlink:href="se.xpt">
        <def:title>crt/datasets/1234/se.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="SV"
      Name="SV"
      Repeating="Yes"
      IsReferenceData="No"
      Purpose="Tabulation"
      def:Label="Subject Visits"
      def:Structure="One Record Per Subject Visit"
      def:DomainKeys="STUDYID, VISIT"
      def:Class="Study Design"
      def:ArchiveLocationID="Location.SV">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="1"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="2"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="USUBJID"
        OrderNumber="3"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="SV.VISIT"
        OrderNumber="4"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="SV.VISITNUM"
        OrderNumber="5"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="SV.SVSTDTC"
        OrderNumber="7"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="SV.SVENDTC"
        OrderNumber="8"
        Mandatory="Yes"
        Role="Timing"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.SV" xlink:href="sv.xpt">
        <def:title>crt/datasets/1234/sv.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="EX"
      Name="EX"
      Repeating="Yes"
      IsReferenceData="No"
      Purpose="Tabulation"
      def:Label="Exposure"
      def:Structure="One record per constant dosing interval per subject"
      def:DomainKeys="USUBJID, EXTRT, EXSEQ"
      def:Class="Interventions"
      def:ArchiveLocationID="Location.EX">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="10"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="20"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="USUBJID"
        OrderNumber="30"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="EX.EXSEQ"
        OrderNumber="40"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="EX.EXTRT"
        OrderNumber="70"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="EX.EXCAT"
        OrderNumber="80"
        Mandatory="Yes"
        Role="Grouping Qualifier"/>
      <ItemRef ItemOID="EX.EXDOSE"
        OrderNumber="100"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="EX.EXDOSTXT"
        OrderNumber="110"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="EX.EXDOSU"
        OrderNumber="120"
        Mandatory="Yes"
        Role="Variable Qualifier"/>
      <ItemRef ItemOID="EX.EXDOSTOT"
        OrderNumber="150"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="EX.EXROUTE"
        OrderNumber="170"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="EX.EXSTDTC"
        OrderNumber="210"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="EX.EXENDTC"
        OrderNumber="220"
        Mandatory="Yes"
        Role="Timing"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.EX" xlink:href="ex.xpt">
        <def:title>crt/datasets/1234/ex.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="CM"
      Name="CM"
      Repeating="Yes"
      IsReferenceData="No"
      Purpose="Tabulation"
      def:Label="Concomitant Medications"
      def:Structure="One record per event per subject"
      def:DomainKeys="USUBJID, CMTRT, CMSEQ"
      def:Class="Interventions"
      def:ArchiveLocationID="Location.CM">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="10"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="20"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="USUBJID"
        OrderNumber="30"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="CM.CMSEQ"
        OrderNumber="40"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="CM.CMTRT"
        OrderNumber="70"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="CM.CMDECOD"
        OrderNumber="90"
        Mandatory="Yes"
        Role="Synonym Qualifier"/>
      <ItemRef ItemOID="CM.CMCAT"
        OrderNumber="100"
        Mandatory="Yes"
        Role="Grouping Qualifier"/>
      <ItemRef ItemOID="CM.CMSCAT"
        OrderNumber="110"
        Mandatory="Yes"
        Role="Grouping Qualifier"/>
      <ItemRef ItemOID="CM.CMDOSU"
        OrderNumber="200"
        Mandatory="Yes"
        Role="Variable Qualifier"/>
      <ItemRef ItemOID="CM.CMDOSTOT"
        OrderNumber="230"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="CM.CMSTDTC"
        OrderNumber="260"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="CM.CMENDTC"
        OrderNumber="270"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="CM.CMSTDY"
        OrderNumber="280"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="CM.CMENDY"
        OrderNumber="290"
        Mandatory="Yes"
        Role="Timing"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.CM" xlink:href="cm.xpt">
        <def:title>crt/datasets/1234/cm.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="SU"
      Name="SU"
      Repeating="Yes"
      IsReferenceData="No"
      Purpose="Tabulation"
      def:Label="Substance Use"
      def:Structure="One record per substance use type per subject"
      def:DomainKeys="USUBJID, SUTRT, SUSEQ"
      def:Class="Interventions"
      def:ArchiveLocationID="Location.SU">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="10"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="20"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="USUBJID"
        OrderNumber="30"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="SU.SUSEQ"
        OrderNumber="40"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="SU.SUGRPID"
        OrderNumber="50"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="SU.SUTRT"
        OrderNumber="70"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="SU.SUDECOD"
        OrderNumber="90"
        Mandatory="Yes"
        Role="Synonym Qualifier"/>
      <ItemRef ItemOID="SU.SUCAT"
        OrderNumber="100"
        Mandatory="Yes"
        Role="Grouping Qualifier"/>
      <ItemRef ItemOID="SU.SUSCAT"
        OrderNumber="110"
        Mandatory="Yes"
        Role="Grouping Qualifier"/>
      <ItemRef ItemOID="SU.SUOCCUR"
        OrderNumber="120"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="SU.SUSTAT"
        OrderNumber="130"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="SU.SUDOSE"
        OrderNumber="170"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="SU.SUDOSTXT"
        OrderNumber="180"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="SU.SUDOSU"
        OrderNumber="190"
        Mandatory="Yes"
        Role="Variable Qualifier"/>
      <ItemRef ItemOID="SU.SUDOSFRQ"
        OrderNumber="210"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="SU.SUROUTE"
        OrderNumber="230"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="SU.VISITNUM"
        OrderNumber="240"
        Mandatory="Yes"
        Role="Timing"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.SU" xlink:href="su.xpt">
        <def:title>crt/datasets/1234/su.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="AE"
      Name="AE"
      Repeating="Yes"
      IsReferenceData="No"
      Purpose="Tabulation"
      def:Label="Adverse Events"
      def:Structure="One record per event per subject"
      def:DomainKeys="USUBJID, AETERM, AESEQ"
      def:Class="Events"
      def:ArchiveLocationID="Location.AE">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="10"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="20"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="USUBJID"
        OrderNumber="30"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="AE.AESEQ"
        OrderNumber="40"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="AE.AESPID"
        OrderNumber="70"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="AE.AETERM"
        OrderNumber="80"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="AE.AEDECOD"
        OrderNumber="100"
        Mandatory="Yes"
        Role="Synonym Qualifier"/>
      <ItemRef ItemOID="AE.AEBODSYS"
        OrderNumber="140"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="AE.AESEV"
        OrderNumber="160"
        Mandatory="Yes"
        Role="Record Qualifier"/>
      <ItemRef ItemOID="AE.AESER"
        OrderNumber="170"
        Mandatory="Yes"
        Role="Record Qualifier"/>
      <ItemRef ItemOID="AE.AEACN"
        OrderNumber="180"
        Mandatory="Yes"
        Role="Record Qualifier"/>
      <ItemRef ItemOID="AE.AEACNOTH"
        OrderNumber="190"
        Mandatory="Yes"
        Role="Record Qualifier"/>
      <ItemRef ItemOID="AE.AEREL"
        OrderNumber="200"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="AE.AERELNST"
        OrderNumber="210"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="AE.AEOUT"
        OrderNumber="230"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="AE.AESTDTC"
        OrderNumber="340"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="AE.AEENDTC"
        OrderNumber="350"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="AE.AESTDY"
        OrderNumber="360"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="AE.AEENDY"
        OrderNumber="370"
        Mandatory="Yes"
        Role="Timing"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.AE" xlink:href="ae.xpt">
        <def:title>crt/datasets/1234/ae.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="DS"
      Name="DS"
      Repeating="Yes"
      IsReferenceData="No"
      Purpose="Tabulation"
      def:Label="Disposition"
      def:Structure="One record per disposition status or protocol milestone per subject"
      def:DomainKeys="USUBJID, DSTERM, DSSEQ"
      def:Class="Events"
      def:ArchiveLocationID="Location.DS">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="10"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="20"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="USUBJID"
        OrderNumber="30"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DS.DSSEQ"
        OrderNumber="40"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DS.DSREFID"
        OrderNumber="60"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DS.DSTERM"
        OrderNumber="80"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="DS.DSDECOD"
        OrderNumber="90"
        Mandatory="Yes"
        Role="Synonym Qualifier"/>
      <ItemRef ItemOID="DS.DSCAT"
        OrderNumber="100"
        Mandatory="Yes"
        Role="Grouping Qualifier"/>
      <ItemRef ItemOID="DS.EPOCH"
        OrderNumber="150"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="DS.DSDTC"
        OrderNumber="160"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="DS.DSSTDTC"
        OrderNumber="170"
        Mandatory="Yes"
        Role="Timing"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.DS" xlink:href="ds.xpt">
        <def:title>crt/datasets/1234/ds.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="MH"
      Name="MH"
      Repeating="Yes"
      IsReferenceData="No"
      Purpose="Tabulation"
      def:Label="Medical History"
      def:Structure="One record per event per subject"
      def:DomainKeys="USUBJID, MHTERM, MHSEQ"
      def:Class="Events"
      def:ArchiveLocationID="Location.MH">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="10"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="20"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="USUBJID"
        OrderNumber="30"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="MH.MHSEQ"
        OrderNumber="40"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="MH.MHGRPID"
        OrderNumber="50"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="MH.MHSPID"
        OrderNumber="70"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="MH.MHTERM"
        OrderNumber="80"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="MH.MHDECOD"
        OrderNumber="100"
        Mandatory="Yes"
        Role="Synonym Qualifier"/>
      <ItemRef ItemOID="MH.MHCAT"
        OrderNumber="110"
        Mandatory="Yes"
        Role="Grouping Qualifier"/>
      <ItemRef ItemOID="MH.MHSTAT"
        OrderNumber="140"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="MH.MHBODSYS"
        OrderNumber="160"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="MH.VISITNUM"
        OrderNumber="170"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="MH.MHDTC"
        OrderNumber="200"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="MH.MHSTDTC"
        OrderNumber="210"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="MH.MHENRF"
        OrderNumber="240"
        Mandatory="Yes"
        Role="Timing"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.MH" xlink:href="mh.xpt">
        <def:title>crt/datasets/1234/mh.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="EG"
      Name="EG"
      Repeating="Yes"
      IsReferenceData="No"
      Purpose="Tabulation"
      def:Label="ECG Test Results"
      def:Structure="One record per event per subject"
      def:DomainKeys="USUBJID, EGTESTCD, EGSEQ"
      def:Class="Findings"
      def:ArchiveLocationID="Location.EG">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="10"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="20"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="USUBJID"
        OrderNumber="30"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="EG.EGSEQ"
        OrderNumber="40"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="EG.EGSPID"
        OrderNumber="70"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="EG.EGTESTCD"
        OrderNumber="80"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="EG.EGTEST"
        OrderNumber="90"
        Mandatory="Yes"
        Role="Synonym Qualifier"/>
      <ItemRef ItemOID="EG.EGCAT"
        OrderNumber="100"
        Mandatory="Yes"
        Role="Grouping Qualifier"/>
      <ItemRef ItemOID="EG.EGPOS"
        OrderNumber="120"
        Mandatory="Yes"
        Role="Record Qualifier"/>
      <ItemRef ItemOID="EG.EGORRES"
        OrderNumber="130"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="EG.EGORRESU"
        OrderNumber="140"
        Mandatory="Yes"
        Role="Variable Qualifier"/>
      <ItemRef ItemOID="EG.EGSTRESC"
        OrderNumber="160"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="EG.EGSTRESN"
        OrderNumber="170"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="EG.EGSTRESU"
        OrderNumber="180"
        Mandatory="Yes"
        Role="Variable Qualifier"/>
      <ItemRef ItemOID="EG.EGBLFL"
        OrderNumber="250"
        Mandatory="Yes"
        Role="Record Qualifier"/>
      <ItemRef ItemOID="EG.EGEVAL"
        OrderNumber="270"
        Mandatory="Yes"
        Role="Record Qualifier"/>
      <ItemRef ItemOID="EG.VISITNUM"
        OrderNumber="280"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="EG.VISIT"
        OrderNumber="290"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="EG.EGDTC"
        OrderNumber="310"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="EG.EGDY"
        OrderNumber="320"
        Mandatory="Yes"
        Role="Timing"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.EG" xlink:href="eg.xpt">
        <def:title>crt/datasets/1234/eg.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="IE"
      Name="IE"
      Repeating="Yes"
      IsReferenceData="No"
      Purpose="Tabulation"
      def:Label="Inclusion/Exclusion Exceptions"
      def:Structure="One record per event per subject"
      def:DomainKeys="USUBJID, IETEST, IESEQ"
      def:Class="Findings"
      def:ArchiveLocationID="Location.IE">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="10"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="20"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="USUBJID"
        OrderNumber="30"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="IE.IESEQ"
        OrderNumber="40"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="IE.IETESTCD"
        OrderNumber="60"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="IE.IETEST"
        OrderNumber="70"
        Mandatory="Yes"
        Role="Synonym Qualifier"/>
      <ItemRef ItemOID="IE.IECAT"
        OrderNumber="80"
        Mandatory="Yes"
        Role="Grouping Qualifier"/>
      <ItemRef ItemOID="IE.IEORRES"
        OrderNumber="100"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="IE.IESTRESC"
        OrderNumber="110"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="IE.VISITNUM"
        OrderNumber="120"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="IE.VISIT"
        OrderNumber="130"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="IE.IEDTC"
        OrderNumber="150"
        Mandatory="Yes"
        Role="Timing"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.IE" xlink:href="ie.xpt">
        <def:title>crt/datasets/1234/ie.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="LB"
      Name="LB"
      Repeating="Yes"
      IsReferenceData="No"
      Purpose="Tabulation"
      def:Label="Laboratory Tests"
      def:Structure="One record per lab test per subject"
      def:DomainKeys="USUBJID, LBTESTCD, VISITNUM, TPTNUM, LBSEQ"
      def:Class="Findings"
      def:ArchiveLocationID="Location.LB">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="10"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="20"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="USUBJID"
        OrderNumber="30"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="LB.LBSEQ"
        OrderNumber="40"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="LB.LBSPID"
        OrderNumber="70"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="LB.LBTESTCD"
        OrderNumber="80"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="LB.LBTEST"
        OrderNumber="90"
        Mandatory="Yes"
        Role="Synonym Qualifier"/>
      <ItemRef ItemOID="LB.LBCAT"
        OrderNumber="100"
        Mandatory="Yes"
        Role="Grouping Qualifier"/>
      <ItemRef ItemOID="LB.LBORRES"
        OrderNumber="120"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="LB.LBORRESU"
        OrderNumber="130"
        Mandatory="Yes"
        Role="Variable Qualifier"/>
      <ItemRef ItemOID="LB.LBORNRLO"
        OrderNumber="140"
        Mandatory="Yes"
        Role="Variable Qualifier"/>
      <ItemRef ItemOID="LB.LBORNRHI"
        OrderNumber="150"
        Mandatory="Yes"
        Role="Variable Qualifier"/>
      <ItemRef ItemOID="LB.LBSTRESC"
        OrderNumber="160"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="LB.LBSTRESN"
        OrderNumber="180"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="LB.LBSTRESU"
        OrderNumber="190"
        Mandatory="Yes"
        Role="Variable Qualifier"/>
      <ItemRef ItemOID="LB.LBSTNRLO"
        OrderNumber="200"
        Mandatory="Yes"
        Role="Variable Qualifier"/>
      <ItemRef ItemOID="LB.LBSTNRHI"
        OrderNumber="210"
        Mandatory="Yes"
        Role="Variable Qualifier"/>
      <ItemRef ItemOID="LB.LBNRIND"
        OrderNumber="220"
        Mandatory="Yes"
        Role="Variable Qualifier"/>
      <ItemRef ItemOID="LB.LBBLFL"
        OrderNumber="300"
        Mandatory="Yes"
        Role="Record Qualifier"/>
      <ItemRef ItemOID="LB.VISITNUM"
        OrderNumber="350"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="LB.VISIT"
        OrderNumber="360"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="LB.LBDTC"
        OrderNumber="380"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="LB.LBDY"
        OrderNumber="390"
        Mandatory="Yes"
        Role="Timing"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.LB" xlink:href="lb.xpt">
        <def:title>crt/datasets/1234/lb.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="PE"
      Name="PE"
      Repeating="Yes"
      IsReferenceData="No"
      Purpose="Tabulation"
      def:Label="Physical Examination"
      def:Structure="One record per event per subject"
      def:DomainKeys="USUBJID, PETEST, PESEQ"
      def:Class="Findings"
      def:ArchiveLocationID="Location.PE">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="10"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="20"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="USUBJID"
        OrderNumber="30"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="PE.PESEQ"
        OrderNumber="40"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="PE.PETESTCD"
        OrderNumber="70"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="PE.PETEST"
        OrderNumber="80"
        Mandatory="Yes"
        Role="Synonym Qualifier"/>
      <ItemRef ItemOID="PE.PEBODSYS"
        OrderNumber="130"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="PE.PEORRES"
        OrderNumber="140"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="PE.PESTRESC"
        OrderNumber="160"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="PE.PESTAT"
        OrderNumber="190"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="PE.VISITNUM"
        OrderNumber="230"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="PE.VISIT"
        OrderNumber="240"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="PE.PEDTC"
        OrderNumber="260"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="PE.PEDY"
        OrderNumber="270"
        Mandatory="Yes"
        Role="Timing"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.PE" xlink:href="pe.xpt">
        <def:title>crt/datasets/1234/pe.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="SC"
      Name="SC"
      Repeating="Yes"
      IsReferenceData="No"
      Purpose="Tabulation"
      def:Label="Subject Characteristics"
      def:Structure="One record per subject characteristic"
      def:DomainKeys="USUBJID, SCTESTCD"
      def:Class="Findings"
      def:ArchiveLocationID="Location.SC">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="10"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="20"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="USUBJID"
        OrderNumber="30"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="SC.SCSEQ"
        OrderNumber="40"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="SC.SCTESTCD"
        OrderNumber="70"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="SC.SCTEST"
        OrderNumber="80"
        Mandatory="Yes"
        Role="Synonym Qualifier"/>
      <ItemRef ItemOID="SC.SCCAT"
        OrderNumber="90"
        Mandatory="Yes"
        Role="Grouping Qualifier"/>
      <ItemRef ItemOID="SC.SCORRES"
        OrderNumber="110"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="SC.SCSTRESC"
        OrderNumber="130"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="SC.SCSTRESN"
        OrderNumber="140"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="SC.SCSTRESU"
        OrderNumber="150"
        Mandatory="Yes"
        Role="Variable Qualifier"/>
      <ItemRef ItemOID="SC.SCDTC"
        OrderNumber="180"
        Mandatory="Yes"
        Role="Timing"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.SC" xlink:href="sc.xpt">
        <def:title>crt/datasets/1234/sc.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="VS"
      Name="VS"
      Repeating="Yes"
      IsReferenceData="No"
      Purpose="Tabulation"
      def:Label="Vital Signs"
      def:Structure="One record per subject per vital sign"
      def:DomainKeys="USUBJID, VSTESTCD"
      def:Class="Findings"
      def:ArchiveLocationID="Location.VS">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="10"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="20"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="USUBJID"
        OrderNumber="30"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="VS.VSSEQ"
        OrderNumber="40"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="VS.VSTESTCD"
        OrderNumber="70"
        Mandatory="Yes"
        Role="Topic"/>
      <ItemRef ItemOID="VS.VSTEST"
        OrderNumber="80"
        Mandatory="Yes"
        Role="Synonym Qualifier"/>
      <ItemRef ItemOID="VS.VSPOS"
        OrderNumber="110"
        Mandatory="Yes"
        Role="Record Qualifier"/>
      <ItemRef ItemOID="VS.VSORRES"
        OrderNumber="120"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="VS.VSORRESU"
        OrderNumber="130"
        Mandatory="Yes"
        Role="Variable Qualifier"/>
      <ItemRef ItemOID="VS.VSSTRESC"
        OrderNumber="140"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="VS.VSSTRESN"
        OrderNumber="150"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="VS.VSSTRESU"
        OrderNumber="160"
        Mandatory="Yes"
        Role="Variable Qualifier"/>
      <ItemRef ItemOID="VS.VSSTAT"
        OrderNumber="170"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="VS.VSLOC"
        OrderNumber="200"
        Mandatory="Yes"
        Role="Record Qualifier"/>
      <ItemRef ItemOID="VS.VISITNUM"
        OrderNumber="230"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="VS.VISIT"
        OrderNumber="240"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="VS.VSDTC"
        OrderNumber="260"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="VS.VSDY"
        OrderNumber="270"
        Mandatory="Yes"
        Role="Timing"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.VS" xlink:href="vs.xpt">
        <def:title>crt/datasets/1234/vs.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <ItemGroupDef OID="CO"
      Name="CO"
      Repeating="Yes"
      IsReferenceData="No"
      Purpose="Tabulation"
      def:Label="Comments"
      def:Structure="One record per comment per subject"
      def:DomainKeys="STUDYID, COSEQ"
      def:Class="Special Purpose"
      def:ArchiveLocationID="Location.CO">
      <!-- ************************************************************ -->
      <!-- Each variable is listed here for this ItemGroupDef (domain)  -->
      <!-- ************************************************************ -->
      <ItemRef ItemOID="STUDYID"
        OrderNumber="1"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="DOMAIN"
        OrderNumber="2"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="RDOMAIN"
        OrderNumber="3"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="USUBJID"
        OrderNumber="4"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="CO.COSEQ"
        OrderNumber="5"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="CO.IDVAR"
        OrderNumber="6"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="CO.IDVARVAL"
        OrderNumber="7"
        Mandatory="Yes"
        Role="Identifier"/>
      <ItemRef ItemOID="CO.COREF"
        OrderNumber="8"
        Mandatory="Yes"
        Role="Record Qualifier"/>
      <ItemRef ItemOID="CO.CODTC"
        OrderNumber="9"
        Mandatory="Yes"
        Role="Timing"/>
      <ItemRef ItemOID="CO.COVAL"
        OrderNumber="10"
        Mandatory="Yes"
        Role="Result Qualifier"/>
      <ItemRef ItemOID="CO.COEVAL"
        OrderNumber="11"
        Mandatory="Yes"
        Role="Record Qualifier"/>
      <!-- ************************************************************** -->
      <!-- def:leaf details for hypertext linking the dataset             -->
      <!-- ************************************************************** -->
      <def:leaf ID="Location.CO" xlink:href="co.xpt">
        <def:title>crt/datasets/1234/co.xpt </def:title>
      </def:leaf>
    </ItemGroupDef>
    <!-- ************************************************************ -->
    <!-- The details of each variable is here for all domains         -->
    <!-- ************************************************************ -->
    <ItemDef OID="AE.AEACN"
      Name="AEACN"
      DataType="text"
      Length="26"       Origin="CRF Page 16, 18"       Comment="Adverse Events CRF Page 16"
      def:Label="ACTION TAKEN WITH STUDY TREATMENT">
    </ItemDef>
    <ItemDef OID="AE.AEACNOTH"
      Name="AEACNOTH"
      DataType="text"
      Length="200"       Origin="CRF Page"       Comment="Adverse Events CRF Page 16"
      def:Label="OTHER ACTION TAKEN">
    </ItemDef>
    <ItemDef OID="AE.AEBODSYS"
      Name="AEBODSYS"
      DataType="text"
      Length="50"       Origin="DERIVED"       Comment="Body system text"
      def:Label="BODY SYSTEM OR ORGAN CLASS">
    </ItemDef>
    <ItemDef OID="AE.AEDECOD"
      Name="AEDECOD"
      DataType="text"
      Length="50"       Origin="DERIVED"       Comment="Preferred text (COSTART dictionary)"
      def:Label="DICTIONARY-DERIVED TERM">
    </ItemDef>
    <ItemDef OID="AE.AEENDTC"
      Name="AEENDTC"
      DataType="date"
      Length="26"       Origin="CRF Page"       Comment="Adverse Events CRF Page 16"
      def:Label="END DATE/TIME OF ADVERSE EVENT">
    </ItemDef>
    <ItemDef OID="AE.AEENDY"
      Name="AEENDY"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="Event to day - relative to study baseline/first active day."
      def:Label="STUDY DAY OF END OF EVENT">
    </ItemDef>
    <ItemDef OID="AE.AEOUT"
      Name="AEOUT"
      DataType="text"
      Length="13"       Origin="CRF Page"       Comment="Adverse Events CRF Page 16"
      def:Label="OUTCOME OF ADVERSE EVENT">
    </ItemDef>
    <ItemDef OID="AE.AEREL"
      Name="AEREL"
      DataType="text"
      Length="200"       Origin="CRF Page"       Comment="Adverse Events CRF Page 16"
      def:Label="CAUSALITY">
    </ItemDef>
    <ItemDef OID="AE.AERELNST"
      Name="AERELNST"
      DataType="text"
      Length="200"       Origin="CRF Page"       Comment="Adverse Events CRF Page 16"
      def:Label="RELATIONSHIP TO NON-STUDY TREATMENT">
    </ItemDef>
    <ItemDef OID="AE.AESEQ"
      Name="AESEQ"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="SEQUENCE NUMBER"
      def:Label="SEQUENCE NUMBER">
    </ItemDef>
    <ItemDef OID="AE.AESER"
      Name="AESER"
      DataType="text"
      Length="1"       Origin="CRF Page"       Comment="Adverse Events CRF Page 16"
      def:Label="SERIOUS EVENT">
    </ItemDef>
    <ItemDef OID="AE.AESEV"
      Name="AESEV"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="Adverse Events CRF Page 16"
      def:Label="SEVERITY/INTENSITY">
    </ItemDef>
    <ItemDef OID="AE.AESPID"
      Name="AESPID"
      DataType="text"
      Length="8"       Origin="DERIVED"       Comment="SPONSOR ID"
      def:Label="SPONSOR ID">
    </ItemDef>
    <ItemDef OID="AE.AESTDTC"
      Name="AESTDTC"
      DataType="date"
      Length="26"       Origin="CRF Page"       Comment="Adverse Events CRF Page 16"
      def:Label="START DATE/TIME OF ADVERSE EVENT">
    </ItemDef>
    <ItemDef OID="AE.AESTDY"
      Name="AESTDY"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="Event from day - relative to study baseline/first active day"
      def:Label="STUDY DAY OF START OF EVENT">
    </ItemDef>
    <ItemDef OID="AE.AETERM"
      Name="AETERM"
      DataType="text"
      Length="100"       Origin="CRF Page"       Comment="Adverse Events CRF Page 16"
      def:Label="REPORTED TERM FOR THE ADVERSE EVENT">
    </ItemDef>
    <ItemDef OID="DOMAIN"
      Name="DOMAIN"
      DataType="text"
      Length="2"       Origin="CRF Page"       Comment="DOMAIN ABBREVIATION"
      def:Label="DOMAIN ABBREVIATION">
    </ItemDef>
    <ItemDef OID="STUDYID"
      Name="STUDYID"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="Demographics CRF Page 4"
      def:Label="STUDY IDENTIFIER">
    </ItemDef>
    <ItemDef OID="SUBJID"
      Name="SUBJID"
      DataType="text"
      Length="60"       Origin="CRF Page"       Comment="Demographics CRF Page 4"
      def:Label="SUBJECT IDENTIFIER">
    </ItemDef>
    <ItemDef OID="USUBJID"
      Name="USUBJID"
      DataType="text"
      Length="60"       Origin="CRF Page"       Comment="Demographics CRF Page 4"
      def:Label="UNIQUE SUBJECT IDENTIFIER">
    </ItemDef>
    <ItemDef OID="CM.CMCAT"
      Name="CMCAT"
      DataType="text"
      Length="14"       Origin="CRF Page"       Comment="CATEGORY FOR MEDICATION"
      def:Label="CATEGORY FOR MEDICATION">
    </ItemDef>
    <ItemDef OID="CM.CMDECOD"
      Name="CMDECOD"
      DataType="text"
      Length="50"       Origin="DERIVED"       Comment="STANDARDIZED MEDICATION NAME"
      def:Label="STANDARDIZED MEDICATION NAME">
    </ItemDef>
    <ItemDef OID="CM.CMDOSTOT"
      Name="CMDOSTOT"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="TOTAL DAILY DOSE USING CMDOSU"
      def:Label="TOTAL DAILY DOSE USING CMDOSU">
    </ItemDef>
    <ItemDef OID="CM.CMDOSU"
      Name="CMDOSU"
      DataType="text"
      Length="34"       Origin="DERIVED"       Comment="DOSE UNITS"
      def:Label="DOSE UNITS">
    </ItemDef>
    <ItemDef OID="CM.CMENDTC"
      Name="CMENDTC"
      DataType="date"
      Length="29"       Origin="CRF Page"       Comment="Concomitant Medication CRF Page 10, Concomitant Medication CRF Page 35"
      def:Label="END DATE/TIME OF MEDICATION">
    </ItemDef>
    <ItemDef OID="CM.CMENDY"
      Name="CMENDY"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="Study day of end of medication"
      def:Label="STUDY DAY OF END OF MEDICATION">
    </ItemDef>
    <ItemDef OID="CM.CMSCAT"
      Name="CMSCAT"
      DataType="text"
      Length="50"       Origin="DERIVED"       Comment="SUBCATEGORY FOR MEDICATION"
      def:Label="SUBCATEGORY FOR MEDICATION">
    </ItemDef>
    <ItemDef OID="CM.CMSEQ"
      Name="CMSEQ"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="SEQUENCE NUMBER"
      def:Label="SEQUENCE NUMBER">
    </ItemDef>
    <ItemDef OID="CM.CMSTDTC"
      Name="CMSTDTC"
      DataType="date"
      Length="29"       Origin="CRF Page"       Comment="Concomitant Medication CRF Page 10, Concomitant Medication CRF Page 35"
      def:Label="START DATE/TIME OF MEDICATION">
    </ItemDef>
    <ItemDef OID="CM.CMSTDY"
      Name="CMSTDY"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="Study day of start of medication"
      def:Label="STUDY DAY OF START OF MEDICATION">
    </ItemDef>
    <ItemDef OID="CM.CMTRT"
      Name="CMTRT"
      DataType="text"
      Length="200"       Origin="CRF Page"       Comment="Concomitant Medication CRF Page 10, Concomitant Medication CRF Page 35"
      def:Label="REPORTED NAME OF DRUG, MED, OR THERAPY">
    </ItemDef>
    <ItemDef OID="CO.CODTC"
      Name="CODTC"
      DataType="text"
      Length="19"       Origin="DERIVED"       Comment="Date/Time of Comment"
      def:Label="DATE/TIME OF COMMENT">
    </ItemDef>
    <ItemDef OID="CO.COEVAL"
      Name="COEVAL"
      DataType="text"
      Length="1"       Origin="CRF Page"       Comment="EVALUATOR, USED TO DESCRIBE THE ORIGINATOR OF THE COMMENT"
      def:Label="EVALUATOR">
    </ItemDef>
    <ItemDef OID="CO.COREF"
      Name="COREF"
      DataType="text"
      Length="1"       Origin="CRF Page"       Comment="COMMENT REFERENCE"
      def:Label="COMMENT REFERENCE">
    </ItemDef>
    <ItemDef OID="CO.COSEQ"
      Name="COSEQ"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="SEQUENCE NUMBER"
      def:Label="SEQUENCE NUMBER">
    </ItemDef>
    <ItemDef OID="CO.COVAL"
      Name="COVAL"
      DataType="text"
      Length="200"       Origin="CRF Page"       Comment="Comment"
      def:Label="COMMENT">
    </ItemDef>
    <ItemDef OID="CO.IDVAR"
      Name="IDVAR"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="IDENTIFIER VARIABLE"
      def:Label="IDENTIFIER VARIABLE NAME">
    </ItemDef>
    <ItemDef OID="CO.IDVARVAL"
      Name="IDVARVAL"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="IDENTIFIER VARIABLE VALUE"
      def:Label="IDENTIFIER VARIABLE VALUE">
    </ItemDef>
    <ItemDef OID="RDOMAIN"
      Name="RDOMAIN"
      DataType="text"
      Length="2"       Origin="CRF Page"       Comment="RELATED DOMAIN ABBREVIATION"
      def:Label="RELATED DOMAIN ABBREVIATION">
    </ItemDef>
    <ItemDef OID="DM.AGE"
      Name="AGE"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="AGE IN AGEU AT REFERENCE DATE/TIME"
      def:Label="AGE IN AGEU AT REFERENCE DATE/TIME">
    </ItemDef>
    <ItemDef OID="DM.AGEU"
      Name="AGEU"
      DataType="text"
      Length="13"       Origin="DERIVED"       Comment="AGE UNITS"
      def:Label="AGE UNITS">
    </ItemDef>
    <ItemDef OID="DM.ARM"
      Name="ARM"
      DataType="text"
      Length="80"       Origin="DERIVED"       Comment="DESCRIPTION OF PLANNED ARM"
      def:Label="DESCRIPTION OF ARM">
    </ItemDef>
    <ItemDef OID="DM.ARMCD"
      Name="ARMCD"
      DataType="text"
      Length="80"       Origin="DERIVED"       Comment="PLANNED ARM CODE"
      def:Label="ARM CODE">
    </ItemDef>
    <ItemDef OID="DM.BRTHDTC"
      Name="BRTHDTC"
      DataType="date"
      Length="26"       Origin="CRF Page"       Comment="Demographics CRF Page 4"
      def:Label="DATE/TIME OF BIRTH">
    </ItemDef>
    <ItemDef OID="DM.COUNTRY"
      Name="COUNTRY"
      DataType="text"
      Length="80"       Origin="CRF Page"       Comment="COUNTRY"
      def:Label="COUNTRY">
    </ItemDef>
    <ItemDef OID="DM.DMDTC"
      Name="DMDTC"
      DataType="date"
      Length="26"       Origin="CRF Page"       Comment="Demographics CRF Page 4"
      def:Label="DATE/TIME OF COLLECTION">
    </ItemDef>
    <ItemDef OID="DM.DMDY"
      Name="DMDY"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="STUDY DAY OF COLLECTION"
      def:Label="STUDY DAY OF COLLECTION">
    </ItemDef>
    <ItemDef OID="DM.INVID"
      Name="INVID"
      DataType="text"
      Length="20"       Origin="CRF Page"       Comment="Demographics CRF Page 4"
      def:Label="INVESTIGATOR IDENTIFIER">
    </ItemDef>
    <ItemDef OID="DM.RACE"
      Name="RACE"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="Demographics CRF Page 4"
      def:Label="RACE">
    </ItemDef>
    <ItemDef OID="DM.RFENDTC"
      Name="RFENDTC"
      DataType="date"
      Length="26"       Origin="CRF Page"       Comment="SUBJECT REFERENCE START DATE/TIME"
      def:Label="SUBJECT REFERENCE END DATE/TIME">
    </ItemDef>
    <ItemDef OID="DM.RFSTDTC"
      Name="RFSTDTC"
      DataType="date"
      Length="26"       Origin="CRF Page"       Comment="SUBJECT REFERENCE END DATE/TIME"
      def:Label="SUBJECT REFERENCE START DATE/TIME">
    </ItemDef>
    <ItemDef OID="DM.SEX"
      Name="SEX"
      DataType="text"
      Length="80"       Origin="CRF Page"       Comment="Demographics CRF Page 4"
      def:Label="SEX">
    </ItemDef>
    <ItemDef OID="DM.SITEID"
      Name="SITEID"
      DataType="text"
      Length="161"       Origin="CRF Page"       Comment="Demographics CRF Page 4"
      def:Label="STUDY SITE IDENTIFIER">
    </ItemDef>
    <ItemDef OID="DS.DSCAT"
      Name="DSCAT"
      DataType="text"
      Length="20"       Origin="CRF Page"       Comment="CATEGORY OF DISPOSITION EVENT"
      def:Label="CATEGORY FOR DISPOSITION EVENT">
    </ItemDef>
    <ItemDef OID="DS.DSDECOD"
      Name="DSDECOD"
      DataType="text"
      Length="200"       Origin="CRF Page"       Comment="Disposition CRF Page 37"
      def:Label="CONTROLLED TERMINOLOGY FOR DSTERM">
    </ItemDef>
    <ItemDef OID="DS.DSDTC"
      Name="DSDTC"
      DataType="date"
      Length="26"       Origin="CRF Page"       Comment="Disposition CRF Page 4, Disposition CRF Page 37"
      def:Label="DATE/TIME OF COLLECTION">
    </ItemDef>
    <ItemDef OID="DS.DSREFID"
      Name="DSREFID"
      DataType="text"
      Length="8"       Origin="DERIVED"       Comment="REFERENCE ID"
      def:Label="REFERENCE ID">
    </ItemDef>
    <ItemDef OID="DS.DSSEQ"
      Name="DSSEQ"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="SEQUENCE NUMBER"
      def:Label="SEQUENCE NUMBER">
    </ItemDef>
    <ItemDef OID="DS.DSSTDTC"
      Name="DSSTDTC"
      DataType="date"
      Length="26"       Origin="CRF Page"       Comment="Disposition CRF Page 37"
      def:Label="START DATE/TIME OF DISPOSITION EVENT">
    </ItemDef>
    <ItemDef OID="DS.DSTERM"
      Name="DSTERM"
      DataType="text"
      Length="200"       Origin="CRF Page"       Comment="Disposition CRF Page 4, Disposition CRF Page 37"
      def:Label="REPORTED TERM FOR THE DISPOSITION EVENT">
    </ItemDef>
    <ItemDef OID="DS.EPOCH"
      Name="EPOCH"
      DataType="text"
      Length="30"       Origin="DERIVED"       Comment="TRIAL EPOCH"
      def:Label="TRIAL EPOCH">
    </ItemDef>
    <ItemDef OID="EG.EGBLFL"
      Name="EGBLFL"
      DataType="text"
      Length="1"       Origin="CRF Page"       Comment="BASELINE FLAG"
      def:Label="BASELINE FLAG">
    </ItemDef>
    <ItemDef OID="EG.EGCAT"
      Name="EGCAT"
      DataType="text"
      Length="11"       Origin="CRF Page"       Comment="CATEGORY FOR ECG"
      def:Label="CATEGORY FOR ECG">
    </ItemDef>
    <ItemDef OID="EG.EGDTC"
      Name="EGDTC"
      DataType="date"
      Length="26"       Origin="CRF Page"       Comment="ECG Test Results Page 14"
      def:Label="DATE/TIME OF ECG">
    </ItemDef>
    <ItemDef OID="EG.EGDY"
      Name="EGDY"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="STUDY DAY OF ECG"
      def:Label="STUDY DAY OF ECG">
    </ItemDef>
    <ItemDef OID="EG.EGEVAL"
      Name="EGEVAL"
      DataType="text"
      Length="1"       Origin="CRF Page"       Comment="EVALUATOR"
      def:Label="EVALUATOR">
    </ItemDef>
    <ItemDef OID="EG.EGORRES"
      Name="EGORRES"
      DataType="text"
      Length="25"       Origin="CRF Page"       Comment="RESULT OR FINDING IN ORIGINAL UNITS"
      def:Label="RESULT OR FINDING IN ORIGINAL UNITS">
    </ItemDef>
    <ItemDef OID="EG.EGORRESU"
      Name="EGORRESU"
      DataType="text"
      Length="25"       Origin="CRF Page"       Comment="ORIGINAL UNITS"
      def:Label="ORIGINAL UNITS">
    </ItemDef>
    <ItemDef OID="EG.EGPOS"
      Name="EGPOS"
      DataType="text"
      Length="6"       Origin="CRF Page"       Comment="ECG POSITION OF SUBJECT"
      def:Label="ECG POSITION OF SUBJECT">
    </ItemDef>
    <ItemDef OID="EG.EGSEQ"
      Name="EGSEQ"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="SEQUENCE NUMBER"
      def:Label="SEQUENCE NUMBER">
    </ItemDef>
    <ItemDef OID="EG.EGSPID"
      Name="EGSPID"
      DataType="text"
      Length="8"       Origin="DERIVED"       Comment="SPONSOR ID"
      def:Label="SPONSOR ID">
    </ItemDef>
    <ItemDef OID="EG.EGSTRESC"
      Name="EGSTRESC"
      DataType="text"
      Length="20"       Origin="CRF Page"       Comment="CHARACTER RESULT/FINDING IN STD FORMAT"
      def:Label="CHARACTER RESULT/FINDING IN STD FORMAT">
    </ItemDef>
    <ItemDef OID="EG.EGSTRESN"
      Name="EGSTRESN"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="NUMERIC RESULT/FINDING IN STANDARD UNITS"
      def:Label="NUMERIC RESULT/FINDING IN STANDARD UNITS">
    </ItemDef>
    <ItemDef OID="EG.EGSTRESU"
      Name="EGSTRESU"
      DataType="text"
      Length="25"       Origin="CRF Page"       Comment="Default units."
      def:Label="STANDARD UNITS">
    </ItemDef>
    <ItemDef OID="EG.EGTEST"
      Name="EGTEST"
      DataType="text"
      Length="40"       Origin="CRF Page"       Comment="ECG TEST OR EXAMINATION NAME"
      def:Label="ECG TEST OR EXAMINATION NAME">
    </ItemDef>
    <ItemDef OID="EG.EGTESTCD"
      Name="EGTESTCD"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="ECG TEST OR EXAMINATION SHORT NAME"
      def:Label="ECG TEST OR EXAMINATION SHORT NAME">
    </ItemDef>
    <ItemDef OID="EG.VISIT"
      Name="VISIT"
      DataType="text"
      Length="20"       Origin="CRF Page"       Comment="VISIT NAME"
      def:Label="VISIT NAME">
    </ItemDef>
    <ItemDef OID="EG.VISITNUM"
      Name="VISITNUM"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="Clinical encounter number."
      def:Label="VISIT NUMBER">
    </ItemDef>
    <ItemDef OID="EX.EXCAT"
      Name="EXCAT"
      DataType="text"
      Length="30"       Origin="CRF Page"       Comment="CATEGORY FOR TREATMENT"
      def:Label="CATEGORY FOR TREATMENT">
    </ItemDef>
    <ItemDef OID="EX.EXDOSE"
      Name="EXDOSE"
      DataType="float"
      Length="8"       SignificantDigits="3"       Origin="CRF Page"       Comment="DOSE PER ADMINISTRATION"
      def:Label="DOSE PER ADMINISTRATION">
    </ItemDef>
    <ItemDef OID="EX.EXDOSTOT"
      Name="EXDOSTOT"
      DataType="float"
      Length="8"       SignificantDigits="3"       Origin="CRF Page"       Comment="TOTAL DAILY DOSE USING EXDOSU"
      def:Label="TOTAL DAILY DOSE USING EXDOSU">
    </ItemDef>
    <ItemDef OID="EX.EXDOSTXT"
      Name="EXDOSTXT"
      DataType="text"
      Length="80"       Origin="CRF Page"       Comment="DOSE DESCRIPTION"
      def:Label="DOSE DESCRIPTION">
    </ItemDef>
    <ItemDef OID="EX.EXDOSU"
      Name="EXDOSU"
      DataType="text"
      Length="2"       Origin="CRF Page"       Comment="DOSE UNITS"
      def:Label="DOSE UNITS">
    </ItemDef>
    <ItemDef OID="EX.EXENDTC"
      Name="EXENDTC"
      DataType="date"
      Length="26"       Origin="CRF Page"       Comment="Exposure CRF Page 11"
      def:Label="END DATE/TIME OF TREATMENT">
    </ItemDef>
    <ItemDef OID="EX.EXROUTE"
      Name="EXROUTE"
      DataType="text"
      Length="80"       Origin="CRF Page"       Comment="ROUTE OF ADMINISTRATION"
      def:Label="ROUTE OF ADMINISTRATION">
    </ItemDef>
    <ItemDef OID="EX.EXSEQ"
      Name="EXSEQ"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="SEQUENCE NUMBER"
      def:Label="SEQUENCE NUMBER">
    </ItemDef>
    <ItemDef OID="EX.EXSTDTC"
      Name="EXSTDTC"
      DataType="date"
      Length="26"       Origin="CRF Page"       Comment="Exposure CRF Page 11"
      def:Label="START DATE/TIME OF TREATMENT">
    </ItemDef>
    <ItemDef OID="EX.EXTRT"
      Name="EXTRT"
      DataType="text"
      Length="80"       Origin="CRF Page"       Comment="NAME OF ACTUAL TREATMENT"
      def:Label="NAME OF ACTUAL TREATMENT">
    </ItemDef>
    <ItemDef OID="IE.IECAT"
      Name="IECAT"
      DataType="text"
      Length="9"       Origin="CRF Page"       Comment="CATEGORY OF DISPOSITION EVENT"
      def:Label="CATEGORY FOR EXCEPTION CRITERION">
    </ItemDef>
    <ItemDef OID="IE.IEDTC"
      Name="IEDTC"
      DataType="date"
      Length="26"       Origin="CRF Page"       Comment="Inclusion/Exclusion Exceptions CRF Page 2, Inclusion/Exclusion Exceptions CRF Page 3"
      def:Label="DATE/TIME OF COLLECTION">
    </ItemDef>
    <ItemDef OID="IE.IEORRES"
      Name="IEORRES"
      DataType="text"
      Length="3"       Origin="CRF Page"       Comment="Inclusion/Exclusion Exceptions CRF Page 2, Inclusion/Exclusion Exceptions CRF Page 3"
      def:Label="CRITERION MET">
    </ItemDef>
    <ItemDef OID="IE.IESEQ"
      Name="IESEQ"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="SEQUENCE NUMBER"
      def:Label="SEQUENCE NUMBER">
    </ItemDef>
    <ItemDef OID="IE.IESTRESC"
      Name="IESTRESC"
      DataType="text"
      Length="3"       Origin="CRF Page"       Comment="Character result/finding in std format"
      def:Label="CHARACTER RESULT/FINDING IN STD FORMAT">
    </ItemDef>
    <ItemDef OID="IE.IETEST"
      Name="IETEST"
      DataType="text"
      Length="200"       Origin="CRF Page"       Comment="Inclusion/Exclusion Exceptions CRF Page 2, Inclusion/Exclusion Exceptions CRF Page 3"
      def:Label="EXCEPTION CRITERION">
    </ItemDef>
    <ItemDef OID="IE.IETESTCD"
      Name="IETESTCD"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="Inclusion/Exclusion Exceptions CRF Page 2, Inclusion/Exclusion Exceptions CRF Page 3"
      def:Label="EXCEPTION CRITERION SHORT NAME">
    </ItemDef>
    <ItemDef OID="IE.VISIT"
      Name="VISIT"
      DataType="text"
      Length="20"       Origin="CRF Page"       Comment="VISIT NAME"
      def:Label="VISIT NAME">
    </ItemDef>
    <ItemDef OID="IE.VISITNUM"
      Name="VISITNUM"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="Clinical encounter number."
      def:Label="VISIT NUMBER">
    </ItemDef>
    <ItemDef OID="LB.LBBLFL"
      Name="LBBLFL"
      DataType="text"
      Length="1"       Origin="DERIVED"       Comment="BASELINE FLAG"
      def:Label="BASELINE FLAG">
    </ItemDef>
    <ItemDef OID="LB.LBCAT"
      Name="LBCAT"
      DataType="text"
      Length="30"       Origin="DERIVED"       Comment="CATEGORY FOR LAB TEST"
      def:Label="CATEGORY FOR LAB TEST">
    </ItemDef>
    <ItemDef OID="LB.LBDTC"
      Name="LBDTC"
      DataType="date"
      Length="26"       Origin="CRF Page"       Comment="Laboratory Tests CRF Page 9, Laboratory Tests CRF Page 11"
      def:Label="DATE/TIME OF SPECIMEN COLLECTION">
    </ItemDef>
    <ItemDef OID="LB.LBDY"
      Name="LBDY"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="STUDY DAY OF SPECIMEN COLLECTION"
      def:Label="STUDY DAY OF SPECIMEN COLLECTION">
    </ItemDef>
    <ItemDef OID="LB.LBNRIND"
      Name="LBNRIND"
      DataType="text"
      Length="1"       Origin="DERIVED"       Comment="REFERENCE RANGE INDICATOR"
      def:Label="REFERENCE RANGE INDICATOR">
    </ItemDef>
    <ItemDef OID="LB.LBORNRHI"
      Name="LBORNRHI"
      DataType="text"
      Length="8"       Origin="DERIVED"       Comment="NORMAL RANGE UPPER LIMIT IN ORIG UNITS"
      def:Label="NORMAL RANGE UPPER LIMIT IN ORIG UNITS">
    </ItemDef>
    <ItemDef OID="LB.LBORNRLO"
      Name="LBORNRLO"
      DataType="text"
      Length="8"       Origin="DERIVED"       Comment="NORMAL RANGE LOWER LIMIT IN ORIG UNITS"
      def:Label="NORMAL RANGE LOWER LIMIT IN ORIG UNITS">
    </ItemDef>
    <ItemDef OID="LB.LBORRES"
      Name="LBORRES"
      DataType="text"
      Length="80"       Origin="CRF Page"       Comment="RESULT OR FINDING IN ORIGINAL UNITS"
      def:Label="RESULT OR FINDING IN ORIGINAL UNITS">
    </ItemDef>
    <ItemDef OID="LB.LBORRESU"
      Name="LBORRESU"
      DataType="text"
      Length="30"       Origin="CRF Page"       Comment="ORIGINAL UNITS"
      def:Label="ORIGINAL UNITS">
    </ItemDef>
    <ItemDef OID="LB.LBSEQ"
      Name="LBSEQ"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="SEQUENCE NUMBER"
      def:Label="SEQUENCE NUMBER">
    </ItemDef>
    <ItemDef OID="LB.LBSPID"
      Name="LBSPID"
      DataType="text"
      Length="8"       Origin="DERIVED"       Comment="SPONSOR ID"
      def:Label="SPONSOR ID">
    </ItemDef>
    <ItemDef OID="LB.LBSTNRHI"
      Name="LBSTNRHI"
      DataType="float"
      Length="8"       SignificantDigits="2"       Origin="DERIVED"       Comment="NORMAL RANGE UPPER LIMIT IN STANDARD UNI"
      def:Label="NORMAL RANGE UPPER LIMIT-STANDARD UNITS">
    </ItemDef>
    <ItemDef OID="LB.LBSTNRLO"
      Name="LBSTNRLO"
      DataType="float"
      Length="8"       SignificantDigits="3"       Origin="DERIVED"       Comment="NORMAL RANGE LOWER LIMIT IN STANDARD UNI"
      def:Label="NORMAL RANGE LOWER LIMIT-STANDARD UNITS">
    </ItemDef>
    <ItemDef OID="LB.LBSTRESC"
      Name="LBSTRESC"
      DataType="text"
      Length="8"       Origin="DERIVED"       Comment="CHARACTER RESULT/FINDING IN STD FORMAT"
      def:Label="CHARACTER RESULT/FINDING IN STD FORMAT">
    </ItemDef>
    <ItemDef OID="LB.LBSTRESN"
      Name="LBSTRESN"
      DataType="float"
      Length="8"       SignificantDigits="4"       Origin="DERIVED"       Comment="NUMERIC RESULT/FINDING IN STANDARD UNITS"
      def:Label="NUMERIC RESULT/FINDING IN STANDARD UNITS">
    </ItemDef>
    <ItemDef OID="LB.LBSTRESU"
      Name="LBSTRESU"
      DataType="text"
      Length="30"       Origin="DERIVED"       Comment="STANDARD UNITS"
      def:Label="STANDARD UNITS">
    </ItemDef>
    <ItemDef OID="LB.LBTEST"
      Name="LBTEST"
      DataType="text"
      Length="50"       Origin="CRF Page"       Comment="LAB TEST OR EXAMINATION NAME"
      def:Label="LAB TEST OR EXAMINATION NAME">
    </ItemDef>
    <ItemDef OID="LB.LBTESTCD"
      Name="LBTESTCD"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="SEQUENCE NUMBER"
      def:Label="LAB TEST OR EXAMINATION SHORT NAME">
    </ItemDef>
    <ItemDef OID="LB.VISIT"
      Name="VISIT"
      DataType="text"
      Length="10"       Origin="CRF Page"       Comment="VISIT NAME"
      def:Label="VISIT NAME">
    </ItemDef>
    <ItemDef OID="LB.VISITNUM"
      Name="VISITNUM"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="Clinical encounter number."
      def:Label="VISIT NUMBER">
    </ItemDef>
    <ItemDef OID="MH.MHBODSYS"
      Name="MHBODSYS"
      DataType="text"
      Length="50"       Origin="CRF Page"       Comment="BODY SYSTEM OR ORGAN CLASS"
      def:Label="BODY SYSTEM OR ORGAN CLASS">
    </ItemDef>
    <ItemDef OID="MH.MHCAT"
      Name="MHCAT"
      DataType="text"
      Length="7"       Origin="CRF Page"       Comment="CATEGORY FOR CONDITION OR PROCEDURE"
      def:Label="CATEGORY FOR MEDICAL HISTORY">
    </ItemDef>
    <ItemDef OID="MH.MHDECOD"
      Name="MHDECOD"
      DataType="text"
      Length="50"       Origin="CRF Page"       Comment="DICTIONARY-DERIVED TEXT DESCRIPTION"
      def:Label="DICTIONARY-DERIVED TERM">
    </ItemDef>
    <ItemDef OID="MH.MHDTC"
      Name="MHDTC"
      DataType="date"
      Length="26"       Origin="CRF Page"       Comment="Medical History CRF Page 5"
      def:Label="DATE/TIME OF HISTORY COLLECTION">
    </ItemDef>
    <ItemDef OID="MH.MHENRF"
      Name="MHENRF"
      DataType="text"
      Length="6"       Origin="CRF Page"       Comment="END RELATIVE TO REFERENCE PERIOD"
      def:Label="END RELATIVE TO REFERENCE PERIOD">
    </ItemDef>
    <ItemDef OID="MH.MHGRPID"
      Name="MHGRPID"
      DataType="text"
      Length="15"       Origin="CRF Page"       Comment="GROUP ID"
      def:Label="GROUP ID">
    </ItemDef>
    <ItemDef OID="MH.MHSEQ"
      Name="MHSEQ"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="SEQUENCE NUMBER"
      def:Label="UNIQUE SEQUENCE NUMBER">
    </ItemDef>
    <ItemDef OID="MH.MHSPID"
      Name="MHSPID"
      DataType="text"
      Length="5"       Origin="DERIVED"       Comment="SPONSOR ID"
      def:Label="SPONSOR ID">
    </ItemDef>
    <ItemDef OID="MH.MHSTAT"
      Name="MHSTAT"
      DataType="text"
      Length="25"       Origin="CRF Page"       Comment="Medical History CRF Page 5"
      def:Label="MEDICAL HISTORY STATUS">
    </ItemDef>
    <ItemDef OID="MH.MHSTDTC"
      Name="MHSTDTC"
      DataType="text"
      Length="1"       Origin="CRF Page"       Comment="START DATE/TIME OF MEDICAL HISTORY EVENT"
      def:Label="START DATE/TIME OF MEDICAL HISTORY EVENT">
    </ItemDef>
    <ItemDef OID="MH.MHTERM"
      Name="MHTERM"
      DataType="text"
      Length="80"       Origin="CRF Page"       Comment="Medical History CRF Page 5"
      def:Label="REPORTED TERM FOR THE MEDICAL HISTORY">
    </ItemDef>
    <ItemDef OID="MH.VISITNUM"
      Name="VISITNUM"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="Clinical encounter number."
      def:Label="VISIT NUMBER">
    </ItemDef>
    <ItemDef OID="PE.PEBODSYS"
      Name="PEBODSYS"
      DataType="text"
      Length="80"       Origin="CRF Page"       Comment="BODY SYSTEM OR ORGAN CLASS"
      def:Label="BODY SYSTEM OR ORGAN CLASS">
    </ItemDef>
    <ItemDef OID="PE.PEDTC"
      Name="PEDTC"
      DataType="date"
      Length="26"       Origin="CRF Page"       Comment="Physical Examinations CRF Page 8"
      def:Label="DATE/TIME OF EXAMINATION">
    </ItemDef>
    <ItemDef OID="PE.PEDY"
      Name="PEDY"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="STUDY DAY OF EXAMINATION"
      def:Label="STUDY DAY OF EXAMINATION">
    </ItemDef>
    <ItemDef OID="PE.PEORRES"
      Name="PEORRES"
      DataType="text"
      Length="200"       Origin="CRF Page"       Comment="Physical Examinations CRF Page 8, CRF Page 31"
      def:Label="VERBATIM EXAMINATION FINDING">
    </ItemDef>
    <ItemDef OID="PE.PESEQ"
      Name="PESEQ"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="SEQUENCE NUMBER"
      def:Label="SEQUENCE NUMBER">
    </ItemDef>
    <ItemDef OID="PE.PESTAT"
      Name="PESTAT"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="Physical Examinations CRF Page 8"
      def:Label="EXAMINATION STATUS">
    </ItemDef>
    <ItemDef OID="PE.PESTRESC"
      Name="PESTRESC"
      DataType="text"
      Length="200"       Origin="CRF Page"       Comment="CHARACTER RESULT/FINDING IN STD FORMAT"
      def:Label="CHARACTER RESULT/FINDING IN STD. FORMAT">
    </ItemDef>
    <ItemDef OID="PE.PETEST"
      Name="PETEST"
      DataType="text"
      Length="40"       Origin="CRF Page"       Comment="SUBJECT CHARACTERISTIC"
      def:Label="BODY SYSTEM EXAMINED">
    </ItemDef>
    <ItemDef OID="PE.PETESTCD"
      Name="PETESTCD"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="Physical Examinations CRF Page 8, CRF Page 31"
      def:Label="BODY SYSTEM EXAMINED SHORT NAME">
    </ItemDef>
    <ItemDef OID="PE.VISIT"
      Name="VISIT"
      DataType="text"
      Length="20"       Origin="CRF Page"       Comment="VISIT NAME"
      def:Label="VISIT NAME">
    </ItemDef>
    <ItemDef OID="PE.VISITNUM"
      Name="VISITNUM"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="Clinical encounter number."
      def:Label="VISIT NUMBER">
    </ItemDef>
    <ItemDef OID="SC.SCCAT"
      Name="SCCAT"
      DataType="text"
      Length="29"       Origin="CRF Page"       Comment="CATEGORY FOR SUBJECT CHARACTERISTIC"
      def:Label="CATEGORY FOR SUBJECT CHARACTERISTIC">
    </ItemDef>
    <ItemDef OID="SC.SCDTC"
      Name="SCDTC"
      DataType="date"
      Length="26"       Origin="CRF Page"       Comment="Subject Characteristics CRF Page 4"
      def:Label="DATE/TIME OF COLLECTION">
    </ItemDef>
    <ItemDef OID="SC.SCORRES"
      Name="SCORRES"
      DataType="text"
      Length="80"       Origin="CRF Page"       Comment="Subject Characteristics CRF Page 4"
      def:Label="RESULT OR FINDING IN ORIGINAL UNITS">
    </ItemDef>
    <ItemDef OID="SC.SCSEQ"
      Name="SCSEQ"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="SEQUENCE NUMBER"
      def:Label="SEQUENCE NUMBER">
    </ItemDef>
    <ItemDef OID="SC.SCSTRESC"
      Name="SCSTRESC"
      DataType="text"
      Length="80"       Origin="CRF Page"       Comment="CHARACTER RESULT/FINDING IN STD FORMAT"
      def:Label="CHARACTER RESULT/FINDING IN STD FORMAT">
    </ItemDef>
    <ItemDef OID="SC.SCSTRESN"
      Name="SCSTRESN"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="NUMERIC RESULT/FINDING IN STANDARD UNITS"
      def:Label="NUMERIC RESULT/FINDING IN STANDARD UNITS">
    </ItemDef>
    <ItemDef OID="SC.SCSTRESU"
      Name="SCSTRESU"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="Default units."
      def:Label="STANDARD UNITS">
    </ItemDef>
    <ItemDef OID="SC.SCTEST"
      Name="SCTEST"
      DataType="text"
      Length="40"       Origin="CRF Page"       Comment="SUBJECT CHARACTERISTIC"
      def:Label="SUBJECT CHARACTERISTIC">
    </ItemDef>
    <ItemDef OID="SC.SCTESTCD"
      Name="SCTESTCD"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="Subject Characteristics CRF Page 4"
      def:Label="SUBJECT CHARACTERISTIC SHORT NAME">
      <def:ValueListRef ValueListOID="ValueList.SC.SCTESTCD"/>
    </ItemDef>
    <ItemDef OID="SE.ELEMENT"
      Name="ELEMENT"
      DataType="text"
      Length="200"       Origin="DERIVED"       Comment="The name of the Element."
      def:Label="DESCRIPTION OF ELEMENT">
    </ItemDef>
    <ItemDef OID="SE.ETCD"
      Name="ETCD"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="Element Code"
      def:Label="ELEMENT CODE">
    </ItemDef>
    <ItemDef OID="SE.SEENDTC"
      Name="SEENDTC"
      DataType="date"
      Length="26"       Origin="DERIVED"       Comment="End date/time of an Element for each subject."
      def:Label="END DATE/TIME OF ELEMENT">
    </ItemDef>
    <ItemDef OID="SE.SESTDTC"
      Name="SESTDTC"
      DataType="date"
      Length="26"       Origin="DERIVED"       Comment="Start date/time for an Element for each subject."
      def:Label="START DATE/TIME OF ELEMENT">
    </ItemDef>
    <ItemDef OID="SU.SUCAT"
      Name="SUCAT"
      DataType="text"
      Length="7"       Origin="CRF Page"       Comment="CATEGORY FOR SUBSTANCE USE"
      def:Label="CATEGORY FOR SUBSTANCE USE">
    </ItemDef>
    <ItemDef OID="SU.SUDECOD"
      Name="SUDECOD"
      DataType="text"
      Length="7"       Origin="CRF Page"       Comment="STANDARDIZED SUBSTANCE NAME"
      def:Label="STANDARDIZED SUBSTANCE NAME">
    </ItemDef>
    <ItemDef OID="SU.SUDOSE"
      Name="SUDOSE"
      DataType="float"
      Length="8"       SignificantDigits="1"       Origin="CRF Page"       Comment="Substance Use CRF Page 4"
      def:Label="SUBSTANCE USE CONSUMPTION">
    </ItemDef>
    <ItemDef OID="SU.SUDOSFRQ"
      Name="SUDOSFRQ"
      DataType="text"
      Length="5"       Origin="CRF Page"       Comment="USE FREQUENCY PER INTERVAL"
      def:Label="USE FREQUENCY PER INTERVAL">
    </ItemDef>
    <ItemDef OID="SU.SUDOSTXT"
      Name="SUDOSTXT"
      DataType="text"
      Length="12"       Origin="CRF Page"       Comment="Substance Use CRF Page 4"
      def:Label="SUBSTANCE USE CONSUMPTION TEXT">
    </ItemDef>
    <ItemDef OID="SU.SUDOSU"
      Name="SUDOSU"
      DataType="text"
      Length="7"       Origin="CRF Page"       Comment="Default units."
      def:Label="CONSUMPTION UNITS">
    </ItemDef>
    <ItemDef OID="SU.SUGRPID"
      Name="SUGRPID"
      DataType="text"
      Length="13"       Origin="CRF Page"       Comment="GROUP ID"
      def:Label="GROUP ID">
    </ItemDef>
    <ItemDef OID="SU.SUOCCUR"
      Name="SUOCCUR"
      DataType="text"
      Length="1"       Origin="CRF Page"       Comment="SU OCCURRENCE"
      def:Label="SU OCCURRENCE">
    </ItemDef>
    <ItemDef OID="SU.SUROUTE"
      Name="SUROUTE"
      DataType="text"
      Length="15"       Origin="CRF Page"       Comment="ROUTE OF ADMINISTRATION"
      def:Label="ROUTE OF ADMINISTRATION">
    </ItemDef>
    <ItemDef OID="SU.SUSCAT"
      Name="SUSCAT"
      DataType="text"
      Length="40"       Origin="CRF Page"       Comment="SUBCATEGORY FOR SUBSTANCE USE"
      def:Label="SUBCATEGORY FOR SUBSTANCE USE">
    </ItemDef>
    <ItemDef OID="SU.SUSEQ"
      Name="SUSEQ"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="SEQUENCE NUMBER"
      def:Label="SEQUENCE NUMBER">
    </ItemDef>
    <ItemDef OID="SU.SUSTAT"
      Name="SUSTAT"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="SUBSTANCE USE STATUS"
      def:Label="SUBSTANCE USE STATUS">
    </ItemDef>
    <ItemDef OID="SU.SUTRT"
      Name="SUTRT"
      DataType="text"
      Length="12"       Origin="CRF Page"       Comment="Substance Use CRF Page 4"
      def:Label="NAME OF SUBSTANCE">
      <def:ValueListRef ValueListOID="ValueList.SU.SUTRT"/>
    </ItemDef>
    <ItemDef OID="SU.VISITNUM"
      Name="VISITNUM"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="Clinical encounter number."
      def:Label="VISIT NUMBER">
    </ItemDef>
    <ItemDef OID="SV.SVENDTC"
      Name="SVENDTC"
      DataType="date"
      Length="26"       Origin="DERIVED"       Comment="End date/time of a Visit treatment."
      def:Label="END DATE/TIME OF VISIT">
    </ItemDef>
    <ItemDef OID="SV.SVSTDTC"
      Name="SVSTDTC"
      DataType="date"
      Length="26"       Origin="DERIVED"       Comment="Start date/time for a Visit."
      def:Label="START DATE/TIME OF VISIT">
    </ItemDef>
    <ItemDef OID="SV.VISIT"
      Name="VISIT"
      DataType="text"
      Length="200"       Origin="CRF Page"       Comment="VISIT NAME"
      def:Label="VISIT NAME">
    </ItemDef>
    <ItemDef OID="SV.VISITNUM"
      Name="VISITNUM"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="Clinical encounter number."
      def:Label="VISIT NUMBER">
    </ItemDef>
    <ItemDef OID="TA.ARM"
      Name="ARM"
      DataType="text"
      Length="21"       Origin="DERIVED"       Comment="DESCRIPTION OF PLANNED ARM"
      def:Label="DESCRIPTION OF ARM (TREATMENT GROUP)">
    </ItemDef>
    <ItemDef OID="TA.ARMCD"
      Name="ARMCD"
      DataType="text"
      Length="7"       Origin="DERIVED"       Comment="PLANNED ARM CODE"
      def:Label="ARM CODE (TREATMENT CODE)">
    </ItemDef>
    <ItemDef OID="TA.ELEMENT"
      Name="ELEMENT"
      DataType="text"
      Length="200"       Origin="DERIVED"       Comment="Topic variable for an Element."
      def:Label="DESCRIPTION OF ELEMENT">
    </ItemDef>
    <ItemDef OID="TA.ETCD"
      Name="ETCD"
      DataType="text"
      Length="200"       Origin="CRF Page"       Comment="Element Code"
      def:Label="ELEMENT CODE">
    </ItemDef>
    <ItemDef OID="TA.TABRANCH"
      Name="TABRANCH"
      DataType="text"
      Length="200"       Origin="DERIVED"       Comment="Condition subject met, at a 'branch' in the trial design at the end of this Element."
      def:Label="BRANCH">
    </ItemDef>
    <ItemDef OID="TA.TAETORD"
      Name="TAETORD"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="Number that gives the order of the Element within the Arm."
      def:Label="ORDER OF ELEMENT WITHIN ARM">
    </ItemDef>
    <ItemDef OID="TA.TATRANS"
      Name="TATRANS"
      DataType="text"
      Length="200"       Origin="DERIVED"       Comment="If the trial design allows a subject to transition to an Element other than the next Element in sequence."
      def:Label="TRANSITION RULE">
    </ItemDef>
    <ItemDef OID="TE.ELEMENT"
      Name="ELEMENT"
      DataType="text"
      Length="200"       Origin="DERIVED"       Comment="Topic variable for an Element."
      def:Label="DESCRIPTION OF ELEMENT">
    </ItemDef>
    <ItemDef OID="TE.ETCD"
      Name="ETCD"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="Element Code"
      def:Label="ELEMENT CODE">
    </ItemDef>
    <ItemDef OID="TE.TEDUR"
      Name="TEDUR"
      DataType="text"
      Length="6"       Origin="CRF Page"       Comment="Planned Duration of Element"
      def:Label="PLANNED DURATION OF ELEMENT">
    </ItemDef>
    <ItemDef OID="TE.TEENRL"
      Name="TEENRL"
      DataType="text"
      Length="200"       Origin="DERIVED"       Comment="Expresses rule for ending Element."
      def:Label="RULE FOR END OF ELEMENT">
    </ItemDef>
    <ItemDef OID="TE.TESTRL"
      Name="TESTRL"
      DataType="text"
      Length="200"       Origin="DERIVED"       Comment="Expresses rule for beginning Element."
      def:Label="RULE FOR START OF ELEMENT">
    </ItemDef>
    <ItemDef OID="TV.ARM"
      Name="ARM"
      DataType="text"
      Length="21"       Origin="DERIVED"       Comment="DESCRIPTION OF PLANNED ARM"
      def:Label="DESCRIPTION OF ARM">
    </ItemDef>
    <ItemDef OID="TV.ARMCD"
      Name="ARMCD"
      DataType="text"
      Length="7"       Origin="DERIVED"       Comment="PLANNED ARM CODE"
      def:Label="ARM CODE (TREATMENT CODE)">
    </ItemDef>
    <ItemDef OID="TV.TVENRL"
      Name="TVENRL"
      DataType="text"
      Length="200"       Origin="DERIVED"       Comment="Rule describing when the Visit ends."
      def:Label="VISIT END RULE">
    </ItemDef>
    <ItemDef OID="TV.TVSTRL"
      Name="TVSTRL"
      DataType="text"
      Length="200"       Origin="DERIVED"       Comment="Rule describing when the Visit starts."
      def:Label="VISIT START RULE">
    </ItemDef>
    <ItemDef OID="TV.VISIT"
      Name="VISIT"
      DataType="text"
      Length="200"       Origin="CRF Page"       Comment="VISIT NAME"
      def:Label="VISIT NAME">
    </ItemDef>
    <ItemDef OID="TV.VISITNUM"
      Name="VISITNUM"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="Clinical encounter number."
      def:Label="VISIT SEQUENCE NUMBER">
    </ItemDef>
    <ItemDef OID="VS.VISIT"
      Name="VISIT"
      DataType="text"
      Length="30"       Origin="CRF Page"       Comment="VISIT NAME"
      def:Label="VISIT NAME">
    </ItemDef>
    <ItemDef OID="VS.VISITNUM"
      Name="VISITNUM"
      DataType="integer"
      Length="8"       Origin="DERIVED"       Comment="Clinical encounter number."
      def:Label="VISIT NUMBER">
    </ItemDef>
    <ItemDef OID="VS.VSDTC"
      Name="VSDTC"
      DataType="date"
      Length="26"       Origin="CRF Page"       Comment="Vital Signs CRF Page 4, CRF Page 7"
      def:Label="DATE/TIME OF MEASUREMENTS">
    </ItemDef>
    <ItemDef OID="VS.VSDY"
      Name="VSDY"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="STUDY DAY OF VITAL SIGNS"
      def:Label="STUDY DAY OF VITAL SIGNS">
    </ItemDef>
    <ItemDef OID="VS.VSLOC"
      Name="VSLOC"
      DataType="text"
      Length="1"       Origin="CRF Page"       Comment="LOCATION OF VITAL SIGNS MEASUREMENT"
      def:Label="LOCATION OF VITAL SIGNS MEASUREMENT">
    </ItemDef>
    <ItemDef OID="VS.VSORRES"
      Name="VSORRES"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="Vital Signs CRF Page 4, CRF Page 7"
      def:Label="RESULT OR FINDING IN ORIGINAL UNITS">
    </ItemDef>
    <ItemDef OID="VS.VSORRESU"
      Name="VSORRESU"
      DataType="text"
      Length="15"       Origin="CRF Page"       Comment="ORIGINAL UNITS"
      def:Label="ORIGINAL UNITS">
    </ItemDef>
    <ItemDef OID="VS.VSPOS"
      Name="VSPOS"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="POSITION OF THE SUBJECT DURING A MEASUREMENT OR EXAMINATION."
      def:Label="VITAL SIGNS POSITION OF SUBJECT">
    </ItemDef>
    <ItemDef OID="VS.VSSEQ"
      Name="VSSEQ"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="SEQUENCE NUMBER"
      def:Label="SEQUENCE NUMBER">
    </ItemDef>
    <ItemDef OID="VS.VSSTAT"
      Name="VSSTAT"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="VITALS STATUS"
      def:Label="VITALS STATUS">
    </ItemDef>
    <ItemDef OID="VS.VSSTRESC"
      Name="VSSTRESC"
      DataType="text"
      Length="20"       Origin="CRF Page"       Comment="CHARACTER RESULT/FINDING IN STD FORMAT"
      def:Label="CHARACTER RESULT/FINDING IN STD FORMAT">
    </ItemDef>
    <ItemDef OID="VS.VSSTRESN"
      Name="VSSTRESN"
      DataType="float"
      Length="8"       SignificantDigits="1"       Origin="CRF Page"       Comment="CHARACTER RESULT/FINDING IN STD FORMAT"
      def:Label="NUMERIC RESULT/FINDING IN STANDARD UNITS">
    </ItemDef>
    <ItemDef OID="VS.VSSTRESU"
      Name="VSSTRESU"
      DataType="text"
      Length="15"       Origin="CRF Page"       Comment="Default units."
      def:Label="STANDARD UNITS">
    </ItemDef>
    <ItemDef OID="VS.VSTEST"
      Name="VSTEST"
      DataType="text"
      Length="40"       Origin="CRF Page"       Comment="VITALS SIGNS TEST NAME"
      def:Label="VITAL SIGNS TEST NAME">
    </ItemDef>
    <ItemDef OID="VS.VSTESTCD"
      Name="VSTESTCD"
      DataType="text"
      Length="8"       Origin="CRF Page"       Comment="Vital Signs CRF Page 4, CRF Page 7"
      def:Label="VITAL SIGNS TEST SHORT NAME">
      <def:ValueListRef ValueListOID="ValueList.VS.VSTESTCD"/>
    </ItemDef>
    <ItemDef OID="SC.SCTESTCD.ALLERGY"
      Name="ALLERGY"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="Subject Characteristics CRF Page 4"
      def:Label="Allergy Status">
      <CodeListRef CodeListOID="YESNOUNK"/>
    </ItemDef>
    <ItemDef OID="SC.SCTESTCD.EDLEVLN"
      Name="EDLEVLN"
      DataType="float"
      Length="8"       SignificantDigits="1"       Origin="CRF Page"       Comment="Subject Characteristics CRF Page 4"
      def:Label="EDUCATIONAL LEVEL-DVN">
    </ItemDef>
    <ItemDef OID="SC.SCTESTCD.EXCLSN"
      Name="EXCLSN"
      DataType="float"
      Length="8"       SignificantDigits="1"       Origin="CRF Page"       Comment="Subject Characteristics CRF Page 4"
      def:Label="EXERCISE CLASSIFICATION-DVN">
    </ItemDef>
    <ItemDef OID="SC.SCTESTCD.RACEOTH"
      Name="RACEOTH"
      DataType="text"
      Length="80"       Origin="CRF Page"       Comment="Subject Characteristics CRF Page 4"
      def:Label="Text for other race">
    </ItemDef>
    <ItemDef OID="SU.SUTRT.ALCBEERA"
      Name="ALCBEERA"
      DataType="float"
      Length="8"       SignificantDigits="1"       Origin="CRF Page"       Comment="Substance Use CRF Page 4"
      def:Label="Beer consumed-oz/week">
    </ItemDef>
    <ItemDef OID="SU.SUTRT.ALCHIST2"
      Name="ALCHIST2"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="Substance Use CRF Page 4"
      def:Label="Does the patient drink">
      <CodeListRef CodeListOID="YESNO"/>
    </ItemDef>
    <ItemDef OID="SU.SUTRT.ALCOTHA"
      Name="ALCOTHA"
      DataType="float"
      Length="8"       SignificantDigits="1"       Origin="CRF Page"       Comment="Substance Use CRF Page 4"
      def:Label="Spirits/liquor consumed-oz/week">
    </ItemDef>
    <ItemDef OID="SU.SUTRT.ALCWINEA"
      Name="ALCWINEA"
      DataType="float"
      Length="8"       SignificantDigits="1"       Origin="CRF Page"       Comment="Substance Use CRF Page 4"
      def:Label="Wine consumption-oz/week">
    </ItemDef>
    <ItemDef OID="SU.SUTRT.SMKCLASS"
      Name="SMKCLASS"
      DataType="integer"
      Length="8"       Origin="CRF Page"       Comment="Substance Use CRF Page 4"
      def:Label="Smoking classification">
      <CodeListRef CodeListOID="SMKCLAS"/>
    </ItemDef>
    <ItemDef OID="VS.VSTESTCD.FRAME"
      Name="FRAME"
      DataType="float"
      Length="8"       SignificantDigits="1"       Origin="CRF Page"       Comment="Vital Signs CRF Page 4"
      def:Label="Frame">
      <CodeListRef CodeListOID="FRAME"/>
    </ItemDef>
    <ItemDef OID="VS.VSTESTCD.HTRAW"
      Name="HTRAW"
      DataType="text"
      Length="80" Origin="CRF Page" Comment="Vital Signs CRF Page 4"
      def:Label="Height raw">
    </ItemDef>
    <ItemDef OID="VS.VSTESTCD.WTRAW"
      Name="WTRAW"
      DataType="text"
      Length="80" Origin="CRF Page" Comment="Vital Signs CRF Page 4"
      def:Label="Weight raw">
    </ItemDef>
    <ItemDef OID="VS.VSTESTCD.MEANBP" 
	Name="MEANBP" 
	DataType="float" 
	Length="8"
	SignificantDigits="2"
	Origin="VSSTRESN" 
	def:Label="Mean Blood Pressure" 	
	def:DisplayFormat="8.2"
	def:ComputationMethodOID="COMPMETHOD.MEANBP">
    </ItemDef>
    <!-- ************************************************************ -->
    <!-- The Codelist details are here for all domains                -->
    <!-- ************************************************************ -->
    <CodeList OID="FRAME" Name="FRAME" DataType="text">
      <CodeListItem CodedValue="S">
        <Decode>
          <TranslatedText xml:lang="en">Small</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="M">
        <Decode>
          <TranslatedText xml:lang="en">Medium</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="L">
        <Decode>
          <TranslatedText xml:lang="en">Large</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="XL">
        <Decode>
          <TranslatedText xml:lang="en">Extra large</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="SMKCLAS" Name="SMKCLAS" DataType="integer">
      <CodeListItem CodedValue="1">
        <Decode>
          <TranslatedText xml:lang="en">NEVER SMOKED</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="2">
        <Decode>
          <TranslatedText xml:lang="en">SMOKER</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="3">
        <Decode>
          <TranslatedText xml:lang="en">EX SMOKER</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="YESNO" Name="YESNO" DataType="text">
      <CodeListItem CodedValue="Y">
        <Decode>
          <TranslatedText xml:lang="en">YES</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="N">
        <Decode>
          <TranslatedText xml:lang="en">NO</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="U">
        <Decode>
          <TranslatedText xml:lang="en">NOT APPLICABLE</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="YESNOUNK" Name="YESNOUNK" DataType="text">
      <CodeListItem CodedValue="Y">
        <Decode>
          <TranslatedText xml:lang="en">YES</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="N">
        <Decode>
          <TranslatedText xml:lang="en">NO</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="U">
        <Decode>
          <TranslatedText xml:lang="en">UNKNOWN</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="NA">
        <Decode>
          <TranslatedText xml:lang="en">NOT APPLICABLE</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
  </MetaDataVersion>
</Study>
</ODM>
