<?xml version="1.0" encoding="UTF-8"?>
<ODM xmlns="http://www.cdisc.org/ns/odm/v1.3"
     xmlns:sdm="http://www.cdisc.org/ns/studydesign/v1.0"
     xmlns:xs="http://www.w3.org/2001/XMLSchema"
     xmlns:xlink="http://www.w3.org/1999/xlink"
     CreationDateTime="2009-06-23T14:30:03+01:00"
     Description="CDISC ODM version 1.3 format"
     FileOID="TDM_00_ARM"
     FileType="Snapshot"
     Granularity="Metadata"
     ODMVersion="1.3"
     SourceSystem="XML4Pharma CDISC ODM Study Designer"
     SourceSystemVersion="2008R2">
   <Study OID="SAMPLE_TRIAL">
      <GlobalVariables>
         <StudyName>Xanomeline (LY246708)</StudyName>
         <StudyDescription>Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer's Disease</StudyDescription>
         <ProtocolName>H2Q-MC-LZZT(c)</ProtocolName>
      </GlobalVariables>
      <BasicDefinitions/>
      <MetaDataVersion Description="H2Q-MC-LZZT(c)" Name="H2Q-MC-LZZT(c)" OID="MDV-H2Q-MC-LZZT-c">
         <Protocol>
            <Description>
               <TranslatedText xml:lang="en"> A randomized, double-blind, parallel (3 arm), placebo-controlled trial of 26 weeks duration.</TranslatedText>
            </Description>
            <StudyEventRef Mandatory="Yes" StudyEventOID="SCRN_VISIT"/>
            <StudyEventRef Mandatory="Yes" StudyEventOID="ECG_VISIT"/>
            <StudyEventRef Mandatory="Yes" StudyEventOID="RAND_VISIT"/>
            <sdm:Summary>
                    <sdm:Parameter OID="PARMIND" OrderNumber="1" ShortName="DESIGN">
                        <sdm:Term>Indication</sdm:Term>
                        <sdm:Value>ASTHMA</sdm:Value>
                    </sdm:Parameter>
                </sdm:Summary>
            <sdm:InclusionExclusionCriteria>
                    <sdm:Criterion Category="INCLUSION" ConditionOID="AGECOND00" OID="CRIT00"/>
                    <sdm:Criterion Category="EXCLUSION" ConditionOID="AGECOND01" OID="CRIT01"/>
                </sdm:InclusionExclusionCriteria>
            <sdm:Structure>
                <sdm:Epoch OID="SCREPOCH" OrderNumber="1">
                   <Description>
                      <TranslatedText xml:lang="en">Screening Epoch</TranslatedText>
                   </Description>
                </sdm:Epoch>
                <sdm:Epoch OID="TREEPOCH" OrderNumber="2">
                   <Description>
                      <TranslatedText xml:lang="en">Treatment Epoch</TranslatedText>
                   </Description>
                </sdm:Epoch>                
                <sdm:Epoch OID="FUPEPOCH" OrderNumber="3">
                   <Description>
                      <TranslatedText xml:lang="en">Follow-Up Epoch</TranslatedText>
                   </Description>
                </sdm:Epoch> 

                <!-- ================================================== -->
                <!-- ============= ARM DEFINITIONS ==================== -->
                <!-- ================================================== -->
                <sdm:Arm OID="PLACEBO_ARM">
                   <Description>
                      <TranslatedText xml:lang="en">Placebo arm</TranslatedText>
                   </Description>
                </sdm:Arm>
                <sdm:Arm OID="LOWDOSE_ARM">
                   <Description>
                      <TranslatedText xml:lang="en">Low-dose xanomeline arm (50cm^2 TTS Formulation E, 54 mg xanomeline)</TranslatedText>
                   </Description>
                </sdm:Arm>                
                <sdm:Arm OID="HIGHDOSE_ARM">
                   <Description>
                      <TranslatedText xml:lang="en">High-dose xanomeline arm (75cm^2 TTS Formulation E, 81 mg xanomeline)</TranslatedText>
                   </Description>
                </sdm:Arm> 

                <!-- ================================================== -->
                <!-- ============= CELL DEFINITIONS =================== -->
                <!-- ================================================== -->
                <sdm:CellDef EpochOID="SCREPOCH" OID="SCREENCELL">
                   <Description>
                      <TranslatedText xml:lang="en">Screening cell</TranslatedText>
                   </Description>
                   <sdm:SegmentRef OrderNumber="1" SegmentOID="SCREENSEG"/>
                </sdm:CellDef>
                <sdm:CellDef EpochOID="TREPOCH" OID="TRECELL">
                   <Description>
                      <TranslatedText xml:lang="en">Treatment cell</TranslatedText>
                   </Description>
                   <sdm:ArmAssociation type="blinded">
                     <sdm:ArmRef ArmOID="PLACEBO_ARM"/>
                     <sdm:ArmRef ArmOID="LOWDOSE_ARM"/>
                     <sdm:ArmRef ArmOID="HIGHDOSE_ARM"/>
                   </sdm:ArmAssociation>
                   <sdm:SegmentRef OrderNumber="1" SegmentOID="TRESEG"/>
                </sdm:CellDef>               

                <!-- ================================================== -->
                <!-- ============ SEGMENT DEFINITIONS ================= -->
                <!-- ================================================== -->
                <sdm:SegmentDef OID="SCREENSEG">
                    <Description>
                        <TranslatedText xml:lang="en">Screening segment/period</TranslatedText>
                    </Description>
                   <sdm:ActivityRef ActivityOID="ACTDEF_INFORMEDCONSENT_01" OrderNumber="1"/>
                   <sdm:ActivityRef ActivityOID="ACTDEF_PATIENTNUMBERASSIGNED_01" OrderNumber="2"/>
                   <sdm:ActivityRef ActivityOID="ACTDEF_MEDICALHISTORY_01" OrderNumber="3"/>
                   <sdm:ActivityRef ActivityOID="ACTDEF_VITALSIGNS_01" OrderNumber="4"/>
                   <sdm:ActivityRef ActivityOID="ACTDEF_AMBECGPLACED_01" OrderNumber="5"/>
                   <sdm:ActivityRef ActivityOID="ACTDEF_AMBECGREMOVED_01" OrderNumber="6"/>
                   <sdm:ActivityRef ActivityOID="ACTDEF_VITALSIGNS_02" OrderNumber="7"/>
                   <sdm:ActivityRef ActivityOID="ACTDEF_PATIENTRANDOMIZED" OrderNumber="8"/>
                </sdm:SegmentDef>
                <sdm:SegmentDef OID="TRESEG">
                    <Description>
                        <TranslatedText xml:lang="en">Treatment segment/period</TranslatedText>
                    </Description>
                </sdm:SegmentDef> 
                <sdm:SegmentDef OID="FUPSEG">
                    <Description>
                        <TranslatedText xml:lang="en">Treatment segment/period</TranslatedText>
                    </Description>
                </sdm:SegmentDef>
                                
                <!-- ================================================== -->
                <!-- ============ ACTIVITY DEFINITIONS ================ -->
                <!-- ================================================== --> 
                <sdm:ActivityDef OID="ACTDEF_TRIALSTART" Type="Study Start"/>
                                
                <sdm:ActivityDef OID="ACTDEF_INFORMEDCONSENT_01" Type="Data Collection">
                    <Description>
                        <TranslatedText xml:lang="en">Collection of Informed Consent</TranslatedText>
                    </Description>
                   <FormRef FormOID="ECGFORM" Mandatory="Yes"/>
                </sdm:ActivityDef>

                <sdm:ActivityDef OID="ACTDEF_PATIENTNUMBERASSIGNED_01" Type="Data Collection">
                    <Description>
                        <TranslatedText xml:lang="en">Assignation of Study Participant ID</TranslatedText>
                    </Description>
                   <FormRef FormOID="ECGFORM" Mandatory="Yes"/>
                </sdm:ActivityDef>

                <sdm:ActivityDef OID="ACTDEF_MEDICALHISTORY_01" Type="Data Collection">
                    <Description>
                        <TranslatedText xml:lang="en">Collection of Medical History</TranslatedText>
                    </Description>
                   <FormRef FormOID="ECGFORM" Mandatory="Yes"/>
                </sdm:ActivityDef>

                <sdm:ActivityDef OID="ACTDEF_VITALSIGNS_01" Type="Data Collection">
                    <Description>
                        <TranslatedText xml:lang="en">Collection of Vital Signs: Pre-Ambulatory-ECG</TranslatedText>
                    </Description>
                   <FormRef FormOID="ECGFORM" Mandatory="Yes"/>
                </sdm:ActivityDef>

                <sdm:ActivityDef OID="ACTDEF_AMBECGPLACED_01" Type="Data Collection">
                    <Description>
                        <TranslatedText xml:lang="en">Placement of Ambulatory ECG</TranslatedText>
                    </Description>
                   <FormRef FormOID="ECGFORM" Mandatory="Yes"/>
                </sdm:ActivityDef>
                
                <sdm:ActivityDef OID="ACTDEF_AMBECGREMOVED_01" Type="Data Collection">
                    <Description>
                        <TranslatedText xml:lang="en">Removal of Ambulatory ECG</TranslatedText>
                    </Description>
                   <FormRef FormOID="ECGFORM" Mandatory="Yes"/>
                </sdm:ActivityDef>

                <sdm:ActivityDef OID="ACTDEF_VITALSIGNS_02" Type="Data Collection">
                    <Description>
                        <TranslatedText xml:lang="en">Collection of Vital Signs: Post-Ambulatory-ECG</TranslatedText>
                    </Description>
                   <FormRef FormOID="ECGFORM" Mandatory="Yes"/>
                </sdm:ActivityDef>
                
                <sdm:ActivityDef OID="ACTDEF_PATIENTRANDOMIZED" Type="Data Collection">
                    <Description>
                        <TranslatedText xml:lang="en">Randomization of the PAtient to a Trial Arm</TranslatedText>
                    </Description>
                   <FormRef FormOID="ECGFORM" Mandatory="Yes"/>
                </sdm:ActivityDef>
                                                
                <sdm:ActivityDef OID="ACTDEF_TRIALFINISH" Type="Study Finish"/>
                                         
              </sdm:Structure>
            <sdm:Workflow>
               <sdm:EntryExitCriteria OID="CRIT_TRT_EPCH" StructuralElementOID="TREPOCH"
                                      StructuralElementType="epoch">
                   <sdm:EntryCriteria>
                     <sdm:Criterion ConditionOID="COND_00" OID="CRIT_TRT_EPCH_01"/>
                   </sdm:EntryCriteria>
                   <sdm:ExitCriteria>
                     <sdm:Criterion ConditionOID="COND_01" OID="CRIT_TRT_EPCH_02"/>
                   </sdm:ExitCriteria>
                 </sdm:EntryExitCriteria>
               <sdm:EntryExitCriteria OID="CRIT_ACG_ACT" StructuralElementOID="ACTDEF_ECG"
                                      StructuralElementType="activity">
                   <sdm:EntryCriteria>
                     <sdm:Criterion ConditionOID="COND_02" OID="CRIT_ACG_ACT_01"/>
                   </sdm:EntryCriteria>
                   <sdm:ExitCriteria>
                     <sdm:Criterion ConditionOID="COND_03" OID="CRIT_ACG_ACT_02"/>
                   </sdm:ExitCriteria>
                 </sdm:EntryExitCriteria>
               <sdm:Transition OID="START_TRANS" SourceActivityOID="ACTDEF_TRIALSTART">
                    <sdm:Switch Type="single">
                      <sdm:TransitionDefault TargetActivityOID="ACTDEF_INFORMEDCONSENT_01"/>
                    </sdm:Switch>
                 </sdm:Transition>
               <sdm:Transition OID="INFCONSENT_TRANS" SourceActivityOID="ACTDEF_INFORMEDCONSENT_01">
                  <sdm:Switch Type="single">
                     <sdm:TransitionDestination ConditionOID="COND_INFCONSENT"
                                                OID="INFCONSENT_TRANS_TO_ACTDEF_PATIENTNUMBERASSIGNED_01"
                                                OrderNumber="1"
                                                TargetActivityOID="ACTDEF_PATIENTNUMBERASSIGNED_01"/>
                     <sdm:TransitionDefault TargetActivityOID="ACTDEF_TRIALFINISH"/>
                  </sdm:Switch>
               </sdm:Transition>
               <sdm:Transition OID="PATNO_TRANS" SourceActivityOID="ACTDEF_PATIENTNUMBERASSIGNED_01">
                    <sdm:Switch Type="single">
                      <sdm:TransitionDefault TargetActivityOID="ACTDEF_MEDICALHISTORY_01"/>
                    </sdm:Switch>
                 </sdm:Transition>
               <sdm:Transition OID="MEDHIS_TRANS" SourceActivityOID="ACTDEF_MEDICALHISTORY_01">
                  <sdm:Switch Type="single">
                     <sdm:TransitionDefault TargetActivityOID="ACTDEF_VITALSIGNS_01"/>
                  </sdm:Switch>
               </sdm:Transition>
               <sdm:Transition OID="VS_1_TRANS" SourceActivityOID="ACTDEF_VITALSIGNS_01">
                  <sdm:Switch Type="single">
                     <sdm:TransitionDefault TargetActivityOID="ACTDEF_AMBECGPLACED_01"/>
                  </sdm:Switch>
               </sdm:Transition>
               <sdm:Transition OID="ECG_PLACED_TRANS" SourceActivityOID="ACTDEF_AMBECGPLACED_01">
                  <sdm:Switch Type="single">
                     <sdm:TransitionDefault TargetActivityOID="ACTDEF_AMBECGREMOVED_01"/>
                  </sdm:Switch>
               </sdm:Transition>
               <sdm:Transition OID="ECG_REMOVED_TRANS" SourceActivityOID="ACTDEF_AMBECGREMOVED_01">
                  <sdm:Switch Type="single">
                     <sdm:TransitionDefault TargetActivityOID="ACTDEF_VITALSIGNS_02"/>
                  </sdm:Switch>
               </sdm:Transition>
               <sdm:Transition OID="VS_2_TRANS" SourceActivityOID="ACTDEF_VITALSIGNS_02">
                  <sdm:Switch Type="single">
                     <sdm:TransitionDefault TargetActivityOID="ACTDEF_PATIENTRANDOMIZED"/>
                  </sdm:Switch>
               </sdm:Transition>
               <sdm:Transition OID="PATRAND_TRANS" SourceActivityOID="ACTDEF_PATIENTRANDOMIZED">
                  <sdm:Switch Type="single">
                     <sdm:TransitionDefault TargetActivityOID="ACTDEF_TRIALFINISH"/>
                  </sdm:Switch>
               </sdm:Transition>
            </sdm:Workflow>
            <sdm:Timing>
                <sdm:AbsoluteTimingConstraint ActivityOID="ACTDEF_INFORMEDCONSENT_01" OID="TC_A_01"
                                             TimepointTarget="2009-09-20T11:07:23-05:00"/>
                <sdm:RelativeTimingConstraint OID="TC_R_01" PredecessorActivityOID="ACTDEF_INFORMEDCONSENT_01"
                                             SuccessorActivityOID="ACTDEF_PATIENTNUMBERASSIGNED_01"
                                             TimepointRelativeTarget="P7D"/>
                <sdm:TransitionTimingConstraint OID="TC_T_01" TimepointRelativeTarget="PT48H"
                                               TransitionDestinationOID="INFCONSENT_TRANS_TO_ACTDEF_PATIENTNUMBERASSIGNED_01"/>
              </sdm:Timing>
         </Protocol>
         <StudyEventDef Name="Screening" OID="SCRN_VISIT" Repeating="No" Type="Scheduled">
                <Description>
                    <TranslatedText xml:lang="en">Screening Visit</TranslatedText>
                </Description>
                <FormRef FormOID="ECGFORM" Mandatory="Yes" OrderNumber="1"/>
                <FormRef FormOID="VSFORM" Mandatory="Yes" OrderNumber="2"/>
                <!-- 
                1) complete neuropsychiatric assessment
                2) psychometric testing
                3) general medical assessment (incl. medical history, pre-existing conditions, physical examination).
                4) Vital signs, temperature, medication history, ECG, chest x-ray and safety laboratories
                5) 
                -->                
            </StudyEventDef>
         <StudyEventDef Name="Ambulatory ECG" OID="ECG_VISIT" Repeating="No" Type="Scheduled">
                <Description>
                    <TranslatedText xml:lang="en">24-Hour Ambulatory ECG Applied</TranslatedText>
                </Description>
                <FormRef FormOID="ECGFORM" Mandatory="Yes" OrderNumber="1"/>
            </StudyEventDef>
         <StudyEventDef Name="Randomization" OID="RAND_VISIT" Repeating="No" Type="Scheduled">
                <!-- The ambulatory ECG is removed, and patients are randomized into 1 of 3 treatment arms -->
                <Description>
                    <TranslatedText xml:lang="en">ECG Removal, Randomization</TranslatedText>
                </Description>
                <FormRef FormOID="ECGFORM" Mandatory="Yes" OrderNumber="1"/>
            </StudyEventDef>
         <StudyEventDef Name="Treatment Visit 1" OID="TRT_VISIT_01" Repeating="No" Type="Scheduled">
                <FormRef FormOID="VSFORM" Mandatory="Yes" OrderNumber="2"/>
                <!-- Vital Signs -->
                <!-- Temperature -->
                <!-- Adverse event assessment -->
            </StudyEventDef>
         <StudyEventDef Name="Treatment Visit 2" OID="TRT_VISIT_02" Repeating="No" Type="Scheduled">
                <FormRef FormOID="VSFORM" Mandatory="Yes" OrderNumber="2"/>
                <!-- Vital Signs -->
                <!-- Temperature -->
                <!-- Adverse event assessment -->                
            </StudyEventDef>
         <StudyEventDef Name="Treatment Visit 3" OID="TRT_VISIT_03" Repeating="No" Type="Scheduled">
                <FormRef FormOID="VSFORM" Mandatory="Yes" OrderNumber="2"/>
                <!-- Vital Signs -->
                <!-- Temperature -->
                <!-- Adverse event assessment -->
                <!-- Efficacy instrument (ADAS-Cog, CIBIC+, DAD) administration -->
                <!-- Use of concomitant medications collection -->
                <!-- Plasma levels of xanomeline and metabolites collection -->
                <!-- Medication dispensed -->
            </StudyEventDef>
         <StudyEventDef Name="Treatment Visit 4" OID="TRT_VISIT_04" Repeating="No" Type="Scheduled">
                <FormRef FormOID="VSFORM" Mandatory="Yes" OrderNumber="2"/>
                <FormRef FormOID="ECGFORM" Mandatory="Yes" OrderNumber="1"/>
                <!-- Vital Signs -->
                <!-- Temperature -->
                <!-- Adverse event assessment -->
                <!-- ECG -->
                <!-- Chemistry/Hematology safety labs -->
                <!-- Urinalysis -->
                <!-- Use of concomitant medications collection -->
                <!-- Plasma levels of xanomeline and metabolites collection -->
                <!-- Medication dispensed -->
            </StudyEventDef>
         <StudyEventDef Name="Treatment Visit 5" OID="TRT_VISIT_05" Repeating="No" Type="Scheduled">
                <FormRef FormOID="VSFORM" Mandatory="Yes" OrderNumber="2"/>
                <FormRef FormOID="ECGFORM" Mandatory="Yes" OrderNumber="1"/>
                <!-- Vital Signs -->
                <!-- Temperature -->
                <!-- Adverse event assessment -->
                <!-- ECG -->
                <!-- Chemistry/Hematology safety labs -->
                <!-- Use of concomitant medications collection -->
                <!-- Plasma levels of xanomeline and metabolites collection -->
                <!-- Medication dispensed -->
            </StudyEventDef>
         <StudyEventDef Name="Treatment Visit 6" OID="TRT_VISIT_06" Repeating="No" Type="Scheduled">
                <FormRef FormOID="VSFORM" Mandatory="Yes" OrderNumber="2"/>
                <!-- Vital Signs -->
                <!-- Temperature -->
                <!-- Adverse event assessment -->
            </StudyEventDef>
         <StudyEventDef Name="Treatment Visit 7" OID="TRT_VISIT_07" Repeating="No" Type="Scheduled">
                <FormRef FormOID="VSFORM" Mandatory="Yes" OrderNumber="2"/>
                <FormRef FormOID="ECGFORM" Mandatory="Yes" OrderNumber="1"/>
                <!-- Vital Signs -->
                <!-- Temperature -->
                <!-- Adverse event assessment -->
                <!-- ECG -->
                <!-- Chemistry/Hematology safety labs -->
                <!-- Use of concomitant medications collection -->
                <!-- Plasma levels of xanomeline and metabolites collection -->
                <!-- Medication dispensed -->
            </StudyEventDef>
         <StudyEventDef Name="Treatment Visit 8" OID="TRT_VISIT_08" Repeating="No" Type="Scheduled">
                <FormRef FormOID="VSFORM" Mandatory="Yes" OrderNumber="2"/>
                <FormRef FormOID="ECGFORM" Mandatory="Yes" OrderNumber="1"/>
                <!-- Vital Signs -->
                <!-- Temperature -->
                <!-- Adverse event assessment -->
                <!-- Efficacy instrument (ADAS-Cog, CIBIC+, DAD) administration -->
                <!-- ECG -->
                <!-- Chemistry/Hematology safety labs -->
                <!-- Use of concomitant medications collection -->
                <!-- Medication dispensed -->
            </StudyEventDef>
         <StudyEventDef Name="Treatment Visit 9" OID="TRT_VISIT_09" Repeating="No" Type="Scheduled">
                <FormRef FormOID="VSFORM" Mandatory="Yes" OrderNumber="2"/>
                <FormRef FormOID="ECGFORM" Mandatory="Yes" OrderNumber="1"/>
                <!-- Vital Signs -->
                <!-- Temperature -->
                <!-- Adverse event assessment -->
                <!-- ECG -->
                <!-- Chemistry/Hematology safety labs -->
                <!-- Urinalysis -->
                <!-- Use of concomitant medications collection -->
                <!-- Plasma levels of xanomeline and metabolites collection -->
                <!-- Medication dispensed -->
            </StudyEventDef>
         <StudyEventDef Name="Treatment Visit 10" OID="TRT_VISIT_10" Repeating="No" Type="Scheduled">
                <FormRef FormOID="VSFORM" Mandatory="Yes" OrderNumber="2"/>
                <FormRef FormOID="ECGFORM" Mandatory="Yes" OrderNumber="1"/>
                <!-- Vital Signs -->
                <!-- Temperature -->
                <!-- Adverse event assessment -->
                <!-- Efficacy instrument (ADAS-Cog, CIBIC+, DAD) administration -->
                <!-- ECG -->
                <!-- Chemistry/Hematology safety labs -->
                <!-- Use of concomitant medications collection -->
                <!-- Medication dispensed -->
            </StudyEventDef>
         <StudyEventDef Name="Treatment Visit 11" OID="TRT_VISIT_11" Repeating="No" Type="Scheduled">
                <FormRef FormOID="VSFORM" Mandatory="Yes" OrderNumber="2"/>
                <FormRef FormOID="ECGFORM" Mandatory="Yes" OrderNumber="1"/>
                <!-- Vital Signs -->
                <!-- Temperature -->
                <!-- Adverse event assessment -->
                <!-- ECG -->
                <!-- Chemistry/Hematology safety labs -->
                <!-- Use of concomitant medications collection -->
                <!-- Plasma levels of xanomeline and metabolites collection -->
                <!-- Medication dispensed -->
            </StudyEventDef>
         <StudyEventDef Name="Treatment Visit 12" OID="TRT_VISIT_12" Repeating="No" Type="Scheduled">
                <FormRef FormOID="VSFORM" Mandatory="Yes" OrderNumber="2"/>
                <FormRef FormOID="ECGFORM" Mandatory="Yes" OrderNumber="1"/>
                <!-- Vital Signs -->
                <!-- Temperature -->
                <!-- Adverse event assessment -->
                <!-- Efficacy instrument (ADAS-Cog, CIBIC+, DAD) administration -->
                <!-- ECG -->
                <!-- Chemistry/Hematology safety labs -->
                <!-- Urinalysis -->
                <!-- Use of concomitant medications collection -->
                <!-- Medication dispensed -->
            </StudyEventDef>
         <StudyEventDef Name="Treatment Visit 13" OID="TRT_VISIT_13" Repeating="No" Type="Scheduled">
                <FormRef FormOID="VSFORM" Mandatory="Yes" OrderNumber="2"/>
                <FormRef FormOID="ECGFORM" Mandatory="Yes" OrderNumber="1"/>
                <!-- Vital Signs -->
                <!-- Temperature -->
                <!-- Adverse event assessment -->
                <!-- ECG -->
                <!-- Chemistry/Hematology safety labs -->
                <!-- Use of concomitant medications collection -->
            </StudyEventDef>
         <FormDef Name="ECG Form" OID="ECGFORM" Repeating="No">
                <Description>
                    <TranslatedText xml:lang="en">ECG Results</TranslatedText>
                </Description>
                <ItemGroupRef ItemGroupOID="EG" Mandatory="Yes"/>
            </FormDef>
         <FormDef Name="Vital Signs Form" OID="VSFORM" Repeating="No">
                <Description>
                    <TranslatedText xml:lang="en">Vital Signs Measurements</TranslatedText>
                </Description>
                <ItemGroupRef ItemGroupOID="VS" Mandatory="Yes"/>
            </FormDef>
         <ItemGroupDef IsReferenceData="No" Name="EG" OID="EG" Purpose="Tabulation" Repeating="No">
                <ItemRef ItemOID="STUDYID" Mandatory="Yes" OrderNumber="10" Role="Identifier"/>
                <ItemRef ItemOID="DOMAIN" Mandatory="Yes" OrderNumber="20" Role="Identifier"/>
                <ItemRef ItemOID="USUBJID" Mandatory="Yes" OrderNumber="30" Role="Identifier"/>
                <ItemRef ItemOID="EG.EGSEQ" Mandatory="Yes" OrderNumber="40" Role="Identifier"/>
                <ItemRef ItemOID="EG.EGSPID" Mandatory="Yes" OrderNumber="70" Role="Identifier"/>
                <ItemRef ItemOID="EG.EGTESTCD" Mandatory="Yes" OrderNumber="80" Role="Topic"/>
                <ItemRef ItemOID="EG.EGTEST" Mandatory="Yes" OrderNumber="90" Role="Synonym Qualifier"/>
                <ItemRef ItemOID="EG.EGCAT" Mandatory="Yes" OrderNumber="100" Role="Grouping Qualifier"/>
                <ItemRef ItemOID="EG.EGPOS" Mandatory="Yes" OrderNumber="120" Role="Record Qualifier"/>
                <ItemRef ItemOID="EG.EGORRES" Mandatory="Yes" OrderNumber="130" Role="Result Qualifier"/>
                <ItemRef ItemOID="EG.EGORRESU" Mandatory="Yes" OrderNumber="140"
                     Role="Variable Qualifier"/>
                <ItemRef ItemOID="EG.EGSTRESC" Mandatory="Yes" OrderNumber="160" Role="Result Qualifier"/>
                <ItemRef ItemOID="EG.EGSTRESN" Mandatory="Yes" OrderNumber="170" Role="Result Qualifier"/>
                <ItemRef ItemOID="EG.EGSTRESU" Mandatory="Yes" OrderNumber="180"
                     Role="Variable Qualifier"/>
                <ItemRef ItemOID="EG.EGBLFL" Mandatory="Yes" OrderNumber="250" Role="Record Qualifier"/>
                <ItemRef ItemOID="EG.EGEVAL" Mandatory="Yes" OrderNumber="270" Role="Record Qualifier"/>
                <ItemRef ItemOID="EG.VISITNUM" Mandatory="Yes" OrderNumber="280" Role="Timing"/>
                <ItemRef ItemOID="EG.VISIT" Mandatory="Yes" OrderNumber="290" Role="Timing"/>
                <ItemRef ItemOID="EG.EGDTC" Mandatory="Yes" OrderNumber="310" Role="Timing"/>
                <ItemRef ItemOID="EG.EGDY" Mandatory="Yes" OrderNumber="320" Role="Timing"/>
            </ItemGroupDef>
         <ItemGroupDef IsReferenceData="No" Name="Vital Signs" OID="VS" Purpose="Tabulation"
                       Repeating="Yes">
            	<ItemRef ItemOID="STUDYID" Mandatory="Yes" OrderNumber="10" Role="Identifier"/>
            	<ItemRef ItemOID="DOMAIN" Mandatory="Yes" OrderNumber="20" Role="Identifier"/>
            	<ItemRef ItemOID="USUBJID" Mandatory="Yes" OrderNumber="30" Role="Identifier"/>
            	<ItemRef ItemOID="VS.VSSEQ" Mandatory="Yes" OrderNumber="40" Role="Identifier"/>
            	<ItemRef ItemOID="VS.VSTESTCD" Mandatory="Yes" OrderNumber="70" Role="Topic"/>
            	<ItemRef ItemOID="VS.VSTEST" Mandatory="Yes" OrderNumber="80" Role="Synonym Qualifier"/>
            	<ItemRef ItemOID="VS.VSPOS" Mandatory="Yes" OrderNumber="110" Role="Record Qualifier"/>
            	<ItemRef ItemOID="VS.VSORRES" Mandatory="Yes" OrderNumber="120" Role="Result Qualifier"/>
            	<ItemRef ItemOID="VS.VSORRESU" Mandatory="Yes" OrderNumber="130"
                     Role="Variable Qualifier"/>
            	<ItemRef ItemOID="VS.VSSTRESC" Mandatory="Yes" OrderNumber="140" Role="Result Qualifier"/>
            	<ItemRef ItemOID="VS.VSSTRESN" Mandatory="Yes" OrderNumber="150" Role="Result Qualifier"/>
            	<ItemRef ItemOID="VS.VSSTRESU" Mandatory="Yes" OrderNumber="160"
                     Role="Variable Qualifier"/>
            	<ItemRef ItemOID="VS.VSSTAT" Mandatory="Yes" OrderNumber="170" Role="Result Qualifier"/>
            	<ItemRef ItemOID="VS.VSLOC" Mandatory="Yes" OrderNumber="200" Role="Record Qualifier"/>
            	<ItemRef ItemOID="VS.VISITNUM" Mandatory="Yes" OrderNumber="230" Role="Timing"/>
            	<ItemRef ItemOID="VS.VISIT" Mandatory="Yes" OrderNumber="240" Role="Timing"/>
            	<ItemRef ItemOID="VS.VSDTC" Mandatory="Yes" OrderNumber="260" Role="Timing"/>
            	<ItemRef ItemOID="VS.VSDY" Mandatory="Yes" OrderNumber="270" Role="Timing"/>
            </ItemGroupDef>
         <ItemDef Comment="DOMAIN ABBREVIATION" DataType="text" Length="2" Name="DOMAIN"
                  OID="DOMAIN"
                  Origin="CRF Page"/>
         <ItemDef Comment="Demographics CRF Page 4" DataType="text" Length="8" Name="STUDYID"
                  OID="STUDYID"
                  Origin="CRF Page"/>
         <ItemDef Comment="Demographics CRF Page 4" DataType="text" Length="60" Name="SUBJID"
                  OID="SUBJID"
                  Origin="CRF Page"/>
         <ItemDef Comment="Demographics CRF Page 4" DataType="text" Length="60" Name="USUBJID"
                  OID="USUBJID"
                  Origin="CRF Page"/>
         <ItemDef Comment="BASELINE FLAG" DataType="text" Length="1" Name="EGBLFL"
                  OID="EG.EGBLFL"
                  Origin="CRF Page"/>
         <ItemDef Comment="CATEGORY FOR ECG" DataType="text" Length="11" Name="EGCAT"
                  OID="EG.EGCAT"
                  Origin="CRF Page"/>
         <ItemDef Comment="ECG Test Results Page 14" DataType="date" Length="26" Name="EGDTC"
                  OID="EG.EGDTC"
                  Origin="CRF Page"/>
         <ItemDef Comment="STUDY DAY OF ECG" DataType="integer" Length="8" Name="EGDY"
                  OID="EG.EGDY"
                  Origin="DERIVED"/>
         <ItemDef Comment="EVALUATOR" DataType="text" Length="1" Name="EGEVAL" OID="EG.EGEVAL"
                  Origin="CRF Page"/>
         <ItemDef Comment="RESULT OR FINDING IN ORIGINAL UNITS" DataType="text" Length="25"
                  Name="EGORRES"
                  OID="EG.EGORRES"
                  Origin="CRF Page"/>
         <ItemDef Comment="ORIGINAL UNITS" DataType="text" Length="25" Name="EGORRESU"
                  OID="EG.EGORRESU"
                  Origin="CRF Page"/>
         <ItemDef Comment="ECG POSITION OF SUBJECT" DataType="text" Length="6" Name="EGPOS"
                  OID="EG.EGPOS"
                  Origin="CRF Page"/>
         <ItemDef Comment="SEQUENCE NUMBER" DataType="integer" Length="8" Name="EGSEQ"
                  OID="EG.EGSEQ"
                  Origin="CRF Page"/>
         <ItemDef Comment="SPONSOR ID" DataType="text" Length="8" Name="EGSPID" OID="EG.EGSPID"
                  Origin="DERIVED"/>
         <ItemDef Comment="CHARACTER RESULT/FINDING IN STD FORMAT" DataType="text" Length="20"
                  Name="EGSTRESC"
                  OID="EG.EGSTRESC"
                  Origin="CRF Page"/>
         <ItemDef Comment="NUMERIC RESULT/FINDING IN STANDARD UNITS" DataType="integer"
                  Length="8"
                  Name="EGSTRESN"
                  OID="EG.EGSTRESN"
                  Origin="CRF Page"/>
         <ItemDef Comment="Default units." DataType="text" Length="25" Name="EGSTRESU"
                  OID="EG.EGSTRESU"
                  Origin="CRF Page"/>
         <ItemDef Comment="ECG TEST OR EXAMINATION NAME" DataType="text" Length="40"
                  Name="EGTEST"
                  OID="EG.EGTEST"
                  Origin="CRF Page"/>
         <ItemDef Comment="ECG TEST OR EXAMINATION SHORT NAME" DataType="text" Length="8"
                  Name="EGTESTCD"
                  OID="EG.EGTESTCD"
                  Origin="CRF Page"/>
         <ItemDef Comment="VISIT NAME" DataType="text" Length="20" Name="VISIT" OID="EG.VISIT"
                  Origin="CRF Page"/>
         <ItemDef Comment="Clinical encounter number." DataType="integer" Length="8"
                  Name="VISITNUM"
                  OID="EG.VISITNUM"
                  Origin="DERIVED"/>
         <ItemDef Comment="VISIT NAME" DataType="text" Length="30" Name="VISIT" OID="VS.VISIT"
                  Origin="CRF Page"/>
         <ItemDef Comment="Clinical encounter number." DataType="integer" Length="8"
                  Name="VISITNUM"
                  OID="VS.VISITNUM"
                  Origin="DERIVED"/>
         <ItemDef Comment="Vital Signs CRF Page 4, CRF Page 7" DataType="date" Length="26"
                  Name="VSDTC"
                  OID="VS.VSDTC"
                  Origin="CRF Page"/>
         <ItemDef Comment="STUDY DAY OF VITAL SIGNS" DataType="integer" Length="8" Name="VSDY"
                  OID="VS.VSDY"
                  Origin="CRF Page"/>
         <ItemDef Comment="LOCATION OF VITAL SIGNS MEASUREMENT" DataType="text" Length="1"
                  Name="VSLOC"
                  OID="VS.VSLOC"
                  Origin="CRF Page"/>
         <ItemDef Comment="Vital Signs CRF Page 4, CRF Page 7" DataType="text" Length="8"
                  Name="VSORRES"
                  OID="VS.VSORRES"
                  Origin="CRF Page"/>
         <ItemDef Comment="ORIGINAL UNITS" DataType="text" Length="15" Name="VSORRESU"
                  OID="VS.VSORRESU"
                  Origin="CRF Page"/>
         <ItemDef Comment="POSITION OF THE SUBJECT DURING A MEASUREMENT OR EXAMINATION."
                  DataType="text"
                  Length="8"
                  Name="VSPOS"
                  OID="VS.VSPOS"
                  Origin="CRF Page"/>
         <ItemDef Comment="SEQUENCE NUMBER" DataType="integer" Length="8" Name="VSSEQ"
                  OID="VS.VSSEQ"
                  Origin="CRF Page"/>
         <ItemDef Comment="VITALS STATUS" DataType="text" Length="8" Name="VSSTAT"
                  OID="VS.VSSTAT"
                  Origin="CRF Page"/>
         <ItemDef Comment="CHARACTER RESULT/FINDING IN STD FORMAT" DataType="text" Length="20"
                  Name="VSSTRESC"
                  OID="VS.VSSTRESC"
                  Origin="CRF Page"/>
         <ItemDef Comment="CHARACTER RESULT/FINDING IN STD FORMAT" DataType="float" Length="8"
                  Name="VSSTRESN"
                  OID="VS.VSSTRESN"
                  Origin="CRF Page"
                  SignificantDigits="1"/>
         <ItemDef Comment="Default units." DataType="text" Length="15" Name="VSSTRESU"
                  OID="VS.VSSTRESU"
                  Origin="CRF Page"/>
         <ItemDef Comment="VITALS SIGNS TEST NAME" DataType="text" Length="40" Name="VSTEST"
                  OID="VS.VSTEST"
                  Origin="CRF Page"/>
         <ItemDef Comment="Vital Signs CRF Page 4, CRF Page 7" DataType="text" Length="8"
                  Name="VSTESTCD"
                  OID="VS.VSTESTCD"
                  Origin="CRF Page"/>
         <ConditionDef Name="Minimum Age" OID="AGECOND00">
                <Description>
                    <TranslatedText xml:lang="en">Over Age 21</TranslatedText>
                </Description>
                <FormalExpression Context="xpath">Age &gt; 21</FormalExpression>
            <!--  'computer-executable' -->
            </ConditionDef>
         <ConditionDef Name="Informed Consent Granted" OID="COND_INFCONSENT">
                <Description>
                    <TranslatedText xml:lang="en">Informed Consent Granted</TranslatedText>
                </Description>
                <FormalExpression Context="xpath">Consented = 'true'</FormalExpression>
            <!--  'computer-executable' -->
            </ConditionDef>
      </MetaDataVersion>
   </Study>
</ODM>