<xs:schema xmlns="http://www.cdisc.org/ns/odm/v1.3" xmlns:xs="http://www.w3.org/2001/XMLSchema" xmlns:ds="http://www.w3.org/2000/09/xmldsig#" xmlns:xml="http://www.w3.org/XML/1998/namespace" xmlns:odm="http://www.cdisc.org/ns/odm/v1.3" targetNamespace="http://www.cdisc.org/ns/odm/v1.3" elementFormDefault="qualified" attributeFormDefault="unqualified">
	<xs:import namespace="http://www.w3.org/XML/1998/namespace" schemaLocation="xml.xsd"/>
	<xs:import namespace="http://www.w3.org/2000/09/xmldsig#" schemaLocation="xmldsig-core-schema.xsd"/>
	<!--
        +===========================================================================+
        | ODM datatype definitions                                                  |
        +===========================================================================+
    -->
	<xs:simpleType name="text">
		<xs:restriction base="xs:string"/>
	</xs:simpleType>
	<xs:simpleType name="integer">
		<xs:restriction base="xs:integer"/>
	</xs:simpleType>
	<xs:simpleType name="float">
		<xs:restriction base="xs:decimal"/>
	</xs:simpleType>
	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | added the Zulu(UTC) suffix pattern on time & datetime                     |
        | tightened the restriction pattern on time & datetime to disallow 24-29 HH |
        | tightened the restriction pattern on date & datetime to disallow 32-39 DD |
        | ODM (v1.3.1)																|
        | removed the pattern on xs:date, xs:time and xs:datetime                   |
        +===========================================================================+
    -->
	<xs:simpleType name="date">
		<xs:restriction base="xs:date"/>
	</xs:simpleType>
	<xs:simpleType name="time">
		<xs:restriction base="xs:time">
			<!--xs:pattern value="(((([0-1][0-9])|([2][0-3])):([0-5][0-9]):([0-5][0-9])(\.[0-9]+)?)(((\+|-)(([0-1][0-9])|([2][0-3])):[0-5][0-9])|(Z))?)"/-->
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="datetime">
		<xs:restriction base="xs:dateTime">
			<!--xs:pattern value="((([0-9][0-9][0-9][0-9])-(([0][0-9])|([1][0-2]))-(([0-2][0-9])|([3][0-1])))T(((([0-1][0-9])|([2][0-3])):([0-5][0-9]):([0-5][0-9])(\.[0-9]+)?)(((\+|-)(([0-1][0-9])|([2][0-3])):[0-5][0-9])|(Z))?))"/-->
		</xs:restriction>
	</xs:simpleType>
	<!--
        +===========================================================================+
        | ODM extended datatype definitions (v1.3.0)                                |
        +===========================================================================+
    -->
	<!-- this is used to restrict the Length attribute on ItemDef -->
	<!--xs:simpleType name="positiveInteger">
		<xs:restriction base="xs:integer">
			<xs:minInclusive value="1"/>
		</xs:restriction>
	</xs:simpleType-->
	<xs:simpleType name="positiveInteger">
		<xs:restriction base="xs:positiveInteger">
			<!--xs:minInclusive value="1"/-->
		</xs:restriction>
	</xs:simpleType>
	<!-- this is used for the SignificantDigits attribute on ItemDef -->
	<xs:simpleType name="nonNegativeInteger">
		<xs:restriction base="xs:nonNegativeInteger">
			<!--xs:minInclusive value="0"/-->
		</xs:restriction>
	</xs:simpleType>


	<xs:simpleType name="boolean">
		<xs:restriction base="xs:boolean"/>
	</xs:simpleType>
	<!--
              a new datatype to specifically allow scientific notation (was alias)
              the ODM float is based on xs:decimal which does not range validate
              so, we base the ODM double on string to similarly defeat range validation
              and also allow the xs:double special values to be accepted by pattern
                 E (float)  exponent range check is -149 to 104 inclusive
                 D (double) exponent range check is -1075 to 970 inclusive
              E or D permits an application to also differentiate precision if desired.
              this is a beneficial side-effect since ODM float is not actually a
              single precision value; it only indicates the possibility of a decimal portion.
              pattern also include signed zero, infinity and Nan notation per xs:double
          -->
	<xs:simpleType name="double">
		<xs:restriction base="xs:string">
			<xs:pattern value="(((\+|-)?[0-9]+(\.[0-9]+)?((D|d|E|e)(\+|-)[0-9]+)?)|(-?INF)|(NaN))"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="string">
		<xs:restriction base="xs:string"/>
	</xs:simpleType>
	<xs:simpleType name="hexBinary">
		<xs:restriction base="xs:hexBinary"/>
	</xs:simpleType>
	<xs:simpleType name="base64Binary">
		<xs:restriction base="xs:base64Binary"/>
	</xs:simpleType>
	<!--
        hexFloat and base64Float are binary types intended for precise exchange of floating-point data in a
        machine/platform independent manner. the types are defined as the same internal data representation
        as the IBM Mainframe format currently used in the submission V5 Transport standard as described in
           SAS Technical Support document "TS-140 The Record Layout of a Data set in SAS Transport (XPORT) Format"
           http://ftp.sas.com/techsup/download/technote/ts140.html
        with the appropriate direct translation of the converted value to either hexBinary format or the
        base64Binary (MIME) representation. This secondary conversion ensures XML encoding compatability.

        these data values will not be humanly readable in the XML markup or by a standard XML-based tool,
        and the decision to use these types should be based on retention of numeric precision vs readability.

        implementers should note that the less constrained hexBinary and base64Binary datatypes could also be
        used for exchange of floating point values, but will suffer from
             1) inability to diagnose that a value is actually to be converted back to a float rather than a string
             2) encoded values may only be reliably exchanged across similar hardware platforms (representation)
                i.e., platforms may be IEEE-adherent for floating point storage yet be big-endian vs. little-endian
    -->
	<xs:simpleType name="hexFloat">
		<xs:restriction base="xs:hexBinary">
			<xs:maxLength value="16"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="base64Float">
		<xs:restriction base="xs:base64Binary">
			<xs:maxLength value="12"/>
		</xs:restriction>
	</xs:simpleType>
	<!--
             Standard Schema definitions do not allow the EMPTY/NULL construct.
             We define the "empytTag" type for use in union derivations where an EMPTY/NULL value is acceptable.
          -->
	<xs:simpleType name="emptyTag">
		<xs:restriction base="xs:string">
			<xs:pattern value="([ ])?"/>
		</xs:restriction>
	</xs:simpleType>
	<!--
              Partial dates are defined by the sequences as follows
                  YYYY-MM-DD              xs:date
                  YYYY-MM                 gYearMonth
                  YYYY                    gYear
                  EMPTY/NULL              emptyTag
          -->
	<xs:simpleType name="partialDate">
		<xs:union memberTypes="emptyTag xs:date xs:gYearMonth xs:gYear"/>
	</xs:simpleType>
	<!--
              Partial times are defined by the sequences as follows
                  HH:MM:SS[.sss][(+/-)HH:SS] xs:time
                  HH:MM:SS[.sss][Z]          xs:time
                  HH:MM:SS[.sss]             xs:time
                  HH:MM:SS                   xs:time
                  HH:MM                      xs:time
                  HH[(+/-)HH:SS]             tHour
                  HH[Z]                      tHour
                  EMPTY/NULL                 emptyTag
          -->
	<xs:simpleType name="tHour">
		<xs:restriction base="xs:string">
			<xs:pattern value="((([0-1][0-9])|([2][0-3]))(:[0-5][0-9])?(((\+|-)(([0-1][0-9])|([2][0-3])):[0-5][0-9])|(Z))?)"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="partialTime">
		<xs:union memberTypes="emptyTag xs:time tHour"/>
	</xs:simpleType>
	<!--
              Partial datetimes are defined by the sequences as follows
              YYYY-MM-DDTHH:MM:SS[.sss][(+/-)HH:SS]
              YYYY-MM-DDTHH:MM:SS[Z]
              YYYY-MM-DDTHH:MM:SS[(+/-)HH:SS]
              YYYY-MM-DDTHH:MM:SS[Z]
              YYYY-MM-DDTHH:MM
              YYYY-MM-DDTHH
              YYYY-MM-DD
              YYYY-MM
              YYYY

              pattern not perfect for 28/30/31 days in which months
              but if a complete datetime, then the xs:dateTime facet will validate it
          -->
	<xs:simpleType name="tDatetime">
		<xs:restriction base="xs:string">
			<xs:pattern value="((([0-9][0-9][0-9][0-9])((-(([0][1-9])|([1][0-2])))((-(([0][1-9])|([1-2][0-9])|([3][0-1])))(T((([0-1][0-9])|([2][0-3]))((:([0-5][0-9]))(((:([0-5][0-9]))((\.[0-9]+)?))?)?)?((((\+|-)(([0-1][0-9])|([2][0-3])):[0-5][0-9])|(Z)))?))?)?)?))"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="partialDatetime">
		<xs:union memberTypes="emptyTag xs:dateTime tDatetime"/>
	</xs:simpleType>
	<!--
              Durations may be either EMPTY/NULL
              or the XML-Schema type duration
              XML-Schema permits carry-over of components and negative durations
              neither concept is supported directly by ISO-8601 but we allow them here
              by specifically NOT restricting the use of the type by a pattern override
              ISO-8601 reference points
                  5.5.3.1 (positive integer or zero)
                  5.5.3.2 (carry-over points)
              XML-Schema reference point
                  3.2.6.1 (lexical representation)
              the full tDuration pattern was used with the tInterval derivation but only a truncated form
              must still be employed because XML-Schema implementation does NOT support the WEEKS form of ISO-8601
          -->
	<xs:simpleType name="tDuration">
		<xs:restriction base="xs:string">
			<xs:pattern value="((\+|-)?P([0-9]([0-9]+)?)W)"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="durationDatetime">
		<xs:union memberTypes="emptyTag xs:duration tDuration"/>
	</xs:simpleType>
	<!--
              The Interval is technically just a combination type composed of either
                    partialDatetime  "/" partialDatetime
                    durationDatetime "/" partialDatetime
                    partialDatetime  "/" durationDatetime
              but we must enumerate the entire pattern to define it via Schema.
          -->
	<xs:simpleType name="tInterval">
		<xs:restriction base="xs:string">
			<xs:pattern value="((((([0-9][0-9][0-9][0-9])((-(([0][1-9])|([1][0-2])))((-(([0][1-9])|([1-2][0-9])|([3][0-1])))(T((([0-1][0-9])|([2][0-3]))((:([0-5][0-9]))(((:([0-5][0-9]))((\.[0-9]+)?))?)?)?((((\+|-)(([0-1][0-9])|([2][0-3])):[0-5][0-9])|(Z)))?))?)?)?))/((([0-9][0-9][0-9][0-9])((-(([0][1-9])|([1][0-2])))((-(([0][1-9])|([1-2][0-9])|([3][0-1])))(T((([0-1][0-9])|([2][0-3]))((:([0-5][0-9]))(((:([0-5][0-9]))((\.[0-9]+)?))?)?)?((((\+|-)(([0-1][0-9])|([2][0-3])):[0-5][0-9])|(Z)))?))?)?)?)))|(((([0-9][0-9][0-9][0-9])((-(([0][1-9])|([1][0-2])))((-(([0][1-9])|([1-2][0-9])|([3][0-1])))(T((([0-1][0-9])|([2][0-3]))((:([0-5][0-9]))(((:([0-5][0-9]))((\.[0-9]+)?))?)?)?((((\+|-)(([0-1][0-9])|([2][0-3])):[0-5][0-9])|(Z)))?))?)?)?))/(((\+|-)?P(((([0-9]([0-9]+)?)Y)?(([0-9]([0-9]+)?)M)?(([0-9]([0-9]+)?)D)?)(T((([0-9]([0-9]+)?)H)?(([0-9]([0-9]+)?)M)?(([0-9]([0-9]+)?)((\.[0-9]+)?)S)?)?)?|((([0-9]([0-9]+)?)W))))))|((((\+|-)?P(((([0-9]([0-9]+)?)Y)?(([0-9]([0-9]+)?)M)?(([0-9]([0-9]+)?)D)?)(T((([0-9]([0-9]+)?)H)?(([0-9]([0-9]+)?)M)?(([0-9]([0-9]+)?)((\.[0-9]+)?)S)?)?)?|((([0-9]([0-9]+)?)W)))))/((([0-9][0-9][0-9][0-9])((-(([0][1-9])|([1][0-2])))((-(([0][1-9])|([1-2][0-9])|([3][0-1])))(T((([0-1][0-9])|([2][0-3]))((:([0-5][0-9]))(((:([0-5][0-9]))((\.[0-9]+)?))?)?)?((((\+|-)(([0-1][0-9])|([2][0-3])):[0-5][0-9])|(Z)))?))?)?)?))))"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="intervalDatetime">
		<xs:union memberTypes="emptyTag tInterval"/>
	</xs:simpleType>
	<!--
              incompleteDatetime are defined similar to partialDateime
              with the exception that each individual datetime component may be
              substituted with a single dash to indicate omission
              ISO-8601 reference points
                  4.5 Note 1 (Use of separators)
              pattern required in restriction to add omitted values
              this type must also accept standard ODM datetime values as defined above
          -->
	<xs:simpleType name="tIncomplete">
		<xs:restriction base="xs:string">
			<xs:pattern value="(((([0-9][0-9][0-9][0-9]))|-)-(((([0][1-9])|([1][0-2])))|-)-(((([0][1-9])|([1-2][0-9])|([3][0-1])))|-)T(((([0-1][0-9])|([2][0-3])))|-):((([0-5][0-9]))|-):((([0-5][0-9](\.[0-9]+)?))|-)((((\+|-)(([0-1][0-9])|([2][0-3])):[0-5][0-9])|Z|-))?)"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="incompleteDatetime">
		<xs:union memberTypes="emptyTag xs:dateTime tDatetime tIncomplete"/>
	</xs:simpleType>

	<xs:simpleType name="tIncompleteDate">
		<xs:restriction base="xs:string">
			<xs:pattern value="(((([0-9][0-9][0-9][0-9]))|-)-(((([0][1-9])|([1][0-2])))|-)-(((([0][1-9])|([1-2][0-9])|([3][0-1])))|-))"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="tIncompleteTime">
		<xs:restriction base="xs:string">
			<xs:pattern value="((((([0-1][0-9])|([2][0-3])))|-):((([0-5][0-9]))|-):((([0-5][0-9](\.[0-9]+)?))|-)((((\+|-)(([0-1][0-9])|([2][0-3])):[0-5][0-9])|Z|-))?)"/>
		</xs:restriction>
	</xs:simpleType>

	<xs:simpleType name="incompleteTime">
		<xs:union memberTypes="emptyTag xs:time tHour tIncompleteTime"/>
	</xs:simpleType>

	<xs:simpleType name="incompleteDate">
		<xs:union memberTypes="emptyTag xs:date xs:gYearMonth xs:gYear tIncompleteDate"/>
	</xs:simpleType>
 	<!--
        +===========================================================================+
        | ODM datatype definitions                                                  |
        | ODM extended datatype definitions (v1.3.0)                                |
        +===========================================================================+
    -->
	<xs:simpleType name="DataType">
		<xs:restriction base="xs:string">
			<xs:enumeration value="integer"/>
			<xs:enumeration value="float"/>
			<xs:enumeration value="date"/>
			<xs:enumeration value="datetime"/>
			<xs:enumeration value="time"/>
			<xs:enumeration value="text"/>
			<xs:enumeration value="string"/>
			<xs:enumeration value="double"/>
			<xs:enumeration value="URI"/>
			<xs:enumeration value="boolean"/>
			<xs:enumeration value="hexBinary"/>
			<xs:enumeration value="base64Binary"/>
			<xs:enumeration value="hexFloat"/>
			<xs:enumeration value="base64Float"/>
			<xs:enumeration value="partialDate"/>
			<xs:enumeration value="partialTime"/>
			<xs:enumeration value="partialDatetime"/>
			<xs:enumeration value="durationDatetime"/>
			<xs:enumeration value="intervalDatetime"/>
			<xs:enumeration value="incompleteDatetime"/>
			<xs:enumeration value="incompleteDate"/>
			<xs:enumeration value="incompleteTime"/>
			<!-- original ODM datatypes (pre-1.3) -->
			<!-- aliases added for 1.3 -->
			<!-- binary datatypes for 1.3 -->
			<!-- extended datetime datatypes -->
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="CLDataType">
		<xs:restriction base="xs:string">
			<xs:enumeration value="integer"/>
			<xs:enumeration value="float"/>
			<xs:enumeration value="text"/>
			<xs:enumeration value="string"/>
		</xs:restriction>
	</xs:simpleType>
	<!--
        +===========================================================================+
        | ODM internal type definitions                                             |
        +===========================================================================+
    -->
	<xs:simpleType name="oid">
		<xs:restriction base="xs:string">
			<xs:minLength value="1"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="oidref">
		<xs:restriction base="xs:string">
			<xs:minLength value="1"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="value">
		<xs:restriction base="xs:string"/>
	</xs:simpleType>
	<xs:simpleType name="subjectKey">
		<xs:restriction base="xs:string">
			<xs:minLength value="1"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="repeatKey">
		<xs:restriction base="xs:string">
			<xs:minLength value="1"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="name">
		<xs:restriction base="xs:string">
			<xs:minLength value="1"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="sasName">
		<xs:restriction base="xs:string">
			<xs:maxLength value="8"/>
			<xs:pattern value="[A-Za-z_][A-Za-z0-9_]*"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="sasFormat">
		<xs:restriction base="xs:string">
			<xs:maxLength value="8"/>
			<xs:pattern value="[A-Za-z_$][A-Za-z0-9_.]*"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="fileName">
		<xs:restriction base="xs:anyURI"/>
	</xs:simpleType>
	<!--
        +===========================================================================+
        | ODM attribute value enumerations                                          |
        +===========================================================================+
    -->
	<xs:simpleType name="FileType">
		<xs:restriction base="xs:string">
			<xs:enumeration value="Snapshot"/>
			<xs:enumeration value="Transactional"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="Granularity">
		<xs:restriction base="xs:string">
			<xs:enumeration value="All"/>
			<xs:enumeration value="Metadata"/>
			<xs:enumeration value="AdminData"/>
			<xs:enumeration value="ReferenceData"/>
			<xs:enumeration value="AllClinicalData"/>
			<xs:enumeration value="SingleSite"/>
			<xs:enumeration value="SingleSubject"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="ODMVersion">
		<xs:restriction base="xs:string">
			<xs:enumeration value="1.2"/>
			<xs:enumeration value="1.2.1"/>
			<xs:enumeration value="1.3"/>
			<xs:enumeration value="1.3.1"/>
			<xs:enumeration value="1.3.2"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="EventType">
		<xs:restriction base="xs:string">
			<xs:enumeration value="Scheduled"/>
			<xs:enumeration value="Unscheduled"/>
			<xs:enumeration value="Common"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="Comparator">
		<xs:restriction base="xs:string">
			<xs:enumeration value="LT"/>
			<xs:enumeration value="LE"/>
			<xs:enumeration value="GT"/>
			<xs:enumeration value="GE"/>
			<xs:enumeration value="EQ"/>
			<xs:enumeration value="NE"/>
			<xs:enumeration value="IN"/>
			<xs:enumeration value="NOTIN"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="SoftOrHard">
		<xs:restriction base="xs:string">
			<xs:enumeration value="Soft"/>
			<xs:enumeration value="Hard"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="TransactionType">
		<xs:restriction base="xs:string">
			<xs:enumeration value="Insert"/>
			<xs:enumeration value="Update"/>
			<xs:enumeration value="Remove"/>
			<xs:enumeration value="Upsert"/>
			<xs:enumeration value="Context"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="UserType">
		<xs:restriction base="xs:string">
			<xs:enumeration value="Sponsor"/>
			<xs:enumeration value="Investigator"/>
			<xs:enumeration value="Lab"/>
			<xs:enumeration value="Other"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="LocationType">
		<xs:restriction base="xs:string">
			<xs:enumeration value="Sponsor"/>
			<xs:enumeration value="Site"/>
			<xs:enumeration value="CRO"/>
			<xs:enumeration value="Lab"/>
			<xs:enumeration value="Other"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="CommentType">
		<xs:restriction base="xs:string">
			<xs:enumeration value="Sponsor"/>
			<xs:enumeration value="Site"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="SignMethod">
		<xs:restriction base="xs:string">
			<xs:enumeration value="Digital"/>
			<xs:enumeration value="Electronic"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="EditPointType">
		<xs:restriction base="xs:string">
			<xs:enumeration value="Monitoring"/>
			<xs:enumeration value="DataManagement"/>
			<xs:enumeration value="DBAudit"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="YesOrNo">
		<xs:restriction base="xs:string">
			<xs:enumeration value="Yes"/>
			<xs:enumeration value="No"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="YesOnly">
		<xs:restriction base="xs:string">
			<xs:enumeration value="Yes"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="MethodType">
		<xs:restriction base="xs:string">
			<xs:enumeration value="Computation"/>
			<xs:enumeration value="Imputation"/>
			<xs:enumeration value="Transpose"/>
			<xs:enumeration value="Other"/>
		</xs:restriction>
	</xs:simpleType>
	<!--
        +===========================================================================+
        | attribute definition groups                                               |
        | these definitions are NOT to be extended and are internal to ODM USE ONLY |
        +===========================================================================+
    -->
	<xs:attributeGroup name="ODMAttributeDefinition">
		<xs:attribute name="Description" type="text"/>
		<xs:attribute name="FileType" type="FileType" use="required"/>
		<xs:attribute name="Granularity" type="Granularity"/>
		<xs:attribute name="Archival" type="YesOnly"/>
		<xs:attribute name="FileOID" type="oid" use="required"/>
		<xs:attribute name="CreationDateTime" type="datetime" use="required"/>
		<xs:attribute name="PriorFileOID" type="oidref"/>
		<xs:attribute name="AsOfDateTime" type="datetime"/>
		<xs:attribute name="ODMVersion" type="ODMVersion"/>
		<xs:attribute name="Originator" type="text"/>
		<xs:attribute name="SourceSystem" type="text"/>
		<xs:attribute name="SourceSystemVersion" type="text"/>
		<xs:attribute name="Id" type="xs:ID"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="TranslatedTextAttributeDefinition">
		<xs:attribute ref="xml:lang"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="ImputationMethodAttributeDefinition">
		<xs:attribute name="OID" type="oid" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="PresentationAttributeDefinition">
		<xs:attribute name="OID" type="oid" use="required"/>
		<xs:attribute ref="xml:lang"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="CommentAttributeDefinition">
		<xs:attribute name="SponsorOrSite" type="CommentType"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="FlagValueAttributeDefinition">
		<xs:attribute name="CodeListOID" type="oidref" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="FlagTypeAttributeDefinition">
		<xs:attribute name="CodeListOID" type="oidref" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="IncludeAttributeDefinition">
		<xs:attribute name="StudyOID" type="oidref" use="required"/>
		<xs:attribute name="MetaDataVersionOID" type="oidref" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="StudyEventRefAttributeDefinition">
		<xs:attribute name="StudyEventOID" type="oidref" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="FormRefAttributeDefinition">
		<xs:attribute name="FormOID" type="oidref" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="ItemGroupRefAttributeDefinition">
		<xs:attribute name="ItemGroupOID" type="oidref" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="ArchiveLayoutAttributeDefinition">
		<xs:attribute name="OID" type="oid" use="required"/>
		<xs:attribute name="PdfFileName" type="fileName" use="required"/>
		<xs:attribute name="PresentationOID" type="oidref"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="ItemRefAttributeDefinition">
		<xs:attribute name="ItemOID" type="oidref" use="required"/>
		<xs:attribute name="KeySequence" type="integer"/>
		<xs:attribute name="MethodOID" type="oidref"/>
		<xs:attribute name="ImputationMethodOID" type="oidref"/>
		<xs:attribute name="Role" type="text"/>
		<xs:attribute name="RoleCodeListOID" type="oidref"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="AliasAttributeDefinition">
		<xs:attribute name="Context" type="text" use="required"/>
		<xs:attribute name="Name" type="text" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="ExternalSharedAttributeDefinition">
		<xs:attribute name="Dictionary" type="text"/>
		<xs:attribute name="Version" type="text"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="ExternalQuestionAttributeDefinition">
		<xs:attribute name="Code" type="text"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="MeasurementUnitRefAttributeDefinition">
		<xs:attribute name="MeasurementUnitOID" type="oidref" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="CodeListRefAttributeDefinition">
		<xs:attribute name="CodeListOID" type="oidref" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="ExternalCodeListAttributeDefinition">
		<xs:attribute name="href" type="xs:anyURI"/>
		<xs:attribute name="ref" type="text"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="PictureAttributeDefinition">
		<xs:attribute name="PictureFileName" type="fileName" use="required"/>
		<xs:attribute name="ImageType" type="name"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="LocationRefAttributeDefinition">
		<xs:attribute name="LocationOID" type="oidref" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="MetaDataVersionRefAttributeDefinition">
		<xs:attribute name="StudyOID" type="oidref" use="required"/>
		<xs:attribute name="MetaDataVersionOID" type="oidref" use="required"/>
		<xs:attribute name="EffectiveDate" type="date" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="ArchiveLayoutRefAttributeDefinition">
		<xs:attribute name="ArchiveLayoutOID" type="oidref" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="UserRefAttributeDefinition">
		<xs:attribute name="UserOID" type="oidref" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="SignatureRefAttributeDefinition">
		<xs:attribute name="SignatureOID" type="oidref" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="InvestigatorRefAttributeDefinition">
		<xs:attribute name="UserOID" type="oidref" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="SiteRefAttributeDefinition">
		<xs:attribute name="LocationOID" type="oidref" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="StudyAttributeDefinition">
		<xs:attribute name="OID" type="oid" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="MeasurementUnitAttributeDefinition">
		<xs:attribute name="OID" type="oid" use="required"/>
		<xs:attribute name="Name" type="text" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="MetaDataVersionAttributeDefinition">
		<xs:attribute name="OID" type="oid" use="required"/>
		<xs:attribute name="Name" type="name" use="required"/>
		<xs:attribute name="Description" type="text"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="StudyEventDefAttributeDefinition">
		<xs:attribute name="OID" type="oid" use="required"/>
		<xs:attribute name="Name" type="name" use="required"/>
		<xs:attribute name="Repeating" type="YesOrNo" use="required"/>
		<xs:attribute name="Type" type="EventType" use="required"/>
		<xs:attribute name="Category" type="text"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="FormDefAttributeDefinition">
		<xs:attribute name="OID" type="oid" use="required"/>
		<xs:attribute name="Name" type="name" use="required"/>
		<xs:attribute name="Repeating" type="YesOrNo" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="ItemGroupDefAttributeDefinition">
		<xs:attribute name="OID" type="oid" use="required"/>
		<xs:attribute name="Name" type="name" use="required"/>
		<xs:attribute name="Repeating" type="YesOrNo" use="required"/>
		<xs:attribute name="IsReferenceData" type="YesOrNo"/>
		<xs:attribute name="SASDatasetName" type="sasName"/>
		<xs:attribute name="Domain" type="text"/>
		<xs:attribute name="Origin" type="text"/>
		<xs:attribute name="Role" type="name"/>
		<xs:attribute name="Purpose" type="text"/>
		<xs:attribute name="Comment" type="text"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="ItemDefAttributeDefinition">
		<xs:attribute name="OID" type="oid" use="required"/>
		<xs:attribute name="Name" type="name" use="required"/>
		<xs:attribute name="DataType" type="DataType" use="required"/>
		<xs:attribute name="Length" type="positiveInteger"/>
		<!--xs:attribute name="SignificantDigits" type="integer"/-->
		<xs:attribute name="SignificantDigits" type="nonNegativeInteger"/>
		<xs:attribute name="SASFieldName" type="sasName"/>
		<xs:attribute name="SDSVarName" type="sasName"/>
		<xs:attribute name="Origin" type="text"/>
		<xs:attribute name="Comment" type="text"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="RangeCheckAttributeDefinition">
		<!--xs:attribute name="Comparator" type="Comparator" use="required"/-->
		<xs:attribute name="Comparator" type="Comparator" use="optional"/>
		<xs:attribute name="SoftHard" type="SoftOrHard" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="CodeListAttributeDefinition">
		<xs:attribute name="OID" type="oid" use="required"/>
		<xs:attribute name="Name" type="name" use="required"/>
		<xs:attribute name="DataType" type="CLDataType" use="required"/>
		<xs:attribute name="SASFormatName" type="sasFormat"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="CodeListItemAttributeDefinition">
		<xs:attribute name="CodedValue" type="value" use="required"/>
		<xs:attribute name="Rank" type="float"/>
    <xs:attribute name="OrderNumber" type="integer"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="AdminDataAttributeDefinition">
		<xs:attribute name="StudyOID" type="oidref"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="UserAttributeDefinition">
		<xs:attribute name="OID" type="oid" use="required"/>
		<xs:attribute name="UserType" type="UserType"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="LocationAttributeDefinition">
		<xs:attribute name="OID" type="oid" use="required"/>
		<xs:attribute name="Name" type="name" use="required"/>
		<xs:attribute name="LocationType" type="LocationType"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="SignatureDefAttributeDefinition">
		<xs:attribute name="OID" type="oid" use="required"/>
		<xs:attribute name="Methodology" type="SignMethod"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="ReferenceDataAttributeDefinition">
		<xs:attribute name="StudyOID" type="oidref" use="required"/>
		<xs:attribute name="MetaDataVersionOID" type="oidref" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="ClinicalDataAttributeDefinition">
		<xs:attribute name="StudyOID" type="oidref" use="required"/>
		<xs:attribute name="MetaDataVersionOID" type="oidref" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="SubjectDataAttributeDefinition">
		<xs:attribute name="SubjectKey" type="subjectKey" use="required"/>
		<xs:attribute name="TransactionType" type="TransactionType"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="StudyEventDataAttributeDefinition">
		<xs:attribute name="StudyEventOID" type="oidref" use="required"/>
		<xs:attribute name="StudyEventRepeatKey" type="repeatKey"/>
		<xs:attribute name="TransactionType" type="TransactionType"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="FormDataAttributeDefinition">
		<xs:attribute name="FormOID" type="oidref" use="required"/>
		<xs:attribute name="FormRepeatKey" type="repeatKey"/>
		<xs:attribute name="TransactionType" type="TransactionType"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="ItemGroupDataAttributeDefinition">
		<xs:attribute name="ItemGroupOID" type="oidref" use="required"/>
		<xs:attribute name="ItemGroupRepeatKey" type="repeatKey"/>
		<xs:attribute name="TransactionType" type="TransactionType"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="ItemDataAttributeSharedDefinition">
		<xs:attribute name="ItemOID" type="oidref" use="required"/>
		<xs:attribute name="TransactionType" type="TransactionType"/>
		<xs:attribute name="IsNull" type="YesOnly"/>
	</xs:attributeGroup>
	<!-- addition J.Aerts, 2009-05-28 -->
	<xs:attributeGroup name="ItemDataTypeAttributeSharedDefinition">
		<xs:attribute name="ItemOID" type="oidref" use="required"/>
		<xs:attribute name="TransactionType" type="TransactionType"/>
		<!-- no IsNull attribute here -->
	</xs:attributeGroup>
	<!-- end of addition J.Aerts -->
	<xs:attributeGroup name="ItemDataAttributeDefinition">
		<xs:attribute name="Value" type="value"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="AssociationAttributeDefinition">
		<xs:attribute name="StudyOID" type="oidref" use="required"/>
		<xs:attribute name="MetaDataVersionOID" type="oidref" use="required"/>
	</xs:attributeGroup>
	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | Simple OID added.                                                         |
        +===========================================================================+
    -->
	<xs:attributeGroup name="KeySetAttributeDefinition">
		<xs:attribute name="StudyOID" type="oidref" use="required"/>
		<xs:attribute name="SubjectKey" type="subjectKey"/>
		<xs:attribute name="StudyEventOID" type="oidref"/>
		<xs:attribute name="StudyEventRepeatKey" type="repeatKey"/>
		<xs:attribute name="FormOID" type="oidref"/>
		<xs:attribute name="FormRepeatKey" type="repeatKey"/>
		<xs:attribute name="ItemGroupOID" type="oidref"/>
		<xs:attribute name="ItemGroupRepeatKey" type="repeatKey"/>
		<xs:attribute name="ItemOID" type="oidref"/>
		<xs:attribute name="OID" type="oidref"/>
	</xs:attributeGroup>
	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | ConditionDef added.                                                       |
        | MethodDef added.                                                          |
        | ValueListDef added.                                                       |
        | ValueListRef added.                                                       |
        | ValueListDef removed.                                                     |
        | ValueListRef removed.                                                     |
        +===========================================================================+
    -->
	<xs:attributeGroup name="RefAttributeSharedDefinition">
		<xs:attribute name="OrderNumber" type="integer"/>
		<xs:attribute name="Mandatory" type="YesOrNo" use="required"/>
		<xs:attribute name="CollectionExceptionConditionOID" type="oidref"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="FormalExpressionAttributeDefinition">
		<xs:attribute name="Context" type="text"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="ConditionDefAttributeDefinition">
		<xs:attribute name="OID" type="oid" use="required"/>
		<xs:attribute name="Name" type="name" use="required"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="MethodDefAttributeDefinition">
		<xs:attribute name="OID" type="oid" use="required"/>
		<xs:attribute name="Name" type="name" use="required"/>
		<xs:attribute name="Type" type="MethodType" use="optional"/>
	</xs:attributeGroup>
	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | Container definitions                                                     |
        +===========================================================================+
    -->
	<xs:attributeGroup name="AnnotationAttributeDefinition">
		<xs:attribute name="SeqNum" type="integer" use="required"/>
		<xs:attribute name="TransactionType" type="TransactionType"/>
		<xs:attribute name="ID" type="xs:ID"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="SignatureAttributeDefinition">
		<xs:attribute name="ID" type="xs:ID"/>
	</xs:attributeGroup>
	<xs:attributeGroup name="AuditRecordAttributeDefinition">
		<xs:attribute name="EditPoint" type="EditPointType"/>
		<xs:attribute name="UsedImputationMethod" type="YesOrNo"/>
		<xs:attribute name="ID" type="xs:ID"/>
	</xs:attributeGroup>
	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | Extended ItemDataStar definitions                                         |
        +===========================================================================+
    -->
	<xs:attributeGroup name="ItemDataStarAttributeDefinition">
		<xs:attribute name="AuditRecordID" type="xs:IDREF"/>
		<xs:attribute name="SignatureID" type="xs:IDREF"/>
		<xs:attribute name="AnnotationID" type="xs:IDREF"/>
		<xs:attribute name="MeasurementUnitOID" type="oidref"/>
	</xs:attributeGroup>
	<!--
        +===========================================================================+
        | these are purposely empty attributeGroups to permit vendor extensions to  |
        | the corresponding elements via the standard XML-Schema redefine mechanism |
        +===========================================================================+
    -->
	<xs:attributeGroup name="StudyNameAttributeExtension"/>
	<xs:attributeGroup name="StudyDescriptionAttributeExtension"/>
	<xs:attributeGroup name="ProtocolNameAttributeExtension"/>
	<xs:attributeGroup name="TranslatedTextAttributeExtension"/>
	<xs:attributeGroup name="ImputationMethodAttributeExtension"/>
	<xs:attributeGroup name="PresentationAttributeExtension"/>
	<xs:attributeGroup name="LoginNameAttributeExtension"/>
	<xs:attributeGroup name="DisplayNameAttributeExtension"/>
	<xs:attributeGroup name="FullNameAttributeExtension"/>
	<xs:attributeGroup name="FirstNameAttributeExtension"/>
	<xs:attributeGroup name="LastNameAttributeExtension"/>
	<xs:attributeGroup name="OrganizationAttributeExtension"/>
	<xs:attributeGroup name="StreetNameAttributeExtension"/>
	<xs:attributeGroup name="CityAttributeExtension"/>
	<xs:attributeGroup name="StateProvAttributeExtension"/>
	<xs:attributeGroup name="CountryAttributeExtension"/>
	<xs:attributeGroup name="PostalCodeAttributeExtension"/>
	<xs:attributeGroup name="OtherTextAttributeExtension"/>
	<xs:attributeGroup name="EmailAttributeExtension"/>
	<xs:attributeGroup name="PagerAttributeExtension"/>
	<xs:attributeGroup name="FaxAttributeExtension"/>
	<xs:attributeGroup name="PhoneAttributeExtension"/>
	<xs:attributeGroup name="CertificateAttributeExtension"/>
	<xs:attributeGroup name="MeaningAttributeExtension"/>
	<xs:attributeGroup name="LegalReasonAttributeExtension"/>
	<xs:attributeGroup name="CommentAttributeExtension"/>
	<xs:attributeGroup name="FlagValueAttributeExtension"/>
	<xs:attributeGroup name="FlagTypeAttributeExtension"/>
	<xs:attributeGroup name="DateTimeStampAttributeExtension"/>
	<xs:attributeGroup name="ReasonForChangeAttributeExtension"/>
	<xs:attributeGroup name="SourceIDAttributeExtension"/>
	<xs:attributeGroup name="CryptoBindingManifestAttributeExtension"/>
	<xs:attributeGroup name="RoleAttributeExtension"/>
	<xs:attributeGroup name="IncludeAttributeExtension"/>
	<xs:attributeGroup name="StudyEventRefAttributeExtension"/>
	<xs:attributeGroup name="FormRefAttributeExtension"/>
	<xs:attributeGroup name="ItemGroupRefAttributeExtension"/>
	<xs:attributeGroup name="ArchiveLayoutAttributeExtension"/>
	<xs:attributeGroup name="ItemRefAttributeExtension"/>
	<xs:attributeGroup name="AliasAttributeExtension"/>
	<xs:attributeGroup name="ExternalQuestionAttributeExtension"/>
	<xs:attributeGroup name="MeasurementUnitRefAttributeExtension"/>
	<xs:attributeGroup name="CheckValueAttributeExtension"/>
	<xs:attributeGroup name="CodeListRefAttributeExtension"/>
	<xs:attributeGroup name="ExternalCodeListAttributeExtension"/>
	<xs:attributeGroup name="PictureAttributeExtension"/>
	<xs:attributeGroup name="LocationRefAttributeExtension"/>
	<xs:attributeGroup name="MetaDataVersionRefAttributeExtension"/>
	<xs:attributeGroup name="ArchiveLayoutRefAttributeExtension"/>
	<xs:attributeGroup name="UserRefAttributeExtension"/>
	<xs:attributeGroup name="SignatureRefAttributeExtension"/>
	<xs:attributeGroup name="InvestigatorRefAttributeExtension"/>
	<xs:attributeGroup name="SiteRefAttributeExtension"/>
	<xs:attributeGroup name="StudyAttributeExtension"/>
	<xs:attributeGroup name="GlobalVariablesAttributeExtension"/>
	<xs:attributeGroup name="BasicDefinitionsAttributeExtension"/>
	<xs:attributeGroup name="MeasurementUnitAttributeExtension"/>
	<xs:attributeGroup name="MetaDataVersionAttributeExtension"/>
	<xs:attributeGroup name="SymbolAttributeExtension"/>
	<xs:attributeGroup name="ProtocolAttributeExtension"/>
	<xs:attributeGroup name="StudyEventDefAttributeExtension"/>
	<xs:attributeGroup name="FormDefAttributeExtension"/>
	<xs:attributeGroup name="ItemGroupDefAttributeExtension"/>
	<xs:attributeGroup name="ItemDefAttributeExtension"/>
	<xs:attributeGroup name="QuestionAttributeExtension"/>
	<xs:attributeGroup name="RangeCheckAttributeExtension"/>
	<xs:attributeGroup name="ErrorMessageAttributeExtension"/>
	<xs:attributeGroup name="CodeListAttributeExtension"/>
	<xs:attributeGroup name="CodeListItemAttributeExtension"/>
	<xs:attributeGroup name="DecodeAttributeExtension"/>
	<xs:attributeGroup name="AdminDataAttributeExtension"/>
	<xs:attributeGroup name="UserAttributeExtension"/>
	<xs:attributeGroup name="AddressAttributeExtension"/>
	<xs:attributeGroup name="LocationAttributeExtension"/>
	<xs:attributeGroup name="SignatureDefAttributeExtension"/>
	<xs:attributeGroup name="ReferenceDataAttributeExtension"/>
	<xs:attributeGroup name="ClinicalDataAttributeExtension"/>
	<xs:attributeGroup name="SubjectDataAttributeExtension"/>
	<xs:attributeGroup name="StudyEventDataAttributeExtension"/>
	<xs:attributeGroup name="FormDataAttributeExtension"/>
	<xs:attributeGroup name="ItemGroupDataAttributeExtension"/>
	<xs:attributeGroup name="ItemDataAttributeExtension"/>
	<xs:attributeGroup name="AnnotationAttributeExtension"/>
	<xs:attributeGroup name="FlagAttributeExtension"/>
	<xs:attributeGroup name="SignatureAttributeExtension"/>
	<xs:attributeGroup name="AuditRecordAttributeExtension"/>
	<xs:attributeGroup name="AssociationAttributeExtension"/>
	<xs:attributeGroup name="KeySetAttributeExtension"/>
	<xs:attributeGroup name="ODMAttributeExtension"/>
	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | Description definition                                                    |
        | ConditionDef definition                                                   |
        | EnumeratedItem defniition                                                 |
        | Extended ItemData definitions                                             |
        | MethodDef definition                                                      |
        +===========================================================================+
    -->
	<xs:attributeGroup name="DescriptionAttributeExtension"/>
	<xs:attributeGroup name="ConditionDefAttributeExtension"/>
	<xs:attributeGroup name="FormalExpressionAttributeExtension"/>
	<xs:attributeGroup name="EnumeratedItemAttributeExtension"/>
	<xs:attributeGroup name="ItemDataStarAttributeExtension"/>
	<xs:attributeGroup name="MethodDefAttributeExtension"/>
	<!--
        +===========================================================================+
        | these are purposely empty modelGroups to permit vendor extensions to the  |
        | corresponding elements via the standard XML-Schema redefine mechanism     |
        +===========================================================================+
    -->
	<xs:group name="IncludeElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="StudyEventRefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="FormRefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="ItemGroupRefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="ArchiveLayoutElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="ItemRefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="AliasElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="ExternalQuestionElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="MeasurementUnitRefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="CheckValueElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="CodeListRefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="ExternalCodeListElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="PictureElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="LocationRefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="MetaDataVersionRefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="ArchiveLayoutRefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="UserRefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="SignatureRefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="InvestigatorRefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="SiteRefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="ODMElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="StudyElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="GlobalVariablesElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="BasicDefinitionsElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="MeasurementUnitElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="MetaDataVersionPreIncludeElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="MetaDataVersionElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="SymbolElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="ProtocolElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="StudyEventDefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="FormDefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="ItemGroupDefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="ItemDefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="QuestionElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="RangeCheckElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="ErrorMessageElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="CodeListElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="CodeListItemElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="DecodeElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="AdminDataElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="UserElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="AddressElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="LocationElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="SignatureDefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="ReferenceDataElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="ClinicalDataElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="SubjectDataElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="StudyEventDataElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="FormDataElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="ItemGroupDataElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="ItemDataElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="AnnotationElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="FlagElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="SignatureElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="AuditRecordElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="AssociationElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="KeySetElementExtension">
		<xs:sequence/>
	</xs:group>
	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | Description added.                                                        |
        | ConditionDef added.                                                       |
        | FormalExpression added.                                                   |
        | EnumeratedItem added.                                                     |
        | MethodDef added.                                                          |
        | ValueListDef added.                                                       |
        | ValueListRef added.                                                       |
        | ValueListDef removed.                                                     |
        | ValueListRef removed.                                                     |
        |                                                                           |
        | NOTE: This is not an error of omission.                                   |
        |       There is PURPOSELY no ElementExtension for the ItemDataStar group   |
        +===========================================================================+
    -->
	<xs:group name="DescriptionElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="ConditionDefElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="EnumeratedItemElementExtension">
		<xs:sequence/>
	</xs:group>
	<xs:group name="MethodDefElementExtension">
		<xs:sequence/>
	</xs:group>
	<!--
        +===========================================================================+
        | complexType definitions                                                   |
        +===========================================================================+
    -->
	<xs:complexType name="ODMcomplexTypeDefinition-StudyName">
		<xs:simpleContent>
			<xs:extension base="name">
				<xs:attributeGroup ref="StudyNameAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-StudyDescription">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="StudyDescriptionAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ProtocolName">
		<xs:simpleContent>
			<xs:extension base="name">
				<xs:attributeGroup ref="ProtocolNameAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-TranslatedText">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="TranslatedTextAttributeDefinition"/>
				<xs:attributeGroup ref="TranslatedTextAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ImputationMethod">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="ImputationMethodAttributeDefinition"/>
				<xs:attributeGroup ref="ImputationMethodAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Presentation">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="PresentationAttributeDefinition"/>
				<xs:attributeGroup ref="PresentationAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-LoginName">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="LoginNameAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-DisplayName">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="DisplayNameAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-FullName">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="FullNameAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-FirstName">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="FirstNameAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-LastName">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="LastNameAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Organization">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="OrganizationAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-StreetName">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="StreetNameAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-City">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="CityAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-StateProv">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="StateProvAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Country">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="CountryAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-PostalCode">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="PostalCodeAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-OtherText">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="OtherTextAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Email">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="EmailAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Pager">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="PagerAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Fax">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="FaxAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Phone">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="PhoneAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Certificate">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="CertificateAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Meaning">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="MeaningAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-LegalReason">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="LegalReasonAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Comment">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="CommentAttributeDefinition"/>
				<xs:attributeGroup ref="CommentAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-FlagValue">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="FlagValueAttributeDefinition"/>
				<xs:attributeGroup ref="FlagValueAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-FlagType">
		<xs:simpleContent>
			<xs:extension base="name">
				<xs:attributeGroup ref="FlagTypeAttributeDefinition"/>
				<xs:attributeGroup ref="FlagTypeAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-DateTimeStamp">
		<xs:simpleContent>
			<xs:extension base="datetime">
				<xs:attributeGroup ref="DateTimeStampAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-CryptoBindingManifest">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="CryptoBindingManifestAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ReasonForChange">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="ReasonForChangeAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-SourceID">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="SourceIDAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Role">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="RoleAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Include">
		<xs:sequence>
			<xs:group ref="IncludeElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="IncludeAttributeDefinition"/>
		<xs:attributeGroup ref="IncludeAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-StudyEventRef">
		<xs:sequence>
			<xs:group ref="StudyEventRefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="StudyEventRefAttributeDefinition"/>
		<xs:attributeGroup ref="RefAttributeSharedDefinition"/>
		<xs:attributeGroup ref="StudyEventRefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-FormRef">
		<xs:sequence>
			<xs:group ref="FormRefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="FormRefAttributeDefinition"/>
		<xs:attributeGroup ref="RefAttributeSharedDefinition"/>
		<xs:attributeGroup ref="FormRefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemGroupRef">
		<xs:sequence>
			<xs:group ref="ItemGroupRefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="ItemGroupRefAttributeDefinition"/>
		<xs:attributeGroup ref="RefAttributeSharedDefinition"/>
		<xs:attributeGroup ref="ItemGroupRefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemRef">
		<xs:sequence>
			<xs:group ref="ItemRefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="ItemRefAttributeDefinition"/>
		<xs:attributeGroup ref="RefAttributeSharedDefinition"/>
		<xs:attributeGroup ref="ItemRefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ArchiveLayout">
		<xs:sequence>
			<xs:group ref="ArchiveLayoutElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="ArchiveLayoutAttributeDefinition"/>
		<xs:attributeGroup ref="ArchiveLayoutAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Alias">
		<xs:sequence>
			<xs:group ref="AliasElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="AliasAttributeDefinition"/>
		<xs:attributeGroup ref="AliasAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ExternalQuestion">
		<xs:sequence>
			<xs:group ref="ExternalQuestionElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="ExternalSharedAttributeDefinition"/>
		<xs:attributeGroup ref="ExternalQuestionAttributeDefinition"/>
		<xs:attributeGroup ref="ExternalQuestionAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-MeasurementUnitRef">
		<xs:sequence>
			<xs:group ref="MeasurementUnitRefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="MeasurementUnitRefAttributeDefinition"/>
		<xs:attributeGroup ref="MeasurementUnitRefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-CheckValue">
		<xs:simpleContent>
			<xs:extension base="value">
				<xs:attributeGroup ref="CheckValueAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-CodeListRef">
		<xs:sequence>
			<xs:group ref="CodeListRefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="CodeListRefAttributeDefinition"/>
		<xs:attributeGroup ref="CodeListRefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ExternalCodeList">
		<xs:sequence>
			<xs:group ref="ExternalCodeListElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="ExternalSharedAttributeDefinition"/>
		<xs:attributeGroup ref="ExternalCodeListAttributeDefinition"/>
		<xs:attributeGroup ref="ExternalCodeListAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Picture">
		<xs:sequence>
			<xs:group ref="PictureElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="PictureAttributeDefinition"/>
		<xs:attributeGroup ref="PictureAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-LocationRef">
		<xs:sequence>
			<xs:group ref="LocationRefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="LocationRefAttributeDefinition"/>
		<xs:attributeGroup ref="LocationRefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-MetaDataVersionRef">
		<xs:sequence>
			<xs:group ref="MetaDataVersionRefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="MetaDataVersionRefAttributeDefinition"/>
		<xs:attributeGroup ref="MetaDataVersionRefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ArchiveLayoutRef">
		<xs:sequence>
			<xs:group ref="ArchiveLayoutRefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="ArchiveLayoutRefAttributeDefinition"/>
		<xs:attributeGroup ref="ArchiveLayoutRefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-UserRef">
		<xs:sequence>
			<xs:group ref="UserRefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="UserRefAttributeDefinition"/>
		<xs:attributeGroup ref="UserRefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-SignatureRef">
		<xs:sequence>
			<xs:group ref="SignatureRefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="SignatureRefAttributeDefinition"/>
		<xs:attributeGroup ref="SignatureRefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-InvestigatorRef">
		<xs:sequence>
			<xs:group ref="InvestigatorRefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="InvestigatorRefAttributeDefinition"/>
		<xs:attributeGroup ref="InvestigatorRefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-SiteRef">
		<xs:sequence>
			<xs:group ref="SiteRefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="SiteRefAttributeDefinition"/>
		<xs:attributeGroup ref="SiteRefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Study">
		<xs:sequence>
			<xs:element ref="GlobalVariables"/>
			<xs:element ref="BasicDefinitions" minOccurs="0"/>
			<xs:element ref="MetaDataVersion" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="StudyElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="StudyAttributeDefinition"/>
		<xs:attributeGroup ref="StudyAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-GlobalVariables">
		<xs:sequence>
			<xs:element ref="StudyName"/>
			<xs:element ref="StudyDescription"/>
			<xs:element ref="ProtocolName"/>
			<xs:group ref="GlobalVariablesElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="GlobalVariablesAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-BasicDefinitions">
		<xs:sequence>
			<xs:element ref="MeasurementUnit" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="BasicDefinitionsElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="BasicDefinitionsAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-MeasurementUnit">
		<xs:sequence>
			<xs:element ref="Symbol"/>
			<xs:element ref="Alias" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="MeasurementUnitElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="MeasurementUnitAttributeDefinition"/>
		<xs:attributeGroup ref="MeasurementUnitAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Symbol">
		<xs:sequence>
			<xs:element ref="TranslatedText" maxOccurs="unbounded"/>
			<xs:group ref="SymbolElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="SymbolAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-MetaDataVersion">
		<xs:sequence>
			<xs:group ref="MetaDataVersionPreIncludeElementExtension" minOccurs="0" maxOccurs="1"/>
			<xs:element ref="Include" minOccurs="0"/>
			<xs:element ref="Protocol" minOccurs="0"/>
			<xs:element ref="StudyEventDef" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="FormDef" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemGroupDef" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDef" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="CodeList" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ImputationMethod" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="Presentation" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ConditionDef" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="MethodDef" minOccurs="0" maxOccurs="unbounded"/>
			<!-- define1-3-0 -->
			<xs:group ref="MetaDataVersionElementExtension" minOccurs="0" maxOccurs="1"/>
		</xs:sequence>
		<xs:attributeGroup ref="MetaDataVersionAttributeDefinition"/>
		<xs:attributeGroup ref="MetaDataVersionAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Protocol">
		<xs:sequence>
			<xs:element ref="Description" minOccurs="0"/>
			<xs:element ref="StudyEventRef" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="Alias" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="ProtocolElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="ProtocolAttributeExtension"/>
	</xs:complexType>
	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | Description element added to Def elements                                 |
        +===========================================================================+
    -->
	<xs:complexType name="ODMcomplexTypeDefinition-StudyEventDef">
		<xs:sequence>
			<xs:element ref="Description" minOccurs="0"/>
			<xs:element ref="FormRef" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="Alias" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="StudyEventDefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="StudyEventDefAttributeDefinition"/>
		<xs:attributeGroup ref="StudyEventDefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-FormDef">
		<xs:sequence>
			<xs:element ref="Description" minOccurs="0"/>
			<xs:element ref="ItemGroupRef" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ArchiveLayout" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="Alias" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="FormDefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="FormDefAttributeDefinition"/>
		<xs:attributeGroup ref="FormDefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemGroupDef">
		<xs:sequence>
			<xs:element ref="Description" minOccurs="0"/>
			<xs:element ref="ItemRef" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="Alias" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="ItemGroupDefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="ItemGroupDefAttributeDefinition"/>
		<xs:attributeGroup ref="ItemGroupDefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDef">
		<xs:sequence>
			<xs:element ref="Description" minOccurs="0"/>
			<xs:element ref="Question" minOccurs="0"/>
			<xs:element ref="ExternalQuestion" minOccurs="0"/>
			<xs:element ref="MeasurementUnitRef" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="RangeCheck" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="CodeListRef" minOccurs="0"/>
			<xs:element ref="Role" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="Alias" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="ItemDefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="ItemDefAttributeDefinition"/>
		<xs:attributeGroup ref="ItemDefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Question">
		<xs:sequence>
			<xs:element ref="TranslatedText" maxOccurs="unbounded"/>
			<xs:group ref="QuestionElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="QuestionAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-RangeCheck">
		<xs:sequence>
			<xs:choice>
				<xs:element ref="CheckValue" maxOccurs="unbounded"/>
				<xs:element ref="FormalExpression" maxOccurs="unbounded"/>
			</xs:choice>
			<xs:element ref="MeasurementUnitRef" minOccurs="0"/>
			<xs:element ref="ErrorMessage" minOccurs="0"/>
			<xs:group ref="RangeCheckElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="RangeCheckAttributeDefinition"/>
		<xs:attributeGroup ref="RangeCheckAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ErrorMessage">
		<xs:sequence>
			<xs:element ref="TranslatedText" maxOccurs="unbounded"/>
			<xs:group ref="ErrorMessageElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="ErrorMessageAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-CodeList">
		<xs:sequence>
			<xs:element ref="Description" minOccurs="0"/><!-- ODM 1.3.1 -->
			<xs:choice>
				<xs:element ref="CodeListItem" minOccurs="1" maxOccurs="unbounded"/>
				<xs:element ref="ExternalCodeList"/>
				<xs:element ref="EnumeratedItem" minOccurs="1" maxOccurs="unbounded"/>
			</xs:choice>
			<xs:element ref="Alias" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="CodeListElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="CodeListAttributeDefinition"/>
		<xs:attributeGroup ref="CodeListAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-CodeListItem">
		<xs:sequence>
			<xs:element ref="Decode"/>
			<xs:element ref="Alias" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="CodeListItemElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="CodeListItemAttributeDefinition"/>
		<xs:attributeGroup ref="CodeListItemAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Decode">
		<xs:sequence>
			<xs:element ref="TranslatedText" maxOccurs="unbounded"/>
			<xs:group ref="DecodeElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="DecodeAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-AdminData">
		<xs:sequence>
			<xs:element ref="User" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="Location" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="SignatureDef" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="AdminDataElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="AdminDataAttributeDefinition"/>
		<xs:attributeGroup ref="AdminDataAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-User">
		<xs:sequence>
			<xs:element ref="LoginName" minOccurs="0"/>
			<xs:element ref="DisplayName" minOccurs="0"/>
			<xs:element ref="FullName" minOccurs="0"/>
			<xs:element ref="FirstName" minOccurs="0"/>
			<xs:element ref="LastName" minOccurs="0"/>
			<xs:element ref="Organization" minOccurs="0"/>
			<xs:element ref="Address" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="Email" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="Picture" minOccurs="0"/>
			<xs:element ref="Pager" minOccurs="0"/>
			<xs:element ref="Fax" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="Phone" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="LocationRef" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="Certificate" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="UserElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="UserAttributeDefinition"/>
		<xs:attributeGroup ref="UserAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Address">
		<xs:sequence>
			<xs:element ref="StreetName" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="City" minOccurs="0"/>
			<xs:element ref="StateProv" minOccurs="0"/>
			<xs:element ref="Country" minOccurs="0"/>
			<xs:element ref="PostalCode" minOccurs="0"/>
			<xs:element ref="OtherText" minOccurs="0"/>
			<xs:group ref="AddressElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="AddressAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Location">
		<xs:sequence>
			<xs:element ref="MetaDataVersionRef" maxOccurs="unbounded"/>
			<xs:group ref="LocationElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="LocationAttributeDefinition"/>
		<xs:attributeGroup ref="LocationAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-SignatureDef">
		<xs:sequence>
			<xs:element ref="Meaning"/>
			<xs:element ref="LegalReason"/>
			<xs:group ref="SignatureDefElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="SignatureDefAttributeDefinition"/>
		<xs:attributeGroup ref="SignatureDefAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ReferenceData">
		<xs:sequence>
			<xs:element ref="ItemGroupData" minOccurs="0" maxOccurs="unbounded"/>
			<!-- ODM 1.3.1 additions: AuditRecords, Signatures, Annotations -->
			<xs:element ref="AuditRecords" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="Signatures" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="Annotations" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="ReferenceDataElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="ReferenceDataAttributeDefinition"/>
		<xs:attributeGroup ref="ReferenceDataAttributeExtension"/>
	</xs:complexType>
	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | Container definitions                                                     |
        +===========================================================================+
    -->
	<xs:complexType name="ODMcomplexTypeDefinition-ClinicalData">
		<xs:sequence>
			<xs:element ref="SubjectData" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="AuditRecords" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="Signatures" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="Annotations" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="ClinicalDataElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="ClinicalDataAttributeDefinition"/>
		<xs:attributeGroup ref="ClinicalDataAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-SubjectData">
		<xs:sequence>
			<xs:element ref="AuditRecord" minOccurs="0"/>
			<xs:element ref="Signature" minOccurs="0"/>
			<xs:element ref="InvestigatorRef" minOccurs="0"/>
			<xs:element ref="SiteRef" minOccurs="0"/>
			<xs:element ref="Annotation" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="StudyEventData" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="SubjectDataElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="SubjectDataAttributeDefinition"/>
		<xs:attributeGroup ref="SubjectDataAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-StudyEventData">
		<xs:sequence>
			<xs:element ref="AuditRecord" minOccurs="0"/>
			<xs:element ref="Signature" minOccurs="0"/>
			<xs:element ref="Annotation" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="FormData" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="StudyEventDataElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="StudyEventDataAttributeDefinition"/>
		<xs:attributeGroup ref="StudyEventDataAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-FormData">
		<xs:sequence>
			<xs:element ref="AuditRecord" minOccurs="0"/>
			<xs:element ref="Signature" minOccurs="0"/>
			<xs:element ref="ArchiveLayoutRef" minOccurs="0"/>
			<xs:element ref="Annotation" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemGroupData" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="FormDataElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="FormDataAttributeDefinition"/>
		<xs:attributeGroup ref="FormDataAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemGroupData">
		<xs:sequence>
			<xs:element ref="AuditRecord" minOccurs="0"/>
			<xs:element ref="Signature" minOccurs="0"/>
			<xs:element ref="Annotation" minOccurs="0" maxOccurs="unbounded"/>
			<xs:choice>
				<xs:group ref="ItemDataGroup" minOccurs="0" maxOccurs="unbounded"/>
				<xs:group ref="ItemDataStarGroup" minOccurs="0" maxOccurs="unbounded"/>
			</xs:choice>
			<xs:group ref="ItemGroupDataElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="ItemGroupDataAttributeDefinition"/>
		<xs:attributeGroup ref="ItemGroupDataAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemData">
		<xs:sequence>
			<xs:element ref="AuditRecord" minOccurs="0"/>
			<xs:element ref="Signature" minOccurs="0"/>
			<xs:element ref="MeasurementUnitRef" minOccurs="0"/>
			<xs:element ref="Annotation" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="ItemDataElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/>
		<xs:attributeGroup ref="ItemDataAttributeDefinition"/>
		<xs:attributeGroup ref="ItemDataAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Annotation">
		<xs:sequence>
			<xs:element ref="Comment" minOccurs="0"/>
			<xs:element ref="Flag" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="AnnotationElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="AnnotationAttributeDefinition"/>
		<xs:attributeGroup ref="AnnotationAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Flag">
		<xs:sequence>
			<xs:element ref="FlagValue"/>
			<xs:element ref="FlagType" minOccurs="0"/>
			<xs:group ref="FlagElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="FlagAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Signature">
		<xs:sequence>
			<xs:element ref="UserRef"/>
			<xs:element ref="LocationRef"/>
			<xs:element ref="SignatureRef"/>
			<xs:element ref="DateTimeStamp"/>
			<xs:element ref="CryptoBindingManifest" minOccurs="0"/>
			<xs:group ref="SignatureElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="SignatureAttributeDefinition"/>
		<xs:attributeGroup ref="SignatureAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-AuditRecord">
		<xs:sequence>
			<xs:element ref="UserRef"/>
			<xs:element ref="LocationRef"/>
			<xs:element ref="DateTimeStamp"/>
			<xs:element ref="ReasonForChange" minOccurs="0"/>
			<xs:element ref="SourceID" minOccurs="0"/>
			<xs:group ref="AuditRecordElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="AuditRecordAttributeDefinition"/>
		<xs:attributeGroup ref="AuditRecordAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Association">
		<xs:sequence>
			<xs:element ref="KeySet"/>
			<xs:element ref="KeySet"/>
			<xs:element ref="Annotation"/>
			<xs:group ref="AssociationElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="AssociationAttributeDefinition"/>
		<xs:attributeGroup ref="AssociationAttributeExtension"/>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-KeySet">
		<xs:sequence>
			<xs:group ref="KeySetElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="KeySetAttributeDefinition"/>
		<xs:attributeGroup ref="KeySetAttributeExtension"/>
	</xs:complexType>
	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | EnumeratedItem element is new to support simple enumerations in CodeList  |
        +===========================================================================+
    -->
	<xs:complexType name="ODMcomplexTypeDefinition-EnumeratedItem">
		<xs:sequence>
			<xs:element ref="Alias" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="EnumeratedItemElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="CodeListItemAttributeDefinition"/>
		<xs:attributeGroup ref="EnumeratedItemAttributeExtension"/>
		<!-- this is not a typo, EnumeratedItem uses CodeListItem attributes -->
	</xs:complexType>
	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | Description added.                                                        |
        +===========================================================================+
    -->
	<xs:complexType name="ODMcomplexTypeDefinition-Description">
		<xs:sequence>
			<xs:element ref="TranslatedText" maxOccurs="unbounded"/>
			<xs:group ref="DescriptionElementExtension" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
		<xs:attributeGroup ref="DescriptionAttributeExtension"/>
	</xs:complexType>
	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | ConditionDef added.                                                       |
        | MethodDef added.                                                          |
        | ValueListDef added.                                                       |
        | ValueListRef added.                                                       |
        | ValueListDef removed.                                                     |
        | ValueListRef removed.                                                     |
        +===========================================================================+
    -->
	<xs:complexType name="ODMcomplexTypeDefinition-FormalExpression">
		<xs:simpleContent>
			<xs:extension base="text">
				<xs:attributeGroup ref="FormalExpressionAttributeDefinition"/>
				<xs:attributeGroup ref="FormalExpressionAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:element name="FormalExpression" type="ODMcomplexTypeDefinition-FormalExpression"/>
	<xs:complexType name="ODMcomplexTypeDefinition-ConditionDef">
		<xs:sequence>
			<xs:element ref="Description"/>
			<xs:element ref="FormalExpression" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="Alias" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="ConditionDefElementExtension"/>
		</xs:sequence>
		<xs:attributeGroup ref="ConditionDefAttributeDefinition"/>
		<xs:attributeGroup ref="ConditionDefAttributeExtension"/>
	</xs:complexType>
	<xs:element name="ConditionDef" type="ODMcomplexTypeDefinition-ConditionDef">
		<xs:unique name="UC-CON-1">
			<xs:selector xpath="odm:Alias"/>
			<xs:field xpath="@Context"/>
		</xs:unique>
	</xs:element>
	<xs:complexType name="ODMcomplexTypeDefinition-MethodDef">
		<xs:sequence>
			<xs:element ref="Description"/>
			<xs:element ref="FormalExpression" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="Alias" minOccurs="0" maxOccurs="unbounded"/>
			<xs:group ref="MethodDefElementExtension"/>
		</xs:sequence>
		<xs:attributeGroup ref="MethodDefAttributeDefinition"/>
		<xs:attributeGroup ref="MethodDefAttributeExtension"/>
	</xs:complexType>
	<xs:element name="MethodDef" type="ODMcomplexTypeDefinition-MethodDef">
		<xs:unique name="UC-ME-1">
			<xs:selector xpath="odm:Alias"/>
			<xs:field xpath="@Context"/>
		</xs:unique>
	</xs:element>
	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | Extended ItemDataStar definitions                                         |
        |                                                                           |
        | It looks redundant to have a single entry in the group,                   |
        | but it looks nicer in the ItemGroupData to allow a choice of two groups.  |
        | This construct (with the ItemGroupData choice) disables mixing of the     |
        | ItemData(untyped) and ItemDataStar(typed) elements in a single ItemGroup. |
        +===========================================================================+
    -->
	<xs:group name="ItemDataStarGroup">
		<xs:sequence>
			<xs:element ref="ItemDataURI" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataAny" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataBoolean" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataString" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataInteger" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataFloat" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataDouble" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataDate" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataTime" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataDatetime" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataHexBinary" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataBase64Binary" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataHexFloat" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataBase64Float" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataPartialDate" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataPartialTime" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataPartialDatetime" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataDurationDatetime" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataIntervalDatetime" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataIncompleteDatetime" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataIncompleteDate" minOccurs="0" maxOccurs="unbounded"/>
			<xs:element ref="ItemDataIncompleteTime" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
	</xs:group>
	<xs:group name="ItemDataGroup">
		<xs:sequence>
			<xs:element ref="ItemData" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
	</xs:group>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataURI">
		<xs:simpleContent>
			<xs:extension base="xs:anyURI">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataBoolean">
		<xs:simpleContent>
			<xs:extension base="boolean">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataString">
		<xs:simpleContent>
			<xs:extension base="string">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>

	<!-- added by J.Aerts 2009-05-28 -->
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataAny">
		<xs:simpleContent>
			<xs:extension base="string">
				<xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>

	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataInteger">
		<xs:simpleContent>
			<xs:extension base="integer">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataFloat">
		<xs:simpleContent>
			<xs:extension base="float">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataDouble">
		<xs:simpleContent>
			<xs:extension base="double">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataDate">
		<xs:simpleContent>
			<xs:extension base="date">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataTime">
		<xs:simpleContent>
			<xs:extension base="time">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataDatetime">
		<xs:simpleContent>
			<xs:extension base="datetime">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataHexBinary">
		<xs:simpleContent>
			<xs:extension base="hexBinary">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataBase64Binary">
		<xs:simpleContent>
			<xs:extension base="base64Binary">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataHexFloat">
		<xs:simpleContent>
			<xs:extension base="hexFloat">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataBase64Float">
		<xs:simpleContent>
			<xs:extension base="base64Float">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataPartialDate">
		<xs:simpleContent>
			<xs:extension base="partialDate">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataPartialTime">
		<xs:simpleContent>
			<xs:extension base="partialTime">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataPartialDatetime">
		<xs:simpleContent>
			<xs:extension base="partialDatetime">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataDurationDatetime">
		<xs:simpleContent>
			<xs:extension base="durationDatetime">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataIntervalDatetime">
		<xs:simpleContent>
			<xs:extension base="intervalDatetime">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataIncompleteDatetime">
		<xs:simpleContent>
			<xs:extension base="incompleteDatetime">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataIncompleteDate">
		<xs:simpleContent>
			<xs:extension base="incompleteDate">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-ItemDataIncompleteTime">
		<xs:simpleContent>
			<xs:extension base="incompleteTime">
				<!--xs:attributeGroup ref="ItemDataAttributeSharedDefinition"/-->
				<!-- replaced by J.Aerts 2009-05-28 -->
				<xs:attributeGroup ref="ItemDataTypeAttributeSharedDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeDefinition"/>
				<xs:attributeGroup ref="ItemDataStarAttributeExtension"/>
			</xs:extension>
		</xs:simpleContent>
	</xs:complexType>
	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | Container definitions                                                     |
        +===========================================================================+
    -->
	<xs:complexType name="ODMcomplexTypeDefinition-AuditRecords">
		<xs:sequence>
			<xs:element ref="AuditRecord" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Signatures">
		<xs:sequence>
			<xs:element ref="Signature" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
	</xs:complexType>
	<xs:complexType name="ODMcomplexTypeDefinition-Annotations">
		<xs:sequence>
			<xs:element ref="Annotation" minOccurs="0" maxOccurs="unbounded"/>
		</xs:sequence>
	</xs:complexType>
	<!--
        +===========================================================================+
        | element definitions                                                       |
        +===========================================================================+
    -->
	<xs:element name="ODM">
		<xs:complexType>
			<xs:sequence>
				<xs:element ref="Study" minOccurs="0" maxOccurs="unbounded"/>
				<xs:element ref="AdminData" minOccurs="0" maxOccurs="unbounded"/>
				<xs:element ref="ReferenceData" minOccurs="0" maxOccurs="unbounded"/>
				<xs:element ref="ClinicalData" minOccurs="0" maxOccurs="unbounded"/>
				<xs:element ref="Association" minOccurs="0" maxOccurs="unbounded"/>
				<xs:element ref="ds:Signature" minOccurs="0" maxOccurs="unbounded"/>
				<xs:group ref="ODMElementExtension" minOccurs="0" maxOccurs="unbounded"/>
			</xs:sequence>
			<xs:attributeGroup ref="ODMAttributeDefinition"/>
			<xs:attributeGroup ref="ODMAttributeExtension"/>
		</xs:complexType>
		<xs:unique name="UC-O-1">
			<xs:selector xpath="odm:Study"/>
			<xs:field xpath="@OID"/>
		</xs:unique>
	</xs:element>
	<!--
        +===========================================================================+
        |                                                                           |
        +===========================================================================+
    -->
	<xs:element name="Association" type="ODMcomplexTypeDefinition-Association"/>
	<xs:element name="KeySet" type="ODMcomplexTypeDefinition-KeySet"/>
	<xs:element name="TranslatedText" type="ODMcomplexTypeDefinition-TranslatedText"/>
	<!--
        +===========================================================================+
        |                                                                           |
        +===========================================================================+
    -->
	<xs:element name="Study" type="ODMcomplexTypeDefinition-Study">
		<xs:unique name="UC-S-1">
			<xs:selector xpath="odm:BasicDefinitions/odm:MeasurementUnit"/>
			<xs:field xpath="@OID"/>
		</xs:unique>
		<xs:unique name="UC-S-2">
			<xs:selector xpath="odm:MetaDataVersion"/>
			<xs:field xpath="@OID"/>
		</xs:unique>
	</xs:element>
	<xs:element name="GlobalVariables" type="ODMcomplexTypeDefinition-GlobalVariables"/>
	<xs:element name="StudyName" type="ODMcomplexTypeDefinition-StudyName"/>
	<xs:element name="StudyDescription" type="ODMcomplexTypeDefinition-StudyDescription"/>
	<xs:element name="ProtocolName" type="ODMcomplexTypeDefinition-ProtocolName"/>
	<xs:element name="BasicDefinitions" type="ODMcomplexTypeDefinition-BasicDefinitions"/>
	<xs:element name="MeasurementUnit" type="ODMcomplexTypeDefinition-MeasurementUnit"/>
	<xs:element name="Symbol" type="ODMcomplexTypeDefinition-Symbol">
		<xs:unique name="UC-SYM-1">
			<xs:selector xpath="odm:TranslatedText"/>
			<xs:field xpath="@xml:lang"/>
		</xs:unique>
	</xs:element>
	<xs:element name="MetaDataVersion" type="ODMcomplexTypeDefinition-MetaDataVersion">
		<xs:unique name="UC-MDV-1">
			<xs:selector xpath="odm:StudyEventDef"/>
			<xs:field xpath="@OID"/>
		</xs:unique>
		<xs:unique name="UC-MDV-2">
			<xs:selector xpath="odm:FormDef"/>
			<xs:field xpath="@OID"/>
		</xs:unique>
		<xs:unique name="UC-MDV-3">
			<xs:selector xpath="odm:ItemGroupDef"/>
			<xs:field xpath="@OID"/>
		</xs:unique>
		<xs:unique name="UC-MDV-4">
			<xs:selector xpath="odm:ItemDef"/>
			<xs:field xpath="@OID"/>
		</xs:unique>
		<xs:unique name="UC-MDV-5">
			<xs:selector xpath="odm:CodeList"/>
			<xs:field xpath="@OID"/>
		</xs:unique>
		<xs:unique name="UC-MDV-6">
			<xs:selector xpath="odm:ImputationMethod"/>
			<xs:field xpath="@OID"/>
		</xs:unique>
		<xs:unique name="UC-MDV-7">
			<xs:selector xpath="odm:Presentation"/>
			<xs:field xpath="@OID"/>
		</xs:unique>
		<!-- ODM v1.3.0 -->
		<xs:unique name="UC-MDV-8">
			<xs:selector xpath="odm:ConditionDef"/>
			<xs:field xpath="@OID"/>
		</xs:unique>
		<xs:unique name="UC-MDV-10">
			<xs:selector xpath="odm:MethodDef"/>
			<xs:field xpath="@OID"/>
		</xs:unique>

    <xs:unique name="UC-MDV-OID-unique">
      <xs:selector xpath="*"/>
      <xs:field xpath="@OID"/>
    </xs:unique>



	</xs:element>
	<xs:element name="Include" type="ODMcomplexTypeDefinition-Include"/>
	<xs:element name="Protocol" type="ODMcomplexTypeDefinition-Protocol">
		<xs:unique name="UC-P-1">
			<xs:selector xpath="odm:StudyEventRef"/>
			<xs:field xpath="@StudyEventOID"/>
		</xs:unique>
		<xs:unique name="UC-P-2">
			<xs:selector xpath="odm:StudyEventRef"/>
			<xs:field xpath="@OrderNumber"/>
		</xs:unique>
		<xs:unique name="UC-P-3">
			<xs:selector xpath="odm:Alias"/>
			<xs:field xpath="@Context"/>
		</xs:unique>
	</xs:element>
	<xs:element name="StudyEventRef" type="ODMcomplexTypeDefinition-StudyEventRef"/>
	<xs:element name="StudyEventDef" type="ODMcomplexTypeDefinition-StudyEventDef">
		<xs:unique name="UC-SED-1">
			<xs:selector xpath="odm:FormRef"/>
			<xs:field xpath="@FormOID"/>
		</xs:unique>
		<xs:unique name="UC-SED-2">
			<xs:selector xpath="odm:FormRef"/>
			<xs:field xpath="@OrderNumber"/>
		</xs:unique>
		<xs:unique name="UC-SED-3">
			<xs:selector xpath="odm:Alias"/>
			<xs:field xpath="@Context"/>
		</xs:unique>
	</xs:element>
	<xs:element name="FormRef" type="ODMcomplexTypeDefinition-FormRef"/>
	<xs:element name="FormDef" type="ODMcomplexTypeDefinition-FormDef">
		<xs:unique name="UC-FD-1">
			<xs:selector xpath="odm:ItemGroupRef"/>
			<xs:field xpath="@ItemGroupOID"/>
		</xs:unique>
		<xs:unique name="UC-FD-2">
			<xs:selector xpath="odm:ItemGroupRef"/>
			<xs:field xpath="@OrderNumber"/>
		</xs:unique>
		<xs:unique name="UC-FD-3">
			<xs:selector xpath="odm:ArchiveLayout"/>
			<xs:field xpath="@OID"/>
		</xs:unique>
		<xs:unique name="UC-FD-4">
			<xs:selector xpath="odm:Alias"/>
			<xs:field xpath="@Context"/>
		</xs:unique>
	</xs:element>
	<xs:element name="ItemGroupRef" type="ODMcomplexTypeDefinition-ItemGroupRef"/>
	<xs:element name="ArchiveLayout" type="ODMcomplexTypeDefinition-ArchiveLayout"/>
	<xs:element name="ItemGroupDef" type="ODMcomplexTypeDefinition-ItemGroupDef">
		<xs:unique name="UC-IGD-1">
			<xs:selector xpath="odm:ItemRef"/>
			<xs:field xpath="@ItemOID"/>
		</xs:unique>
		<xs:unique name="UC-IGD-2">
			<xs:selector xpath="odm:ItemRef"/>
			<xs:field xpath="@OrderNumber"/>
		</xs:unique>
		<xs:unique name="UC-IGD-3">
			<xs:selector xpath="odm:ItemRef"/>
			<xs:field xpath="@KeySequence"/>
		</xs:unique>
		<xs:unique name="UC-IGD-4">
			<xs:selector xpath="odm:Alias"/>
			<xs:field xpath="@Context"/>
		</xs:unique>
	</xs:element>
	<xs:element name="ItemRef" type="ODMcomplexTypeDefinition-ItemRef"/>
	<xs:element name="ItemDef" type="ODMcomplexTypeDefinition-ItemDef">
		<xs:unique name="UC-ID-1">
			<xs:selector xpath="odm:Alias"/>
			<xs:field xpath="@Context"/>
		</xs:unique>
	</xs:element>
	<xs:element name="Question" type="ODMcomplexTypeDefinition-Question">
		<xs:unique name="UC-QU-1">
			<xs:selector xpath="odm:TranslatedText"/>
			<xs:field xpath="@xml:lang"/>
		</xs:unique>
	</xs:element>
	<xs:element name="ExternalQuestion" type="ODMcomplexTypeDefinition-ExternalQuestion"/>
	<xs:element name="MeasurementUnitRef" type="ODMcomplexTypeDefinition-MeasurementUnitRef"/>
	<xs:element name="RangeCheck" type="ODMcomplexTypeDefinition-RangeCheck"/>
	<xs:element name="CheckValue" type="ODMcomplexTypeDefinition-CheckValue"/>
	<xs:element name="ErrorMessage" type="ODMcomplexTypeDefinition-ErrorMessage">
		<xs:unique name="UC-ERM-1">
			<xs:selector xpath="odm:TranslatedText"/>
			<xs:field xpath="@xml:lang"/>
		</xs:unique>
	</xs:element>
	<xs:element name="CodeListRef" type="ODMcomplexTypeDefinition-CodeListRef"/>
	<xs:element name="Role" type="ODMcomplexTypeDefinition-Role"/>
	<xs:element name="Alias" type="ODMcomplexTypeDefinition-Alias"/>
	<xs:element name="CodeList" type="ODMcomplexTypeDefinition-CodeList">
		<xs:unique name="UC-CL-1">
			<xs:selector xpath="odm:CodeListItem"/>
			<xs:field xpath="@CodedValue"/>
		</xs:unique>
		<xs:unique name="UC-CL-2">
			<xs:selector xpath="odm:CodeListItem"/>
			<xs:field xpath="@OrderNumber"/>
		</xs:unique>
		<xs:unique name="UC-CL-3">
			<xs:selector xpath="odm:EnumeratedItem"/>
			<xs:field xpath="@CodedValue"/>
		</xs:unique>
		<xs:unique name="UC-CL-4">
			<xs:selector xpath="odm:EnumeratedItem"/>
			<xs:field xpath="@OrderNumber"/>
		</xs:unique>
		<xs:unique name="UC-CL-5">
			<xs:selector xpath="odm:Alias"/>
			<xs:field xpath="@Context"/>
		</xs:unique>
	</xs:element>
	<xs:element name="CodeListItem" type="ODMcomplexTypeDefinition-CodeListItem">
		<xs:unique name="UC-CLI-1">
			<xs:selector xpath="odm:Alias"/>
			<xs:field xpath="@Context"/>
		</xs:unique>
	</xs:element>
	<xs:element name="Decode" type="ODMcomplexTypeDefinition-Decode">
		<xs:unique name="UC-DEC-1">
			<xs:selector xpath="odm:TranslatedText"/>
			<xs:field xpath="@xml:lang"/>
		</xs:unique>
	</xs:element>
	<xs:element name="ExternalCodeList" type="ODMcomplexTypeDefinition-ExternalCodeList"/>
	<xs:element name="ImputationMethod" type="ODMcomplexTypeDefinition-ImputationMethod"/>
	<xs:element name="Presentation" type="ODMcomplexTypeDefinition-Presentation"/>
	<!--
        +===========================================================================+
        |                                                                           |
        +===========================================================================+
    -->
	<xs:element name="AdminData" type="ODMcomplexTypeDefinition-AdminData">
		<xs:unique name="UC-AD-1">
			<xs:selector xpath="odm:User"/>
			<xs:field xpath="@OID"/>
		</xs:unique>
		<xs:unique name="UC-AD-2">
			<xs:selector xpath="odm:Location"/>
			<xs:field xpath="@OID"/>
		</xs:unique>
		<xs:unique name="UC-AD-3">
			<xs:selector xpath="odm:SignatureDef"/>
			<xs:field xpath="@OID"/>
		</xs:unique>
	</xs:element>
	<xs:element name="User" type="ODMcomplexTypeDefinition-User"/>
	<xs:element name="LoginName" type="ODMcomplexTypeDefinition-LoginName"/>
	<xs:element name="DisplayName" type="ODMcomplexTypeDefinition-DisplayName"/>
	<xs:element name="FullName" type="ODMcomplexTypeDefinition-FullName"/>
	<xs:element name="FirstName" type="ODMcomplexTypeDefinition-FirstName"/>
	<xs:element name="LastName" type="ODMcomplexTypeDefinition-LastName"/>
	<xs:element name="Organization" type="ODMcomplexTypeDefinition-Organization"/>
	<xs:element name="Address" type="ODMcomplexTypeDefinition-Address"/>
	<xs:element name="StreetName" type="ODMcomplexTypeDefinition-StreetName"/>
	<xs:element name="City" type="ODMcomplexTypeDefinition-City"/>
	<xs:element name="StateProv" type="ODMcomplexTypeDefinition-StateProv"/>
	<xs:element name="Country" type="ODMcomplexTypeDefinition-Country"/>
	<xs:element name="PostalCode" type="ODMcomplexTypeDefinition-PostalCode"/>
	<xs:element name="OtherText" type="ODMcomplexTypeDefinition-OtherText"/>
	<xs:element name="Email" type="ODMcomplexTypeDefinition-Email"/>
	<xs:element name="Picture" type="ODMcomplexTypeDefinition-Picture"/>
	<xs:element name="Pager" type="ODMcomplexTypeDefinition-Pager"/>
	<xs:element name="Fax" type="ODMcomplexTypeDefinition-Fax"/>
	<xs:element name="Phone" type="ODMcomplexTypeDefinition-Phone"/>
	<xs:element name="LocationRef" type="ODMcomplexTypeDefinition-LocationRef"/>
	<xs:element name="Certificate" type="ODMcomplexTypeDefinition-Certificate"/>
	<xs:element name="Location" type="ODMcomplexTypeDefinition-Location"/>
	<xs:element name="MetaDataVersionRef" type="ODMcomplexTypeDefinition-MetaDataVersionRef"/>
	<xs:element name="SignatureDef" type="ODMcomplexTypeDefinition-SignatureDef"/>
	<xs:element name="Meaning" type="ODMcomplexTypeDefinition-Meaning"/>
	<xs:element name="LegalReason" type="ODMcomplexTypeDefinition-LegalReason"/>
	<!--
        +===========================================================================+
        |                                                                           |
        +===========================================================================+
    -->
	<xs:element name="ReferenceData" type="ODMcomplexTypeDefinition-ReferenceData"/>
	<!--
        +===========================================================================+
        |                                                                           |
        +===========================================================================+
    -->
	<xs:element name="ClinicalData" type="ODMcomplexTypeDefinition-ClinicalData"/>
	<xs:element name="SubjectData" type="ODMcomplexTypeDefinition-SubjectData"/>
	<xs:element name="AuditRecord" type="ODMcomplexTypeDefinition-AuditRecord"/>
	<xs:element name="UserRef" type="ODMcomplexTypeDefinition-UserRef"/>
	<xs:element name="DateTimeStamp" type="ODMcomplexTypeDefinition-DateTimeStamp"/>
	<xs:element name="ReasonForChange" type="ODMcomplexTypeDefinition-ReasonForChange"/>
	<xs:element name="SourceID" type="ODMcomplexTypeDefinition-SourceID"/>
	<xs:element name="Signature" type="ODMcomplexTypeDefinition-Signature"/>
	<xs:element name="SignatureRef" type="ODMcomplexTypeDefinition-SignatureRef"/>
	<xs:element name="CryptoBindingManifest" type="ODMcomplexTypeDefinition-CryptoBindingManifest"/>
	<xs:element name="InvestigatorRef" type="ODMcomplexTypeDefinition-InvestigatorRef"/>
	<xs:element name="SiteRef" type="ODMcomplexTypeDefinition-SiteRef"/>
	<xs:element name="Annotation" type="ODMcomplexTypeDefinition-Annotation"/>
	<xs:element name="Comment" type="ODMcomplexTypeDefinition-Comment"/>
	<xs:element name="Flag" type="ODMcomplexTypeDefinition-Flag"/>
	<xs:element name="FlagValue" type="ODMcomplexTypeDefinition-FlagValue"/>
	<xs:element name="FlagType" type="ODMcomplexTypeDefinition-FlagType"/>
	<xs:element name="StudyEventData" type="ODMcomplexTypeDefinition-StudyEventData"/>
	<xs:element name="FormData" type="ODMcomplexTypeDefinition-FormData"/>
	<xs:element name="ArchiveLayoutRef" type="ODMcomplexTypeDefinition-ArchiveLayoutRef"/>
	<xs:element name="ItemGroupData" type="ODMcomplexTypeDefinition-ItemGroupData"/>
	<xs:element name="ItemData" type="ODMcomplexTypeDefinition-ItemData"/>
	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | Extended ItemDataStar definitions                                         |
        +===========================================================================+

        NOTE: the ItemDataText element definition has been purposely omitted
              to push the "text" into deprecation as a non-schema datatype.
              ItemDataAny is a purposeful escape mechanism for applications aware of content
              e.g., SAS special MISSING values, and Oracle Clinical putting "trace" in a numeric field
              neither case will pass the schema validation for ItemDataFloat and should use ItemDataAny
    -->
	<xs:element name="ItemDataURI" type="ODMcomplexTypeDefinition-ItemDataURI"/>
	<!--xs:element name="ItemDataAny" type="ODMcomplexTypeDefinition-ItemDataString"/-->
	<!-- changed by J.Aerts 2009-05-28 -->
	<xs:element name="ItemDataAny" type="ODMcomplexTypeDefinition-ItemDataAny"/>
	<xs:element name="ItemDataBoolean" type="ODMcomplexTypeDefinition-ItemDataBoolean"/>
	<xs:element name="ItemDataString" type="ODMcomplexTypeDefinition-ItemDataString"/>
	<xs:element name="ItemDataInteger" type="ODMcomplexTypeDefinition-ItemDataInteger"/>
	<xs:element name="ItemDataFloat" type="ODMcomplexTypeDefinition-ItemDataFloat"/>
	<xs:element name="ItemDataDouble" type="ODMcomplexTypeDefinition-ItemDataDouble"/>
	<xs:element name="ItemDataDate" type="ODMcomplexTypeDefinition-ItemDataDate"/>
	<xs:element name="ItemDataTime" type="ODMcomplexTypeDefinition-ItemDataTime"/>
	<xs:element name="ItemDataDatetime" type="ODMcomplexTypeDefinition-ItemDataDatetime"/>
	<xs:element name="ItemDataHexBinary" type="ODMcomplexTypeDefinition-ItemDataHexBinary"/>
	<xs:element name="ItemDataBase64Binary" type="ODMcomplexTypeDefinition-ItemDataBase64Binary"/>
	<xs:element name="ItemDataHexFloat" type="ODMcomplexTypeDefinition-ItemDataHexFloat"/>
	<xs:element name="ItemDataBase64Float" type="ODMcomplexTypeDefinition-ItemDataBase64Float"/>
	<xs:element name="ItemDataPartialDate" type="ODMcomplexTypeDefinition-ItemDataPartialDate"/>
	<xs:element name="ItemDataPartialTime" type="ODMcomplexTypeDefinition-ItemDataPartialTime"/>
	<xs:element name="ItemDataPartialDatetime" type="ODMcomplexTypeDefinition-ItemDataPartialDatetime"/>
	<xs:element name="ItemDataDurationDatetime" type="ODMcomplexTypeDefinition-ItemDataDurationDatetime"/>
	<xs:element name="ItemDataIntervalDatetime" type="ODMcomplexTypeDefinition-ItemDataIntervalDatetime"/>
	<xs:element name="ItemDataIncompleteDatetime" type="ODMcomplexTypeDefinition-ItemDataIncompleteDatetime"/>
	<xs:element name="ItemDataIncompleteDate" type="ODMcomplexTypeDefinition-ItemDataIncompleteDate"/>
	<xs:element name="ItemDataIncompleteTime" type="ODMcomplexTypeDefinition-ItemDataIncompleteTime"/>

	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | EnumeratedItem added                                                      |
        +===========================================================================+
    -->
	<xs:element name="EnumeratedItem" type="ODMcomplexTypeDefinition-EnumeratedItem">
		<xs:unique name="UC-ENU-1">
			<xs:selector xpath="odm:Alias"/>
			<xs:field xpath="@Context"/>
		</xs:unique>
	</xs:element>
	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | Container definitions                                                     |
        +===========================================================================+
    -->
	<xs:element name="AuditRecords" type="ODMcomplexTypeDefinition-AuditRecords"/>
	<xs:element name="Signatures" type="ODMcomplexTypeDefinition-Signatures"/>
	<xs:element name="Annotations" type="ODMcomplexTypeDefinition-Annotations"/>
	<!--
        +===========================================================================+
        | ODM (v1.3.0)                                                              |
        | Description definition                                                    |
        +===========================================================================+
    -->
	<xs:element name="Description" type="ODMcomplexTypeDefinition-Description">
		<xs:unique name="UC-DES-1">
			<xs:selector xpath="odm:TranslatedText"/>
			<xs:field xpath="@xml:lang"/>
		</xs:unique>
	</xs:element>
</xs:schema>