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<ItemGroupDef OID="INCLUSION" Name="Inclusion Criteria" Repeating="No">
		   ...
		   <ItemRef ItemOID="IDef.GENDER" Mandatory="Yes"/>
		   <ItemRef ItemOID="IDef.ISPREG" Mandatory="Yes" CollectionExceptionConditionOID="CECID.ISMALE"/>
</ItemGroupDef>

              <ConditionDef OID="CECID.ISMALE" Name="Subject's gender is Male">
          	      <Description>
                      	<TranslatedText xml:lang="en" type="text/plain">Do not collect data for Male subjects</TranslatedText>
               	 </Description>
     <FormalExpression
                <MethodSignature>
                    <Parameter Name="Gender" DataType="text"></Parameter>
                    <ReturnValue Name="IsMale" DataType="boolean"></ReturnValue>
                </MethodSignature>
                <FormalExpression Context="PL/SQL">
		                    <Code>INCLUSION.IDef.GENDER = 'Male'</Code>
	                </FormalExpression>
            </ConditionDef>