The InclusionExclusionCriteria element can contain two 2 lists of Criterion elements, represented by the two 2 elements InclusionCriteria and ExclusionCriteria. Together, these criteria determine the eligibility of a subject for the study. The actual condition to be evaluated is contained in an ODM ConditionDef, which is referenced by each Criterion‟s ConditionOID attribute.
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| InclusionExclusionCriteria Example |
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| InclusionExclusionCriteria Example |
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