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The Inclusion/Exclusion Criteria (IE) domain is a findings Findings domain that contains criteria that cause the subject to be in violation of the protocol inclusion/exclusion criteria. The trial design domain TI (not shown here; see Section 3.3.1, Trial Design) is used to describe the criteria. One record for each of the inclusion and exclusion criteria for the trial are included in TI. The TI domain is not subject oriented.       

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