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Inclusion/Exclusion Criteria Not Met (IE) is a findings Findings domain used for those criteria that cause the subject to be in violation of the inclusion/exclusion criteria. The IE domain is used to collect failures on or exceptions to the inclusion/exclusion criteria during the screening process before a subject is enrolled in a study. It is not intended to collect protocol deviations or violations that occur after enrollment; protocol deviations are collected using the DV domain.

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