Page History

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The sponsor collected the Race and Ethnicity values listed in the FDA guidance on collecting race and ethnicity data. However, the sponsor allowed subject to record multiple answers to the Race question. When multiple races were self reported, the sponsor recorded "MULTIPLE" as the Race and used Supplemental Qualifiers to record the self-reported race, . The sponsor also collected more details associated with those subject that self-reported Race as ASIAN, or selected Race as BLACK OR AFRICAN AMERICAN. These collected details  were reported as Supplemental Qualifiers.  

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