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Has evidence been adequately evaluated in terms of whether clinically important sex/gender and racial/ethnic differences in the intervention effect are to be expected?

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Has evidence been adequately evaluated in terms of whether clinically important sex/gender and racial/ethnic differences in the intervention effect are to be expected?

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• Has the planned trial been designed to take into account these clinically important sex/gender and/or racial/ethnic differences so that appropriate numbers from each group are planned to be included in the study, including the need to: (a) detect significant differences when available evidence strongly indicates significant sex/gender and/or racial/ethnic differences; or, (b) permit valid analyses when there is no clear-cut scientific evidence to rule out significant differences between sex/gender and/or racial/ethnic groups in intervention effect? E3. Will the criteria for addressing the inclusion of women and minorities in the applicant’s plan affect the assigned score for scientific and technical merit? YES. The Scientific Review Groups (SRGs) will treat the evaluation of the representation of women and minorities and their subpopulations in a manner consistent with the evaluation of all other factors that contribute to the overall priority score. Below are the codes assigned to e

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