Abstract:Formal proof of efficacy of a drug requires that in a prospective experiment, superiority over placebo, or either superiority or at least non‐inferiority to an established standard, is demonstrated. Traditionally one primary endpoint is specified, but various diseases exist where treatment success needs to be based on the assessment of two primary endpoints. With co‐primary endpoints, both need to be “significant” as a prerequisite to claim study success. Here, no adjustment of the study‐wise type‐1‐error is n… Show more
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