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Purpose Unveil the properties of a two-stage design (TSD) for bioequivalence (BE) studies. Methods A TSD with an upper sample size limit (UL) is described and analyzed under different conditions using Monte Carlo simulations. TSD was split into three branches: A, B1, and B2. The first stage included branches A and B1, while stage two referred to branch B2. Sample size re-estimation at B2 relies...
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