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Hypothetical scenario. Numbers represent the values of a positive outcome. The noninferiority margin is determined by halving the control effect, based on a historical placebo-controlled trial. The upper limit of the 95% confidence interval (CI) for the treatment difference by the new treatment compared to the control is less than the margin to conclude noninferiority, although there is an implication of incomparability. Δ: margin for equivalence/noninferiority.
