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Simulation results of superiority trials where the primary outcome was mortality assuming 80% power to find a treatment-associated mortality reduction of 3 to 15%. n = 33 randomized clinical trials as noted in Figure 1 with the exception of the Prospective Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis and Septic Shock (PROWESS-SHOCK) trial due to the use of an adaptive control arm.
