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Trial Sequential Analysis for all‐cause mortality at 5 years calculated based on control event rate of 55%; a RRR of 20%; a type I error of 2.5%, a type II error of 10%; and diversity of 70%. The DARIS of 3400 was not achieved and Z‐curve did not cross the alpha spending boundary, (RR 0.61, alpha spending boundary adjusted CI 0.13 to 2.86).
