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Trial Sequential Analysis for number of participants with reinterventions at 5 years is calculated based on control event rate of 52%; a RRR of 20%; a type I error of 2.5%, a type II error of 10%; and diversity of 56%. The DARIS of 2594 was not achieved and Z‐curve did not cross the alpha‐spending boundary (RR 0.13, alpha‐spending boundary‐adjusted CI 0.01 to 2.80).
