We calculated that 844 primary outcome events would provide the trial with a power of 90% to detect a hazard ratio of 0.80 for the comparison between dapagliflozin and placebo, using a two sided alpha level of 0.05. With an expected annual event incidence of 11% in the placebo group,we estimated that the enrollment of approximately 4500 patients would provide the required number of primary events, based on an anticipated recruitment period of 18 months and an average follow-up period of approximately 24 months. We used a closed testing procedure, with prespecified hierarchical testing of the primary and secondary outcomes. The type I error was controlled at a two-sided alpha level of 0.0499 for multiple comparisons across primary and secondary outcomes, with one interim efficacy analysis taken into account