RE:futility assessmentThe trial is currently designed to proceed until 250 adjucated MACE events have occured. Only first event per patient counts; subsequent events in same patient do not count toward 250. At 125 events, the futility analysis occurs. The time to accumulate the first 125 events will definitely be longer than the time to accumulate the next 125 events because more study sites will be activated as you pointed out. In the latest NR, Resverlogix stated that over 1200 patients have been enrolled out of the 2400 goal. Resverlogix recently (sometime in the past 3 months) stated that they expect to have 2400 fully enrolled by end of 2017. Also, in a past presentation Resverlogix stated that at 175 events there will be a sample size estimate analysis. The results of which may increase the patient enrollment and target MACE events to 3600 and 375, respectively (I'm pretty that Michael Sweeney made this statement at a 2016 presentation, but I am going off memory and can't find my notes right now).
BDAZ