I may have been somewhat wrong in my previous statement about the 175 event sample size analysis. Here is what I noted from the March 2016 update:

Mike Sweeney did a great job covering this. Even if you didn't like DM's presentation, you should listen to Sweeney's presentation. He comprehensively covered the logistics of this huge endeavor. Half of total study sites should be active by end of March 2016. Enrollment is slow now, but as most study sites become active, enrollment will increase exponentially. 125 MACE event target by mid 2017, at which time futility analysis will occur; 250 MACE event target by mid 2018. There will be a sample size estimate analysis at 175 MACE events at which time the trial could be adjusted to continue until 375 MACE events. Austrailia had been added as a study site and will be used if additional patients are necessary. Taiwan will be included and should launch soon. US still possible pending FDA required animal work.