They designed the trial for 18 months median dosing, and ended up with 27 months.  They said the power went from 80% to 85% because of this.  So still miss the primary endpoint because of "rigorous academic requirements" is a surprise to me.  

I do remember DM telling me that the MACE events happened far more slowly than they expected.  Could it be that once someone gets a MACE event, the next MACE event comes a lot slower than what earlier trials had suggested? 

And how many such trials have happened in the past?  MACE rate for placebo from those previous trials?