I can only offer an answer to number 1.

The question of sample size is always a balancing act...and a gamble. Everyone wants a trial that has a high likelihood of giving a certain answer, but that can mean a one that is too big to be feasible (there is a lot of competition for trial participants for CVD drugs) and/or too expensive. The sample size of BoM was always optimistic in my view. I think lack of funding and feasibility issues were probably both factors. They could be fixed by a BP partnership, and adjustments to the inclusion and exclusion criteria with the help of the FDA.