KK - What worries me is that BoM could have been designed better:

1. It was underpowered. The % reduction in events upon which the power calculations were based was always optimistic despite the imo. The history of CVD trials is that the placebo group usually has done better than expected. 

2. Without stratified randomisation based on GFR, there would always have been a question mark over the CKD subgroup analyses whatever the outcome. If you're seriously interested in a subgroup, you have to stratify patients before you randomise them to treatment or placebo.

3. Including stroke in the composite endpoint never made sense imo. CHF would have made sense.

4. The trial could have been designed so that an extension would have been feasible in the event of borderline results.

These were all weaknesses, probably based on insufficient funding. Will funding be sufficient for BoM2 without a partner? It makes me worry.