[yummyfajitas]

I also know better than to change the criteria after the study starts. A study was proposed. None of the critics of the study had anything negative to say about it until after the results were in - that's probably because they thought it would vindicate the 45,000 number.

[Fomite]

Actually looking at the results isn't "changing the criteria", it's looking at the results in a more nuanced way than null hypothesis testing.

I would have said that looking at chronic health outcomes after just a few years was probably a losing proposition, and asked to see some power calculations, or a longer term analysis plan.

I've done so for other studies. Was actually grousing about one in a meeting...two weeks ago?