Concur, yes there are always screening criteria, of one sort or another, my comment was too broad in a general, non legal, sense. I was referring to them not screening for B2GP1 levels. Had they have run a trial with pre knowledge of the impact of B2GP1 levels they may or may not have had different results.
BTW have you ever used cluster analysis or a similar technique to capture hidden relationships?
AVII77-No idea why MRK did what they did. I do recall having a conversation with the Chairman/CEO of AMLN where the issue was not Symlin efficacy but rather was it worth their while to pursue another expensive trial to gain FDA approval for insulin titration requirements. He obviously went ahead because as he said to me, "It is in the patient's best interests" or words to that effect. The case could also have been made that the payoff was small and to halt the effort.