Then why wasn't the trial designed that way in the first place? Why did originally design it with 1730 patients and a different endpoint? I can see the cost savings in reducing it to 600 patients, but if the reason for that it that it was unlikely the (original) primary endpoint was going to be met, then surely that's just a failure? You can't cost save yourself rich if have no product to sell!!
Ann: Phase 3 Heart Failure Trial Size Substantially Reduced, page-14
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