OK, we have a placebo arm. But am I right in thinking the trial should move pretty quickly as patients should be lining up at the door to be part of the trial based on P2 results and no safety issues?
Will try and dig up average time between the finish of a P2 and the start of a P3 if fast tracked.
My concern with the B-OM trial is the number of trial participants. The lower the N-sample number the riskier the results to be accurate in what they hope to measure.
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