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Re: akasidney86 post# 28781

Thursday, 01/29/2015 2:25:34 PM

Thursday, January 29, 2015 2:25:34 PM

Post# of 720879
Sid, the 348 is comparable to the 240 main cohort of the previous design, not the 312, which included the psPD cohort of 72. This was clear on the German site all along, which always showed 240 enrollees until the change to 348, and confirmed from the various leaks of the original trial design doc. The 72 were never to be part of the trial results and stat calcs used for approval.

NW has been unnecessarily (IMO) opaque on this detail, but it is the case nevertheless.

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