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Re: DewDiligence post# 41486

Friday, 02/02/2007 9:29:15 AM

Friday, February 02, 2007 9:29:15 AM

Post# of 257257
re statistical analysis
I didn't catch that as such a blunder, but then again I am a neophyte and statistical idiot. to me it was clear a patient is considered a dropout if they stop either the placebo or vx even if they continue soc. it was also clear in the final analysis all dropouts are (appropriately) analyzed on an ITT basis, so for example a patient takes 4 weeks of triple, gets a rash, drops the vx/placebo, continues rib-peg to svr, that is considered a positive efficacy endpoint for the respective arm even if they received minmal duration of vx (or placebo)..seems pretty basic to me and that is what I thought werber was asking
if anything I would have just liked clarification and confirmation that ITT is how they were handling the interim data releases..so the 88% pcr neg at 12 weeks back in dec should include patients who are randomized to vx regardless of duration of vx use, but frankly i can't imagine they are handling it any other way unless they explicitly specify otherwise
please correct me if I am wrong

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