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Re: RRdog post# 75932

Thursday, 03/01/2012 12:34:29 PM

Thursday, March 01, 2012 12:34:29 PM

Post# of 347009
Since this can not be a randomized, placeboed trial which is the gold standard

It can't even be a blinded trial, it seems to me, since if a patient gets a hole bored in his skull, he'll be getting Cotara. It is a dilemma for the FDA, I would imagine whether they'll be able to approve a drug based on an open-label trial.
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