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genisi

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genisi

Re: DewDiligence post# 71284

Monday, 01/12/2009 9:57:55 AM

Monday, January 12, 2009 9:57:55 AM

Post# of 257253

patients will be enrolled as two cohorts, with randomization of the second larger cohort being initiated based on 12 week safety data of the first cohort.



I guess that this kind of conditioned enrollment reflects the FDA's worry over safety and will slow the trial.
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