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DewDiligence

01/06/15 8:57 AM

#185511 RE: ghmm #185501

OCRX—What do you dislike about the phase-2b design?

It may be difficult to show a statisg reduction in time to HE improvement (the primary endpoint) because the SoC laxative, which will be given in both trial arms, works fairly well, despite its being despised by patients and hospital staff for obvious reasons. The trial is powered at 80% to show a 23% reduction in time to HE improvement.