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Re: dewophile post# 3542

Thursday, 02/28/2008 9:42:23 PM

Thursday, February 28, 2008 9:42:23 PM

Post# of 8473
>do I now think this placebo arm poses an inordinate risk? I'll leave that to the statisticians on this board, except to point out there is usually not much of a placebo effect on a hard endpoint like this - in fact, much like an antiviral trial, expectations are that the placebo arms will continue to trend negatively - magnifying any positive efficacy signal in the tx arm<

The lack of a placebo effect in this indication has already been taken into account in the statistical model that generated the 85% power figure. It is not a distinct, bullish factor, as you suggest.

As previously noted, the 85% power figure is not especially illuminating without knowing how dropouts and protocol violations were modeled. Regards, Dew

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