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Alias Born 10/30/2005

Re: None

Sunday, 11/25/2007 1:00:01 PM

Sunday, November 25, 2007 1:00:01 PM

Post# of 12660
From an ethical point of view, at what point (if at all) would a statistician advising a DSMB in 9902b and Vital-1 decide that the trial should be unblinded and reported to the sponsor since it would be a virtual certainty that the end trial alpha adjusted p value would b bettered? Is there a precedent for this?

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