Are you guys assuming that the extra patients are just to make up for the loss of power created by the known protocol violations, or are you also assuming that based on some rule patients have been removed from the ITT population? Also, were the peek points (and final N) adjusted?
I haven't listened to any of the recent conference calls, but hirogen (who speaks statistics) reported the following (see link). It roughly lines up with the way they changed the total enrollment - and it is statistically reasonable.
As for the peek numbers - I believe that the numbers remain the same but only from the mITT population.
All that said, when trying to get statistics info from CEOs I've seen only 3 CEOs that I would have trusted to actually understand it well enough to not mislead. So there is always risk.