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Re: rafunrafun post# 109120

Sunday, 07/02/2017 11:40:04 AM

Sunday, July 02, 2017 11:40:04 AM

Post# of 430175
Raf - Cannot recall dates, but believe it was in a CC transcript, and was discussed on this board at the time. It was very clear that all key SEs did NOT need to be significant, just "robust." To me, robust means consistent with each other and the overall PE result. If you look at the JELIS SEs compared to the PE, the % risk reduction was fairly similar across the board for the components, but not significant due to smaller numbers of events. Since R-It does not include the soft angina definition used in JELIS, a much higher proportion of events in R-It will have to be the hard MACE outcomes that comprise the PE. No idea whether the numbers of each will be high enough to reach significance, but I certainly would expect some to be significant if the RRR is in the 20%+ range.
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