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Sunday, 09/14/2014 5:00:19 PM

Sunday, September 14, 2014 5:00:19 PM

Post# of 430692
R-IT SPA predefined one interim analysis at 60%, however it is not forbidden to make additional analysis without SPA modification, since analysis not equal with unblinding the study, The sponsor does not known the result, just the DMC and the statisticians.

For 90% power R-IT has to show at least x% eff. at y %(number) of events:

15% / 100% (1,612) / acc. to SPA
19% / 60% (967) / acc. to SPA
20% / 55% (887)
20.75% / 50% (806)
22% / 45% (725)
23% / 40% (645)
24.25% / 35% (564)
26% / 30% (484)

As of today R-IT could meet with the 26% / 30% (484) only.
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