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Re: Anshu2 post# 444277

Wednesday, 12/27/2023 3:19:15 AM

Wednesday, December 27, 2023 3:19:15 AM

Post# of 462174
Ummm. The argument isn't if one of the two primary endpoints achieves p<0.025 but one endpoint passes with p<0.025 and the secondary endpoint also achieves an endpoint of p<0.025.

A crucial detail in this discussion.

The trial is successful in meeting the co-primary endpoints if the significance of each endpoint is P < 0.05, or if the significance of only one co-primary endpoint is P < 0.025. If only one primary endpoint is significant at an a level of 0.025, then the secondary endpoint will be evaluated at the same level of 0.025. The trial was successful, since the differences in the least-squares mean (LSM) change from baseline to 48 weeks between the blarcamesine and placebo groups were -1.783 [95% CI, -3.314 to -0.251]; (P = 0.0226) for ADAS-Cog13, and -0.456 [95% CI, -0.831 to -0.080]; (P = 0.0175) for CDR-SB in patients with early Alzheimer’s disease.


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