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Wednesday, 04/30/2014 8:40:48 AM

Wednesday, April 30, 2014 8:40:48 AM

Post# of 8439
"In this Phase II study, women receiving oral Trimesta plus injectable Copaxone® demonstrated a statistically significant 47 percent decrease in annualized MS relapse rate in the first 12 months of treatment compared to women receiving placebo plus Copaxone (p=0.0306), and a 32 percent decrease in annualized relapse rate at 24 months (p=0.1527). Patients in both treatment arms demonstrated improved scores on the Expanded Disability Status Scale (EDSS) compared to baseline. Cognitive function test scores, as measured by the Paced Auditory Serial Addition Test (PASAT), in women receiving Trimesta plus Copaxone also improved compared to baseline and were significantly different from placebo plus Copaxone at 12 months."

I was looking at that as well because typically the p-value has to be under 0.1 to be stat significant . so the first 12 months was stat significant p = .0306 but the p value at 24 months was p = .1527 which is greater than 0.1 for stat significance. In essence the p value failed to be below stat significant threshold which means the primary endpoint of the study failed.
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