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  • A textual or media-based representation of the sample size consideration, including details needed to replicate sample size calculations. EXAMPLE(S): \'Approximately 100 patients will be randomized to each of the 3 treatment groups. Previous experience with the oral formulation of xanomeline suggests that this sample size has 90% power to detect a 3.0 mean treatment difference in ADAS-Cog (p<.05, two-sided), based on a standard deviation of 6.5. Furthermore, this sample size has 80% power to detect a 0.36 mean treatment difference in CIBIC+ (p<.05, two-sided), based on a standard deviation of 0.9.\' OTHER NAME(S): NOTE(S): Details included could be: difference to be detected, variability, assumptions.
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