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As described in the statistical analysis plan, for the single-dose part of the study, assuming an anti-GDF8 + anti-ActA combination treatment effect of 6% over placebo in thigh muscle volume by MRI and an anti-GDF8 alone treatment effect of 3% over placebo, sample sizes of 12 for the anti-GDF8 + anti-ActA combination, six for anti-GDF8 alone, and 12 for placebo (pooled) were estimated to provide 99% power in demonstrating a treatment difference between the anti-GDF8 + anti-ActA combination final dose and placebo at a two-sided 0.05 level based on an assumed common standard deviation of 3%

PMID: 27707767 [11] Veronese N, Dominguez LJ, Pizzol D, Demurtas J, Smith L, Barbagallo M

Your body is encountering a GLP-1 receptor agonist for the first time, and the gastrointestinal effects are at their peak

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