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In April 2026, the FDA made that requirement explicit, taking concrete steps to let its reviewers see trial data as it is generated

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The more muscle you maintain during weight loss, the higher your resting metabolic rate, and the easier it is to keep the weight off long-term

doi: 10.1038/s41573-020-00135-8 Cardoso, Fernanda C., Castro, Joel, Grundy, Luke, Schober, Gudrun, Garcia-Caraballo, Sonia, Zhao, Tianjiao, Herzig, Volker, King, Glenn F., Brierley, Stuart M

doi: 10.1016/j.tree.2016.03.006 109 ShawR