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This GRAS designation does not imply FDA approval for therapeutic, drug, or compounded use , and it is sometimes misrepresented in marketing copy

Clinical trials have consistently demonstrated significant weight loss outcomes, improved glycemic control, and cardiovascular benefits, even in high-risk patient populations

New England Journal of Medicine , NEJMoa2511774

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Studies have indicated that SMAD3, SMAD4, and SMAD5 have close relationships with apoptosis of granulosa cells, the main mechanism underlying follicular atresia (279, 280)