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Efficacy and safety of once weekly semaglutide 2.4 mg for weight management in a predominantly East Asian population with overweight or obesity (STEP 7): a double-blind, multicentre, randomised controlled trial

While its ability to influence multiple pathways of repair is supported by compelling preclinical data, the absence of high-quality human trials, the FDAs strict regulatory stance, and the risk of contamination from unregulated sources raise serious safety and legal concerns (including malpractice concerns and fines)

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It also states that available safety information is insufficient to know whether harm could occur