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The clinical trials showed increasing weight loss with each dose tier, and 7.5 mg represents the middle of the escalation

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Response: While we did not receive public comments regarding this redesignation, upon further review, we have identified that current requirements at redesignated (c)(5) do not adequately address same-day make-up sessions delivered Online

Growth hormone promotes lipolysis, the breakdown of stored fat into free fatty acids

We agree that cardiologists are in the best position to co-manage patients and share responsibilities with primary care and the exclusion of cardiology sub-specialists is appropriate given that they are more apt to treat complex patients

However, GMP certification covers manufacturing process rather than product efficacy