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And because the fat loss dwarfs it, the ratio of fat to lean mass improves either way

Temporary adjustments may sometimes be recommended if symptoms interfere with eating, hydration or normal daily activities

Approved in 1997, withdrawn in 2008 for commercial (not safety/efficacy) reasons

Three pilot studies with very small sample sizes, a Phase II trial whose results remain unpublished, and a regulatory record that reflects the FDA's own assessment that sufficient human safety data do not exist that is the complete ledger as of 2025