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Regulatory Status AOD-9604 is not FDA-approved for any medical use and is listed by the FDA as a bulk drug substance that may present safety risks. Clinical development was halted after Phase IIb trials failed to meet efficacy endpoints. Summary AOD-9604 is a synthetic analog of the HGH 177191 fragment developed for fat-metabolism research

Because we had already determined that services with a provisional designation satisfy the standards represented in steps 1 through 3 in prior rulemaking cycles, we do not believe further review would be required to justify their inclusion on the Medicare Telehealth Services List under the revised process

A study in the Journal of the American Geriatrics Society showed benefits

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