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It is not a drug, dietary supplement, food, cosmetic, or medical device, and it is not approved by the FDA, EMA, or any other regulatory authority for human or veterinary use

Indeed, the gonadal steroids secreted during both sexual and gonadal maturation induce a clear seasonal pattern in the GH plasma levels in aquatic species (9395)

FDA approval means that the agency has evaluated the drug for quality, safety and effectiveness
The study was sponsored by Aphios Corporation and to investigate the effects of intranasal APH-1105, an alpha-secretase modulator

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