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"We emphasize that as the clinical investigator, it is your responsibility to ensure that studies are conducted in accordance with the investigational plan, both to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data." FDA noted that two of the nine randomized subjects who received the investigational product were not eligible under the enrollment criteria

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The FDA does not conduct premarket review for compounded drugs to evaluate their safety, effectiveness, or quality

It has shown efficacy in enhancing cognition, supporting wound healing, delaying skin aging, and protecting neural tissue from degeneration and injury