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In 2014, the US Food and Drug Administration (FDA) acknowledged a GRAS (Generally Recognised as Safe) notification for AOD 9604 as a food ingredient meaning the FDA raised no questions about the notifier's own safety conclusion

Ethics declarations Ethics approval and consent to participate All procedures described herein were approved by the Institutional Review Board for the Protection of Human Subjects of Baylor University (Protocol # 7920244) and Research Ethical Review Committee of Kyowa Hakko Kirin Co., Ltd

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Individualized Maintenance Schedules While most get 1,000 mcg monthly, some may need different schedules