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3 linked pagesOpen original clinicaltrials-gov-aod-9604 Certain bulk drug substances for use in compounding may present significant safety risks U.S

AOD9604 has been studied in preclinical and early clinical settings, and it received GRAS (Generally Recognized as Safe) designation from the US FDA for use as a food ingredient

In adults and older children, the total volume used should also stay within safe limits animal studies suggest up to about 30 mL (the full vial) can be given to an adult without benzyl-alcohol toxicity, but one should still use only the amount needed and discard the rest if sterility is lost