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The FDA considers it a non-toxic substance under the Generally Recognized as Safe (GRAS) classification for specific applications

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Cox, Daniel Eichner Published: Drug Testing and Analysis, Volume 7, Issue 1, January 2015, pages 3138 DOI: 10.1002/dta.1715 URL: AOD9604 was incubated in human serum and rat plasma at room temperature to study in vitro metabolic degradation

The potential risks to the fetus or infant are not well understood, and therefore caution is advised