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doi:10.1016/j.phymed.2008.04.018 Geuenich S, Goffinet C, Venzke S, et al

Post-Market Surveillance Gap: Because AOD-9604 never received FDA approval for any indication, there is no post-market surveillance system capturing safety signals from widespread clinical use

The lack of human clinical trials combining these agents reflects ethical constraints, not confirmed safety

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10.1136/bmj.i4919 [DOI] [PMC free article] [PubMed] [Google Scholar] Sterne J
