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It is a designation used primarily by the FDA (Food and Drug Administration) for products, often in vitro diagnostic (IVD) components like reagents or instruments, that are in the laboratory research phase of development and are not intended for clinical diagnostic use

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Furthermore, the observed effects could be mediated by other unmeasured biological or lifestyle factors

Practitioners who work with AOD-9604 do so under research-use frameworks, and the evidence base for efficacy, while mechanistically interesting, did not survive the Phase IIb primary endpoint test