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c) The trial involves a drug, biological, or device product that is manufactured in the United States or its territories and is exported for research. 4 See 5 See 6 See 7 See 8 It also referenced other policy documents, including the 1993 International Conference on Harmonization (ICH) guideline, which advised against arbitrary upper-age cutoffs in clinical trials that may result in underrepresentation of older adults

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Carriere A, Romeo Y, Acosta-Jaquez HA, Moreau J, Bonneil E, Thibault P, et al