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For Phase 0 it is not needed that your IND is filed, submitted, and approved by the FDA

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Hum Mol Genet 8 : 425430 Campo GM, D'Ascola A, Avenoso A, Campo S, Ferlazzo AM, Micali C, Zanghi L, Calatroni A 2004 Glycosaminoglycans reduce oxidative damage induced by copper (Cu +2 ), iron (Fe +2 ) and hydrogen peroxide (H2O2) in human fibroblast cultures