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The FDA's Digital Health Technology guidance requires investigators have timely access to the data used for safety monitoring a compliance bar that's difficult to clear when every trial runs on different, poorly integrated tools

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These ROS are generated at the mitochondrial level during oxidative phosphorylation by the activation of oxidase enzymes involved in signaling processes and by neurochemical reactions regulated by Cu(I) and Fe(II) ions in the Fenton and Haber-Weiss reactions

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