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Clinical translation requires human CSF pharmacokinetic assays to prove BBB bypass, a rigorous dose-escalation Phase I trial to establish a safe human NOAEL for chronic dosing, and an RCT utilizing precise neurocognitive testing (e.g., MoCA) to confirm that murine transcriptomic shifts yield functional neuroprotection in humans

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Dietary induction of obesity and insulin resistance is associated with changes in Fgf21 DNA methylation in liver of mice

Therefore, we questioned whether data from animal studies is sufficient to extrapolate to human populations for the purposes of demonstrating substantial clinical improvement