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A scientifically credible path to human use would require, at minimum, the following sequential steps: Step 1, IND-enabling preclinical package: A full GLP toxicology package including 28-day repeat-dose rat and dog studies, genotoxicity assays (Ames test, in-vitro micronucleus), cardiovascular safety pharmacology (hERG channel, in-vivo telemetry), and a non-human primate pharmacokinetic study to establish bioavailability, volume of distribution, and clearance
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