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[DOI] [PubMed] [Google Scholar] 119.Rascol O, Brooks DJ, Melamed E, Oertel W, Poewe W, Stocchi F, Tolosa E the LARGO study group

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Not approved or evaluated by the FDA for human use.” (Regentherapy) Thus any use in humans—outside a formal clinical trial—is off-label and subject to regulatory risks (depending on jurisdiction)