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Dosing concentrations designed for research titration , not calibrated for human pharmacokinetics a mismatch that has been linked in FDA adverse event reports to severe gastrointestinal illness and, in some cases, overdose from concentration errors

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The relative increase in cardiovascular thrombotic events over baseline appears to be similar in patients with or without cardiovascular disease or risk factors for cardiovascular disease

What has human clinical evidence: ARA-290 produced measurable nerve fiber regrowth in humans with small fiber neuropathy in placebo-controlled trials over 28 days