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We invited public comment on whether VasQ TM meets the device category criterion at 419.66(c)(2)

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One randomized placebo-controlled trial that assessed the effect of oral lipoic acid supplementation in 58 patients diagnosed with metabolic syndrome, a condition characterized by abnormal glucose and lipid metabolism, showed that flow-mediated vasodilation improved by 44% with 300 mg/day of lipoic acid for four weeks (66)

Tolerability (preclinical): Each peptide is generally well tolerated in animal studies, with occasional mild injection-site reactions

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