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Genetic variants in growth factor receptors and collagen regulation pathways may influence tissue remodeling capacity

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144 The study used a randomized, open-label design and employed magnetic resonance imaging technology (MRI-PDFF) to measure liver fat content (LFC) after 24 weeks of treatment

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IV forms may pose liver injury risks Pregnant/nursing individuals and those on medication should consult a certified healthcare professional

For the other claims, the applicant provided only background evidence, specifically retrospective studies, which describe findings for a predicate device, the Axoguard Nerve Protector TM , which received FDA 510(k) clearance on January 10, 2014, not the nominated device, the Axoguard HA+ Nerve Protector TM