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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

The goal of long-term therapy is maintaining optimal glutathione status to support cellular resilience against ongoing oxidative challenges rather than achieving supraphysiological effects

Urz, O., Olofsson Bagge, R

The future may hold medicines that prevent chronic diseases before they start, aiming for longer, healthier lives rather than just treating illness when it appears

Hyperalgesia: a dramatic or severe pain in response to a stimulus that normally causes mild pain

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