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Exogenous taurine attenuates mitochondrial oxidative stress and endoplasmic reticulum stress in rat cardiomyocytes

The main recommendations were to increase access to Traditional Chinese Medicine, interpretive services, Chinese-speaking healthcare professionals, and culturally appropriate long-term care

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The primary outcome was the occurrence of any HT at 24-36 hours

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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