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4.9 Alpha-Lipoic Acid In its reduced dihydrolipoate form, alpha-lipoic acid (ALA) reacts with ROS and reactive nitrogen species and protects cell membranes by interfering with the vitamin C and E pathways [124]

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While safety within the phase 3 program is sufficient for marketing authorization (although the risk of cardiovascular events should not exceed a hazard ratio of 1.8 according to a guidance document that was released by the FDA at that time), it is the post-marketing phase in which rare adverse events and any other potential safety risks are identified or resolved