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Mitochondrial dysfunction has been recently proposed as a key pathophysiological mechanism [3] linked to processes commonly found in depression, including neurotoxicity, impaired neuroplasticity, inflammation and insulin resistance [2,3,4,5]

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2023;62(45):e202312925

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Additionally, its ability to reduce stress by stabilizing the hypothalamic-pituitary-adrenal (HPA) axis and lowering cortisol levels may further alleviate depressive symptoms (3)

We are not performing another study under 1833(t)(13)(A) of the Act for this rule, but we will consider if this is appropriate for future rulemaking