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Safety, Tolerability, and Regulatory Perspective Multiple non-clinical toxicology programs and clinical studies have evaluated the safety of AOD 9604: A comprehensive non-clinical dossier reported no evidence of genotoxicity or major toxicological concerns across a range of pharmacokinetic and toxicity studies, supporting a favorable safety profile in standard preclinical models

Levocarnitine is an amino-acid derivative essential for mitochondrial fatty-acid transport, and this injectable formulation is used to treat or prevent clinically significant carnitine deficiency in conditions such as primary systemic carnitine deficiency, certain inborn errors of metabolism, and end-stage renal disease on dialysis

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