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Initially, the FDA issued complete response letters on October 22, 2024, and April 18, 2024, citing deficiencies classified as minor, and requested that the manufacturer address these with new and updated information and clarifications related to the drug substance, drug product, manufacturing, and microbiology

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Altogether, our study and the previous ones confirm the positive effect of L-carnitine on muscle cramps in liver cirrhosis

Dietary modifications including smaller meals and avoiding carbonated beverages are typically the most effective first-line strategies

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