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Contraindications and Precautions: AOD-9604 should be avoided or used only under close medical supervision in individuals with active malignancy or history of cancer, as the effects of the peptide on tumor growth have not been adequately studied

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Concurrently, FDA has increased unannounced inspections of foreign API manufacturers and is also stepping up Remote Inspections via FDA form 4003

Further, there were no significant changes in laboratory parameters, vital signs, or ECGs during the study in any treatment group, including placebo

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