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Chronic oral toxicology studies in Han Wistar rats (6 months) and cynomolgus monkeys (9 months) found no treatment-related unscheduled deaths, toxicologically significant clinical signs, or adverse changes in organ masses, electrocardiographic parameters, or histological profiles at the concentrations examined

doi: 10.1213/01.ANE.0000066019.42467.7A

Long-term efficacy beyond one year, including weight maintenance after treatment cessation and durability of metabolic improvements, remains incompletely characterized

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