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Primary and Secondary Endpoints The primary endpoints for TRIUMPH-1 follow the standard FDA framework for obesity drug approval

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for MOUNJARO and any potential adverse effects o Pregnancy 8.1Pregnancy Risk Summary Available data with MOUNJARO use in pregnant women are insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

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