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The treatment-regimen estimand with weight management represents the estimated average treatment effect regardless of adherence to study intervention or initiation of prohibited weight management treatments

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Kalathil stresses, This momentum presents both opportunity and urgency for pharmaceutical and device manufacturers to ensure delivery systems can keep pace with demand while maintaining safety, sustainability, and regulatory integrity. The complexity of these devices, often involving multilayer packaging, elastomeric seals, and polymeric components, also heightens the need for robust analytical validation