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Mylans challenges target these extensions, arguing that secondary patents, like those for dosage regimes, may be invalid if deemed obvious over prior art, such as Novos earlier GLP-1 drug liraglutide (Reddie & Grose, August 30, 2024)

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Biomarkers including HbA1c, fasting insulin, lipid profiles, and body composition measurements provide the quantitative feedback needed to determine whether the combined approach is producing the intended metabolic effects, whether adjustments to formulation or dosing are needed, and whether the balance between the two therapies remains appropriate as a woman's physiology evolves through and beyond the menopausal transition

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Participants attended visits at baseline, week 4, and week eight

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