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The FDA has formally recognized Model-Informed Drug Development (MIDD) under PDUFA VI as a tool for dose optimization, supportive efficacy evidence, and clinical trial design (Wang et al., 2019, DOI)

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Obesity, insulin resistance, and type 2 diabetes are all known to increase the risk of dementia, largely due to their role in driving inflammation, vascular damage, and other long-term stressors on the brain

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Keywords: Comparative effectiveness, Obesity, Real-world evidence, Semaglutide, Tirzepatide Introduction Obesity is a chronic, progressive, relapsing disease that affects over 40% of adults in the US [1] and is associated with increased risk of morbidity, disability, mortality, and reduced quality of life [24]

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