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Informed by Robust Clinical Literature : Phase 1b, phase 2, and phase 3a programs have generated substantial data in obesity and type 2 diabetes research populations, helping guide mechanistic and translational study design
More recently, the CAPTURE study estimated that the prevalence of established CVD in nearly 10,000 adults with T2D across 13 countries was 34.8% (95% CI 32.736.8%) [12]
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112 However, in recent years, the FDA has introduced the patient-focused drug development initiative, where patient-reported outcomes such as improvements in quality of life and healthy life years in MASH patients following treatment can serve as trial endpoints, potentially influencing final approval based on these data
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