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The most comprehensive evidence comes from three sources: the Phase 2 trial published in the New England Journal of Medicine , the Phase 3 TRIUMPH-4 trial, and a systematic review and meta-analysis that synthesized data from 878 total participants across three randomized controlled trials
Patients with higher baseline visceral fat volumes may experience more noticeable waist circumference reductions
These development complexities contribute to substantial research and development costs, lengthy preclinical and clinical evaluation timelines, and rigorous regulatory approval requirements
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The CAPTAIN I and CAPTAIN II trials examined its effects on moderate to severe traumatic brain injury, defined as Glasgow Coma Scale scores between 7 and 12
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