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Application of a Non-Invasive Integrated Screening Algorithm to Improve Enrollment in NAFLD/NASH Clinical Trials

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Despite NAFLD/NASH being a prevalent co-morbidity in obesity and type 2 diabetes, the clinical development of NAFLD/NASH therapeutics is currently hindered by significant challenges in clinical trial enrollment. Traditional study screening is commonly associated with screen failure rates of >90%. Given the cost- and timeline implications of subjects failing to meet MRI- or biopsy-based inclusion criteria, there is a clear need for optimized screening strategies in NAFLD/NASH clinical studies.

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