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Digestion 73 , 142150 (2006)
The FDAs current framework for combination products generally requires that each component contributes meaningfully to the combined effect, that the safety profile of the combination has been characterized, and that the combinations risk-benefit ratio is superior to its individual components or to standard of care
Indeed, the clinical literature exhibits heterogeneity in design, dosing, duration, and outcome measures, frequent reliance on parent reported scales without uniform blinding, and underpowered samples that hinder strong inference and guideline development (Doherty et al., 2022
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