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Asian participants are the most underrepresented relative to Census share in pooled national pivotal-trial data (1.6% versus a 5.9% Census share) ( [41] ), while Black and Hispanic patients are the most underrepresented relative to disease burden in specific high-burden areas such as oncology, cardiovascular disease, and Alzheimer's disease ( [68] )

Such intercurrent events will likely result in different placebo-adjusted treatment effects than if they had not occurred and raise questions about how these events should be accounted for and how trial results should be interpreted (Table 1)