Interim safety analysis of the BRAVE trial cohort at 24 months

Abstract

We report results from a pre-specified interim safety analysis of 3,412 participants enrolled across 86 sites in 24 countries. Adverse event profiles were consistent with prior evidence, and no unexpected safety signals were identified. Serious adverse events occurred at comparable rates between study arms (5.1% vs 5.4%; p=0.62). The Data Safety Monitoring Board recommended continuation of the trial without modification. These findings support the ongoing conduct of the BRAVE Study and reinforce confidence in the intervention’s safety profile across diverse international populations.

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