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    Subjects/PSM/RCT Principles
    RCT Principles
    hard
    users PSM

    A pharmaceutical company sponsors a double-blind RCT of a novel antihypertensive agent versus placebo in 300 Indian adults with stage 2 hypertension. The primary outcome is change in systolic blood pressure (SBP) at 8 weeks. At week 4, an interim analysis reveals that the treatment arm has achieved a mean SBP reduction of 18 mmHg versus 6 mmHg in the placebo arm (p = 0.008). The Data Safety Monitoring Board (DSMB) is asked whether the trial should continue to completion. The DSMB notes that the pre-specified stopping rule was p < 0.001 for interim efficacy. What is the most appropriate recommendation by the DSMB?

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