For the remaining questions, assume that the primary endpoin…
For the remaining questions, assume that the primary endpoint is change from baseline in the number of monthly migraine days at Week 24. More negative values indicate greater improvement. Define the treatment effect as: Δ = Mean change for STAT-509 – Mean change for placebo Therefore, negative values of Δ favor STAT-509.
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For the remainder of the examination, assume that the development team ultimately chooses a randomized, double-blind, placebo-controlled Phase 3 superiority trial comparing STAT-509 with placebo over 24 weeks. Participants in both treatment groups may continue their usual acute migraine medications.
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