Estimand Sample Clauses

Estimand. The primary efficacy endpoint is defined as the change in monthly migraine days from Baseline (last 28 days prior to randomization) to month 3 (last 28 days of treatment). For defining months, diary days will be divided into 28 day “months”; Days 1 to 28 will be Month 1; Days 29 to 56 will be Month 2; and Days 57 to 84 will be Month 3. The change in count of days with migraine vs the baseline will be compared between treatment groups. The target population is all patients in the mITT population with CMs as defined by the inclusion/exclusion criteria.