PROCEDURES IN CASE OF EMERGENCYInvestigator Agreement • May 8th, 2025
days in the Run-In period, but every effort should be made to minimize to the fewest days needed for the given washout period(s) in the protocol. During the Run-In, patients will be required to answer questions daily regarding headaches and rescue (abortive) medication use on an electronic diary (e-diary) regardless of whether patients experienced a headache on that day. It is a patient’s responsibility to be compliant with e-diary entries. Each patient’s headache frequency, as well as e-diary compliance, will be evaluated at the end of the Run-in Period to ensure a patient meets all required eligibility criteria for treatment randomization. For evaluating randomization eligibility, the last 28 days of Run-In diary entries will be used, which includes diary entries logged on the morning of the Baseline Visit. A patient must not be informed of the minimum number of headache days and migraine headache days required to be randomized to study treatment as this might bias e-diary entries