Criteria used to define additional types of analysis in protocols (Pro) and publications (Pub).

aThe table does not include an additional type of analysis (“Efficacy evaluable”) specified in the SAP for study 945-220. See Text S1 for details.bTo be eligible for inclusion in a type of analysis, participants had to meet the criteria that are checked. For example, per the description of modified ITT in the publication for study 945-220 [23], data from participants who were randomized into the trial and met criteria related to completing treatment at a minimum dose and/or for a minimum duration, and availability of measurements for the outcome variable at baseline and during follow-up, were included in the modified ITT analysis (“This population included any patient who was randomized, took at least one dose of study medication during SP2 [Stabilization Period 2], maintained a stable dose of 2400 mg/day during SP2, had baseline migraine headache data and at least 1 day of migraine headache evaluations during SP2.” [23]).