Criteria used to define ITT analysis in protocols (Pro) and publications (Pub).

To be eligible for inclusion in the ITT analysis, participants had to meet the criteria that are marked with an “X”. For example, per the description of ITT in the publication for study 945-209 [24], 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 were included in the ITT analysis (“The efficacy analyses were carried out on the intent-to-treat (ITT) population that included all randomized patients who received at least one dose of study medication.” [24]).