2.5. Patient populations
ADVERSE EVENTS, SECONDARY
Efficacy was evaluated in both the modified intent-to-treat (m-ITT) population, including all randomized patients who took at least 1 dose of the investigational medicinal product (IMP) and performed the T2min efficacy assessment with STRRS, and the per-protocol (PP) population, including all randomized patients who took at least the first dose of the IMP and performed all Day 0 (up to 120 minutes) STRRS evaluations, with no major protocol violations. As this was a noninferiority study, the PP population was used as the primary analysis population. In order to judge the validity of the PP results, the noninferiority analysis was repeated in the m-ITT population. The safety population (SP), comprising all those who took at least 1 dose of the study medication, was used to evaluate safety data and demographic, baseline, and treatment characteristics. All adverse events (AEs) and treatment emergent AEs (TEAEs) were coded according to MedDRA dictionary (version 23.1). For exploratory purposes only, an additional modified-PP (m-PP) population was included to describe secondary efficacy endpoints after 120 minutes. The m-PP population was defined by the PP population with the exclusion of patients who took concomitant treatments or additional doses of IMP during the at-home period or 3 lozenges before V2 on Day 7.