Time to remission and percent of days in remission
MDD
EVENT, REMISSION
Two definitions of remission were evaluated, remission and consistent remission, that were defined as a MADRS total score ≤ 12 at any given visit and for two consecutive visits, respectively. Time to remission was calculated as the time (in days) between the randomization date and the first time the patient achieved remission. Time to consistent remission was calculated as the time (in days) between the randomization date and the date of the first of two consecutive visits where remission was achieved. For each definition of remission of MDD, a single criterion (i.e., MADRS total score ≤ 12) and a combined endpoint (i.e., MADRS total score ≤ 12 and CGI-SS-r ≤ 1 [not suicidal/questionably suicidal]) were examined. For consistent remission, both criteria (i.e., MADRS total score ≤ 12 and CGI-SS-r ≤ 1) had to be met for two consecutive visits. Patients were censored at the date of the last non-missing assessment if no event was identified over the entire study follow-up (days 1–90). Intermittent missingness was treated as a non-response. Monotone missingness was censored at the last non-missing assessment visit.Number of days in remission (based on MADRS total score ≤ 12) was calculated for the double-blind treatment and follow-up phases. Percent of days in remission was calculated as the number of days in remission divided by the number of days in the study. When calculating the number of days in remission, the last observation carried backward was used within the double-blind treatment and post treatment follow-up phases separately (i.e., the last observed remission or non-remission status was carried backward until the visit with a non-missing value), due to the intermittent assessments at scheduled visits per protocol. For monotone missingness, values were not included in the number of days in the study.