Efficacy endpoints.
SECONDARY, REMISSION
The primary efficacy endpoint of the study was the change from baseline to week 6 in the HDRS-21 scores. In both the ITT set and the CO set (The secondary efficacy endpoints were response and remission rates at the week 6 final visit. In the ITT set, response rates were 60.9% following treatment with the H1 coil and 64.2% following treatment with the H7 coil. Remission rates were 43.5% following treatment with the H1 coil and 48.1% following treatment with the H7 coil. In the CO set, response rates were 62.5% and 65.8%, and remission rates were 45.3% and 49.4% for the H1 and H7 coils, respectively (Exploratory analysis of the change from baseline to week 6 in other clinical measures, including HARS, found significant within-group reductions, but no between-group differences, in both the ITT and the CO sets (