Results
NDI
Between April 6, 2017, and September 15, 2020, 140 participants were randomly assigned to the NSEIT group (n=70) or the NSE group (n=70); 63 (90%) and 64 (91%), respectively, were followed up at 3 months, and 56 (80%) and 58 (83%), respectively, at 15 months. NSEIT demonstrated noninferiority to NSE in the primary outcome NDI, as the 1-sided 95% CI of the mean difference in change did not cross the specified noninferiority margin (7 percentage units). There were no significant between-group differences in change in NDI at the 3- or 15-month follow-up, with a mean difference of 1.4 (95% CI –2.5 to 5.3) and 0.9 (95% CI –3.6 to 5.3), respectively. In both groups, the NDI significantly decreased over time (NSEIT: mean change –10.1, 95% CI –13.7 to –6.5, effect size=1.33; NSE: mean change –9.3, 95% CI –12.8 to –5.7, effect size=1.19 at 15 months; 