Interim analyses
An interim database lock and analysis will be completed after all data have been entered for the Baseline and 12-week visit (Primary Outcome timepoint). Analysis of the primary outcome and other selected 12-week outcomes will be conducted using the same approaches as described above for the main end-of-study analyses. An unblinded analysis of the 6-month outcomes and any remaining 12-week outcomes will be conducted at the study end, after the final database lock. The purpose of an interim analysis would be to allow early dissemination of the results for the study’s primary outcome. It is not intended to modify the study following this analysis, and no further analysis of the primary outcome or selected 12-week outcomes is planned. Therefore, the significance level for this interim analysis will not be adjusted to allow for multiple testing.