Statistical Analysis
SECONDARY, SENSITIVITY
Categorical variables were reported using frequencies and proportions. Continuous variables were reported as means with SDs or medians with IQRs. Participants were analyzed according to the group to which they were randomized (ie, intervention vs control). Comparisons between groups, with 2-tailed This secondary analysis reported on the key secondary objective for the VICTAS trial. The trial was explicitly powered for the primary objective and was administratively terminated after recruiting 501 participants. The secondary analysis was specified a priori with the intent to describe the magnitude of differences between groups rather than to focus on hypothesis tests. Therefore, no adjustments for multiplicity were made, and adjusted effect sizes (ie, odds ratios [ORs]) with 95% CIs were reported. Multiple imputation based on predictive mean matching was used to overcome missing covariate data.Approximately one-third of participants who were interviewed at follow-up were unable or unwilling to complete the full battery of cognitive and psychological assessments (eAppendix 2 and eTable 2 in Sensitivity analysis was performed with a complete case approach. All analyses were conducted between February 2021 and December 2022 using R, version 3.4.3 (R Foundation for Statistical Computing).