Aernoud Fiolet

123 Colchicine in Patients with Chronic Coronary Disease hierarchical testing was included in the protocol in January 2020 before the data were unblinded to be consistent with the new guidelines for statistical reporting in the Journal. 15 The main analysis was performed according to the intention-to-treat principle and included all adjudicated end-point events that occurred between randomization and the end-of-trial date in all patients who had undergone randomization, regardless of whether they adhered to their assigned regimen. Cause-specific hazard ratios in the colchicine group, as comparedwith the placebo group, and 95% confidence intervals were determined with the use of Cox proportional-hazards models, stratified according to country. If an end-point event had not occurred, follow-up data were censored at the time of the competing risk event (death from noncardiovascular causes or death from any cause, as appropriate) or at the end of the trial. Two-sided Pvalues for superioritywere calculatedwith the use of log-rank tests, as governed by the rules of hierarchical testing. The prespecified subgroup analyses were performed with the use of the Cox proportional-hazards method. An exploratory sensitivity analysis of the primary end point in the on-treatment data set was also performed. The on-treatment analysis was performed in patients who had received at least one dose of colchicine or placebo, with additional censoring of data 30 days after the last dose was received (in addition to the data that were censored according to the rules for the main intention-to-treat analysis). Analyses of the primary and secondary end points were also performed with the use of Fine and Gray subdistribution hazard models to account for competing risks. RESULTS Patients Among the 6528 patients who provided written informed consent and started the open-label run-in period, 5522 underwent randomization and 5478 received at least one dose of colchicine or placebo (Figure 1 and Table S3). Among the 1006 patients (15.4%) who had started the run-in period but did not undergo randomization, the most common reason was gastrointestinal upset (in 437 patients). The baseline characteristics of the patients were well balanced between the trial groups (Table 1). The mean (±SD) age of the patients was 66±8.6 years, and 846 (15.3%) were female; 11.7% of the patients were current smokers, and 18.2% had