Aernoud Fiolet

141 Colchicine in Patients with Chronic Coronary Disease For all participants alive at the global end‑of‑trial on 4 th December 2019, an in-person or remote close-out visit was scheduled at the earliest convenience. Participants on trial medication at the global end‑of‑trial date were instructed to cease taking trial medication shortly before or after the close‑out visit. For individual participants, the end‑of‑trial was defined as follows: (1) for participants who had deceased before the global end‑of‑trial date, as the day of death, (2) for participants on trial medication at the global end‑of‑trial date, as the day of last ingestion of trial medication, and (3) for participants off trial medication at the global end‑of‑trial date, as the day of the scheduled close‑out visit. For the one patient that was lost to follow-up, the end‑of‑trial was defined as the day of the last trial visit. No patients withdrew informed consent for collecting follow-up information. All possible events that could be components of the primary and secondary end points (death, myocardial infarction, stroke, ischemia‑driven coronary revascularization) were adjudicated by an Endpoint Adjudication Committee, whosememberswere unaware of randomized treatment assignment.The Endpoint Adjudication Committee determined the occurrence and the date of every end point event, i.e. for every component event of the primary and secondary end points. Baseline characteristics were summarized for all participants, using means and standard deviations for age and counts and percentages for the other categorical variables. No statistical testing was performed for differences between treatment groups. The main analysis was conducted according to the intention-to-treat principle and included all adjudicated outcome events that occurred between randomization and end of trial date in all randomized participants, irrespective of ingestion of trial medication. Kaplan–Meier estimates and curves of the cumulative risk were used to evaluate the timing of end point occurrences in the two trial medication groups. Cause- specific hazard ratios and 95% confidence intervals were generated with the use of a Cox proportional-hazards model with stratification by country. Estimation of the cause-specific hazard ratio by Cox proportional hazards regression analysis implies censoring of follow-up at time of a competing risk event (noncardiovascular or all- cause death) or at the time of end of trial date (as defined above). For participants

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