Aernoud Fiolet

105 The LoDoCo2 trial rationale, design, and baseline characteristics adjudicated by the Clinical Events Committee. 38 In addition, a per protocol analysis for the primary outcome in patients who remained compliant with the trial medication through the duration of the trial will be conducted. The occurrence of the primary endpoint over time will be depicted with Kaplan–Meier curves. The hazard ratio (HR), its 95% confidence interval (CI) and the corresponding P value will be derived from a Cox proportional hazards model with a factor for treatment group (colchicine versus control). P < .05 for the primary endpoint will be considered statistically significant. Secondary endpoints will be analyzed in a similar fashion using HRs and 95% CIs derived from a Cox proportional hazards model. The testing of the primary and secondary endpoints will be assessed in a closed testing procedure to preserve alpha as specified in the statistical analysis plan. Study status Recruitment began in Australia in August 2014 and in The Netherlands in November 2016 and was completed on December 3, 2018. By that date 5522 participants were randomized into the trial, 1.4% more than planned due to slight variance in the drop-out rate during the open label run-in phase. Global end of study was defined as the time when 331 primary endpoints would have occurred with the requirement of a minimal follow-up of 1 year. Based upon projections performed in February 2019, it was decided to set the global end-date for the trial at 4 December 2019. According to this timeline, the median follow-up will be approximately 2.5 years. Table III summarizes baseline demographic and clinical characteristics of all participants in the trial cohort based upon an interim snapshot taken at April 29, 2019 after completion of enrolment but during ongoing trial and data cleaning. The mean age of the cohort is 66 years and 85% are male. A high proportion of participants are receiving secondary prevention therapy, with 93.8% taking statins (61.6% with dosages equivalent to atorvastatin 40 mg or 80 mg) and 19.3% using ezetimibe. Almost all (99.5%) participants are treated with anti-platelet therapy or anti-coagulation therapy.