Aernoud Fiolet

121 Colchicine in Patients with Chronic Coronary Disease had no role in the design or writing of the protocol and statistical analysis plan; in the selection or monitoring of the participating sites; in the enrollment or follow- up of patients; in the distribution or administration of the trial drug or placebo; in the collection, storage, analysis, and interpretation of the data; in the drafting of the manuscript; or in the decision to submit the manuscript for publication. The trial drug and matching placebo were donated by Aspen Pharmacare in Australia and by Tiofarma in the Netherlands. The members of the steering committee and the trial statisticians had unrestricted access to the data and vouch for the completeness and accuracy of the data and analyses and for the fidelity of the trial to the protocol. Trial population Patients 35 to 82 years of age were eligible if they had any evidence of coronary disease on invasive coronary angiography or computed tomography angiography or a coronary-artery calcium score of at least 400 Agatston units on a coronary- artery calcium scan. Patients were required to have been in a clinically stable condition for at least 6 months before enrollment. Patients were not eligible if they had moderate-to-severe renal impairment, severe heart failure, severe valvular heart disease, or known side effects from colchicine. Renal function was defined on the basis of the Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Acute Kidney Injury. 14 A full list of the inclusion and exclusion criteria is provided in Table S1 in the Supplementary Appendix. All the patients provided written informed consent to participate. Run-in, randomization, and follow-up After signing the informed-consent form, eligible patients entered an open-label run-in phase for 1 month, during which time they received 0.5 mg of colchicine once daily. At the end of the open-label run-in phase, the patients who were in stable condition and had no unacceptable side effects, had adhered to the open- label colchicine regimen, and remained willing to continue participation were randomly assigned in a 1:1 ratio to receive 0.5 mg of colchicine once daily or matching placebo. Randomization was performed in a double-blind manner with the use of a computerized algorithm, with stratification according to country. Clinical evaluations were scheduled before the run-in phase, at the time of randomization, and at 6-month intervals until the completion of the trial. All follow-up assessments were performed in person, if possible, or by telephone. The