Jong-Hyeon Jeong.

Before randomization, a history and physical examination, upper body radiography, bilateral mammography, and electrocardiography were required. The scholarly study was approved by the ethics committees or institutional review boards of all participating institutions. Written informed consent was needed. Study Design This randomized, multicenter, phase 3 trial was conducted by the NSABP in collaboration with the Eastern Cooperative Oncology Group, the Southwest Oncology Group, and the North Central Cancer Treatment Group.Randomization From 16 November, 2006, through June 4, 2009, 363 patients were signed up for the trial. The follow-up of patients throughout the trial is demonstrated in Fig. 1 in the Supplementary Appendix . The niacin dose was increased from an initial dosage of 500 mg at bedtime, by 500 mg almost every other week, to the utmost tolerated dose . Niacin was provided by the sponsor, as was ezetimibe, after it was obtained by the sponsor from a industrial resource. Randomization was performed through a computer-generated sequence of random quantities.