Raj R. Makkar, M.D., Gregory Fontana, M.D., Hasan Jilaihawi, M.D., Tarun Chakravarty, M.D., Klaus F. Kofoed, M.D., D.M.Sc., Ole de Backer, M.D., Ph.D., Federico M. Asch, M.D., Carlos E. Ruiz, M.D., Niels T. Olsen, M.D., Ph.D., Alfredo Trento, M.D., John Friedman, M.D., Daniel Berman, M.D., Wen Cheng, M.D., Mohammad Kashif, M.D., Vladimir Jelnin, M.D., Chad A. Kliger, M.D., Hongfei Guo, Ph.D., Augusto D. Pichard, M.D., Neil J. Weissman, M.D., Samir Kapadia, M.D., Eric Manasse, M.D., Deepak L. Bhatt, M.D., M.P.H., Martin B. Leon, M.D.D.: Feasible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves.A second interim evaluation was planned after the primary end point had occurred in at least 705 patients, along with a 0.5 percent possibility of declaring false positive results or a 5.0 percent possibility of declaring negative results by using a group sequential-design method.13 The analysis was completed on 752 events, leading to an efficacy boundary for the hazard ratio of 0.833 and a lack-of-efficacy boundary of 0.936 . At this interim evaluation, the lack-of-efficacy boundary was crossed, and the committee suggested the release of results. We compared between-group distinctions using the log-rank test and a Cox proportional-hazards model to regulate for the minimization elements . We calculated prices of osteonecrosis of the jaw using cumulative incidence features, in which deaths with out a analysis of osteonecrosis of the jaw had been regarded as competing-risk occasions and were compared with the use of the log-rank test.