title: Comment on derivation of sample size requirements for evaluating heart valves with constant risk events.
authors.forename: Olga
authors.initials: O
authors.lastname: Korosteleva
authors.forename: Sergey
authors.initials: S
authors.lastname: Lototsky
mesh_terms: D006349:Heart Valve Diseases / Q000453:epidemiology / Q000601:surgery*; D006350:Heart Valve Prosthesis / Q000592:standards*; D006801:Humans; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology; D012307:Risk Factors; D014481:United States; D014486:United States Food and Drug Administration