Study Design and Participants
NMIBC, Cancer
BLADDER TUMOR, CANCER
From July 17, 2007, to October 10, 2011, SELENIB recruited patients with newly diagnosed NMIBC to a double-blinded, placebo-controlled, 2 × 2 factorial randomized clinical trial from 10 UK hospitals. Eligible patients were 18 years or older with newly diagnosed, pathologically confirmed urothelial NMIBC who were able to give informed consent. Ethnicity data were not collected because they were not considered to be relevant for a study of this nature. Patients were required to be randomized within 12 months of initial transurethral resection of bladder tumor. All patients provided written informed consent. SELENIB was coordinated by the Cancer Research UK Clinical Trials Unit at the University of Birmingham. The trial was conducted in accordance with the principles of the Good Clinical Practice guidelines and the Declaration of Helsinki.