CONSORT 2010 checklist of information to include when reporting a randomised trial*.
(DOC)Click here for additional data file.(DOCX)Click here for additional data file.(DOCX)Click here for additional data file.(XLSX)Click here for additional data file.The authors would like to thank all the staff and patients involved in the study at Kobe, Nagoya City, and Chiba University, and the Trial Steering Committee and Data Monitoring Committee for their ongoing support throughout the trial. The authors acknowledge the role of the Clinical Research Centre of Chiba University Hospital in supporting the ongoing delivery of the trial at the sites. The authors thank Hidetaka Kudo, Daigo Yoshikawa, and Masao Yoshikawa of the Mayo Company for their technical help. The authors would also like to thank Editage (