Author contributions
SJS
PATHOLOGY
PW (Chief Investigator and first author): conception and design of the study, interpretation of data, drafting and review of paper. PG: Senior trial statistician, analysis of data, interpretation of data, drafting and review of paper. CG: trial statistician, analysis of data, interpretation of data, drafting and review of paper. DH: central pathology review, drafting and review of the paper. RY, IRJ, MGL, CB, BMS, MM, NA, SJS, AH, BK, CI: acquisition of data, interpretation of data, drafting and review of paper. LB: Professor of statistics, study design, analysis of data, interpretation of data and review of paper.