Authors’ contributions
MB and PB conceptualised the study and designed the trial. MB prepared the statistical analysis plan. KUG and JB were responsible for the data collection. MB and JB did the statistical analysis, accessed and verified the underlying data, and wrote the first draft of the report. PB and KUG revised the manuscript, and all authors had full access to all the data in the study and had final responsibility for the decision to submit for publication. All authors read and approved the final manuscript.