Authors’ contributions
BS contributed to the design of the trial, analysed and interpreted the data, and drafted and revised the manuscript. DE, AM and PP contributed to the design of the trial and acquired the data. UM performed the sample size calculations and drafted the statistical analysis plan. MB and OH contributed to the design of the trial. PM and PK contributed to the design of the trial and the interpretation of the data and revised the manuscript. The author(s) read and approved the final manuscript.