Author contributions
AK is the principal investigator and takes responsibility for the integrity of the data. AH, EB, SEG and SAE are sub-investigators, enrolling and evaluating subjects and collecting data. PL, MNB, JB, MS, MR and KRW are trial chairs, supervising subjects’ safety and conduct of the trial. JK is the trial statistician. AK and JK take responsibility for the accuracy of the data analysis. All authors contributed to the current submission and critically reviewed the manuscript. AK is corresponding author for this work and attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.