Randomization and blinding
The former was carried out using SAS software for Windows version 9.4 (SAS Institute, Cary, NC) by dividing participants into blocks of 14, 17, and 22. The study coordinator enrolled the participants and assigned them to one of the two treatment groups based on the randomization algorithm. Therefore, the coordinator was unblinded and aware of the randomization scheme. The Principal Investigator (PI), statistician and study personnel assessing outcome measures were blinded to the treatment assignments throughout the study. Participants were labelled as receiving either treatment A or B. Only the study coordinator knew the treatment allocations that each participant received. Participants’ group assignment was unmasked by the study coordinator at conclusion of statistical analyses.