Randomization and masking
Participants were randomized in a 1:1 ratio using a computer-generated random-number list in the GHESKIO Data Management Unit. A data manager who had no other involvement in study procedures conducted randomization by using a computer-number generator, using permuted blocks with variable block sizes from 2 to 6. The data manager transmitted participant allocation to the study physician. Participants, site personnel, and investigators were not masked to group assignment.