Randomization and Masking
RECRUITMENT, BLIND
Randomization occurred centrally via a sequence generated within the randomize R library of R statistical software version 3.5.1 (R Project for Statistical Computing) by S.M. Randomization was 1:1 in permuted blocks of 2 and 4 to reduce predictability and ensure balance between study groups. Study staff responsible for recruitment, follow-up outcome assessors, and individuals responsible for statistical analysis were blinded to allocation. Due to the nature of the intervention, it was not possible to blind participants.