2.2. Randomization and Masking
BLIND
All participants were randomized 1:1 via blinded envelope to either the TRF or SC arm through the use of a randomization software using predetermined permuted blocks of six, and the randomization sequence was prepared by an independent statistician. Investigators collecting data and performing analyses were blind to the group allocation throughout the study. Due to the nature of the intervention, blinding of the participants was not possible.