Allocation and Blinding
Randomization was performed by Castor EDC in a 1:1 ratio using random permuted blocks of 4-8 participants. Following randomization, allocation disclosure was conducted by the principal investigator, who communicated each participant’s allocation to respective investigators in each study arm, ensuring that blinding was maintained before allocation. Considering the nature of the intervention, investigators and participants were unblinded to group allocation. However, analyses were conducted independently by 2 statisticians blinded to group allocation.