Randomization and blindings
Eligible participants were randomized 1:1 to Intervention or Control groups using permuted block randomization generated in advance, in block sizes of 4, 6, and 8. Random seeds were generated to assure allocation concealment and pre-guessing of the allocation sequence at the end of each block. Randomization was stratified by baseline ISI (≤14 and ≥ 15). The randomization scheme was generated and setup in REDCap [