2.3. Randomization and Blinding
RECRUITMENT, BLIND
Participants were randomly assigned to two groups after passing the screening visit and confirming their participation in the trial. A stratified randomization list (stratified by center) was generated using SPSS 26.0 software by a biostatistician who is independent of the investigator team, and allocations were concealed in sequentially numbered opaque envelopes. These envelopes were opened only after written consent had been obtained, ensuring that participants and research staff were blind prior to the allocation. Researchers who conducted the recruitment, data collection, and data analysis were blinded to group allocation.