Randomization and allocation concealment
Randomization was completed using stratified permuted block randomization according to sex. The participants were divided into two strata: male and female. Blocked randomization was used in each stratum. The randomization sequence was generated using PASS 2021 software (version 21.0.2; NCSS, Kaysville, UT, USA). The randomization list was kept with a person who was not included in the trial.