Allocation
Randomization is performed in a one-to-one ratio. The randomization sequence was generated by the principal investigator (MB) using Stata 16.0. Blocks of different size were combined randomly. Allocation concealment is ensured by sealed, opaque, and consecutively numbered envelopes. The envelopes are opened in the study center for randomization only after participants have given informed consent. The group assignment is documented in the study center in the study list through the identification number.