Study protocol
RECRUITMENT
This was a single-center, prospective, randomized (1:1) controlled, double-blind, parallel group study. The study was approved by the local ethics committee (OMU-KAEK 2021/379) and Ministry of Health (2021-AKD-764205) and registered on ClinicalTrials.gov prior to the initial patient recruitment with registration number NCT05408403. The manuscript was written in accordance with the CONSORT guidelines.