Randomization and blinding
MAY, RECRUITMENT
Computer-generated randomization was adopted for patient allocation. After distribution into the groups, a code was assigned to each patient, allowing allocation concealment that was maintained for the patients and the laboratory researchers. The code was only revealed at the conclusion of the study after the statistical analysis was completed. Allocation in each group was performed by two senior researchers. During the study project planning phase, patient recruitment and sample collection were set to start in February 2021 and end in April 2021. However, due to a delay in the implementation of the methodological steps in the patients’ assistant routine, the recruitment and sample collections began in April 2021 and ended in May 2021.