Ethical considerations
This study was approved by the Ethics Committee of the Department of Medical Services, Ministry of Public Health, Thailand (Approval No. 0001/2565, approval date: 12/04/2022) and registered with the ClinicalTrials.gov; Date of first registration: 03/05/2022; Registration number: NCT05358873. All procedures were performed following the principles of the Declaration of Helsinki and the ICH-GCP guidelines. All participants provided written informed consent before the commencement of the study and voluntarily participated in this clinical trial.