Institutional Review Board Statement
The study protocol received approval from the Institutional Review Boards and Ethical Committees at CHA Bundang Medical Center (approval number 2018-10-013-034, October 2018) and the Ministry of Food and Drug Safety of Republic of Korea (approval number 202100348, March 2021). The study rigorously followed the principles stated in the Declaration of Helsinki and adhered to the guidelines of good clinical practice (ISO 14155). This clinical trial was registered with the ClinicalTrials.gov database under the identifier: NCT05011474.