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The data used in this study was obtained from clinical trial sponsored by the Korea Ministry of Food and Drug Safety (MFDS). This study was supported by 2025 Research Grant from Kangwon National University.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"The authors declared no competing interests for this work.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"This study was registered at clinicaltrials.gov as NCT04937634. This study was approved by the Institutional Review Board of Seoul National University Hospital (H-2006-051-1131) and was performed in accordance with the ethical standards set forth in the 1964 Declaration of Helsinki.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}},{"value":"A written informed consent document was used, incorporating the elements of informed consent outlined in the Declaration of Helsinki and following the International Committee for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice. Informed consent was obtained in compliance with 21 CFR 50.25 and 45 CFR 46 before any protocol-specified procedures or interventions were performed. Participants, or their legally authorized representatives, provided written consent to participate in the study.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"Patients or their representatives signed informed consent regarding the publishing of their de-identified data. They were informed that their identity will not be revealed.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}},{"value":"The data used in this study are available from the corresponding author upon reasonable request.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data Availability"}},{"value":"The NONMEM code used in this study are available from the corresponding author upon reasonable request.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code Availability"}},{"value":"JYC, BWK, HJP, BKK, KTH, SHL, and HJK contributed to study conception and design of the study. JYC, and BWK acquired the data and conducted analysis including safety and NCA data. BWK performed the pharmacometrics modeling and simulations. JYC and BWK wrote the manuscript. All authors interpreted the data for the work and revised the work critically for important intellectual content.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author Contributions"}}]}}