Document is current

Article History

Received: 26 December 2024

Accepted: 11 November 2025

First Online: 20 December 2025

Declarations

:

: Soo Hyeon Bae, Jueun Kang, Sangil Jeon, Seon Mi Kim, Hun-Teak Kim, Seunghoon Han, and Sungpil Han declare that the research was carried out without any commercial or financial relationships that could be interpreted as a potential conflict of interest.

: The datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request.

: The study protocols were reviewed and approved by the Institutional Review Board at Asan Medical Center, Seoul and registered at ClinicalTrials.gov (NCT02202408). The protocol for the German cohort was reviewed and approved by the Ethics Committee of the Ärztekammer Nordrhein (EudraCT number: 2017-002558-35). The studies were performed at Asan Medical Center (Korea) and CRS Clinical Research Services Mannheim GmbH (Germany), and these were conducted in accordance with the 2013 Declaration of Helsinki (Fortaleza, Brazil) and the guidelines of the International Council for Harmonization Good Clinical Practice.

: All participants provided written informed consent prior to screening.

: Not applicable.

: Not applicable.

: Sungpil Han developed the concepts and designed the experiments. Soohyeon Bae and Jueun Kang conducted the data analysis, PK/PD modeling, and simulation and wrote the paper. Sangil Jeon and Seunghoon Han analyzed the data throughout the study and provided valuable insights and guidance. Seon Mi Kim and Hun-Teak Kim designed and managed the clinical trials that provided the datasets for this modeling.