Kim, Young Jin
So, Ki-Youn
Lee, Hyo Min
Hahn, Changtae
Song, Seung-Hoon
Lee, Yong-Seok
Kim, Sang Woo
Park, Heui Cheun
Ryu, Jaehyung
Lee, Jung Seok
Kang, Min Ju
Kim, JinRan
Lee, Yoona
Lee, Jun Hong http://orcid.org/0000-0002-5023-6009
Funding for this research was provided by:
Eisai Korea
Article History
Received: 26 June 2023
Accepted: 4 January 2024
First Online: 12 January 2024
Declarations
:
: Institutional Review Board (IRB) and regulatory authority review and approval of the study protocol were obtained according to local laws and regulations, as applicable. A complete list of all study sites and corresponding IRBs is provided in Supplementary Table InternalRef removed. The following IRBs reviewed and approved the study protocol and waived the need for informed consent: Sungae Hospital IRB, Gwangju Veterans Hospital IRB, The Public Institutional Review Board (Public IRB), Daegu Fatima Hospital IRB, Daejeon St. Mary's Hospital IRB, Seoul Metropolitan Government-Seoul National University Boramae Medical Center IRB, Busan St. Mary's Hospital IRB, Andong Medical Group Hospital IRB, Jeju National University Hospital IRB, Veterans Healthcare Medical Center IRB, Changwon Fatima Hospital IRB, National Health Insurance Service Ilsan Hospital IRB, BongSeng Memorial Hospital IRB. This was a retrospective observational study and because the study did not involve more than minimum risks to subjects, the need for informed consent was not required by any of the IRBs that reviewed and approved the study protocol. The study was conducted in compliance with the relevant regulations provided by the Declaration of Helsinki and International Conference for Harmonization (ICH) Good Clinical Practice guidelines. Anonymity of subjects was maintained rigorously throughout the study.
: Not applicable.
: JinRan Kim and Yoona Lee are both employees of Eisai Korea Inc. The other authors declare that they have no competing interests.