Inui, Toshio
Kruglova, Oksana
Martynenko, Olga
Martynenko, Kostiantyn
Tieroshyn, Vadym
Gavrylov, Anatoliy
Kubo, Kentaro
Yamakage, Hajime
Kutsyn, Borys
Kubashko, Alla
Veklych, Zoryana
Terashima, Yurika
Mette, Martin
Kutsyna, Galyna
Article History
Received: 29 April 2023
Accepted: 3 April 2024
First Online: 23 May 2024
Declarations
:
: The study was conducted in accordance with ICH Good Clinical Practice and with the ethical principles expressed in the Declaration of Helsinki. The clinical trial protocol was reviewed and approved by the ethics committees affiliated with the clinical sites: (1) Research Ethics Committee of the Luhansk State Medical University, Rubijne, Luhansk region, Ukraine, and (2) Commission on Ethics at the Municipal Non-Profit Enterprise of the Kharkiv Regional Council “Regional Clinical Infectious Diseases Hospital”, Kharkiv, Ukraine. As part of the consent process, clinical study participants were informed about the risks and benefits of participating in the study. Written informed consent for the investigational treatment, study data collection, data analysis, and publication were obtained from all study participants.
: Not applicable.
: MM provided part-time English editing services for SAISEI Mirai.GK has a history of external consulting services for SAISEI Mirai.KK and TI are employed by SAISEI MiraiOK, OM, KM, VT, AG, HY, BK, AK, ZV, and YT declare no competing interests.