Czumbel, Norbert
Acs, Tamas
Bator, Gyorgy
Halmosi, Agnes
Egorov, Evgeniy A.
Maltsev, Dmitrii S.
Article History
Received: 19 December 2023
Accepted: 17 July 2024
First Online: 29 July 2024
Declarations
:
: The study had the ethical and regulatory approval from the National Institute of Pharmacy and Nutrition (OGYEI, OGYEI/41779- 11/2018) and the Ethics Committee for Clinical Pharmacology (KFEB) of Hungary and from the Ministry of Healthcare of the Russian Federation (MOH of Russia) prior to the beginning of the study (642/25.12.2018). The study was conducted in accordance with the ICH guidelines for Good Clinical Practice (GCP, E6) and the Declaration of Helsinki (Version 6 of 64th General Assembly of WMA in Fortaleza, Brazil 2013). Data management was conducted in compliance with Good Clinical Data Management Practices.
: Not applicable.
: Informed consent was obtained from all the patients included in the study prior to any study-related activities and in accordance with all applicable regulatory requirements. The investigator and/or his/her designee orally informed every patient in addition to the written patient information about all aspects of the patient’s participation in the study.
: The authors declare that they have no competing interests.