Ivashkin, Vladimir T.
Poluektova, Elena A.
Glazunov, Alexey B.
Putilovskiy, Mikhail A.
Epstein, Oleg I.
Article History
Received: 24 July 2019
Accepted: 11 December 2019
First Online: 31 December 2019
Ethics approval and consent to participate
: According to GCP it is quite enough to obtain the approval at least the one for all sites. Since the huge numbers of medical organizations participated in the program it was decided to get unified approval accepted for non interventional study design by the Independent Interdisciplinary Ethics Committee on Ethical Review for Clinical Studies (hereinafter referred to as the “Committee”). The Committee is the independent local research ethic committee, which was established in 2000 by Moscow State University of Medicine and Dentistry, Russian Academy of Medical Sciences, Society for Pharmacoeconomics and Outcomes Research, League to support clinical studies and Scientific Center for medical information “Universimed”, have made, executed and signed corresponding Agreement. The COMFORT was approved by the Committee (Protocol № 19 from 01.12.2017).
: Not applicable.
: Prof. Glazunov and Dr. Putilovskiy authored this publication as employees of LLC “NPF” MATERIA MEDICA HOLDING”. Prof. Epstein is the founder of LLC “NPF “MATERIA MEDICA HOLDING”. Kolofort is a preparation manufactured and marketed by LLC “NPF” MATERIA MEDICA HOLDING”. The authors report no other conflicts of interest in this work.