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Authors
Dlin, Vladimir V.
Abramov-Sommariva, Dimitri
Zakharova, Irina N.
Erman, Mikhail V.
Nastausheva, Tatiana L.
Kirillov, Vladimir I.
Averyanova, Natalia I.
Derevyanko, Tatiana I.
Letifov, Gadji M.
Vyalkova, Albina A.
Margieva, Tea V.
Morozov, Sergey L.
Kolchenko, Ivan I. http://orcid.org/0000-0002-3605-7530
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Funding
Funding for this research was provided by:
Bionorica LLC, Russia
Bionorica SE, Germany
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Article History
Received: 25 April 2018
Accepted: 1 November 2018
First Online: 7 December 2018
Ethics approval and consent to participate
: This non-interventional study was conducted in compliance with the Declaration of Helsinki, the Guidelines for Good Pharmacoepidemiology Practices, all applicable norms of Good Clinical Practice (ICH-GCP) and the Russian national GCP standard. The study was approved by the Independent Interdisciplinary Ethics Committee on Ethical Review for Clinical Studies (Moscow) and local ethics committees.Informed consent process in this study was carried out according to applicable pediatric studies regulations. Only patients, whose parent(s) and legally acceptable representative(s) provided written informed consent, and who provided a written assent form themselves (if aged 14 to 17 years) to participate in the study, were to be enrolled into this study.
: Not applicable.
: Dimitri Abramov-Sommariva is an employee of Bionorica SE, Germany. Dr. Ivan Kolchenko is an employee of Bionorica LLC, Russia. Dr. Tea Margieva was a lecturer for Bionorica. Other authors didn’t have any conflict of interests.
: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
