Ivashkin, Vladimir T.
Maevskaya, Marina V.
Shirokova, Elena N.
Maev, Igor V.
Samsonov, Alexey A.
Sas, Evgeniy I.
Palgova, Liudmila K.
Starostin, Kirill http://orcid.org/0000-0001-6488-7980
Funding for this research was provided by:
Sanofi-Aventis
Article History
Accepted: 15 April 2021
First Online: 15 May 2021
Declarations
:
: This study was funded by Sanofi-Aventis.
: K.S. is a Sanofi employee. VTI, MVM, ENS, IVM, AAS, EIS, and LKP have no conflicts of interest that are directly relevant to the content of this article.
: This study was a secondary analysis of anonymized patient data from three previously conducted studies, so specific ethics approval was not required. All three studies were approved by the Independent Interdisciplinary Ethics Committee on Ethical Review for Clinical Studies, which is the operating ethics committee in the Russian Federation (MANPOWER: Protocol #13 dated 28 August 2015; LIDER 1: protocol #18 dated 23 November 2012; LIDER 2 protocol #08 dated 17 May 2013).
: This study was a secondary analysis of anonymized patient data from three previously conducted studies; therefore, informed patient consent was not required.
: Not applicable.
: Qualified researchers may request access to data and related study documents, including the study report, study protocol with any amendments, statistical analysis plan, and dataset specifications. Further details on Sanofi’s data-sharing criteria, eligible studies, and process for requesting access can be found at ExternalRef removed.
: Not applicable.
: KS developed the study design and draft protocol, reviewed every version of the manuscript, and enriched the discussion section. VTI, MVM, and IVM contributed to the design of the study and its supervision and discussion. All authors participated in the acquisition, analysis, and interpretation of the data. All authors have also read and approved the final version of the manuscript, except for Liudmila K. Palgova who passed away due to COVID-19 before final submission.