Funding for this research was provided by:
MCL Pharma LLC, Moscow, Russia
Article History
Received: 6 May 2020
Accepted: 25 October 2021
First Online: 9 November 2021
Declarations
:
: This study was conducted in compliance with the principles of the Declaration of Helsinki approved by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013 and the rules of Good Clinical Practice that are applied in Russia. The investigators committed not to disclose personal or medical data of the volunteers. The conduct of this clinical study was approved by the Ethics Council of the Ministry of Health of the Russian Federation and local ethical committees of healthcare institutions where the study was to be conducted.
: Not applicable.
: PK was reimbursed for advising another Soledum study by Klosterfrau, Germany, in the last three years he also had honoraria for advisory boards, steering committees and presentations from following companies: AstraZeneca, Bionorica, Boehringer Ingelheim, Chiesi, Engelhardt, GSK, Menarini, MSD, Novartis, Schwabe. OK was principal investigator of the Soledum study. OK: The authors declare that they have no competing interests.