Vencio, Sérgio http://orcid.org/0000-0001-9283-486X
Manosalva, Juan P.
Mathieu, Chantal
Proot, Pieter
Lozno, Hernan Yupanqui
Paldánius, Päivi M.
Funding for this research was provided by:
Novartis Pharma AG
Article History
Received: 10 February 2021
Accepted: 7 June 2021
First Online: 15 June 2021
Declarations
:
: PMP was the medical lead of the VERIFY study and employed by Novartis (till Jan 2020) and received grants from Juselius Foundation and UPM Biomedicals, outside the submitted work. CM, SV and YLH declare that they have no competing interests. PP and JMP are employed by and own stocks in Novartis.
: The study protocol was approved by local ethics committees of all study sites and written informed consent was provided by all participants before the start of the trial. The study was designed and carried out in accordance with International Conference on Harmonization Tripartite Guidelines for Good Clinical Practice (ICH Expert Working Group) and according to the ethical principles of the Declaration of Helsinki, and was overseen by an independent, unmasked data monitoring committee for all safety events.
: All authors have provided consent for the publication of this article.