Radicioni, Milko
Koirala, Ranjan
Fiore, Walter
Leuratti, Chiara http://orcid.org/0000-0001-5594-6029
Guglielmetti, Simone
Arioli, Stefania
Funding for this research was provided by:
Sofar Spa, Italy
Article History
Received: 14 June 2018
Accepted: 14 November 2018
First Online: 29 November 2018
Compliance with ethical standards
:
: The study protocol (No. PSC-DS RECENT-BS 16) was approved by the Ethics Committee of Canton Ticino, Switzerland. All the subjects were given a detailed description of the study and all of them gave written informed consent before enrolment. The study was performed from August to October 2017, in accordance with the Declaration of Helsinki, harmonised European standards for Good Clinical Practice (ICH E6 1.24) and the applicable local laws.
: W.F. is an employee of SOFAR S.p.A., Italy; M.R. and C.L. are employees of CROSS Research S.A.; SA, RK and S.G. are employees of DeFENS, Milan University. CROSS Research S.A. and DeFENS, Milan University, were contracted by SOFAR S.p.A. and received financial support for their services. The authors declare that they have no other relationships or activities that could appear to have influenced the submitted work.