Funding for this research was provided by:
Sigma-tau Industrie Farmaceutiche Riunite S.p.A., Italy, currently Alfasigma S.p.A, Bologna. Italy
Received: 29 December 2020
Accepted: 29 April 2021
First Online: 8 May 2021
: The study followed a centralized regulatory submission at the European Medicines Agency (Approval 2013, prot. n° 3381). Ethical approval was received also by Hospital Ethics Committee in all the Countries participating in the study. Patients were enrolled after Informed consent signature.
: All authors contributed, have reread and consented to the publication.
: GGM and EMP are full-time employee of Alfasigma S.p.A.. ST, MI, AB, were full employee for Alfasigma S.p.A at the time of the design, implementation and data analysis. OB, TJ, AB, ZB, EB, LV, CH, SD and RHB were on Euratesim<sup>®</sup> advisory board of Alfasigma and the legacy company Sigma-tau Industrie Farmaceutiche Riunite and received financial support for the study. NV declared that he has no competing interests.