Crisafulli, Salvatore
Ingrasciotta, Ylenia
Vitturi, Giacomo
Fontana, Andrea
L’Abbate, Luca
Alessi, Ylenia
Ferraù, Francesco
Cantarutti, Luigi
Lazzerini, Debora
Cannavò, Salvatore
Trifirò, Gianluca
Funding for this research was provided by:
Kyowa Kyrin
Article History
Received: 22 December 2023
Accepted: 18 March 2024
First Online: 9 April 2024
Compliance with ethical standards
:
: G.T. has served in the past three years on advisory boards/seminars funded by SANOFI, Eli Lilly, AstraZeneca, Abbvie, Servier, Mylan, Gilead and Amgen; he was the scientific director of a Master program on pharmacovigilance, pharmacoepidemiology and real-world evidence which has received non-conditional grant from various pharmaceutical companies; he coordinated a pharmacoepidemiology team at the University of Messina until October 2020, which has received funding for conducting observational studies from various pharmaceutical companies (Boehringer Ingelheim, Daichii Sankyo, PTC Pharmaceuticals). He is also scientific coordinator of the academic spin-off “INSPIRE srl” which has received funding for conducting observational studies from contract research organizations (RTI Health Solutions, Pharmo Institute N.V.). All the above-mentioned activities are not related to the topic of the manuscript. Y.I. is the CEO of the academic spin-off “INSPIRE srl”, which has received funding for conducting observational studies from contract research organizations (RTI Health Solutions, Pharmo Institute N.V.) and from pharmaceutical Companies (Chiesi Italia, Kyowa Kirin s.r.l., Daiichi Sankyo Italia S.p.A.); D.L. is an employee at Medical Affairs of Kyowa Kirin. All the other authors have no conflict of interest to declare.
: Participants in the study provided written informed consent before participation in the study.
: Participants in the study provided a written statement of consent at the time of registration for their data to be used for the purpose of this research and publication of study results.
: This study (2020-59-IT-CRY, internal protocol code 31-21) was approved by the Ethical Committee of the Azienda Ospedialiera Universitaria Policlinico “G. Martino” (Messina), and formally notified to AIFA (Italian National Medicine Agency) in line with the local applicable regulation.