Terlizzi, Vito http://orcid.org/0000-0003-1106-4424
Lucarelli, Marco
Salvatore, Donatello
Angioni, Adriano
Bisogno, Arianna
Braggion, Cesare
Buzzetti, Roberto
Carnovale, Vincenzo
Casciaro, Rosaria
Castaldo, Giuseppe
Cirilli, Natalia
Collura, Mirella
Colombo, Carla
Di Lullo, Antonella Miriam
Elce, Ausilia
Lucidi, Vincenzina
Madarena, Elisa
Padoan, Rita
Quattrucci, Serena
Raia, Valeria
Seia, Manuela
Termini, Lisa
Zarrilli, Federica
Article History
Received: 21 November 2017
Accepted: 12 December 2018
First Online: 22 December 2018
Ethics approval and consent to participate
: We obtained from all patients (or from their legal guardian) the written consent to participate. In according to National Guidelines, observational studies do not require the formal approval by the Ethics Committee. In any case, we asked to the local ethics committee (University of Naples Federico II) that replied confirming what above and sent us the reference of the guidelines: Ministry of Health, Italian Medicines Agency, Guidelines for the Classification and Conduct of Observational Drugs Studies (2008).
: Not applicable.
: The authors declare that they have no competing interests.
: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.