Mondardini, Maria Cristina http://orcid.org/0000-0002-8398-3166
Sperotto, Francesca
Daverio, Marco
Caramelli, Fabio
Gregori, Dario
Caligiuri, Maria Francesca
Vitale, Francesca
Cecini, Maria Teresa
Piastra, Marco
Mancino, Aldo
Pettenazzo, Andrea
Conti, Giorgio
Amigoni, Angela
Article History
Received: 2 March 2019
Accepted: 10 October 2019
First Online: 11 December 2019
Ethics approval and consent to participate
: The Study Protocol Final Version 2.0 (registered on 18 September 2016) was approved by the Ethics Committee of University-Hospital S.Orsola-Malpighi of Bologna on 22 March 2017. All centers approved the protocol. The study was also authorized by the Italian Medicines Agency National Authority. Written informed consent will be obtained from both parents of each involved child.
: Not applicable.
: Orion Pharma assured the liability insurance of the study (total amount €10,758). The supporter had no role in the study design, decision to publish and preparation of the manuscript, and will have no access to or role in data collection and analysis. The authors have not received any personal funding or compensation for the research. Therefore, the authors did not have any personal interest to declare.