Funding for this research was provided by:
Ministero della Salute (Ricerca Corrente and "5x1000" voluntary contributions)
Università di Pisa (D.R. n. 33134 29/05/2018)
Ministero della Salute (IT) and Regione Toscana (GR-2011-02348280)
Received: 8 July 2019
Accepted: 19 November 2019
First Online: 29 November 2019
Ethics approval and consent to participate
: This study protocol was approved by the Pediatric Ethic Committee of Tuscany Region (Protocol Number: 126/2014), with written informed consent obtained from a parent/guardian of each participant. The study was conducted in accordance with the 1964 Declaration of Helsinki and its later amendments, and the International Conference on Harmonization Guidelines for Good Clinical Practice.
: Not applicable.
: The authors declare that they have no competing interests.