Ethical considerations
MAY
This study will be conducted in accordance with the Declaration of Helsinki, Edinburgh revision (2000), with the directive CPMP/ICH/135/95, implemented by the Ministerial Decree of 15 July 1997 (Good Clinical Practice) and in accordance with the Ministerial Decree of 10 May 2001 published in the Official Gazette no. 139 of 18 June 2001. In this regard, the medical interventions and laboratory and instrumental analysis procedures envisaged by this protocol are normally considered to be of good clinical practice in patients of this type.The protocol has been approved by the Tuscan Pediatric Ethical Committee protocol n. 302/2021, with amendment n. 278–2/2022.