Guerrini, Renzo http://orcid.org/0000-0002-7272-7079
Chancharme, Laurent
Serraz, Benjamin
Chiron, Catherine
Funding for this research was provided by:
Biocodex
Article History
Received: 4 March 2024
Accepted: 10 April 2024
First Online: 9 May 2024
Declarations
:
: Renzo Guerrini has acted as a principal investigator for the STICLO Italy study, sponsored by Biocodex. He acted as an investigator for studies with Zogenix, Biocodex, UCB, Angelini and Eisai Inc. He has been a speaker and on advisory boards for Zogenix, Biocodex, Novartis, Biomarin and GW Pharma, outside the submitted work. Laurent Chancharme and Benjamin Serraz are full time employees of Biocodex. Catherine Chiron has acted as a principal investigator for the STICLO France study, sponsored by Biocodex. She has been a speaker and on advisory boards for Advicenne, BIAL, Biocodex, Eisai, GW Pharma, and Orphelia outside the submitted work.
: According to the regulations, in France the protocol and informed consent form were submitted for review and approved by the Ethics Committee of the principal investigator, Paris-Cochin Hospital Center. In Italy the protocol and informed consent form were reviewed and approved by the Ethics Committees of each center (listed in the Supplementary Material). Both studies were performed in accordance with the Helsinki Declaration of 1964, and its later amendments, Good Clinical Practices, and according to the local regulatory requirements in force in France and in Italy. Parents and children were informed about the aim of the study, its duration, the method used, the benefits that the children could get from this study as well as the potential constraints and risks. Written informed consent of the parents or the authorized representative of participant in this study was required before study enrolment. The informed consent was to be signed, witnessed (if signed by a representative), dated and stored by the investigator.