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Data are however available from the authors upon reasonable request and with permission of Inserm.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data Availability Statement"}},{"value":"NB, AD, LL and JC had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: NB, MH, JMT, JCR. Acquisition, analysis, or interpretation of data: NB, AD, LL and JCR Drafting of the manuscript: NB, LL, JCR. Critical revision of the manuscript for important intellectual content: all authors.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors' Contributions"}},{"value":"Institut national de la sant\u00e9 et de la recherche m\u00e9dicale (Inserm) is the sponsor of the Treocapa trial. The project leading to this application has received funding through the Connect4Children consortium from the Innovative Medicines Initiatives 2 Join Undertaking under Grant Agreement no. 777389. This Joint Undertaking receives the support from the European Union\u2019s Horizon 2020 research and innovation programme and EFPIA.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"The funding organization had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.\u00a0The publication reflects the author's view and neither\u00a0Innovative Medicines Initiatives\u00a0(IMI) nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Role of the Funder\/sponsor"}},{"value":"Written informed consent was obtained from both parents.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"Not applicable.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}},{"value":"Not applicable.","order":10,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code Availability"}}]}}