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Article History

Accepted: 19 December 2023

First Online: 4 February 2024

Declarations

:

: The study was supported by a grant from the French Ministry of Health (PHRC 2017, PREDICT-CF). The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

: The authors have no competing interests to declare in relation to this work.

: This study was approved by the institutional review board (Comité de Protection des Personnes, Nord Ouest IV, no. EUDRACT: 2018-002624-16) and registered in the clinicaltrails.gov database under reference NCT03894657.

: Written, informed consent was obtained from all participants or their guardians.

: Not applicable.

: Data from this study cannot be shared publicly, as the procedures carried out with the French data privacy authority [Commission nationale de l'informatique et des libertés (CNIL)] do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation of the data by other interested researchers may be considered by AP-HP, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable French and European regulations. The request must be addressed to the Delegation for Clinical Research and Innovation (DRCI) at <u>secretariat-direction.drc@aphp.fr</u>.

: Not applicable.

: NB, JMT, and ISG contributed to the study conception and design. Material preparation, data collection, and analysis were performed by NB, SU, FF, LC, GL, LFD, SR, YZ, NS, KB, TB, ECD, CM, ED, ML, PR, MG, MM, RE, CT, LW, RB, MS, SB, and ISG. The first draft of the manuscript was written by NB, EB, ISG, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.