Serrano, Mercedes
Elias, Maria
Llorens, Marta
Bolasell, Mercè
Vall-Roqué, Helena
Villalta, Laia
Funding for this research was provided by:
Fundació la Marató de TV3 (434/U/2022)
Article History
Received: 9 May 2024
Accepted: 20 June 2024
First Online: 20 July 2024
Declarations
:
: Signed informed consent will be obtained from the parents/caregivers of study participants. The study protocol and consents have been reviewed and approved by the Research & Ethics Committee of the Sant Joan de Déu Hospital (SJDH), Barcelona, Spain, and the ethics committees of the collaborator institutions (Vall d’Hebron Hospital and Parc Taulí Hospital). A copy of the consent will be given to the patient’s parent/caregiver. All data will be anonymized and stored by the research group. The study will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practices, and applicable regulatory requirements. We confirm that we have read the journal’s position on issues involved in ethical publication and affirm that this report is consistent with those guidelines.
: In relation to the manuscript, we, the authors, declare that there are no prior publications or submissions of the document. We also declare that the work is not and will not be submitted to any other journal while under consideration by <i>Trials</i>. Every one of the authors has participated sufficiently in the study, meeting the appropriate authorship criteria (all authors have been involved in conception and design, or analysis and interpretation of data, and drafting the article or revising it critically for important intellectual content), and each has seen, reviewed, and approved this version of the manuscript and takes full responsibility for it. We all agree to its submission for publication. Each author believes that the manuscript represents honest work. Nobody who qualifies for authorship has been omitted from the list of authors. All the authors have complete access to the study data. No identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request.
: The authors declare that they have no competing interests. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000. Informed consent was obtained from all patients for being included in the study.