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Authors
Szostek, A. S.
Boucher, P.
Subtil, F.
Zerzaihi, O.
Saunier, C.
de Queiroz Siqueira, M.
Merquiol, F.
Martin, P.
Granier, M.
Gerst, A.
Lambert, A.
Storme, T.
Chassard, D.
Nony, P.
Kassai, B.
Gaillard, S. https://orcid.org/0000-0002-6854-7366
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Funding
Funding for this research was provided by:
PHRCi
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Article History
Received: 24 September 2020
Accepted: 26 February 2021
First Online: 12 March 2021
Declarations
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: The study protocol was approved by the Comité de Protection des Personnes CPP Sud Est III on January 6, 2015 (2014-052B), the French competent authority (Agence National de sécurité du medicament et des produits de santé, ANSM) on November 27, 2014 (141365A-21). This approval applies for all participating centers. It is registered under EudraCT number 2014-004190-16. The study is compliant with the reference methodology of Commission Nationale de l’Informatique et des Libertés. The study is conducted in accordance with the French legislation, the Good Clinical Practice and the Declaration of Helsinki.The parents/legal guardians of the child are informed, orally and through the information sheet given at the preoperative interview. Parents/legal guardians are requested to sign the informed consent before any study procedure is performed (before randomization). A sufficient time is left to the parents/legal guardians for decision to participate.
: Not applicable.
: The authors declare that they have no competing interests.
