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Authors
Baud, Olivier
Lehert, Philippe
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Article History
Received: 2 May 2024
Revised: 2 August 2024
Accepted: 9 September 2024
First Online: 24 October 2024
Competing interests
: The authors thank Aguettant Pharma for a provided unconditional grant. This financial sponsor had no implication in study design, data collection, analysis, decision to publish or preparation of the manuscript.
: The trial was approved by the national ethics committee (Comité de Protection des Personnes, Ile-de-France II, Necker), the French National Drug Safety Agency (EudraCT number 2007-002041-20), and the French data protection authority (Commission Nationale de l’Informatique et des Libertés). Written informed consent was obtained from parents of all eligible infants before randomization. The trial was registered at ClinicalTrials.gov (NCT00623740) before the first patient was enrolled.
