Rodríguez, Mónica
Vozmediano, Valvanera
García-Bea, Aintzane
Novák, Zoltán
Yáñez, Anahí
Campo, Cristina
Labeaga, Luis
Funding for this research was provided by:
FAES FARMA S.A (N/A)
Article History
Received: 7 May 2019
Revised: 25 November 2019
Accepted: 23 December 2019
First Online: 9 January 2020
Compliance with ethical statements
:
: CC, AGB, and LL are full-time employees of FAES FARMA S. A. MR and VV have no conflicts of interest other than receiving funding from FAES FARMA, S.A., for designing the PK trial and conducting the modeling and simulation analysis. The remaining authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
: The study was approved by the Pediatric Committee of the European Medicines Agency (PDCO) and conducted in accordance with the principles of the Declaration of Helsinki. The study was conducted at eight sites in four countries (Australia, Germany, Spain, and Sweden), all of which had received previous approval by the corresponding Institutional Review Board.
: Parents provided written consent and children, when considered to be old enough, provided assent for participation.