León-Valenzuela, Angel
Palacios, Juan Sánchez
del Pino Algarrada, Rogelio
Funding for this research was provided by:
Merz Pharmaceuticals GmbH (N/A)
Article History
Received: 12 September 2019
Accepted: 26 March 2020
First Online: 8 April 2020
Ethics approval and consent to participate
: The study protocol was approved by a local ethics committee and the directors at each participating site, allowing access to data collected in registries and the electronic medical record. The name of the ethics committee that approved the study is “CEIC Cádiz” (Cádiz Ethics and Research Committee).Written informed consent was obtained from the participant’s legal guardians for both the interventions and to participate in the study.The requirement to obtain new informed consent from patients and Committee approval for secondary analysis during the pair review process was waived because it was classified as a retrospective study on an anonymous database, (“EPA-OD”), based on national regulations (Order SAS / 3470/2009 of December 16).
: Not applicable.
: The authors declare no competing interests.