Simon, Arne http://orcid.org/0000-0001-9558-3330
Gehrmann, Susanne
Wagenpfeil, Gudrun
Wagenpfeil, Stefan
Funding for this research was provided by:
AbbVie Deutschland (German Synagis Registry)
Article History
Received: 6 November 2017
Revised: 14 February 2018
Accepted: 29 March 2018
First Online: 12 April 2018
Compliance with ethical standards
:
: AbbVie Deutschland GmbH & Co KG, Wiesbaden, Germany provided financial support for this Registry. AbbVie participated in the review and approval of the manuscript. Susanne Gehrmann is Medical Unit Leader in the Medical Affairs Department of AbbVie Deutschland GmbH & Co.KG, Wiesbaden and may own AbbVie stock or stock options. Arne Simon has received scientific grants from Abbott GmbH, Wiesbaden for the DSM RSV Paed Study and honoraria for the development and scientific administration of Internet-based Version of the German Synagis™ Registry from AbbVie Deutschland GmbH & Co.KG, Wiesbaden, Germany. Stefan Wagenpfeil has received scientific grants from AbbVie Deutschland GmbH & Co. KG for epidemiologic evaluation of the German Synagis™ Registry. Gudrun Wagenpfeil has no conflicts of interest to declare.
: Parents/legal guardians provided written informed consent for data recording on the eCRF and anonymized data analysis and publication for scientific purposes. Before the practical implementation of the protected Internet data entry platform, the medical advisor of the study (AS) obtained approval for the POMS by the Ethics Committee of the Medical Faculty, University of Bonn, Germany (reference no. 132/08). This approval was prolonged to July 2012 on September 9, 2010. After a change of affiliation to the University Hospital Homburg/Saar, approval for the study was obtained by the Ethics Committee of the Medical Association of the Saarland on April 13, 2013 (reference no. Ha89/13).