Pfeil, Alexander http://orcid.org/0000-0002-2709-6685
Nussbaum, Anica
Renz, Diane M.
Jung, Christian
Oelzner, Peter
Malich, Ansgar
Wolf, Gunter
Böttcher, Joachim
Funding for this research was provided by:
UCB Pharma GmbH, Monheim, Germany (IIS-2014-101458)
Article History
Received: 1 August 2018
Accepted: 11 December 2018
First Online: 19 December 2018
Compliance with ethical standards
:
: The authors declare that they have no conflict of interests.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Ethical approval was obtained at each site as described previously [CitationRef removed]. The study protocol including the prespecified analysis of X-rays was registered in clinical trials.gov (trial identifier: NCT00152386). In addition, all examinations were performed in accordance with the rules and regulations of the local Human Research and Ethics Committee of the Friedrich-Schiller-University Jena. The study is a retrospective post hoc analysis of data sets which are considered in the RAPID 1 trial [CitationRef removed]. Based on the regulations of the ethics committee of the Friedrich-Schiller-University Jena, a registration and a separate consent from any patient were not necessary.