Authors' contributions
HLP
Data were documented by each center into an electronic case research file (eCRF). Statistical analysis and data extraction were performed by Stefan Bruns, Winicker-Norimed, Nürnberg. SK was involved in the planning of the trial and the eCRF. SK, SI, and HLP analyzed the data and wrote the manuscript. All coauthors reviewed data, reviewed and amended the manuscript and agreed to the final version of the manuscript.