Acknowledgements

The authors would like to thank all involved investigators for their work in relation to the involved trials and the clinical trial teams at ALK for clinical project management, operational oversight, safety monitoring, data management and statistics. The trials and the pooled safety analysis of trial data were funded by ALK, Hørsholm, Denmark, who assumes overall responsibility of the trials. Medical writing assistance for this manuscript was provided by Sussi Boberg Bæch, freelance Medical Writer, funded by ALK.