Funding for this research was provided by:
Received: 7 August 2019
Accepted: 30 September 2019
First Online: 15 October 2019
Ethics approval and consent to participate
: The study conforms to the International Conference on Harmonisation guidelines on Good Clinical Practice and with national and local regulatory requirements. Ethics approval to conduct the study has been obtained at all sites. Patients are informed that participation is voluntary and they may withdraw at any time without consequences to their further treatment. All patients (or a legally authorised representative) who consent to enrol in the study are required to provide written informed consent.
: Not applicable.
: EC, SS, MM, JA, SPS, YHC, and AB are investigators in the registry. VS and GI are employees of Somahlution. LPP is a consultant for Somahlution. MYE is the Principal Investigator of the registry and a consultant for Somahlution.