Ethics approval and consent to participate
ICH
All patients signed consent to study participation following written and oral information. The study was conducted in compliance with principles in the Declaration of Helsinki, 1996 version, as well as in accordance with the ICH Harmonized Tripartite Guideline for Good Clinical Practice and applicable regulatory requirements. The protocol was approved by the Regional Ethics committee in Stockholm (Dnr 2015:4/11) and the trial is registered in the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) with the number 2015-004571-73. The funder had no role in design and conduct of the trial.