Approval
This study (clinicaltrialsregister.eu registration no. 2017-002766-50) was approved by the Swedish Ethical Review Authority (Dnr 2017/1533-31/2) and the Swedish Medical Products Agency (Dnr 5.1-2017-56212) and registered at ClinicalTrials.gov (NCT03406585). The study was conducted in accordance with the Declaration of Helsinki.