The trial will be carried out in accordance with the Helsinki Declaration and the current statutory requirements and legislation in the participating countries. The study has been approved by the relevant Medical Research Ethics Committees, the Norwegian Medicines Agency and the relevant regulatory authorities of each participating country. Data will be recorded anonymously, but a numeric code will be assigned in order to be able to track the data. All investigators as well as the ethics committees and relevant health authorities, however, will have access to the source data. The principal investigator in each country will establish monitoring of the study by an independent monitor as required.