Data availability
Data collected for the study and presented herein will be made available to others when the end-of-trial reports, after 3 years of follow-up, have been published. Anonymized participant data can be obtained upon reasonable request from the corresponding author. Proposals will be reviewed on the basis of scientific merit, ethical review, available resources and regulatory requirements. After approval of a proposal, anonymized data will be made available for reuse. The corresponding author has the right to review and comment on any draft papers based on these data before publication. Availability will follow General Data Protection Regulations. Data will be organized in a data dictionary and participant data will be de-identified. Related study documents, including the informed consent forms (in Norwegian) will also be available. The study protocols and the SAP are found in the 