Ethics approval and consent to participate
The trial is conducted in accordance with The Declaration of Helsinki, ICH-GCP, local and national regulations. The trial was approved by The Swedish ethical review board (EPM no 2021-02634, amendment 2021-04572), approval 2021-05-25 and 2021-09-22 and The Swedish medical products agency (LV no 5.1-2020-36673), approval 2021-07-06. The trial was registered online (NCT04842448) and EudraCT number: 2021-000764-30 before start of the trial.