Fig. 1.

Study procedure. An overview of all study visits/ measurement points plus the corresponding time periods between the visits is illustrated. For each study visit, a deviation of ± 7 days is allowed. In order to preselect potentially appropriate participants, an online pre-screening precedes the actual screening. Screening and baseline can be performed on the same day. Baseline has to be done at maximum 4 weeks before treatment start; otherwise, there will be an extraordinary visit. An additional follow-up visit 48 weeks after baseline can be conducted on a voluntary basis. Blood samples can be taken at any time point before treatment start (after informed consent) and is not mandatory for participation in the UNITI-RCT