Ethics approval and consent to participate {24}
The study received approval from the ethics committee NedMec, the Netherlands, on 19 September 2022 (reference number 22–750). With the TwiCs design, a stage-informed consent procedure is applied (12). In the first stage, at cohort entry, patients are asked for consent to participate in the cohort study (collection of medical and patient reported outcomes) and for consent to be randomized for future intervention studies within the cohort. Next, patients who are randomly selected for the intervention group in a RCT within the cohort are asked for consent to participate in the intervention study.