Data availability
The data underlying the results presented in the study are available from CSPOR data center after publication (no end date). Data include individual de-identified participant data, a data dictionary as well as clinical trial protocols. Some restrictions apply due to confidentiality of patient data. Because these data are derived from a prospective clinical trial with ongoing follow-up collection there are legal and ethical restrictions to sharing sensitive patient-related data publicly. Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Data can be requested in context of a research project sent to the corresponding author. Research proposals are approved by the NEOS steering committee.