Data availability statement
The data for this study are available to other researchers on request. The data will be made available for scientific research purposes, after the proposed analysis plan has been approved. Data and documentation will be made available through a secure file exchange platform after approval of the proposal. In addition, a data transfer agreement must be signed (which defines obligations that the data requester must adhere to with regard to privacy and data handling). Deidentified participant data limited to the data used for the proposed project will be made available, along with a data dictionary and annotated case report forms. For data access, please contact the corresponding author.