Availability of data and materials
Deidentified, individual participant data, along with a data dictionary describing variables in the dataset, will be made available to researchers whose proposed purpose of use is approved by the EU-SolidAct Trial Steering Committee. To request the dataset, please address directly to the corresponding author (marius.troseid@medisin.uio.no) or to Dominique Costagliola (dominique.costagliola@iplesp.upmc.fr) to obtain a data access form. All requests will be evaluated by the Trial Management Team and the EU-SolidAct Trial Steering Committee. For accepted requests, data will be shared after signing a data transfer agreement with the study sponsor. Data will be shared via a secure online procedure. Related documents, such as the study protocol, statistical analysis plan, and informed consent form, will be made available (with publication) on request to the corresponding author. The data will be open access for the informed consent form, protocol, and statistical analysis plan.