D5.2 / Midterm recruitment report (dBM-DEV study)

This deliverable reports on the progress made on the dBM-DEV study (for further information, including the study protocol, refer to D5.1) with respect to the regulatory approval, in particular the required modifications in the protocol and the resulting amendments submitted to the ethical committees of each clinical site (i.e., TUD, CHUT, FIN, KCL). Clinical sites collaborated to develop and implement targeted recruitment strategies, and each site prepared its associated recruitment material. Clinical experts agreed on the Standard Operating Procedures (SOPs), including the training material, to facilitate the seamless and efficient execution of the dBM-DEV study. Further, the deliverable reports on the initial recruitment rate, challenges faced and mitigation strategies implemented, as well as the available cohorts at each site and the description of the current state of the dataset. Key demographic and clinical information about the study participants enrolled at the time of this report is provided in the Recruitment progress, challenges, and mitigation strategies section.