This report provides Deliverable 6.2: MENTINA Trial study initiation package and ethical approvals report (D6.2) is the second deliverable of Work Package 6 – MENTINA Delivery and Evaluation (WP6).
D6.2 presents key trial information, including special ethical consideration and decisions made in the MENTINA randomized controlled trial (RCT) trial setup. These decisions culminated in the preparation of the MENTINA trial protocol to be submitted for both ethical and separately, Medical Device Regulation (MDR) approval. This deliverable also outlines adherence to GDPR.