This deliverable is the study approvals package for TWOBE, it will include the final version of the TWOBE trial protocol, the registration number of the clinical trial (clinicaltrials.gov) and the regulatory and/or ethics approvals. This deliverable is connected to D4.3 First study subject approvals package for FRONE. The research protocol is first developed for clinical trial FRONE, and afterwards adapted to TWOBE considering the Belgian and Dutch regulations. The deliverable is associated to O4.1 Establish the protocol for two RCT (FRONE in France, TWOBE in both Belgium and the Netherlands) to demonstrate the clinical relevance of GerOnTe.