First study subject approvals package

This deliverable scheduled prior to enrolment of first study subject includes a a final version of study protocol as submitted to regulators ethics committees no need to change deliverable if later amendments b a registration number of clinical study in a WHO or ICMJE approved registry please note result posting for the study must be possible and c approvals ethics committees and national competent authority if applicable required for invitation enrolment of first subject in at least one clinical centre