First study subject approvals package

a. Final version of study protocol as approved by first regulator / ethics committee(s) b. Registration number of clinical study in a WHO- or ICMJE- approved registry that also allows later posting of study results. c. Approvals required for invitation / enrolment of first subject in at least one clinical centre (if applicable): ethics committees, national competent authorities and copies of opinion or confirmation by the competent Institutional Data Protection Officer and/or authorization or notification by the National Data Protection Authority. If the position of a Data Protection Officer is established, its opinion/confirmation that all data collection and processing will be carried out according to EU and national legislation