H - Requirement No. 12

For each clinical study the following documentsinformation must be submitted as a deliverable in one package prior to enrolment of first study subject i Final version of study protocol as submitted to regulatorsethics committees ii Registration number of clinical study in a WHO or ICMJEapproved registry with the possibility to post results iii Approvals ethics committees and national competent authority if applicable required for invitationenrolment of first subject in at least one clinical centre