Clinical trial -Submission package

The package will contain the final version of the study protocol as submitted to regulators, a registration number of the CT in a WHO or ICMJE-approved registry and approvals from ethics committees and national competent authorities if applicable, prior to enrolment of first subject in at least one clinical centre. It will also include all approval packages (all approval from ethics committees and national competent authorities (if applicable) of all study sites once the last approval has been received.