Summary
Includes final version of study protocol as approved by first regulatorethics committees registration number of clinical study in a WHO or ICMJE approved registry and the approvals required for the enrolment of first subject in at least one clinical centre according to EU and national legislation Study protocol will be developed by SERMAS in collaboration with CTUs and EFPIA partners according to ICHE6R2 Guideline For Good Clinical Practice Scheduled CDGO plus 11 months
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