Submission package
Version 1.0 – already submitted
Version 2.0 – already submitted
Version 3.0:
1. Protocol – in preparation
2. Protocol Resume – in preparation
3. Protocol summary of changes – in preparation
4. Protocol appendix – in preparation
5. ICF – in preparation
6. IB – awaits approval from Authorities
7. QoL Questionnaires – awaits approval from Authorities