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