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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