Below is a link to approval documents for all of the substantial amendments which have been made for this trial. The folders below contain the relevant amended documentation and approval letters. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.
- Amendment 6 - IMP processing change
Amendment 5 - Protocol / PIS update
- Ethics Approval [.pdf]
- MHRA Approval [.pdf]
- Amendment 4 - RSI updated
- Amendment 3 - Addition of sites / PI change
Amendment 2 - Protocol / PIS update
- Ethics Approval [.pdf]
- MHRA Approval [.pdf]
- Amendment 1 - Protocol / PIS update
- Ethics Approval [.pdf]
- MHRA Approval [.pdf]