- To clarify that adverse events that are either expected as part of the stroke condition or known side effects of the IMP do not need to be expedited as Serious Adverse Events but will be recorded in the patients' notes.
- Pneumonia and death due to presenting stroke will be reported as trial outcomes.
- Defined events of interest will continue to be collected as SAEs
- Clarifying that co-enrolment with CTIMPS not sponsored by University of Nottingham is permitted where trial treatments are already used in clinical care and if accepted into practice would be used together; would have to be agreed and signed off by the sponsors and CIs of both trials prior to co-enrolment.
- Change of sponsor representative details following adminsitrative change reported in SA01.
- Change of trial pharmacist's name.
- Correction of typos in the text relating to Appendices numbering.
- Changes to protocol in versions 1.1,1.2,1.2 and 1.3 summarised in amendment log at the end of the protocol
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