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- This amendment comprises of the addition of a cognitive sub-study, which introduces further follow up time points at day 180 and day 365, with cognitive scales being used at each follow up point, as well as the scales being used previously in the trial protocol.
- The day 7 follow up has also been removed as this data will be collected after treatment on days 1-6.
- This amendment also comprises various administrative changes, such as wording changes and sentences added for clarification.
- Appendix M has been added to outline the cognition sub study scales, and appendix N has been added to outline the IQCODE scale.
- All patient facing documents (information sheets, consent forms and GP letter) have been updated with the follow up time points, and cognition has been added in as a follow up measure.
- This amendment will also add a postal follow up, should we not be able to contact a participant by telephone to complete the follow up. Finally, this amendment introduces an informant information sheet and consent form, as well as an aphasia friendly information sheet and consent form.
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