- This amendment comprises of updates to the inclusion and exclusion criteria, regarding the consciousness levels of potential participants (NIHSS score added for clarification of which participants can be recruited); the disposition of the participant at day 14 primary outcome (participants need to be in treating organisation for this) and a change to the oxygen levels in the exclusion criteria (up to 35 litres deemed safe with the use of PES).
- This amendment also comprises of various administrative changes; namely a protocol version table has been added, the WHO ID added to the front page, and sentences throughout the protocol added for clarification.
- This amendment also extends the Serious Adverse Event Collection from days 0-7 to days 0-9 to account for the change in the participant treatment schedule, whereby participants can have three days of treatment followed by a 1 or 2 day break, followed by another three days of treatment, to ensure sites that do not operate at weekends can recruit and treat eligible patients.
- Finally, an appendix has been added at the behest of the Austrian ethics committee, to outline their consent procedure that will be approved and followed in Austrian sites.
|
