- This amendment comprises protocol updates changing the primary endpoint definition of early death from day 7 to day 28 in TICH-3. We are updating the definition to ensure the trial would be powered enough to detect a significant difference.
- Amendment has also been made to the DASH-2 eligibility criteria, requiring confirmation of a negative pregancy text, adding the previously omitted massive haemotoma exclusion and updating addictive to additive in exclusion #9.
- We have also updated the TICH-3 eligibility checklist and enrolment form for use in the DASH-2 sub-study.
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