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The recruitment total for the trial to date is: | 54 |
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DASH-1 is now closed to randomisation.
Please continue to enter follow-up data and SAEs for existing
participants.
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NOTE: |
Serious Adverse Events (SAEs) — we have a legal
responsibility to collect all SAEs occurring within the first
7 days (including SARs/SUSARs). Please remember that all fatal SAEs and safety outcome events – hyponatraemia (low sodium), hypervolaemia (fluid overload), seizures, VTE (DVT and/or PE), ischaemic stroke, TIA, MI/ACS and/or PAD – need to be reported, even those after the first 7 day period (until the final day 90 follow-up).
Please assess if expected according to SmPC:
https://medicines.org.uk/emc/product/5447/smpc
Investigators have a legal responsibility to report applicable SAEs
to the chief investigator within 24 hours.
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