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📢 Important
Reminders 📢
* Please
be aware that as of the 30th June 2025 NO stock
from the previous batch, with an expiry of September 2025, should be re
dispensed to participants. It should be collected and destroyed on site. If
the participant requires extra stock, then an unscheduled dispense should
be performed and the participant dispensed an additional bottle.
*
At the TRACK DSMB meeting on 04th June 2025, the DSMB recommended “To
continue the trial unchanged”. In addition, the DSMB recommended “To
continue the trial unchanged” at the DSMB meeting on 04th June 2025. “We encourage the study team and site PIs to
maximize recruitment in active countries during June 2025 and in Germany
during June through September 2025. We encourage the investigators to minimize withdrawal of
consent and loss to follow-up and to re-double efforts to minimize
discontinuation of study drug for non-clinical reasons.”
*
A reminder that outcomes should NOT be reported as ‘Undetermined Cause
of Death’ whenever possible. Please check TRACK Protocol Appendix 1: TRACK
Trial Endpoint Definitions and make sure they cannot be classified
as CV/non-CV death. If two lethal conditions contribute to death
equally and the competing causes of death are cardiovascular and
non-cardiovascular, cardiovascular death should be chosen. If you have any
questions or concerns please do not hesitate to
reach out to the TRACK team.
*
On the Study Medication Page whenever possible the reason for
discontinuation should not be reported as “other”. Rather please
consider all the listed options in the database for short-term and
long-term stoppages (as shown below) before selecting “other”.
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