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Ultimately, in our hospital, three patients were included before the study closure.
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Before these studies, CLOSURE I 23 (the first randomized study) did not show any significant changes in the study endpoints among patients treated with drugs and those who underwent PFO closure by the Starflex device (NMT Medical, Inc., Boston, MA, USA).
Most were known to have discontinued trial treatment: 132/148 (89%) women randomised to combined HRT stopped treatment permanently before one year (n=118) or were on a temporary interruption of treatment at one year (n=14) and did not restart treatment before study closure; in the placebo group 84/106 (79%) had discontinued trial treatment (68 permanently and 16 on a temporary interruption).
No interim analyses were planned and the data were not analyzed before study closure.
Survival periods were counted in months from the date of first visit to date of death or last follow-up before study closure.
We received 202 responses before study closure: 34 faculty, 98 PGY1 residents, and 70 senior residents (PGY2+).
As a result, a large proportion of patients could not be included or were lost to follow-up before study closure.
Planned study closure, Oct/Nov.
Before the early closure of this study, five patients were enrolled, of whom four were evaluable for toxicity/feasibility.
All endpoints and SAE will be finally evaluated before closure of the study.
Information from all cases is used, including cases whose follow-up ends due to closure of the study, and those lost to follow-up before closure.
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