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As two of the three studies used the Amplatzer device and one used the STARFlex device (CLOSURE 1), we conducted a sensitivity analysis for non-fatal ischaemic stroke excluding the CLOSURE study.
Although RB and COM maltodextrins were under the same DE range, the time taken for each cell migration in the wound closure study was found to vary, significantly depending on its maltodextrin source.
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This modeling amendment ensures that the standard velocity model in conditional moment closure studies can now be used for MMC computation as well.
Although most depth of closure studies have been conducted on a limited number of sites, the great quantity of airborne lidar bathymetry data collected over the past decade allows for a much wider study region.
These differences have been observed in our previously published school closure studies [ 8, 19], and arise from shifting the school-closure period to later, thus having greater impact on the peak and duration of the epidemic curve.
A study exit will be documented for any of the following: subject death, study closure, subject withdrawal, investigator withdrawal, or subject lost to follow-up.
Another potential limitation of school-closure studies that rely on surveillance data are that observed reductions in disease might be caused by changes in health care seeking behavior associated with the break and might not represent actual disease reductions.
Additionally, hemostasis was achieved prior to any wound closure and study surgeons were instructed to use each study device according to their respective instructions for use.
In the CLOSURE I study, all patients undergoing PFO closure were assigned to clopidogrel 75 mg/day for 6 months and aspirin 81 or 325 mg/day for 2 years.
In the CLOSURE I study (Starflex device), there was no difference between PFO closure and medical therapy with respect to non-fatal ischaemic stroke (RR 0.87, 95% CI 0.40 to 1.87).
The executive committee will be responsible for high-level decisions affecting the running of the trial (eg, closure of study sites, response to emerging safety issues), and will convene quarterly or more frequently, as required.
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