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No TTP cases were identified in the large trial involving 20,000 patients that was conducted before Plavix gained F.D.A. approval for marketing.
Mitchell Warren, executive director of AVAC, an advocacy group for AIDS vaccines, microbicides and other means for blocking the disease, called the results disappointing, but said the large trial would pave the way for future ones.
Recurrence appeared as a significant clinical problem in the large trial programme of sumatriptan.
The smaller trial was only partially blinded and showed no difference in any of the outcomes; the large trial demonstrated marginal reduction in proportional hematoma growth, but no significant difference in clinical outcome.
The large trial sample included several important US sub-groups African-Americans (50% of sub-groups African-Americansth men (51%), and women (21%)—that are represub-groups African-Americanstive adults in care in the US.
It is worth noting that the large trial was conducted with randomisation stratified for both groups.
Similar(43)
As expected, the large trials showed significantly better reporting quality than small trials.
This was also demonstrated in the large trials comparing TR of SpO2 [ 36].
The larger trial will be run by researchers at the Universities of Sheffield, Dundee and Brunel.
Also, the earlier trials measured vision after only three months while the larger trial measured after one year.
The larger trial was the one on which its application with the F.D.A. mainly rested, she said.
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