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This study was halted after 10 months because of the large number of gynecologic and other adverse events.
Although this study was halted for financial reasons in 2011, the patients that already had received the cellular transplants will be monitored for a period of 15 years according to the original study protocol using public state funding.
This study was halted because of the high mortality rate of diabetic rats following surgery (please see Results section).
This study was halted prior to its completion because of a trend toward increased infection rates in the rhBMP-2 group (19%) compared with the controls (11%).
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By contrast, fewer than 40% had reached the 10-year assessment of HRQoL when the study was halted, resulting in a substantially smaller sample of participants at this time, compared with year 8. (The same was true of the 9-year assessment of HRQoL).
So well, in fact, that the study was halted after following patients an average of 1.9 years instead of the planned five years.
They note that even before the study was halted last summer, more than half of the women who started hormone therapy stopped it on their own within a few years.
In fact, the treatment is considered so effective that the study was halted early because it would have been unethical to continue to administer a placebo to some of the high-risk women in the study group, 459 women at 19 medical centers around the United States.
The patient was declared brain-dead later that day, and the study was halted.
Few participants used adjunctive contraception between the time the study was halted and the time they had their implant removed.
Results Although the planned enrollment was 135 patients, the study was halted after only 71 patients had been randomized because of the unforeseen side effect of leg pain, which occurred almost exclusively in patients with terbogrel treatment.
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