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The trials completed so far on this drug have been exclusively with women in long-term, monogamous relationships where simply the spark has gone.
"Off-label use was rampant, and it was a real problem in getting the trials completed," said Dr. William H. Maisel, a cardiologist at Beth Israel Deaconess Medical Center in Boston, who was chairman of one of the F.D.A. advisory panels.
The publication rate was a little higher at 39.8% than that of the trials completed before July 14, 2009 (see Table 1).
By the year 2000, a meta-analysis of the trials completed in subjects aged 60 years or older, with systolic blood pressure ≥ 160 mm Hg and diastolic blood pressure ≤ 90 mm Hg, had shown that active treatment reduced total mortality (by 13%), and cardiovascular mortality (by 26%), and stroke (by 30%).
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The trial completed 20 months after initiation following the second interim analysis.
The 559 patients who took part in the trial completed the 40-item questionnaire.
All twenty volunteers recruited for the trial completed the study (twelve women and eight men).
The trial completed recruitment in November 2009 and the results were awaited.
Seventy-three percent of the subjects who entered the trial completed 2 years of treatment.
Nineteen out of the 21 patients enrolled in the trial completed the 4-month Treatment Period and laboratory evaluation.
All 100 patients enrolled in the trial completed IV lacosamide infusion, supporting the feasibility of rapid initiation.
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CEO of Professional Science Editing for Scientists @ prosciediting.com