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The agency's initial review of the Record trial, in 2007, found no problems.
The company's conduct of the Record trial has received sharp criticism from medical leaders for other reasons as well.
However, since the Record trial is the only randomized clinical trial to directly evaluate the cardiovascular risks of Avandia, others have said its results should be taken seriously.
In that 2007 advisory meeting, the Record trial -- specifically devised to assess Avandia's heart risks -- was a significant source of reassurance for Avandia's supporters.
Dr. Krall asked Dr. Nissen if his opinion of Avandia would change if the Record trial — a large study then under way to assess Avandia's risks to the heart — showed little risk.
But the Senate report shows that by at least 2004, company executives were aware that the Record trial was going so poorly that it would never answer the heart question with any kind of certainty.
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CAPRISA participants are also given diaries in which to record trial-related and other information.
The maximum angle of these trials was set as the terminal limit of the dynamometer for the recorded trial.
Each recording trial consisted of 2 s of complete darkness followed by a 10 ms flash (to monitor sensitivity).
The questionnaire data recorded trial participant primary and secondary care health service use, costed using national unit costs [ 58, 59].
All individual voice and brain recording trials were manually inspected and discarded if artifacts were noted.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com