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In a long-term extension trial one-quarter of mipomersen-treated patients had an average liver fat fraction greater than 20%.
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That detention facility, they said, is better equipped to handle long-term pre-trial stays, and has better mental health support.
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The FDA is requiring the company to perform a long-term cardiovascular outcomes trial.
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Contrave, but the agency went against its panel's advice and asked the company to conduct a long-term cardiovascular outcomes trial before the FDA would again consider the drug.
WSJ: Federal Panel Approves Weight-Loss Drug Qnexa
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It may take a long-term game of trial and error.
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Januarie is due to arrive this week on a three-year deal while Goode is on trial and hoping for a long-term deal.
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Beyond niacin, the trial is likely to have a long-term impact on how heart drugs are invented, studied and approved.
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The Whole System Demonstrator trial followed the progress of 1, 500 people with three long-term conditions in three different parts of England.
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Still, the most important lesson from the trial may be that it is incredibly difficult to tease out the long-term effects of a medicine.
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However, they warn that the trial was very small, and said patients would be monitored for 15 years to assess long-term effects.
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Vioxx was pulled from the market in September 2004 after a trial clearly showed that it increases the risk of heart attacks and strokes for at least long-term users.
FORBES: Magazine Article