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The phase III placebo-controlled trials of roflumilast evaluated the treatment in two 12-month (Lancet 2009; 374: 685?) and two six-month studies (Lancet 2009; 374: 695?), involving 4,500 patients in ten countries.
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The studies showed a reduction in moderate to severe exacerbations by 17 percent per patient per year (rate of 1.
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