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Nausea, diarrhoea and weight loss were the most common adverse events recorded in patients in the four trials, but they were generally mild to moderate in intensity and generally occurred in the first weeks of treatment.
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The lung function improvements on top of current bronchodilation clearly indicates that roflumilast improves lung function over and above what can be achieved with other COPD treatments alone.
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Drugs used off label may have unrecognized safety and efficacy problems.