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This approval was based on the efficacy and safety demonstrated by the 12-week, replicate, placebo-controlled Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer (GOLDEN) 3 and GOLDEN 4 (NCT02347761 and NCT02347774, respectively), and the 48-week GOLDEN 5 (NCT02276222) phase III randomized clinical trials [20, 21]
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Combining them may increase side effects and risks.
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