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2006), and NF-B activation in lung tissue has been shown to correlate with FEV 1 (Crowther et al

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[See Warnings and Precautions (5.1)] A composite safety endpoint intended to capture clinically significant neuropsychiatric (NPS) adverse events included the following NPS adverse events: anxiety, depression, feeling abnormal, hostility, agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, irritability, suicidal ideation, suicidal behavior or completed suicide