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Clinical study protocol template

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global Clinical Development - General Medicine QAW039/fevipiprantClinical Trial protocol CQAW039A2316 / NCT03215758A 12-week, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of QAW039 when added to standard-of-care asthma therapy in patients with uncontrolled asthmaDocument type: Clinical Trial ProtocolEUDRACT number:2017-001273-16Version number:00 (OriginalProtocol) Clinical trial phase:IIIRelease date:10- May-2017Property of NovartisConfidentialMay not be used, divulged, published, or otherwise disclosedwithout the consent of NovartisClinical Trial protocol template Version (July 2016)NovartisConfidentialPage 2Clinical Trial protocol (Version 00) protocol No.

GINA Global Initiative for Asthma GOLD Global Initiative For Chronic Obstructive Lung Disease H0 null hypothesis Ha alternative hypothesis HbA1c hemoglobin A1c; glycosylated hemoglobin hCG human chorionic gonadotropin HFA hydrofluoroalkane HRQOL health-related quality of life hsCRP high sensitivityC-reactive protein IB investigator brochure

  Global, Disease, Lungs, Initiative, Chronic, Obstructive, Global initiative for chronic obstructive lung disease, Global initiative

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