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Clinical study protocol template

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:2017-001273-16 Version number:00 (OriginalProtocol) Clinical trial phase:IIIR elease date:10- May-2017 Property of NovartisConfidentialMay not be used, divulged, published, or otherwise disclosedwithout the consent of NovartisClinical Trial protocol template Version (July 2016)NovartisConfidentialPage 2 Clinical Trial protocol (Version 00) protocol No. CQAW039A2316 Table of contentsTable of of of of of objectives and and related for study for dose/regimen, route of administration and duration of for choice ofcomparator.

IDR idiosyncratic drug reactions IEC independent ethics committee IgE immunoglobulin E ImmunoCAP® specific IgE test IN investigator notification INR international normalized ratio IRB institutional review board IRT interactive response technology ITT intention-to-treat IUD intrauterine device IUS intrauterine system LABA long-acting -agonist

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