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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.

PRO patient reported outcome PT prothrombin time QM quality management QOL quality of life QTcF Fridericia QT correction formula RAST radioallergosorbent test SABA short-acting -agonist SAE(s) serious adverse event(s) SAF safety analysis set sCr serum creatinine SCR screening SD standard deviation SJS Stevens-Johnson syndrome SoC standard of care

  Patients, Outcome, Reported, Patient reported outcome

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