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Itay Perlstein and Michael Lamson have received consultancy fees from Teva Branded Pharmaceutical Products in relation to this study. Avia Merenlender Wagner, Pavel Farkas, Pippa Loupe, Attila Kalmanczhelyi, Ryan Tiver, Kelli R. Franzenburg, Eran Harary, and Anna Elgart are employees and\/or shareholders of Teva Pharmaceuticals. Ofer Spiegelstein was an employee of Teva Pharmaceuticals at the time of the study and is now affiliated with Ventus Therapeutics.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"The clinical trial was conducted in accordance with the Good Clinical Practice guidelines and the ethical standards as laid down in the 1964 Declaration of Helsinki. The Schulman Associates IRB committee reviewed and approved the study (approval number IRB 201603437).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Written and oral information about the study was provided to all participants in a language understandable by the participants. The information included an adequate explanation of the aims, methods, anticipated benefits, potential hazards, and insurance arrangements in force. Written informed consent was obtained from each participant before any study procedures or assessments were done. It was explained to the participants that they were free to refuse entry into the study and free to withdraw from the study at any time without prejudice to future treatment.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"The data sets used and\/or analyzed for the study described in this manuscript are available upon reasonable request. Qualified researchers may request access to patient-level data and related study documents, including the study protocol and the statistical analysis plan. Patient-level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"All authors were involved in the conception and design of the study. All authors were involved in data analysis, data interpretation, review of literature, and drafting of the manuscript. All authors critically reviewed and revised the work, and all read and approved the final version.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}