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Avia Merenlender Wagner, Kristina Ferderber, Anna Elgart, Dikla Gutman, and Laura Rabinovich-Guilatt are Teva employees and shareholders. Itay Perlstein is a Magic Wand Research employee and a consultant for Teva.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"This study was conducted in accordance with current ICH-Good Clinical Practice guidelines, the Declaration of Helsinki, and any conditions required by regulatory authorities and institutional review boards (IRBs) that approved the study protocol. The study protocol received IRB approval before trial initiation (IRB approval number: Pro00041955).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"Informed consent was obtained from all individual participants included in the study.","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":"Qualified researchers may request access to patient-level data and related study documents, including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, 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 e-mail USMedInfo@tevapharm.com to make your request.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of Data and Material"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code Availability"}},{"value":"All authors participated in data interpretation and drafting the article or revising it critically for important intellectual content. Study conception and design were performed by IC, AMW, RE, IP, NS, GC, KF, JR, AE, and LR-G. Acquisition of data was performed by AMW, RT, IP, and AK. Data analysis was performed by IC, AMW, RE, DB, IP, NS, GC, and DG. All authors approved the final version to be published.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 Contributions"}}]}}