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Gabriela Kivelevitch is an employee of Teva Pharmaceuticals. Byung-Kun Kim served on Lundbeck\u2019s Advisory Board. He received honoraria as a moderator and speaker from AbbVie, Eli Lilly,\u00a0Lundbeck, Pfizer, SK Pharma, Teva Pharmaceuticals, and Yuyu Pharma. He has been the principal investigator of clinical trials sponsored by AbbVie, Eli Lilly, Ildong Pharmaceutical, Lundbeck, Novartis, and Teva Pharmaceuticals. Mi Ji Lee reports clinical trial support from AbbVie, Biohaven, Ildong Pharmaceutical, Lundbeck, Novartis, Otsuka, Pfizer, Teva Pharmaceuticals, and Yuyu Pharma; participation on a data safety monitoring board or advisory board of AbbVie, Eli Lilly, Lundbeck, Pfizer, Samjin, and Teva Pharmaceuticals; lecture honoraria from AbbVie, CKD, Dong-A Pharmaceutical, Eli Lilly, Ildong Pharmaceutical, SK Pharm, Teva Pharmaceuticals, and Yuyu Pharma; and consulting fees from Nu Eyne. Min Kyung Chu reports participation as a site investigator for a multicenter trial sponsored by AbbVie Korea, Biohaven, and Ildong Pharmaceutical; lecture honoraria from Organon Korea, SK Chemicals, and Teva-Handok over the past 24 months; grants from the Korea Health Industry Development Institute (HV22C0106), and a National Research Foundation of Korea grant from the Korean Government (MSIT; 2022R1A2C1091767). Soo-Jin Cho reports participation as a site investigator of a multicenter trial sponsored by AbbVie, Allergan, GC Holdings, JW Pharmaceutical, Novartis International AG, and Pfizer; and lecture honoraria from AbbVie, GC Holdings, Organon, SK Chemicals, and Teva Pharmaceuticals in the past 24 months. Manho Kim reports participation as an investigator of a clinical trial sponsored by AbbVie, Eli Lilly, and Lundbeck; and participation as an investigator of a post-marketing surveillance study sponsored by Eli Lilly. Heui-Soo Moon, Tae-Jin Song, and Soohyun Cho have no conflicts of interest that are directly relevant to the content of this article.","order":1,"name":"Ethics","label":"Conflicts of interest\/competing interests","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The 6-year, non-interventional, prospective, post-marketing surveillance study is being conducted from 27 July, 2021 to 26 July, 2027 in up to 60 hospitals and clinics across South Korea. The study protocol received approval from the MFDS on 27 July, 2021 (autoinjector approval code: MFDS-75, prefilled syringe approval code: MFDS-76), authorizing its implementation for the full 6-year duration. This study was approved by the independent ethics committees\/institutional review boards in the appropriate geographies prior to the start of the study, in accordance with applicable national regulations and institutional requirements. The institutional review board approval number for the corresponding author\u2019s institution was PMS2022-004, which has been provided as a representative reference. Regulatory approval within South Korea was obtained as required by national regulations. All relevant data protection laws in South Korea are being followed.","order":2,"name":"Ethics","label":"Ethics approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study is non-interventional and, by definition, no additional procedures are performed in addition to the normal clinical practice of the treating physician. The decision of the physician to treat the patient with fremanezumab is separated from the decision of the patient to participate in the study. Written informed consent was obtained from all patients for their clinical data to be recorded anonymously. The patient\u2019s willingness to participate in the study was documented on a consent form, which was signed and personally dated by the patient and by the person who conducted the informed consent discussion. Patients were also informed of their right to withdraw their consent at any time during the study.","order":3,"name":"Ethics","label":"Consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":4,"name":"Ethics","label":"Consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"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 email USMedInfo@tevapharm.com to make your request.","order":5,"name":"Ethics","label":"Availability of data and material","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":6,"name":"Ethics","label":"Code availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"DS led the overall management of the study and, as the first author, contributed to its conception and design, data analysis, and the interpretation of the findings. GK was involved in the conception and design of the study, the data analysis, and interpretation of the findings. B-KK contributed to the data collection and interpretation of the findings and, as the corresponding author, was involved in the design and planning of the interim analysis. MK, MJL, MKC, S-JC, H-SM, T-JS, and SC participated in the data collection and interpretation of the findings. All authors read and approved the final version of the manuscript.","order":7,"name":"Ethics","label":"Authors\u2019 contributions","group":{"name":"EthicsHeading","label":"Declarations"}}]}}