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Shinji Saiki has received research funding from argenx BV in connection with this investigator-initiated clinical trial. Tetsu Suzuki, Kota Igari, Shogo Ohuchi, Izumi Mihashi, Takashi Hosaka, Ayako Shioya, and Makoto Terada declare that they have no competing interests.","order":1,"name":"Ethics","label":"Conflict of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study was approved by the University of Tsukuba Clinical Research Review Board, Japan (certified review board no. CRB3180028; reference no. TCRB25-023) on 18 March 2026, and institutional permission was granted by the Director of the University of Tsukuba Hospital on 23 March 2026. The trial was prospectively registered with the Japan Registry of Clinical Trials (jRCT; jRCTs031260127) on 14 May 2026, before the enrolment of any participant. It will be conducted in accordance with the Declaration of Helsinki of 1964 and its later amendments, the Japanese Clinical Trials Act, and relevant institutional and national guidelines; written informed consent will be obtained from every participant before any study procedure. Monitoring will follow the approved plan, and study progress and safety will be reported to the Certified Review Board as required. Study records and data will be retained for 10\u00a0years after study completion, whereas stored serum and plasma samples will generally be retained for 5\u00a0years, in accordance with the approved protocol, with identifiers removed. Because some participants use home SC self-injection, safety safeguards (mandatory pre-injection temperature and symptom self-checks, predefined withholding criteria, weekly reporting, and a contact pathway to the investigator) apply, and the institution can provide prompt fast-acting treatment if worsening occurs. Patients were not involved in the design of this protocol. Patient-reported outcomes are included to evaluate treatment convenience.","order":2,"name":"Ethics","label":"Ethical Approval","group":{"name":"EthicsHeading","label":"Declarations"}}]}}