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Article History

Received: 19 January 2024

Accepted: 1 July 2024

First Online: 8 August 2024

Declarations

:

: The study protocol was approved by the local institutional review boards and/or ethics committees prior to study initiation. All patients or legally authorized representatives provided written informed consent prior to study enrolment. This study was conducted in accordance with the principles of the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines and was consistent with Good Clinical Practices of the International Conference on Harmonization and applicable regulatory requirements. Monitoring and site supervision were performed with oversight by the sponsor.

: Not applicable.

: LL-K, SO, AY, PM, MW, and SP are employees of Adelphi Values who received sponsorship through Regeneron Pharmaceuticals, Inc. to conduct the study. AO is a consultant and steering committee member for Regeneron Pharmaceuticals, Inc.; received sample analysis support for a prior collaborative study () from Regeneron Pharmaceuticals, Inc.; and has a pending patent on C5 inhibitor treatment in CHAPLE disease. HBF and VC received support to conduct the study and provision of the investigational product from Regeneron Pharmaceuticals, Inc. TB, LP, and JJJ are employees/stockholders of Regeneron Pharmaceuticals, Inc. MJL received support for a federally approved Cooperative Research and Development Agreement to support the clinical trial and has a pending patent on C5 inhibitor treatment in CHAPLE disease. OAH is an employee/stockholder of Regeneron Pharmaceuticals, Inc. and has a pending patent on C5 inhibitor treatment in CHAPLE disease.