Document is current

Article History

Accepted: 2 June 2025

First Online: 8 July 2025

Declarations

:

: This study was funded by Neurelis, Inc. (San Diego, California). Open access was funded by Neurelis, Inc. (San Diego, California).

: S.M. is an employee of and has received stock and stock options from Neurelis, Inc. I.A. is a consultant to Neurelis, Inc.; is chairman (unpaid) of the scientific advisory board for the Alliance to Cure Cavernous Malformation; and receives research support from the National Institute of Neurological Disorders and Stroke. M.A.L.T. is an employee of and has received stock options from Neurelis, Inc. L.M. is a consultant to Neurelis, Inc. J.G. was, at the time of this study, an employee of and has received stock options from Neurelis, Inc. L.Y.N. is an employee of and has received stock options from Neurelis, Inc. E.C. is an employee of and has received stock and stock options from Neurelis, Inc. A.L.R. is an employee of and has received stock options from Neurelis, Inc.

: All data are included in the manuscript.

: The study protocol, informed consent, and all other study documents were approved by an institutional review board (Advarra; protocol number, Pro00068446). The study was conducted in accordance with the Declaration of Helsinki, the International Council for Harmonisation, Guideline E6 for Good Clinical Practice (GCP), the Food and Drug Administration GCP Code of Federal Regulations Title 21 (part 56), the European regulation EU 536/2014, and the Tri-Council Policy Statement (Canada).

: Written consent was obtained from each participant prior to study enrollment.

: Not applicable.

: Not applicable.

: S.M., M.A.L.T., J.G., E.C., and A.L.R. were involved in the conception and design of the study, as well as data analysis. All authors were involved in 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.