Powell, Lauren
O’Sullivan, Fiona
Jayasinghe, Pramoda
Rogula, Basia
Dai, Feng
Cirillo, Jessica
Sweeney, Samantha
Abraham, Lucy
Ailani, Jessica
Article History
Received: 27 September 2024
Accepted: 15 November 2024
First Online: 2 January 2025
Declarations
:
: Ethics approval for the BHV3500-301 (NCT04571060) trial was approved was obtained in accordance with the principles of the Guidelines for Good Clinical Practice, the Declaration of Helsinki, and all applicable local regulations. The protocol was approved by a central institutional review board (Advarra IRB, Columbia, MD, USA, number 0000080) and by a local institutional review board (Biomedical Research Alliance of New York Institutional Review Board, Lake Success, NY, USA, number 00010793) for one study centre.
: No applicable.
: BR, FOS, LP, and PJ, and are employees of Broadstreet HEOR, which received funds from Pfizer for this work. FD JC, LA and SS are employed by and own stock/stock options in Pfizer. JA has received personal compensation for serving as a consultant for Pfizer.