Document is current
Any future updates will be listed below
-
Authors
Johnston, Karissa http://orcid.org/0000-0003-4570-9972
Harris, Linda
Powell, Lauren
Popoff, Evan
Coric, Vladimir
L’Italien, Gilbert
Schreiber, Curtis P.
-
Funding
Funding for this research was provided by:
Biohaven Pharmaceuticals
- License Information
-
More Information
Article History
Received: 1 November 2021
Accepted: 21 December 2021
First Online: 17 January 2022
Declarations
:
: This study includes a post-hoc analysis of trial data from Study BHV3000–201. Study BHV3000–201 was conducted in accordance with the ethical principles of Good Clinical Practice (GCP), according to the International Conference on Harmonization (ICH) Harmonized Tripartite Guideline, and in accordance with the ethical principles underlying European Union Directive 2001/20/EC, and the United States (US) Code of Federal Regulations (CFR), Title 21, Part 50 (21CFR50). The study was conducted in compliance with the protocol approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC) prior to initiation of the study. All participants were given a written, informed consent form (ICF) which included all elements required by ICH, GCP, and applicable regulatory requirements. The sample ICF adhered to the ethical principles that have their origin in the Declaration of Helsinki.
: All participants were given a written, informed consent form (ICF) which included all elements required by ICH, GCP, and applicable regulatory requirements, including consent for publication.
: EP, LP and KJ are employees of Broadstreet HEOR, which received funds from Biohaven for this work. LH, VC and GL are employed by and own stock/stock options in Biohaven Pharmaceuticals. CPS receives grant support from Amgen, Genentech, Roche, Teva, and Lilly and is a speaker on the boards of Abbvie, Amgen, Biogen, Biohaven, Lilly, and Teva.
