Zolnourian, Ardalan http://orcid.org/0000-0002-0428-179X
Garland, Patrick http://orcid.org/0000-0002-7679-6426
Holton, Patrick http://orcid.org/0000-0003-1548-9649
Arora, Mukul
Rhodes, Jonathan
Uff, Christopher http://orcid.org/0000-0001-9787-8001
Birch, Tony http://orcid.org/0000-0002-2328-702X
Howat, David http://orcid.org/0000-0001-7296-4165
Franklin, Stephen
Galea, Ian http://orcid.org/0000-0002-1268-5102
Bulters, Diederik http://orcid.org/0000-0001-9884-9050
Funding for this research was provided by:
Evgen Pharma
Article History
Received: 26 April 2024
Revised: 2 July 2024
Accepted: 3 July 2024
First Online: 19 July 2024
Declarations
:
: The trial was approved by the National Research Ethics Service (Southern Central Hampshire A) and Medicinal Health Care Authority (MHRA) and was conducted in accordance with the Declaration of Helsinki and met the international criteria for Good Clinical Practice. Informed consents were obtained from patients or legal representatives. The trial was registered on clinicaltrials.gov (NCT02614742) and the Consolidated Standards of Reporting Trials (CONSORT) was followed.
: Diederik Bulters and Ian Galea have received support for their research from BPL and CSL Behring.David Howatt and Stephen Franklin were employees of Evgen Pharma.Patrick Garland is employed by Kedrion.