Weiss, Karl Heinz
Thompson, Catherine
Dogterom, Peter
Chiou, Yi-jin
Morley, Tim
Jackson, Brinley
Amin, Naseem
Kamlin, Camille Omar Farouk http://orcid.org/0000-0002-4872-3860
Funding for this research was provided by:
Orphalan, France (Industry Sponsored Study)
Article History
Accepted: 29 June 2021
First Online: 6 August 2021
Declarations
:
: This study was funded by Orphalan.
: KHW advises for Alexion, Bayer, Chiesi, Eisai, Orphalan, Pfizer, Ultragenyx, Univar, Vivet Therapeutics; KHW received research funding (to the institution) from Alexion, Novartis, Orphalan, Univar; KHW received travel grants from Abbvie, Bayer and Gilead.
: The clinical trial protocol (version 2), as well as the subject information and consent form, version 2, both dated 4 June 2015, were approved by the Independent Ethics Committee (IEC) on 9 June 2015. There were no amendments to the protocol. The competent authority of the Netherlands [Centrale Commissie Mensgebonden Onderzoek (CCMO)] was notified by the IEC according to the Dutch regulations on 4 June 2015.
: Informed written consent was provided by all participating subjects.
: Not applicable.
: The clinical study report for this pharmacokinetics study, the TRIUMPH study, can be accessed on request from Orphalan.
: Not applicable.
: KHW provided expert consultation on the study findings, presented the study at EASL, and edited and approved the final manuscript. PD designed the study, conducted the study at the study centre, analysed the data, and edited and approved the final manuscript. YC analysed data and approved final manuscript. CT designed the study, analysed the data, and edited and approved the final manuscript. TM provided scientific input into the study outcomes, analysed the data, and edited and approved the final manuscript. BJ provided scientific input into the study outcomes, analysed the data, and edited and approved the final manuscript. NA provided scientific input into the study outcomes, analysed the data, and edited and approved the final manuscript. COFK provided scientific input into the study outcomes, analysed the data, and edited and approved the final manuscript.