Talbot, George H.
Kleinman, Leah
Davies, Evan
Hunsche, Elke
Revicki, Dennis
Roberts, Laurie
Rosenberg, Daniel
Nord, Carl Erik
Funding for this research was provided by:
Actelion Pharmaceuticals (N.A.)
Article History
Received: 22 August 2018
Accepted: 10 April 2019
First Online: 3 May 2019
Ethics approval and consent to participate
: The IMPACT trials were conducted in accordance with the Declaration of Helsinki principles and International Conference on Harmonisation Good Clinical Practice guidelines, approved by Institutional Review Boards or Independent Ethics Committees (IRB/IEC) at each participating site, in accordance with local procedures and regulations for each investigator. All patients provided written informed consent for one of the IMPACT studies and for this validation sub-study.
: No individual’s personal data has been included.
: George H. Talbot has received consulting and scientific advisor fees from Actelion Pharmaceuticals Ltd. and is a Steering Committee member of the IMPACT Study Program. Leah Kleinman and Dennis Revicki, employees of Evidera and received funding from Actelion Pharmaceuticals Ltd. to conduct this research. Laurie Roberts was an employee of Evidera at the time this research was conducted. Daniel Rosenberg and Evan Davies are employees of Actelion Pharmaceuticals Ltd. Elke Hunsche was an employee of Actelion Pharmaceuticals Ltd. at the time of study implementation, analysis, and drafting of this paper. Carl Erik Nord has received scientific advisor fees from Actelion Pharmaceuticals Ltd. and is a Steering Committee member of the IMPACT Study Program.
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