Kern, Johannes S.
Schwieger-Briel, Agnes
Löwe, Sandra
Sumeray, Mark
Davis, Charles
Martinez, Anna E.
Funding for this research was provided by:
Amryt Pharmaceuticals DAC
Article History
Received: 17 September 2018
Accepted: 15 April 2019
First Online: 11 June 2019
Ethics approval and consent to participate
: EASE is conducted in accordance with the principles of the Declaration of Helsinki. The trial has received institutional review board approval at all participating sites. All patients/guardians provide written informed consent for all aspects of the trial (including collection of biological specimens) to the principal investigators before enrollment. Written approval was obtained from institutional review boards of the participating sites; any protocol amendments were signed off by the same bodies.
: The authors have consent from the EASE study group and the sponsor for the publication of this paper. Publication is covered in the patient consent.
: JSK: consultant for Amryt for trial design and is the international coordinating investigator of the study presented here. He participated in an Amryt advisory board meetingASB: consultant for Amryt, conducted the BEB-10 study, and participated in an Amryt advisory board meetingSL: consultant for Amryt Pharmaceuticals DACMS: paid employee of Amryt Pharmaceuticals DACCD: consultant for Amryt Pharmaceuticals DACAM: consultant for Amryt and participated in an Amryt advisory board meeting
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