Document is current
Any future updates will be listed below
-
Authors
Heussler, Helen
Cohen, Jonathan
Silove, Natalie
Tich, Nancy
Bonn-Miller, Marcel O.
Du, Wei
O’Neill, Carol
Sebree, Terri
-
Funding
Funding for this research was provided by:
Zynbera Pharrmaceuticals
- License Information
-
More Information
Article History
Received: 10 December 2018
Accepted: 18 July 2019
First Online: 2 August 2019
Ethics approval and consent to participate
: The study was conducted under Good Clinical Practice (GCP) requirements. The Human Research Ethics Committees (HREC) reviewed and approved the protocol, informed consent form (ICF), patient information, and patient recruitment materials. This trial was designed and monitored in accordance with the procedures of the designated contract research organization (CRO), Covance Pty. Limited (North Ryde, Australia), that oversaw the study conduct. The study complied with the ethical principles of GCP as required by the major regulatory authorities and in accordance with the Declaration of Helsinki. Signed informed consent was obtained at Screening for all patients by their parent/caregivers.
: Not applicable.
: HH, JC, and NS report no competing interests. WD is a consultant for Zynerba Pharmaceuticals. NT, CO, and TS are employees of Zynerba Pharmaceuticals. MBM was an employee of Zynerba Pharmaceuticals during the time of the study conduct and analysis.
