Viglietta, Vissia
Shi, Fuxin
Hu, Qi-Ying
Ren, Yong
Keilty, John
Wolff, Heather
McCarthy, Ryan
Kropp, Jason
Weber, Pete
Soglia, John
Article History
Received: 10 February 2020
Accepted: 27 February 2020
First Online: 10 March 2020
Compliance with ethical standards
:
: Vissia Viglietta is a full-time employee at Decibel Therapeutics, Fuxin Shi is a full-time employee at Decibel Therapeutics, Qi-Ying Hu is a full-time employee at Decibel Therapeutics, Yong Ren is a full-time employee at Decibel Therapeutics, John Keilty is a full-time employee at Decibel Therapeutics, Heather Wolff is a full-time employee at Decibel Therapeutics, Ryan McCarthy is a full-time employee at Decibel Therapeutics, Jason Kropp is a full-time employee at Decibel Therapeutics, Pete Weber is a full-time employee at Decibel Therapeutics, John Soglia is a full-time employee at Decibel Therapeutics.
: All procedures performed in this study were in accordance with the ethical principles of Good Clinical Practice (GCP) as required by the major regulatory authorities, and in accordance with the Declaration of Helsinki. This study was performed at a single study center in Australia (Cmax clinical research, Level 5, 18a North Terrace, Adelaide SA 5000, Australia) who obtained Independent Ethics Committee (IEC) approval for the protocol and written informed consent forms prior to study initiation in adherence with 21 Code of Federal Regulations (CFR) 50 and 21 CFR56.
: Written informed consent was obtained from each subject prior to the first study-specific procedure. Subjects were given adequate time to review the information in the informed consent and could ask, and have answered, questions on all aspects of the study. Subjects were provided with a copy of the signed and dated Informed Consent Form (ICF).