Goss, Jessica
Hair, Pamela
Kumar, Parvathi
Iacono, Giuseppina
Redden, Laura
Morelli, Gaetano
Krishna, Neel
Thienel, Ulrich
Cunnion, Kenji https://orcid.org/0000-0001-8604-348X
Article History
Received: 25 April 2022
Accepted: 16 December 2022
First Online: 6 January 2023
Declarations
:
: This study was conducted in Canada in accordance with the guidelines described in the Declaration of Helsinki and the CIOMS International Ethical Guidelines, ICH GCP Guidelines. The protocol was also reviewed and approved by the local competent Regulatory Authority as well as the local Institutional Review Board. The protocol was approved by Health Canada control number 249562. All participants signed written consent forms.
: Not applicable.
: In accordance with our ethical obligation as researchers, we are reporting that JGoss, PHair, PKumar, NKrishna, UThienel and KCunnion are employed by ReAlta Life Sciences and receive funding in the form of salaries from ReAlta Life Sciences, a company that may be affected by the research reported in the enclosed paper. LRedden is a consultant to ReAlta Life Sciences and receives consulting fees for her expertise provided on safety and pharmacovigilance.