Vernillet, Laurent
Greene, Stephen A.
Kim, Hong Wook
Melnick, Susan M.
Glenn, Kelli
Article History
First Online: 16 April 2020
Compliance with Ethical Standards
:
: This study was funded by SK Life Science, Inc.
: LV, employee of SK Life Science, Inc.; SAG, employee of SK Life Science, Inc.; HWK, employee of SK Life Science, Inc.; SMM, employee of SK Life Science, Inc.; KG, employee of SK Life Science, Inc.
: The authors confirm that the data supporting the main findings of this study are available within the article [and/or] its supplementary materials. Any additional data, noted as ‘data on file’ within the text, are available from the corresponding author [LV] upon reasonable request.
: This research was conducted in accordance with the clinical research guidelines established by the Medical Research Council of Canada, the Basic Principles defined in U.S. 21 CFR Part 312.20, the requirements of Directive 2001/20/EC (Europe), the principles enunciated in the Declaration of Helsinki and the ICH-harmonised tripartite guideline regarding Good Clinical Practice (GCP). The study was approved by the independent MDS Pharma Services Institutional Review Board.
: Informed consent was given by all subjects who participated in the study.
: This data was previously presented at the 12th International Society for the Study of Xenobiotics Meeting, July 28–July 31, 2019.