Hummel, Matthew
Bosje, Tjerk
Shaw, Andrew
Liu, Mark Shiyao
Barve, Abhijit
Kothekar, Mudgal
Socinski, Mark A.
Waller, Cornelius F. http://orcid.org/0000-0002-5777-0212
Funding for this research was provided by:
Viatris, Inc
Universitätsklinikum Freiburg
Article History
Received: 17 February 2021
Accepted: 1 April 2021
First Online: 17 April 2021
Declarations
:
: M Hummel, A Shaw, MS Liu, and A Barve are employees of Viatris Inc and may hold stock with the company. T Bosje was an employee of PRA Health Sciences during the study and has since retired, and has nothing to disclose. M Kothekar was an employee of Biocon Research Ltd at the time of the study and may hold stock with the company. M Socinski has nothing to disclose. CF Waller is a consultant/advisory board member for Viatris Inc.
: The study was approved by the independent ethics committee of the foundation Evaluation of Ethics in Biomedical Research (Assen, The Netherlands) and conducted in accordance with the general principles set forth in the International Ethics Guidelines for Biomedical Research Involving Human Subjects, International Council for Harmonization E6 Guideline for Good Clinical Practice, and the Declaration of Helsinki. Written informed consent was obtained from all subjects before study initiation.
: Written informed consent was obtained from all subjects before study initiation.