Forero, Andres
Bendell, Johanna C.
Kumar, Prasanna
Janisch, Linda
Rosen, Michael
Wang, Qiang
Copigneaux, Catherine
Desai, Madhuri
Senaldi, Giorgio
Maitland, Michael L.
Funding for this research was provided by:
Daiichi Sankyo Company
Article History
Received: 20 October 2016
Accepted: 26 December 2016
First Online: 3 January 2017
Compliance with ethical standards
:
: Dr. Forero declares no conflict of interest.Dr. Bendell declares no conflict of interest.Prasanna Kumar is an employee of Daiichi Sankyo and holds equity in the company.Linda Janisch declares no conflict of interest.Michael Rosen is an employee of Daiichi Sankyo and holds equity in the company.Qiang Wang is an employee of Daiichi Sankyo and holds equity in the company.Catherine Copigneaux is an employee of Daiichi Sankyo and holds equity in the company.Madhuri Desai was an employee of Daiichi Sankyo at the time the study was conducted and has held equity in the company.Giorgio Senaldi is an employee of Daiichi Sankyo and holds equity in the company.Dr. Maitland reports funds provided to the University of Chicago to cover the costs of conducting the study.
: The study was funded by Daiichi Sankyo.
: The study was conducted in compliance with the clinical study protocol, the ethical principles that have their origin in the Declarations of Helsinki, the International Conference on Harmonisation (ICH) consolidated Guideline E6 for Good Clinical Practice (GCP); and the United States (US) Food and Drug Administration (FDA) GCP Guidelines: Code of Federal Regulations (CFR) Title 21, parts 11, 50, 54, 56, and 312, as appropriate. The study was approved by the institutional review boards (IRB) at each of the participating investigational sites.
: was obtained from all individual participants included in this study.