Thomas, M.
Sadjadian, P.
Kollmeier, J.
Lowe, J.
Mattson, P.
Trout, J. R.
Gargano, M.
Patchen, M. L.
Walsh, R.
Beliveau, M.
Marier, J. F.
Bose, N.
Gorden, K.
Schneller, F. III
Article History
Received: 16 February 2017
Accepted: 1 March 2017
First Online: 16 March 2017
Compliance with ethical standards
:
: At the time this study was performed, Nandita Bose, Michele Gargano, Keith Gorden, Jamie Lowe, Paulette Mattson, Myra Patchen, and Richard Walsh were employed in leadership roles at Biothera Pharmaceuticals Inc. and owned stock/stock options in Biothera Pharmaceuticals Inc. Martin Beliveau and JF Marier were compensated by Biothera for pharmacokinetic analysis assistance and J Richard Trout was compensated by Biothera for statistical analysis assistance. The remaining authors declare no conflict of interest.
: This work was supported by Biothera Pharmaceuticals Inc.
: This Phase II study was conducted in full accordance with the Good Clinical Practice: Consolidated Guideline approved by the International Conference on Harmonisation and all other applicable national and local laws/regulations. All study materials were approved by the governing ethics committee or institutional review board at each site.
: Informed consent was obtained from all individual patients included in the study.