Received: 19 October 2017
Accepted: 13 February 2018
First Online: 27 February 2018
: Not applicable.
: Prior to enrollment, all study materials were approved by the governing ethics committee, Technical University Munich, Faculty for Medicine, Ethics Committee, Ismaninger Str. 22, 81,675 Munich, Germany (Project No. 2292/08; EudraCT No. 2008-006780-37) or institutional review boards (Schulman Associates IRB, Inc., 4445 Lake Forest Drive, Suite 300, Cincinnati, OH 45242 USA; Compass Independent Review Board, LLC, 5416 East Baseline Rd., Suite 120, Mesa, AZ 85206 USA; Mary Crowley Medical Research Center, Institutional Review Board, 1700 Pacific Avenue, Suite 1100, Dallas, TX 75201 USA [no patients were enrolled]; UT Health Science Center San Antonio, Institutional Review Board, Mail Code 7830, 7703 Floyd Curl Drive, San Antonio, TX 78229 USA; Brooke Army Medical Center Institutional Review Board, 3551 Roger Brooke Dr., Fort Sam Houston, TX 78234 USA [no patients were enrolled]) at each site. This 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. Adult patients who had given written informed consent were eligible to participate in the study.
: Not applicable.
: WE-R has received honoraria from Eli Lilly and Company, Boehringer-Ingelheim, Roche, BMS, and Merck. At the time this study was performed, JL, PM, RDH, MG, MLP, and RW were employed in leadership roles at Biothera Pharmaceuticals Inc. and owned stock/stock options in Biothera Pharmaceuticals Inc. MMT and MD were compensated by Biothera for pharmacokinetic and data analysis assistance. JRT was compensated by Biothera for statistical analysis assistance. FS has no conflicts of interest to disclose.
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