de Weger, Vincent A.
de Jonge, Maja
Langenberg, Marlies H. G.
Schellens, Jan H. M.
Lolkema, Martijn
Varga, Andrea
Demers, Brigitte
Thomas, Koruth
Hsu, Karl
Tuffal, Gilles
Goodstal, Samantha
Macé, Sandrine
Deutsch, Eric
Funding for this research was provided by:
Sanofi
Article History
Received: 21 June 2018
Revised: 15 November 2018
Accepted: 19 November 2018
First Online: 26 December 2018
Data availability
: Data are available on request. Biomarker data were posted to EU registry in February 2017; all remaining samples were destroyed in January 2017. Raw PK data were archived electronically; all remaining samples were destroyed.
: ML has received an ISS grant from Sanofi. KH, BD and SM are employees of Sanofi. GT is an employee of Sanofi and holds stock in Sanofi. KT is a former contractor with Sanofi. SG is an employee of EMD Serono. VDW, MDJ, MGHL, JS, AV and ED have no conflicts to declare.
: This clinical trial adhered to the principles outlined in the Helsinki declaration and was conducted in compliance with all applicable international and national laws and regulations. The protocol was approved by all relevant Institutional Review Boards/Independent Ethics 400 Committees. All patients provided written, informed consent.
: This work is published under the standard license to publish agreement. After 12 months the work will become freely available and the license terms will switch to a Creative Commons Attribution 4.0 International licence (CC BY 4.0).