Funding for this research was provided by:
F. Hoffmann-La Roche (.)
Text and Data Mining valid from 2019-11-21
Received: 16 August 2019
Accepted: 25 October 2019
First Online: 21 November 2019
Ethics approval and consent to participate
: The first CEC approval was granted on 14 July 2015 from the Comite de Etica e Investigacion Clinicas Niño Jesus, Avenida Menéndez Pelayo, N° 65 Madrid 28009. This site granted approval for the trial in addition to other multiple ethics committees/institutional review board approvals obtained for 11 different countries of enrollment. The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice Guidelines. Informed consent was obtained from each patient or each patient’s authorized representative.
: Not applicable.
: CSS, PC, GR, FD, JR, XW, RB, JJ, and SG are employees and stockholders of Genentech, Inc. and F. Hoffmann-La Roche Ltd. AG and HW were employed by Genentech at the time of these analyses. KJ and RW are employees of Certara and have provided consulting services for this study.