González-Sales, Mario
Djebli, Nassim http://orcid.org/0000-0003-3333-2979
Meneses-Lorente, Georgina
Buchheit, Vincent
Bonnefois, Guillaume
Tremblay, Pierre-Olivier
Frey, Nicolas
Mercier, François
Funding for this research was provided by:
F. Hoffmann-La Roche Ltd
Article History
Received: 17 May 2021
Accepted: 5 September 2021
First Online: 18 September 2021
Declarations
:
: MG-S is an employee of Modelling Great Solutions. ND is an employee of Ignyta (owned by F. Hoffmann-La Roche Ltd.) GM-L is an employee of Roche Products Ltd. VB, NF and FM are employees of Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland. GB was an employee of Syneos Health, who were contracted by F. Hoffmann-La Roche Ltd to support model development; he is currently an employee of Certara. P-OT is an employee of Syneos Health, who were contracted by F. Hoffmann-La Roche Ltd to support model development.
: All studies were carried out in accordance with principles for human experimentation as defined in the Declaration of Helsinki and were approved by the human investigational review board/ethics committee of each trial center, as required by ICH Guidelines for Good Clinical Practice.
: Informed consent was obtained from each patient after having been informed of the potential risks and benefits, as well as the investigational nature of each trial.
: Not applicable.
: Qualified researchers may request access to individual patient-level data through the clinical study data request platform (ExternalRef removed). Further details on Roche's criteria for eligible studies are available here (ExternalRef removed). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (ExternalRef removed).
: Not applicable.