Updates are available Correction dated 2020-11-12

Article History

First Online: 12 October 2020

Change Date: 12 November 2020

Change Type: Correction

Change Details: Page 608, 4 Discussion, right column, second paragraph.

Declarations

:

: This study was supported by Amgen Inc., Thousand Oaks, CA, USA. Open Access funding provided by Projekt DEAL.

: Dietger Niederwieser reports personal fees from Cellectis, Daiichi, and Novartis. David Chien, Vladimir Hanes, and Mindy Mo are employees and stockholders of Amgen Inc. Patrick Cobb, Vincent Delwail, Cecily Forsyth, Roman Hajek, Caroline Hamm, and Alessandra Tucci have nothing to disclose.

: This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines.

: All subjects provided written informed consent prior to entering the study and before initiation of any study-related procedure (including administration of investigational product).

: There is a plan to share data. This may include de-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request, and also related data dictionaries, study protocol, statistical analysis plan, informed consent form, and/or clinical study report. Data sharing requests relating to data in this manuscript will be considered after the publication date and (1) this product and indication (or other new use) have been granted marketing authorization in both the US and Europe or (2) clinical development discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for these data. Qualified researchers may submit a request containing the research objectives, the Amgen product(s), and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labeling. A committee of internal advisors reviews requests. If not approved, a Data Sharing Independent Review Panel may arbitrate and make the final decision. Requests that pose a potential conflict of interest or an actual or potential competitive risk may be declined at Amgen’s sole discretion and without further arbitration. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at .