Sohn, Winnie Y. http://orcid.org/0000-0002-9469-1345
Portale, Anthony A.
Salusky, Isidro B.
Zhang, Hao
Yan, Lucy L.
Ertik, Bella
Shahinfar, Shahnaz
Lee, Edward
Dehmel, Bastian
Warady, Bradley A.
Funding for this research was provided by:
Amgen
Article History
Received: 8 May 2018
Revised: 7 August 2018
Accepted: 10 August 2018
First Online: 23 August 2018
Change Date: 7 December 2018
Change Type: Correction
Change Date: 7 December 2018
Change Type: Correction
Change Details: The original version of this article unfortunately contained three mistakes. In Table 1, the last line under “Key Inclusion Criteria” should read “Normal or clinically acceptable ECGs at screening and at day − 1.” In addition, the abbreviation “IP” in the legend to Table 1 stands for “investigational product.”
Change Details: The original version of this article unfortunately contained three mistakes. In Table 1, the last line under ���Key Inclusion Criteria��� should read ���Normal or clinically acceptable ECGs at screening and at day ������1.��� In addition, the abbreviation ���IP��� in the legend to Table 1 stands for ���investigational product.���
Compliance with ethical standards
: This study was conducted in accordance with applicable country regulations and International Conference on Harmonization (ICH) Good Clinical Practice (GCP). The study protocol (Amgen Protocol Number 20090005;ExternalRef removedIdentifier NCT01290029) was approved by the institutional review board/independent ethics committee (IRB/IEC) at each study center. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all parents or legally acceptable representatives.
: BE, EL, and WS are all employees and stockholders of Amgen, Inc. HZ is a full-time employee of Amgen, Inc. LY and BD were employees of Amgen, Inc. at the time the research was conducted. SS (S. Shahinfar Consulting, Inc.) and BW are paid consultants for Amgen, Inc. IS has research grants from Amgen, Inc. and Abbvie, Inc. and received consulting fees from Keryx, Inc. AP has nothing to disclose.
: 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 USA 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 will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data-sharing agreement. This may include anonymized patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the following:ExternalRef removed.