Billin, Andrew N.
Honeycutt, Samuel E.
McDougal, Alan V.
Kerr, Jaclyn P.
Chen, Zhe
Freudenberg, Johannes M.
Rajpal, Deepak K.
Luo, Guizhen
Kramer, Henning Fritz
Geske, Robert S.
Fang, Frank
Yao, Bert
Clark, Richard V.
Lepore, John
Cobitz, Alex
Miller, Ram
Nosaka, Kazunori
Hinken, Aaron C.
Russell, Alan J. http://orcid.org/0000-0001-7545-5008
Article History
Received: 25 May 2018
Accepted: 14 October 2018
First Online: 13 November 2018
Change Date: 10 December 2018
Change Type: Correction
Change Details: Following publication of the original article [1], the authors flagged that there is a discrepancy with the <i>Availability of data and materials</i> statement on page 12 of the article.
Ethics approval and consent to participate
: All studies with mice were conducted in accordance with the GSK Policy on the Care, Welfare and Treatment of Laboratory Animals. All protocols were reviewed and approved by the Institutional Animal Care and Use Committee of GSK.The clinical study protocol, any amendments, the informed consent, and other information that required pre-approval were reviewed and approved by an investigational center institutional review board, in accordance with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) and applicable country-specific requirements, including United States (US) 21 Code of Federal Regulations (CFR) 312.3(b) for constitution of independent ethics committees.The study was conducted in accordance with ICH GCP and all applicable subject privacy requirements, and, the ethical principles that are outlined in the Declaration of Helsinki 2008. The study was monitored in accordance with ICH E6, Section 5.18. Investigators were trained to conduct the study in accordance with GCPs and the study protocol as defined in ICH E3, Section 9.6. Written commitments were obtained from investigators to comply with GCP and to conduct the study in accordance with the protocol.Written informed consent was obtained from each subject prior to the performance of any study-specific procedures. The investigator agreed to provide the subjects as much time as necessary to review the document, to inquire about details of the trial, and to decide whether or not to participate in the study. The informed consent was signed and dated by the study subjects and by the person who conducted the informed consent discussion. Electronic case report forms were provided for each subject’s data to be recorded.
: AB, SH, AVD, GL, ACH, JPK, JMF, ZC, DKR, HFK, RSG, FF, BY, RC, JL, AC, RM, and AJR were employees and shareholders of GlaxoSmithKline at the time of study conduct. KN was an employee at Edith Cowan University, Joondalup, Australia, at the time of study conduct.
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