Tompson, Debra J. http://orcid.org/0000-0003-1030-2611
Davies, Carwyn http://orcid.org/0000-0003-0363-3375
Scott, Nicola E.
Cannons, Edward P. http://orcid.org/0000-0002-7370-6018
Kostapanos, Michalis http://orcid.org/0000-0002-7513-5319
Gross, Annette S. http://orcid.org/0000-0001-9567-0127
Powell, Marcy http://orcid.org/0000-0001-6528-4663
Ino, Hiroko http://orcid.org/0000-0002-6793-7944
Shimamura, Ryutaro http://orcid.org/0000-0002-7460-7513
Ogura, Hirofumi http://orcid.org/0000-0002-8042-6495
Nagakubo, Takashi http://orcid.org/0000-0002-8353-0968
Igarashi, Harue http://orcid.org/0000-0003-0423-128X
Nakano, Atsushi http://orcid.org/0000-0002-6030-0182
Funding for this research was provided by:
GlaxoSmithKline
Article History
First Online: 9 November 2020
Declarations
:
: Funding for the studies (NCT03305419 and NCT03590613 available from ExternalRef removed) was provided by GlaxoSmithKline (GSK).
: Debra J. Tompson, Carwyn Davies, Nicola E. Scott, Edward P. Cannons, Annette S. Gross, Marcy Powell, Ryutaro Shimamura, Takashi Nagakubo, Atsushi Nakano are employees of and hold equity stock in GlaxoSmithKline. Hirofumi Ogura and Harue Igarashi are employees of GSK. Michalis Kostapanos is an NHS consultant working with a 50% secondment in GSK’s Clinical Unit Cambridge and has no other relevant conflicts of interests for this study. Hiroko Ino is a former employee of GSK.
: For each study, approval was from the investigational centre ethics committee or institutional review board (Study 1: NRES Committee East of England, Cambridgeshire and Hertfordshire, Rolling Mill Road, Jarrow, Tyne and Wear, UK, NE32 3DT; Study 2: Hakata Clinic Institutional Review Board, Random Square 5-7 FL, 6-18 Tenyamachi, Hakata-ku, Fukuoka Japan, 812-0025). The studies were conducted in accordance with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Good Clinical Practice and applicable country-specific requirements and the ethical principles that are outlined in the Declaration of Helsinki.
: Written informed consent was obtained from each subject prior to any study-related activities.
: Within 6 months of this publication, anonymised individual subject data, the annotated case report forms, protocols, reporting and analysis plans, data set specifications, raw datasets, analysis-ready datasets, and clinical study reports will be available for research proposals approved by an independent review committee. Proposals should be submitted to ExternalRef removed. A data access agreement will be required.
: Statistical analyses were performed with SAS (version 9.2 or higher; Cary, NC, USA).
: Debra J. Tompson and Marcy Powell: contributed to the conception or design of the high-dose pharmacokinetic study; Debra J. Tompson, Hiroko Ino, Takashi Nagakubo, Atsushi Nakano, Ryutaro Shimamura contributed to the conception or design of the Japanese study. Debra J. Tompson, Edward P. Cannons, Michalis Kostapanos, Marcy Powell, Hiroko Ino, Hirofumi Ogura, and Harue Igarashi contributed to the acquisition of the data; Debra J. Tompson, Nicola E. Scott, Carwyn Davies, Annette S. Gross, Marcy Powell, Hiroko Ino, Ryutaro Shimamura, Hirofumi Ogura, Takashi Nagakubo, Harue Igarashi, and Atsushi Nakano contributed to the data analysis or interpretation. All authors provided critical review, final approval of the publication, and agree to be accountable for the contents of this work.