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Authors
Bae, Sang-Cheol
Bass, Damon L.
Chu, Myron
Curtis, Paula
Dimelow, Richard
Harvey, Laurence
Ji, Beulah
Kurrasch, Regina
Muzaffar, Saima http://orcid.org/0000-0002-9314-6273
Punwaney, Raj
Roth, David A.
Song, Yeong-Wook
Xie, Wendy
Zhang, Fengchun
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Funding
Funding for this research was provided by:
GlaxoSmithKline (N/A)
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Article History
Received: 14 May 2021
Accepted: 13 January 2022
First Online: 16 February 2022
Declarations
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: Written informed consent was provided by all study participants prior to enrolment. Ethics committee or institutional review board (IRB) approvals were obtained for all study sites (Chinese sites IRB approval numbers: 2016PHA019-01; HS2016041; No 029 of EC approval in 2016; No 54 of EC approval in 2016; No 077 of EC approval in 2016. Korean sites IRB approval numbers: SCHCA PMS2014-004; SC14MSGV0040; 2014-02-034; H-1402-089-558; AJIRB-MED-CT4-14-023. USA sites IRB approval numbers: BRANY IRB File #14-02-486-031; Quorum Review File #29699; Pro00038040. Japanese sites do not issue IRB numbers). The study was conducted in accordance with the Declaration of Helsinki 2008, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice and any applicable country-specific regulatory requirements.
: Not applicable.
: BJ, DLB, LH, MC, PC, RD, RK, SM, RP, DAR, and WX are employees of GSK and hold stocks and shares in the company. FZ is a principal investigator for GSK. SCB and YWS declare that they have no competing interests.
