Funding for this research was provided by:
Text and Data Mining valid from 2020-02-04
Received: 2 November 2018
Accepted: 17 January 2020
First Online: 4 February 2020
Ethics approval and consent to participate
: The study protocol was approved by an ethics committee or institutional review board at each study site (Pharma-Ethics, Centurion, Gauteng, South Africa; Schulman Associates IRB Inc., Cincinnati, OH, USA, and Research Triangle Park, NC, USA). The study was conducted in accordance with the International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) and applicable country-specific requirements, and the ethical principles of the Declaration of Helsinki. Informed written consent was obtained from at least one parent/caregiver along with assent from the subject. This study is registered in ClinicalTrials.gov (NCT02483975).
: Not applicable.
: PB, ST, VI, RM, and SK are employees of and hold shares in GSK. KD and MT have no competing interests to disclose.