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M.T.P.R. is a consultant and speaker for ViiV Healthcare and holds stocks\/shares in the company. P.J.Y. and M.B.C., J.H., J.T.W., V.I., R.A., L.W., S.S., S.H., A.S., and A.P. are employed by GSK and hold financial equities in GSK. P.J.Y. and M.B.C. are former employees of GSK. G.S. and M.A. are employees of Vir Biotechnology, Inc. and may hold stocks\/shares in the company. Y.G.R., M.R., A.F and J.M. report no conflicts of interest in this work.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Anonymized individual participant data and study documents can be requested for further research from\n                      \n                      .","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and materials"}},{"value":"This study was conducted in accordance with consensus ethical principles derived from international guidelines including the Declaration of Helsinki, Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice Guidelines, and applicable country-specific requirements, including US 21 Code of Federal Regulations 312.3(b) for constitution of independent ethics committees. The full names of the ethics committees and institutional review boards that approved the study are included in the ESM.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Written informed consent was obtained from each participant prior to the performance of any study-specific procedures. 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