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IK, KS, DS-P, JS, PdR, RD\u2019A, WRS and JvW employees of ViiV Healthcare and may be stockholders of GSK. RU and AH are employees and may be stockholders of GSK. EA reports consulting fees, payment or honoraria from ViiV Healthcare and Gilead Sciences. BE reports payment for participation in an advisory board for ViiV Healthcare; grants from ViiV Healthcare; consulting fees from ViiV Healthcare; and payment or honoraria from ViiV Healthcare. GC has received research support for their company, The Crofoot Research Center, from ViiV Healthcare; grants for their research company from Merck, Gilead Sciences, and Pfizer. CC and MM-A declare no competing interests.  CM, CC, EA, BE, MM-A and GC were study investigators and\/or participated in the conduct of the study, including recruitment and follow-up of participants. IK, KS, DS-P, RU, AH, JS, PdR, RD\u2019A, WRS and JvW participated in the analysis of the study data, and the conceptualization and design of the studies. 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