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MM was an employee of ViiV Healthcare when the work was conducted, is now with Health Analytics and Outcomes, London, UK, and owns\/owned stock in GlaxoSmithKline. DC is president of FACIT.org, which licenses FAHI, and has been a consultant to ViiV Healthcare. RG has received research support from ViiV Healthcare, Amgen, and Gilead Sciences; consulting fees from Thera Technologies as member of an advisory board; and speaker fees from ViiV Healthcare. DH has received speaker fees and consulting fees from ViiV Healthcare as a member of an advisory board. WT is an employee of Southern California Permanente Medical Group and has received institutional grants from ViiV Healthcare, Bristol-Myers Squibb, Gilead, Dynavax, and Merck. AC, AP, CL, PA, and ML are employees of ViiV Healthcare and own stock in GlaxoSmithKline.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"The study was performed in accordance with Good Clinical Practice, as defined in the International Conference on Harmonisation and in accordance with the ethical principles underlying European Union Directive 2001\/20\/EC and the United States Code of Federal Regulations, Title 21, Part 50. Each site conducted the protocol with oversight from an institutional review board or independent ethics committee.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All participants provided informed consent in agreement with the Declaration of Helsinki principles.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Anonymized individual participant data and study documents can be requested for further research from .","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"CL contributed to the conception of the study. CL contributed to the design of the study. RG, DH, WT, AP, CL, and PA contributed to the acquisition of data. SJA, MM, MW, AC, AP, CL, and PA contributed to the analysis of data. SJA, MM, DC, AC, AP, CL, and PA contributed to the interpretation of data. SJA and MM contributed to the drafting of the manuscript. All listed authors meet the criteria for authorship set forth by the International Committee of Medical Journal Editors. All authors contributed to critically revising the manuscript for important intellectual content and approve the manuscript for publication.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 contributions"}}]}}