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Reddy, Lance Wollenberg, Renae Chavira, and Erik Hahn are employees of Pfizer and hold Pfizer stock. Dustin Huynh (Postdoctoral Fellow) was an unpaid contractor to Pfizer; the fellowship program with the University of California San Diego was supported by an educational grant from Pfizer.","order":1,"name":"Ethics","label":"Conflicts of Interest\/Competing Interests","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"These studies were conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. In addition, all local regulatory requirements were followed, particularly those affording greater protection to the safety of trial participants. An institutional review board approved the protocols, and all participants gave written informed consent.","order":2,"name":"Ethics","label":"Ethics Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All participants provided written informed consent before undergoing any study procedures.","order":3,"name":"Ethics","label":"Consent to Participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":4,"name":"Ethics","label":"Consent for Publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The analyses in this paper were based on a data cutoff of 03\/29\/2016. Upon reasonable request and participant to review, Pfizer will provide the data that support the findings of this study. Participant to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines, and medical devices (1) for indications that have been approved in the USA and\/or European Union or (2) in programs that have been terminated (that is, development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. See\n                      \n                      for more information.Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.","order":5,"name":"Ethics","label":"Availability of Data and Material","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":6,"name":"Ethics","label":"Code Availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"JP, MBR, LW, RC, EH, and DH designed and performed the research, analyzed the data, and wrote the manuscript.","order":7,"name":"Ethics","label":"Authors\u2019 Contributions","group":{"name":"EthicsHeading","label":"Declarations"}}]}}