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Contributors KH designed, wrote and revised the manuscript. LC, RDK and MM participated substantively in design and editing of the final manuscript.
Funding Meghan Bridgid Moran, Ph.D., holds an Innovation in Regulatory Science Award from the Burroughs Wellcome Fund.
Competing interests MM is serving as a paid expert witness in litigation sponsored by the Public Health Advocacy Institute against RJ Reynolds. This arrangement has been reviewed and approved by the Johns Hopkins University in accordance with its conflict of interest policies. RDK has served as an unpaid expert witness in litigation against Philip Morris, USA.
Provenance and peer review Not commissioned; externally peer reviewed.