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Baseline adjustment was performed by subtraction of the pre-existing nicotine concentration from each nicotine concentration obtained after test product administration in that period/day for each subject using the following equation: where C t is the adjusted concentration at time t, C t unadjusted is the observed concentration at time t, C 0 is the pre-product use concentration (5 min), Kel = ln(2)/t, t is 2 h (approximate nicotine half-life), t is the actual sampling time since product administration, and t1 is the actual sampling time since the time of the pre-product use sample

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We also included single-sex studies, such as animal studies conducted only in male or female sex or any case report conducted on a single individual in the sex-based subgroup analysis