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Statistical analysis Subjects were assigned to the PK population set (PK set) if they completed the use of the study product, had data for the critical time points in the plasma nicotine concentrationtime profiles, did not use a concomitant medication that rendered the concentration profile unreliable, and did not violate the protocol (major protocol deviation) in a way that might invalidate or bias the PK results

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The 2018 revision of the Health Promotion Act made it the responsibility of Japans national and local governments to ban or restrict smoking in public facilities and prevent exposure to secondhand smoke