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In each AL Test Session, subjects used the assigned product, administered by trained site personnel, that was either a Vuse Alto product for 10 min ad libitum , high AL comparator (UB cigarette) ad libitum until completion or until 10 min, whichever came first, or low AL comparator (nicotine gum) for approximately 30 min as per product insert

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market without the statutorily required premarket authorisation from the FDA are marketed unlawfully," it said