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Such pre-exposure is a standard procedure to guarantee habituation to the exploratory component of the animals behaviour in the open arm, thereby leaving only the aversive component to be evaluated during the first exposure to the mazes open arm 40

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however, FDA recommends that stakeholders retain such lots in the event that additional scientific information becomes available to support additional extensions

Of these, a total of 12,545 subjects were allocated to a nicotine trial arm, and 15,260 subjects were allocated to a non-nicotine trial arm