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Briefly, human in vitro systems do not reflect all aspects of cellular interaction and tissue organization, in vivo animal models do not necessarily reflect human biology in its finer details, and human clinical studies are hampered by time and cost constraints as well as accessibility to key biological samples (that are accessible in animal studies)

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In 1989, Norway adopted a ban on new nicotine and tobacco products, but the ban was replaced in 2021 by an approval scheme largely based on Article 19 of the TPD

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