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PMI applied for both, but the FDA decided only to grant the exposure modification

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The American Cancer Society's Cancer Prevention Study II found elevated relative risks (i.e., the risk of the conditions among smokers compared to nonsmokers) for current smoking of 10.9 for males and 5.1 for females for lip, oral cavity, and pharyngeal cancers (i.e., male smokers have 10.9 times higher risk of developing these cancers than male nonsmokers, and female smokers have 5.1 times higher risk of developing these cancers than female nonsmokers) and 14.6 for males and 13.0 for females for laryngeal cancer (Ref

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