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We also excluded men with incomplete information on cigarette or cigar use or demographic characteristics (i.e., race/ethnicity, education and marital status), so the final sample for our analyses was 43,202 men (age 4059 years, n = 27,229 and age 5079 years, n = 15,973) with 588,761 person-years and 14,657 deaths

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The draft guidance gives drug manufacturers a recommended statement to include in their labeling when truthful and properly supported: Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). The draft guidance also describes where to place that statement in the product labeling