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rather, FDA was seeking a thoughtful engagement and discussion.[8] How FDA viewed the discussion is summed up in the following sentence: In general, TPSAC felt that the applicants study was reasonable and its proposed modified risk claim seems to convey an accurate message.[9] The TPSAC meeting is also cited in a sub-section on the importance of the epidemiological literature based on Swedish and Norwegian studies and the connection to the Swedish Match internal quality program GOTHIATEK

While there are other causes of lung cancer such as radiation exposure, radon gas, and asbestos, cigarette smoking is the biggest risk factor

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doi: 10.1016/s0015-0282(02)04664-2