Appendix 2: Independent Expert Risk Benefit Assessment by Author

EXECUTIVE SUMMARY ................................................................................................... 2 2.1 Background ........................................................................................................... 2 2.1.1 Tobacco Heating System ...................................................................................... 2 2.1.2 Risk/benefit analysis summary ............................................................................. 3 2.1.3 Risk-benefit assessment ........................................................................................ 5 2.1.4 SUBJECT ......................................................................................................................... 6 2.2 State of the Art Approach to Performing Risk / Benefit Assessment ................... 7 2.2.1 Conclusion .......................................................................................................... 11 2.2.2 EVIDENCE DOCUMENTATION PROVIDED BY PHILIP MORRIS PRODUCTS S.A. ............... 11 2.3 Characterization of “Tobacco Heating System” ................................................. 12 2.3.1 Non-clinical Assessment ..................................................................................... 18 2.3.2 Clinical Assessment ............................................................................................ 22 2.3.3 STATE OF THE ART APPROACH TO PERFORMING RISK / BENEFIT ASSESSMENT ........... 26 2.4 OVERALL CONCLUSION ............................................................................................... 28 2.5