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TO: D'iistribution, DATE: Apri'1 8, 1969 FROiM!: W. L. Dunn, Jr. SUBJECT: Modifiedl Desi'gn of SEX-2 These notes are iintended' to convey thie consensus of the and myself in attendance. The March 3, 19,69 proposal for SEX-2 as wriltten by Myron Johnston is our basiic docuiment. - C'harles, John Tindall, Frank Ryan, Mel Cohen, karbara Forrest - meeti ng on SEX-2' hel d Apri 1 7, 1'969' *wi th Myron Johnston, Jim e question basic to the study is this: "To what extent is daily smoke intake a function of the cigarette smoked?" A contingency q;uestioni is this: "If daily smoke initake is altered by changes in the performance characteristics of- the ci garette, does change i n diai ly smoke intake occur as a functi oni of change in the number of cigarettes smoked, or as a function of change in intake from a single cigarette?"' Wi th these two ques ti ons i n miind, we proceeded to modi fy the originally proposedi SEX-2 design to most effectively meet P.M. R & D needs. The original proposali was ad'dressed to but one speci al case; namely,i the swi tchi ng of' 85mm smokers to 100imm, ci garettes, a case wh i ch we Jiudgedi to be l ess important than the more generall case of switching to higher or lower dellivery ciga- rettes .wi th ci garette llength hel d cons tant. , . A . ~ W12 zv.A- vs e t~ro-+ ---e~ s m o k e rs o f conventi'on~all CJ~ fi l ter ci garettes . Both~g~'~"~'I 1! smoke a standard CAci garette del iiveri'ngi about 20mg of TPM for thie fi rst two weeks. Butt analyses will be performed on daily butt sampless saved Monday through Thursday of the second week. Group 1, with 610 smokers, wi l 1 be swi tched begiinnii ng the thi rd' week to a, ci gia- rette del i veri ng about 15mg of T'PM. Group 2, wiith 60 smokers wi 1 1 be switched at.the same time to a cigarette delivering about 26mg of TP'M'. Butt analyses w1iill be performed' on Monday through Thiurs- day butt sampl!es beginni ng wiithithe thi rd week. The test wi l 1 continue for at lleast three weeks of'"switched" smoking, for a minimum totall of five weeks of smoker participation. Thie study wi 71 be extended to however many weeks requi red for $tabi lli zaiti'oni in mean dlai ly intake to occur. We wi 11 define the stabi l ilzed week as that week in which 0atever trend occurringi during, the first th ree weeks of "swi tchedP' smoki ng i's no 1 onger i ni evi dence -across the growip mean dlai ly intake vallues for the four days of measurement. 1oo32s7ss"7

- 2 - s i ts objecti ves . Marlboro ' smokers wii11 ben gi ven preference in sel ecti on,, wi th Parl i'ament, Vi rgi nli a Sl i ms (nion-menthol ) and'. ' We ' panelists from among R& D and Operations employees, excl udiing those R. & Diempl oyees who, by vi rtue of thei r servi ces bei'ng required to conduct the s tudy!, are pri vy to iing wi th calendar dates wi 1!1 be ronti ngent upon del i very dates for the test cigarettes. Renson & Hedges (noni-menthol 1@0's) as alternates in that order. Panelists will continue'to receive their regular consiignment of branded cigarettes, being supplied additionally wiith,sufficient quanti ties of the nion-branded tesit. ci giarettes to meet- thei r smoking needs. They wi 111 be given $1 per week of pa~rti cipati on,; provided th~ey continue to terminatiion date. The specifi'cations for the test cigarettes at the 15 and 26mg levels wi111 b~e determined immediately by,B. Forrest, J. Charles and W'. Dunn in consul tati on wi th Frank ,Lowman and Louis Long. The 2'©mg stan~dard, wi1!1 be a Marlboro type. S'chedul - I The folilowing data a~re essential. Further requirements and, the formi in whi'chi the data are to, be obtained will be deter- mi ned by J ohn, . Ti n~dia l l. F T~d 1)' Mean dlai 1y smioke i ntake. 2) Number of cigarettes smoked 1), M;ean smoke i ntake/ci'.garette/day ( ( "A These vaTues -raus-t be treated iin such manner as to, answer these questions: 11) W'hat percentage reductioni (increase) in daily mean - intake occurred from Week 2 toiStabilizati'on Week? 2) What is th!e ratio of this reduction (iincrease) to T that whiiich would be predicted assuming cigarette TPM values to be solely determinative of intake?Ini what proportions are the observed departures from predicted daily intake changes (from 2) attributable to a) changes iin the number of cigarettes smoked andd b) changes in, i'ntake per cigarette?

Ils there a relatioinship between observed intake change and level of mean daily intake oni the base ci garette? The folllowing assumptions of responsiibiliity appear to be i'n order: Barbara Forrest: a) Coordinate the execution, of thie study. o-wriite t e final report. test cigarettes. b) Supervise nicotine residual anail!yses. M! ron Johnston: a) Provide consultative aid to Bi. Forrest, parti'cu ar-Ty, in the devellopment of record forms, ilnstruction sheets, and data treatment procedures. b) Co-write the final report. John Tindall: a), Prepare a siuipplemenit to this desi n memo dleta1i ng t e stati sti cal treatment of the data. bi~ Provi de cons ul tati ve ai dl to B. Forres t i n, prepari ng the dlataifor treat- ment, c) S'uipervise the comiputer processing. Aim Char1les: a,) Determine nicotine residue coeffi'cients for the Mel Cohen Frank Ryan and Bi l l Dunn: Provi de thieilr specilal i zed servi ces as requested by B. Forrest. Further research effort uponi this problem is contingent upon the outcome of this i'nitial situdy. If we finidithat meanidailiy iintake is prilmarily determi'ned by cigarette diesig!n, i.e. if the mean daily intake foilllowinig switching iis reduced or, increased as predii'ctedd from the TPM values of the cigarettes smoked, there is llittle justification for continuing. If, on the other hiand, we db establlish that the smoker's initake i's relaitiveliy independent of TPM level [smokes more (less) if TPM is decreased (increased)] we woul dl wi sh to proceed to the documentati on, of thi s fact with other kinds of changes in cigarette diesigin. We wiouldl alll the more wish to pursuie the subject if we discover that the smoker maintains intake constancy by changing hiis intake per cigarette. If such appears to be the case, we woul d wi shito augment the effort-by study of the puffing profile in colllaboratiion with Brand Development personniel', in an attempt to establilsh iin what manner the puffing profile is altered~ to affect the reduction - or i'ncrease i ni i ntake. /j1h Distribution: Dr. H. Wakeham' Mr. Dr. P. Ei chorn Mr. Mr. R. Thomson Mr. Dr. R'. Ikeda Mr. Mr. J. Osmalov ~ R. Tamol Mr. J. Charles G'. Fi 11i as Mr. J. Ti ndal l F. Daylor Mr. F. Ryan M. Johnston Mr. M. Cohen Mrs. B. Forrest f