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T 0 : Diistribution FROK: W. L. Dunn, Jr. SUBJECT: Modiified Design of SEX-2 DATE: Aprill 8, 1969 These notes are intended to convey the consensus of the meeting on SEX-2' heldl April 7, 19619 with Myron, Johnston, Jim Charles, John Tindall, Frank Ryan, Mel Cohen, Barbiara Forrest and myself in attendance. The March 3, 1969 proposal for SEX-2 as wriitten by Myron Johnston is our bas i c documenit. The question basic to the study is thiis: "To1whiat extent is daily smoke intake a function of the cigarette smoked?" A contingency question is this: "If daily smoke intake is altered by changes in the performance characteristics of the cigarette, does change iin daily smoke iintake occur as a funiction of change in the niumber of cigarettes smoked, or as a function of change in initake from a single cigarette?" With these two questions in miind, we proceeded to modify the originally proposed SEX-2 design to most effectively meet P'.M. R & D needs. The origiiinal proposal was addressed to but one special case; namelly, the switching of 85mm smokers to 100mm cigarettes, a case which we judged to be less important than the more general case of switching to higher or lower dellivery ciga- rettes with cigarette length held constant. Accordli ng,ly, we decided to use two groups of smokers of conventional CA filter cigarettes. Both groups wi111 smoke a standard CA cigarette del i veri ngi about 20mg, of TPM for the first two weeks. Bu!tt analyses will'. be performed on daily butt samples saved Monday through Thursday of the s*econd week. Group 1, with 60 smokers, will be switched beginniing the third week toi&ciga- rette d'el i veriing abouit 15mg of TPM. Group 2, with 60 smokers wi l l be switched at the same time to a ci garette del iiveriing about 2'6mg of TPM. Butt analyses will be performed on Monday through Thurs- day f..- butt samplles beginning with, the third week. The test will continue for at 1!eas t three weeks of "switched" smoking, for a minimum total of five weeks of smoker participation. The study ` wi 1'~1 be extended to however many weeks requii red for stabil~i zati~~,on, in mean daily intake to occur. We will define the stabilized week ~ as that week ini which whatever trend occurring during the first three ~weeks of "switched~" smoking is no longer in evidence across the group mean daily imtake values for the four days of ineasurement.

11 2 We will recruiit panelists from among R & D and Operations employees, exclluding those R & D empil'oyees who, by virtue of theiir serviices being required to, conduct the study, are privy to its objectives. Marlboro smokers will be g,iven preference ini selection, with Parliament, Virginia Slims (non-menthol) and Benson & Hedges (non-menithol 100`s) as alternates in that order. Panelists will continue to receiive their regular consignment of branded cigarettes, being suippliied additionally with suffiicient quantities of the non-branded test cigarettes to meet theiir smoking needs. They willl be given, $1 per week of participation; provided they conti niue to termi nati on date. The specifications for the test cigarettes at the 15 and 26mg levels will be determined immediately by B. Forrest, J. Charles and W1. Dunn in consultation with Frank Lowmaniand Louis Long. The 20mg standard will be a Marlboro type. Schedul- ing with calendar dates will be contingent upon delivery dates for the test cigarettes. The foillowingi data are essential. Further requiiremenits and the formii n wh i ch, the data are to~ be obtai n~ed wi l l be dete r- minied by John Tinidall. For each subject for Monday through Thursday of Weeks 2 through StabilizationiWeek: 1) Mean daily smoke intake 2) Number of cigarettes smoked 31 Mean smoke intake/cigarette/day These values must be treated in such manner &s to answer these questio~ns: r 1) What percentage reduction (increase)l in daily mean intake occurred from Week 2 to Stabilization Week? 2) What is the ratiio of this reduction (increase) to that which would be predicted assuming cigarette TPM values to be solely determinative of iintake? In what proportions are the observed departures from predicted d~aily intake changes (from 2) attrilbutable to a), changes in the number of cigarettes smokediandl b) changes iin iint&ke per ciga:rette?

3 4) Is there a relatiioniship~ between observed i!ntake change and level of mean daiily intake on the base cigarette? The following assumptions of responsibility appear to be in, order: Barbara Forrest: a) Coordinate the executiion of the study. Co-write the final report. Jim Charles: a) Determine nicotine residue coefficients for the test cigarettes. b) Supervise nicotine residual analyses. Myron Johnston: a) Proviide consultative aild to B. Forrest, particul!arly in the development of record forms, instruction sheets, and data treatment procedures. b) Co-write the final report. John Tiindall: a) Prepare a supplement to this design memo detailiing the statistical treatment of the data. b) Provide consultative aid to B. Forrest in preparing the data for treat- ment. c) Supervise the computer processing. Mel Cohen, Frank Ryan and Bi l 1 Dunn: Proviide thleiir speciial i zed services as requested by B. Forrest. Further research effort upon this problem is continigent upon the outcome of this initial study. If we find that mean daily intake is primarily determined by cigarette design, i.e. if the mean daily initake following switchling is reduced or increased"as predicted from the TPM values of the cigarettes smoked, there is little justificationi for continuinig:. If, on the othier hiand, we do establish that the smoker's iintake is relatively independent of TPM level [smokes more ( 1 ess )' if TPMii s decreased ( i ncreased)J , we wou!lld wiish to proceed to the documentatiion of this fact with other kinds of changes in cigarette des i gn . We woul d! al l! the more wiish to pursue the subject if we discover that the smoker maintaiins intake constancy by changing his initake per cigarette. If such appears to be the case, we would wish to aug,menit the effort by study of the puffiing profile in collaboratilon with, f-a Brand Development personnel, in an attempt to establilsh in what manner the puffing profile is altered to affect the reduction FC or increase in intake. /jlh Distriibutilon: Dr. HI. Wakeham/Mr. R. Tamol' Mr. J. Charles Dr. P'. Ei chorn Mr. G. Fi 1 i as Mir. J. Tindal 1 Mr. R. Thomson Mr. F. Dlaylor Mr. F. Ryan Dr. R. Ikeda Mr. M. Johinston Mr. M. Cohen Mr. J. Osmal!ov Mrs. B. Forrest

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