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1 II I T~:E RE~: ! Sen~ I~te I~te Rec~ Re~-nea 7 s- t, J~hor I~e I~ BU•." Co:~ec%iana Note: I. 2. This ~ foz~a is in%en4e~ %0 £aoi2/ta%o and. ~o~all "the In~rreas oE G.R. & D.C. Re,oz.• *~he ¢rpesc:t1~ m •hill ~e z~xn~ £m Zln:11~ ap];=mm~L a=~ Im~. ~e p:= ~==:a shoula ~e o,'---m~oecl at ~be t~me of the ~t~ ~-p~z~ and aooc~ the ~7~esc=~ (sz~ ~x~ez aftez g:m%i~n) ~t all subnoq~ten% sta4~a. It :=st 'be ee~t to oen%-zal filing with ~.he ma~e: v~e~ %he :epo:~ i8 l~mzed.. h~J~e~q~ l~8ti~le, d-~a~tm f~:~ I~y~:LD~ 8hou~ ~e ~r~l~%e~ in tJ~. lfte= ~yginK, ~e ~euc=t~t 8hmLla no=ally "De :e%~vnea ~o the J~th:=, who will ~8e~:en~ly Ob"~.t~ the Gl-o~1~ Lea~e~m ~ IB~:4~'• &p1~-~r~l. 3. CiTcul~tlon 8houl~ be ae~ezmlne~ ~y the Issue=. 4. The %?'pesc-~l~t muJr~ =0% be l:~ese~%e~ Eo: p:in~in~ ~n~il the Issue: ha~ in/tlal!e~ ~e ~=~ £©::~ S4sl=~ "P~m M~e~". ~. Aft•.- ~_----.%i-~, one bou.~ co~y ~:s~ be re%-~.--ned to the Issuer_ f~r fimJ~! a;~r~r~! a=~ "~he issuer will ensu_-e ~h&~ ~ne copy 18 see= "by "the ~a~•.-. m r~D BAT Co LTD - MINNESOTA TOBACCO LITIGATION

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ATTENTTON ° t tc This york was produr, ed nn the HaKnetic Card type-,'~£tcr. ] "~ 7 ~r [,Le, TL £s ianperative that all corrections, alteratLons, etc., "~ ~ " are made clearly. E.G. pencilled co~s, full-stops could be easily missed. A cross in the margin, in I/a~e with the correction would draw our attention to the insertion. Would you please be kind enough to write large £nsertions on a separate sheet of paper, and no__.~c cut out portions of typed work. This is because the Magnetic Cards differ £roa Papez" Tapes. - C (" f .... I ""b .'T.t ~c~{.~Cc{~- c .'- f'-" p _! f.~ BAT Co LTD - MINNESOTA TOBACCO LITIGATION ~r

BAT Co LTD - MINNESOTA TOBACCO LITIGATION p',o

INDEX HAS INDICATED GAP IN BATES RANGE HERE

A ST&T'rSTZCAL ANALYS'rS OF THE INCIDENCE OF TUMOUR-BEARING ANIMALS IN JANUS EXPERIMENT B6/B7 REPOET NO. RD.1212-R 9.5.1975 ~UTHOE: E.B. Wilkes ZSSUED BY: M.E. Willis PROJECT JOB NO. ~720 DZSTRIBUTTON: Dr. S.J. G=aen C~py N~. 1 Dr. D,G. FalCon 2, 3 Librar7 " " 4, 5 File No. 46D-2 " " 6 COPT NO. m BAT Co LTD - MINNESOTA TOBACCO LITIGATION

EBW/SMH/46D--2 Group Research & Development Centre, British-American Tobacco Co. Ltd., SOUTHAMPTON. 9th May, 1975 A STATISTICAL ANALYSIS OF THE INCIDENCE OF TUMOUR-R~AR!Nn ANIMALS IN JANUS EXPERIMENT B6/B7 (Report No. ED.1212-R) SUMMARY The major conclusions to be drawn from this analysis are:- 1. Using the all-cumour dana, no siKnlficanc difference between the tumorigenic &cnivities of tobaccos B6 and B7 was found, nor did changing ~he cuts per inch s~gniflcantly effect the ~morigenici~y of the condensates. 2. usinE the maliEnanc tumour data, both the B6/B7 effect and the cuts per inch effect were siEn£ficant. 3. AC the dose Zevels used. both condensates (B6 and B7) were h£Khly ~XiC. A. A marked high dose anomaly i8 present in Ehe dana. making it /mposslble ~o compute a tu~origeu/c ratio ~ith any precision. BAT Co LTD - MINNESOTA TOBACCO LITIGATION r',,,o

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-2- 0eJ~CTZVES The objective of this experiment was co assess the effect of two different modes of tobacco preparatlou on the tumoriKenic activity of the condensate produced by ciKarettes concain~nl the tobacco. The e~fecc of various levels of the cuts per inch used durin8 the muu£actuxe of the cilarectes on the tumorigenic activity o£ the conde~ate8 was also Luvestisaced. 2. DESTGN OF EXPE~ Two modes o£ tobacco -~nu£acture, three level8 oF cuts per /~ch, and three levels o£ condensate application warm used, a total oF 18 tobacco/c.p.i./dose level combinations. Thus the experiment co~isted o£ eighteen Stoups o£ animals, each K~roup contai~4n8 8A animals in the ociK~al desiKn, a total of 1512 animals. These animals were unmated female albino mice o£ S.C.I. breed. When submitted to the exper~nenc they were 8 to 9 weeks old and weiKhed on averase 20 $. The three l~els o£ cuts par inch used were 30 c.p.i., 60 c.p.i., and 120 c.p.i. The ~hree condensate dose levels used were 25 mS, SO m8 and 75 mK. The condensate gas applied every Tuesday, Thursday and Set.day throuKhouC the period o£ the exper~nt in 0.3 ml o£ solution. &11 animals in the exper/ment were shaved with the same sbearln8 rhythm. The details o£ an~m61 husbandry and condensate production are to be found Ln (I). 3. RZSULTS OF ~CPEKZMEHT The practice at 3details, Fra~kJurt~ is to exAmlne each annual weekly. Skin lesions ~rith~n the painted area are recorded as azure /~ they have a diameter o£ at Isaac 2 m and protrude above the 8kLn surface or have a firmer consistency than the 8urroundin8 skin. BAT Co LTD - MINNESOTA TOBACCO LITIGATION t..J-I t'~ ",O OO

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-3- Tf at any subsequent exaalnaciou a cumour is judsed Co have disappeared a reKression is recorded. For the purposes of cabulaCin8 the ~nc£dence of tmnours, the time of appe~arance of a Cumour is taken as the tlme of appearance of the papilloma, recorded as described in the previous paragraph. The condition o£ maliKnancy is noC diagnosed unCll autopsy; the time of onset o£ maliSnancy ~s taken as the t~me o£ death of the animal carryLng the cumour. Tumours are resarded as malignant if they produce mmtastases, or Lf they /~filtrate the dermis and penetrate the tunics muscularls, or i£ they infiltrate the dermis and penatrsta the basal mmabrana of the epithelium. Occasionally tumou=s sho~td 4u~iltracion oE the da~mis, but ~[t could noc be cl~rly escabllshed thaC penmcration of the basal membrane had occ~ed. Such turnouts were recorded as sho3r~a4 the f£~st siKns of real £8~ancy. The results o~ the expe=Lmmnt are shown in Tables I to 18. These ~bles show Che ~c~denca of tumour-bea:iuqL a~imsLs ~n the I8 emper/a~ntal Stoups of animals. The c~sour-b4~r~ ma/~aSs /~ mn axp~r/~mncal poup msy be allocated to the £oLlowiJ~ seven clasaas:- 1. kn~nals hey/Jag no lesion. 2. An~nals haviz~ lesions all of vhlch pex3naneuatly reSrassad. 3. An/~aZs having lesions all o£ which are uncharmcterlsed. A:~Lma~s hevi~s lesions, sows o£ which penmmeuCZy :egressed the :ama£nd~c bataK unchazacCe=£sed. 5. An~nals havlz~ at least one coutirmed amour. 6. An/s~Zs hev£nZ at least one turnout show~ng the £irsC siSas o~ mli~ancy, but no malignant cumomr. 7. An/~aZs heviJzS at least one malignant t~ur. BAT Co LTD - MINNESOTA TOBACCO LITIGATION OO r',o

INDEX HAS INDICATED GAP IN BATES RANGE HERE

V An animal must fall into one and only one of the classes 1 to 5. Classes 6 and 7 are sub--divisions of class 5. The lesions borne by an animal in an experimental Stoup may be allocated to one of the follovinS five classes:- 1. Lesions which permanently resress. 2. Lesions which are tmc~eracterised. 3. Les~ons which are beniBn. A. Lesions which show the first si~na of mal£Snancy. 5. Lesions which are maliKnant. & lesion must fail into one and only one of these five eI&sses. In order co analyse the incidence of t~nour-b~aring anlmals, the t~ne of appearance of ttmour-b@ar~ animals in the ex?er/ment is tabulated as in Tables I to 18. The firs= column shows the duration of the experimene divided into 4-reek periods. The times recorded in the date for each animal e.K- time of appea~anne of turnout, time of death, etc., are recorded in weeks. The second column is defined as the number of animals alive end tumourless st the beEinnln8 of the time period. The third column is defined as the number of aIL'|.msls becoming tumour-boaring durinS the 4-week period. Col,~ A is defined as the number of animals dylng w~thout becoming turnout-be&tins du=inS the #-week period. The fifth eolutn is defined as the mmber of animmls allve vithout a maliE~ant turnout at the belinnLng of the &-weak period. The sixth column is defined as the ntmbe: of animals which have no mal i~Lnt t~mour at the bqi=ins of the time--period and which produce at toast one maliKnanC turnout durinE the 4-~sek period. Since the onset of mal~ancy is dafinld is the date of death o£ an animal b~ar~ng a malignant turnout, columns six may be equivalently defined as the number of an/male dying with a malisnant BAT Co LTD - MINNESOTA TOBACCO LITIGATION

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-5- tcuuour during the 4-week t~ne period. (SLmilerly column 5 may be equivalently defined as the total number of animals alive st the beginning of the 4-week period. ) The seventh column is d~ined as the number of ani:als dying vlthout a malignant turnout during the 4~eek period. Thus if the rows of the table ere numbered from i to i then for columns 2, 3, 4 and 5, 6, 7 Ni+I " Ni - DIi - D2i where Ni is the number of animals ac risk aC the beginning of rime period £, D1i is the number of Qls becoming ctanour-b~ar/ng during rime period i, and D2i is the number of animals dying during eke period i without becomins Cumour-bear£ng. N1 is the number of animals encer£ng the experiment at the beginnins of week 1. The animals ~n an axperin~ntml group enter ohm tables according co their occupancy of the seven classes described above. Thus aninuals from classes 3, 4 and $ will ante: column 3 of the Cable; az~mals from classes 1 end 2 will enter column 4 of the table; animals in class 7 will enter column 6 of the table. Columns 3, 4, 6 and 7 are totalled. These tables form the basis of the statistical analysis. 5ubsidlary tables of the numbers of --4m-ls in the seven classes and of the numbers of lesions in the five class., are shown in Tables 19 to 38. Table 28 is • stamnary of Tables 19 Co 27, end Table 38 is 8 sugary of Tables 29 to 37. Zt v~ll be noted Chat Tables i to 18 frequently show that the numbers of animals in the experimental groups were greater Chart Chose stated at the beginning of section 2. These extra animals are called "I~PLACZIEHT AH~S" and were taken into the experiment Co replace animals dying during the first 4 weeks of ceat~enc. The number of replacement animals used in r_he 18 Kroups were as follows'-. BAT Co LTD - MINNESOTA TOBACCO LITIGATION O

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-6- 25 m8 75 30 c.p.i. i I0 g6 60 c.p. £. e,, l 4 3 120 c.p.i. 1 4 6 30 ¢.p.i. 4 2 3 B7 60 c.p.i. 120 c.p.i. 4 3 3 A torsi of 70 replacement animals were used, maki~ an overall total of 1582 animals uJed in the experiment. 4. ANALYSIS OF RESULTS Using the Weibull distribution, common values of k and w, and separate values of b were fitUed to the da~a from the eighteen groups of animals. A fit was obtained for all turnouts, and for malignant tumours. The est/-eates of ~he parameters are shown in Tables 39 and 40. The associated values of S and V ere shown in Tables 41 and 42 IS and V are the Weibull statistics and arm defined at the £ooc of the tables], t goodness of fit test for these parameter values was carried out, the results beinE shown in Tables 43 and 44. Inspection of Tables 43 and 44 shove that the values of the parameters given in Table 39 do not fit the data too well (X2 " 27.63 with 6 degrees of freedom, significant at 99.98Z) whereas the parameter values given in Table 40 do fit the data re~eouably well (X2 m 11.43 with 6 degrees of freedom, not siEnificanC). A closer inspect£on of Table 43 shows that the lack of fit is occurrlnE dur£~ the experimental weeks 65 to 80, Coo few ct~our-baarinll animals being expected duxin8 weeks 65--72, and coo -,any being expected in weeks 73 Co 80. The total expecLation for this time period, 191.4, is however fairly comparable wi=h chose observed, 214. r~ ~D BAT Co LTD - MINNESOTA TOBACCO LITIGATION

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-7- It is difficult to identify reasons for the lack of fit of the parameter values of Table 39 co the a11-tumour data. Inspection of the data (Tables I to 38) shows that a feature of this experiment is the high toxicity of the col~Ita~,sllUeS used, as Lnd£cated by the death rate in the first 8 weeks of the experiment. The deaths in the first 8 weeks of the expeximent are shown in Table 45 and these deaths expressed as a percentage of the number of animals at the beginning of the experiment (including replacements) are shown in Table &6. Analyses of variance of the dace of Tables A5 and 46 were carried out, the results being shown in Tables A7 and A8 where it can be seen chat ali the main effects (tobaccos, cuts per inch, dose levels) are highly significant. Also, as would be expected, comparison of Table 47 with 48 shows thaC expressing the numbers of deaths in the first 8 weeks of the experiment as a percentage of the s~arting number in each group increalmS the significance levels (the F-ratios) of the main effects. The partitioning of the m,,,in effects indicates than the dose effect is m-tlraly log linear, and that the c.p.i, effect is h~hly Iog linear but with a significant degree of non- Einearicy. This analysis of the early deaths shows that (a) ~he condensates used were unexpectedly toxic, giving rise to very high death races (up to 64.5Z; see Table 46) in the first 8 weeks of the experiment. (b) the condensate from cigarettes contalnln6 tobacco B6 was sisw/ficmntly more toxic than that from cigarettes containing tobacco BT. (c) decreas/~g the cuts per inch siEuificantly increased the toxicity of the condensates produced by the cigarettes. BAT Co LTD - MINNESOTA TOBACCO LITIGATION r',,o ",.O

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-8- Thus the situation is that the high mortality is proportiona~ to the main effects under consideration i.e. a situation wherein the mortality is strongly influencing the observed tumour rates. The extent to which mortality has influenced cumour races can be judged by comparing Tables 49 and 50; the former shows observed percentages of tumour-bearing animals (all turnouts) and the latter shows age-standardised percentages. Lee's m~thod of aEe-sCandardisation was used (2). Table 51 shows the ratio of standardised to observed turnout rates for each experimental Stoup, i.a. the weighers applied to the observed tumour rates co obtain the scandardised races. Obviously some of these weights are far too high. Table 52 shows an analysis of variance of the data of Table 50. The arc sin square root transformation of the age-standardised turnout rates was used during the analysis of variance. From Table 52 it can be seen that, using agrstandardised turnout rates (all turnouts), only the dose levels have a slgn/ficant effect on the tumour races. There is no sigu/ficanC difference between the ~ tobaccos B6/BT, and no slgnLficant e-Ffecc due co changes +tn c.p.i. The dose effect ks more nearly linear if the logarlCtms of the dose levels are used in the analysis (in place of the actual dose levels) but a significant degree of non-lintarity is still present. The form of this non-llnnaricy in the dose-response curves can be seen in Figure l; the da~a display a hilh dose anomaly, the response rates at the highest dose l~vel. 75 ~, being rather loss ~han those at the middle dose level (50 ~). Overall it would seam that the lack of fin of the Wmibull parameters to the all-turnout dace has arlsan as a result of the excessive morCallty durin8 the first few months of the experiment. The malignant turnout dace, produced aminly by the animals which survived this early period, does follow the expected Wsibull dlstribucion. BAT Co LTD - MINNESOTA TOBACCO LITIGATION r',,o

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-9- Even though the We£bull parameters did not fit the data too well it was decided to construct an analysis of variance based upon the likelihoods of the Weibull parameters of the all-tu~our data. The results are sho~n in Table 53, and comparison with Table 52 shows that the results of the analysis of variance of the age-standardlsed tumour races are con£iraed i.e. chert is no significant different beaten the incidence of all tumours for tobaccos B6 and B7, nor does changing the level of the cuts per inch dur~ tobacco manufacture produce a signlficant effect on the incidence of all turnouts. It is to be noted however that the significance levels for the betveen-tobacco effects and the between c.p.i. effacts are considerably hisher in Table 53 ~mn in Table 52, the between- tobacco significance level of 92.6Z in Table 53 being nearly significant. Usin8 the Weibull analysis, the dose-response curves remain siEnificantly non-linear as can be teen in Figure 2. The incidence of animals bearinK malignant turnouts was analysed using the Welbull disurlbution. The goodness-of-flt test showed that the parameter values of Table 40 provide a satisfactory description of the incidence of ~ls bearing malignant turnouts and and analysis of varLance was constructed based upon the likelihoods of the We£bull models of the malignant tumour data. The results are shown in Table 54, where i~ can be seen that there is a slgnlflcant dlfEerence between the two types of tobacco B6/B7 (significance level 95.7Z), B6 being less t~morisanic than ST, and that the chanse in c.p.i. levels during tobacco manufacture significantly reduced the tumorigenicity of both condensates (slgnificance level 97.9Z). The partitioning of the e.p.i, effect into its linear and non-linear components shows that the c.p.i, effects is almost perfectly linear, the non--linear component being vanishinEly small. The amalysis r~ %o BAT Co LTD - MINNESOTA TOBACCO LITIGATION

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-I0- also shows that the dose/response curves are markedly non-linear. This non-linearity is shown in FiEure 3 where it can be seen that, as for the all turnout da~a, the malilnant turnout da~a shows a high dose anomaly. HavinK shown that, for the maliEnant t~nour data, the two tobaccos (B6 and B7) were significantly different in their tumorisenic activity, the tumorisenic ratio was computed and found to be 1.14 with 95Z confidence limits of 0.99 to 1.33. These confidence limits show the tu--oriEenic ratio (based upon maliEnant turnout data) to be just not siEnificann, whereas the analysis of variance shown in Table 54 shows the between tobacco iffect to be just sit~/fioant an the 95X level. (Actual sisnificance level 95.7Z.) This sliEht inconsistency in the siEn£ficance tests arises because the siEnificance nest for the between tobacco effect used in the analysis of var/~nce table uses both the dose In linear and dose in quadratic terms in the model, whereas the computations leading to the tumoriEenic ratio and its confidence ration use only the dose In linear term. Zt is to be expected that in the presence of marked non-llnearlty of dose/response (as in this case) the inclusion of the dose In quadratic term would improve the sensitivity of the siEnificance test. Thus the overall situation is that, usiD~ the maliBnant turnout data, a sisnlficant dLfforance between the tobaccos can be found (B7 beln~ more tumori@enic than B6) hut the tmnorisenic ratio cannot be determined with any precision because of the marked wn-linearity of the dose response curve. Using the all-turnout data no siKnificant between-tobacco effect was found. The effect of cuts per inch on the tumorilenicic~ of the condensates is shown in FiEuze & where the values of In(b) for maliKnaut turnouts are plotted aKainst cuts per inch. As has been noted earlier, the cuts BAT Co LTD - MINNESOTA TOBACCO LITIGATION r~ %0 o-x

r,,o BAT Co LTD - MINNESOTA TOBACCO LITIGATION

-11- significant c.p.i, effect was found. dace are shown plotted in Figure 5. 5. CONCLUSZONS per inch linear term is highly significant and accounts for virtually all the c.p.£, effect. The magnitude of the c.p.i, effect in terms of the tumorigenicity of the condensates may be assessed by noting Chat a change in c.p.i, of 51 (say from 50 Co 81) is equivalent co the difference between the B6/B7 condensates. Again, using the all-tumour dace no For completeness the a11-tumour c.p.£. I. o ~o ~o o The conclusions Co be drawn from this work are:- Using the all-cumour dace no significant difference could be found between the tumorigenic activities of tobaccos B6 and BT. Using the all-cumour data no sisn/ficant effect of changinS the cuts per inch could be found on the tumorigenic activity of the condensates. There was a slgnificant lack of fit of the We£bull distribution function to the all-cutout ctaca if the Weibull parameters were esclmated under the restriction of con~on k, w for all groups, separate b for each group. Conclusions 1 Co 3 have been greatly influenced by the CoxiclCy of the condenmaces, this toxicity leading co high initial death races in the groups of animals. Both the type of tobacco (B6/B7) and the level of cuts per inch had a slgniflc~ut effect on the toxicity of the condensate as measured by the death rate in the first 8 weeks of the experiment, B6 being more toxic Chat B7, and increasinE c.p.i, giving lower Coxlci~y. c~ BAT Co LTD - MINNESOTA TOBACCO LITIGATION

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-12- 6. ~e e UsinS mali6mznt turnout dmt&, • slgni£icent di££ere~ce was found between the tumorigenic activities of tobaccos B6 and B7, B6 being less tumoriSenic than B7. Due co the s~Sz~flcant non-lin~szity of the dose~response curve it was not possible co determine the B6/B7 tumorilen£c ratio vith an7 precision. Using the malia~auc t~ur data, increaslng the cuts per inch s£gni£1cantly reduced the tumor£seniciCy oF the ¢ondeusates. 1. "Long-term skin painting experiments. General report on project JANUS". J. ~endl, G. FJJn~smaun, a. ~ramer. Report B.18. June 1970. 2. "The simulated population method of analysis of nnimal painting experiments in cancer research". P.N. Lee. Biometrics 26 No. 4, 1970. Computer Softvare used im this analysis;- "Syste: Definition to produce an analysis suits for JANUS post-rooftree T.B.A. dace". Syst~ Definition No. BR(J)/OO3. J.N. Davey, E.B, Wilkes. "System for the analysis of JANUS sk£u pa£nciuS experiment (Gener&l L~eAr itypothesis)". STstem Deflation No. BE(J)/OOA. J.M. Devey. memm~ BAT Co LTD - MINNESOTA TOBACCO LITIGATION

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-34- TABLE 22 0-a.1. CO. ll.aHI) 0.~. PuJeclr JANUS 10Ta0.S Of TUllOUR-KLIIINO INIIMLS • (IP~mI~NT Oi~ IZ5 IJUU'T, 16 L~0e 6ocPI I[l~Y PtOSOI AIOlIeAI.S ¢LA~IflCLI IIN I, M ~SlmS I, ~L LESIN ~IKIUI~ ~,, $6n1[ LESIgNS I~RHI~ENTLT N~KSWO, THE INNJlSlU LESlNS IElm W~JlACTERISOD 5. iV LEAST H NNI~ TUm0UIp SUT NO OTHER 1Wi4OUfl 6, a! LIras! o~ TUNOIm Si~v1~l ViC FlieS; IIONS OF NALIGHaliClr, ;bUT M0 MJd.IGNJNI I UIquI Y. A! LEAST N IMLIIHANT IUMUII TOT/L. IINM.S CLASS If ICAT IM i* P[N~NYLT ~55[0 Z* ~ABACTEPI~0 3. I~[N IGii &. IrlIiIl sims ~ HALIaNANCT 50 NAL IWiaNT US 10HI V~ LEIIN tl/I]ST4 ~lll' illild.! Ii(~l.|O MgtCEXI 41 48~ E ~,4 S I,S e 0,4 IS IT,~ O O,O D,Z LD~GNRm iS I T0VN. Plmctwr 9 10.6 S S,9 ZIP 34.1 i O.I 4Z 49.4 iS PMI( T4 Z O N .2 8 U 0 Z Z I O

-35- ?~dl~ 23 ,, inn lI-Li.l. CO. I).J~ 0.1i. PnoJ[CT /OTALS Of" lruILoUII41[AIIIN6 ANINAL$ I[xPITml~mr $1Z 0$0 [XPT. 06 ~ $ecPl ~It~T ANINM.$ C:LiSSIFICATION h 180 L(II01*S Jr. ALL LI[SI01L$ PI[IU4~ENlrLT Ninl[l$1[ll 3. ALL LI[Ii0NS UNCHUACI1ER|SI[0 4,. SOft Li~SINS P[ImdIJ~NTLy lt~Oli[SSi[D9 THI[ It[NAINIl~l i.l[~l(~lS NlkO UNC~III~T[IIISk'O *]. IT L(IST ~ N'NliP4 TiJmm, IJUY tgO olri4[fl TUNOUN 6. J! LEAS1 0t~ IUHOUN SB*0VIkfl |1~ lr|R~! SIGHS Of IJALIGNM4CY, ~UT NO qiLilJNaNr lrwIE~ 1. LiT LKAS! li~ NiLILNIiNlr 71I~NR ¢LJ$SIFICATION I. p(IINAN(NTLY it[GRESS(0 ~. UNCHAIILIC f(gl I S[0 3. NNIGN k,, ¥1R51 SIGNS OIr NK|ONAHCT S, MAL IGHANT ) reel tOTAL LUdlMAL S LTS IONS ~nd~m TOTAl. Lt'SIO~ TOTAL t .S 0 It O Igt eNHNNe. M ~eNMS. TOT~ lZ e o 35 mN~ toe LeI, G~MD ttlO3S74 II[PI.JCI~.IaT iWlHALS IICLUO~rO P[IICEm0T S9.1 ~.$ 5.T 0.0 IZoS i.e zi.s P[mC[Ny IJr.t 9.0 44.4 0.0 35.0 PNO( IS Z -@ F- < ..J O < @ F- < F- Z Z ! F- o U <

t~ n O t-- ! Z Z --3 O t~ t-- .-+ O Z llb ~iI l'l $'li I'I I'I I1435141ld 6'~1 O'O e'| I-I |'o |'o llHn'l.l, pll S'IVNIN IIMIIII~IFId+II ~I#II#II I| w Q II O 01 I t "Ivl0l ll, l, gao II o l..,+oq, II O L I O O M ~JOl 111O1111 11/101 lli011ll l'llllllll "IV 10l lllVll!llllVvl "l A314vlqlIIIIvll J0 IIIUII ISUlJ "qp Mill+Ill "¢ QIS I lllL31111~013~ll "I IIlIIII0]Ill A'IIIIIII~VI+II4 "I IIIV~IIIIIV'K) MAllei IPlVPlPI'IV0g .I~ JIV]'I IV "L IIIIOHlll IWVlIII'IIN ON IIII 01311VNlllVl J0 IIIIII |llllJ Ill llqllOHl lflO0lll, illll IlVll IV "I IMII011111 lllldl, Q ON LIII Olll1011Al 140111111 H IIVI'I Ill "l QISIIIL3IIIWI~M~II IlMIII 10101ll'l IIMIIIII,IIU ]141J, olllll.lllOlil A+IINI~PlIIIIIId INOIIII jbllOl "qp @3S|OfiI|3VlaVH3NII 1~10113"1 "1"111 "I~ II~ISII~IIIIJll JI,'IAN3PIVIelIId SII01£I'I ~ "I illll IW "I II llt~l IlISV'I3 wm IInIIMV lllOl Im Id~ IMISIL 911 °Idlll llO IIII llllMld3+'lll ll111alNl 01011gV]I-IIIOMnJ. JO llvn0J. IfWVP 133f'OlPd "0"0 OeV'lJ °0@ "I'V4 -9C-

N o p-- ! Z Z ++ O t" O. Z Tim ]4)Vd 0"0 (*t Oo2| J~,l:)U~ld t'Z| O*| 0.0 ooe ~e6 6"|~ IWa:)V]d O]0AI~I SlmlW IN]U]3Vld~M 94P ~me, 0 ¢¢ f. |m 3VAoA N ilnvlelVt, I,! I 61 o o o 44 WAOL ~4tCOSZ| SlmiS&'l ~VJ01 INfirm ~OlS]l ANV~I31M "~ A3NINOI~H dO SM~IS lS+lJ *) mlN]V *[ O~Iu]L3VV~t3kn *+ O]ISS]~N£~JN)WNiJJ41 el N0llV31JllSv+3 $1mlm IIIOI • iAOml INIMQI+N ]NO ISlll IV "l dO S/I~Ii livid ]HA ONIMHS M~I ]NO |$+33 IV '9 I]HIO ON LN *MIIO~I I~|M]ii ]U ASlr]l 11 °S OISlUII~I~K2~ NIN SMOlS~ IHINII~]H *O~lSS)l~3111 AltH~IVII~N SN01S]I MS **+ 0]~S]~lJl A~IN~iVNMId IMOIS)I 1'tV "| N0llV31+lSlV~ S'WIIIN~ tescm leOdglJ 143111 emil tl *liT| lll lid JN]~Iiid~] ' S~N/P I~II'OUd "0"0 ~l*i "03 "l'l*l

--I r~ o t- -+ I Z Z ,-+ O R O t- -I O- Z • . All ~gVd O'O ¢'i¢ I*¢ V'S| II'J:lllld ¢'t2 • |'1 I'L! l'g ¢'1 ~'£ t'et lmmN o2mtlOUl rtqmiNv IN'Jl]~ldm ~LI¢Olii ul, mel Oil v9 o Iv ) |Z "~Jot mm o| m o Sl o if. t 1111o1 111o1111 "IV£Ol m~ leOI $l'I l"llulln "IVllOlt INVHgI'IVN *| A=I~II~blIII'IVH 40 SHglS ISUlI *+ II91N30 "[ 0I$1ilI3VllII31111 "I OillillllOil lllNllllKild "I NOllv31dlllv'rJ • IMIOIII! UIIMglllVM ~ ISlll IV "I llflO14011N+II~I'WIM IN INi *£3+IVI~IIVN N INIlll llllld IIII lllllmO~ll IMIOIIII ]1410 ISlll IV "9 IIII0141li ll141DOll 1111 'Sl IIIIINll ]1410 I$V11 If "I IllliI&+vlI~M~III~IIIIIlll II~OII3rloHIMII~I41i 3H& *Oe~J;s~lgN I~INN4VNIId SNOIEII ~0£ ") Olllill~l¥10111 $1e01S]l 331 *[ lllilmlll £1IMIIIVlOII+ llllll "IW "I I~I01111011 "I IIOIIIFJIIIIIv'I~ mm 1111141MY I IIIIII llldlll ld~lll Nil II *Idltl Ill lie Illllllldlll . I'IVNIMVlIIIIIIIIO-IIIIOIIIII Jl I+VlIII lllllVr 1311('I)14 "0"0 lllV'l "03 *I'¥-I -9P.-

-39- TABLE 27 o5't+&o2/ II-A.T, CO. 1.1140 O.O. PllOd[C! JIIilJS IrlITIILS or II~IWJII-I~AIIIIII AIMIMILS (IP(lllli[Nt llb) 111 l[ItP% 14 ?SM IHCPl Nllqll llmll AIIIHALS ¢~ASIIrlCAIIOU I. ml LltSlOIIS Z. ~.L LtSlOmS Ptam*~[mTLV mmsxn ~1. MJ. Ll[Slm4$ KHkllACT[IIISI[0 4, $014( L[S|QN~ p(RII4MMEIIrLY a(IDJ[SSF.O* TH[ KNIININ L[SIONS 1|!140 WiCNAmlCI(alS~O $, IT L(IST Ol~ i(MIGM I~0~, I~r NO 0T~[R T~0~ 6, IT ~[lSI 01~ |UN4~II Sll0~|llO ~H[ P|mSl S|II~S mlLIGI4ANC+, lUT NO mILIOIUMV lUNO~ ?, AT LtISr 014( Hll.ll~lMT IUIIOIJII 10TAL IN I Ni.S L[Sl0flS CLiSSI;ICATI0N I, PII*+~tWTLY mINESS(0 Z, ~¢H~IACltRIStD +. ttMIm 4. FIRST SIGNS OF MALIGNIWC¥ S, MALI011ANT 10TAI. I.I[Sla*~$ feTAL S6 I l I II I Sl TOTAL U 3 O ItO ~S4w, m~ ll/l]/Tlb II~IU~ISII IWlIW.S ll*¢l.IJ~O I " ff.l~l*l ll,I I,I I.| i.l i,i P[mCtlll 4+.~ I.I ]4,t Pllillt III Z .© J @ <~ Z Z I O C~

@ [.- ! Z Z @ N N © ..-] ©. Z LZ ]lMd • O'S ~r'/.C Z'L S'St ¢* Ii P'I S',~l t, 0"¢ b*H UQ0V)d O]10fl'lOlll S'11mlidV liIN)i3V'hl~ .~m,,.o.! ,vee ~,e4, UC o 10¢ Is 'lvi0A m t6/, , mN 69t e 66 q) e~ ~z lviJL llla till "IVAOL Q=...Nb~ Sll0l$]'l SlVwSHV lv~o8 /HVNgl'IVN *S A3Nlmgllv~ 40 SP@JIS J.SlllJ "~ N I N.Ili °L 0lib I II)L2¥UVH:)41/I "~ (]]SS]~J)li A'IILN]INWN]d "| NOIs¥~)I d|SSV'I3 lUlOUn! Io4V~I~IVN ~ JSv)'l ,iv "L ;ll~Nfl| JNVINOI*IVN 0N |/IV *A3flVNgII'WN J0 SIllS LS,iIIJ 3141 ~I|AOliS il0Nnl ~ ~iV31 ~l "9 IIIINIU 8]HL0 0tt 1118 eljfl0810l IOIN]I :)NO lsv]l IV "S I;iSlUaA3Vll~3m llMlJl SnOI$)l ImINIvN)U O]ISIILII)VUII~Nfl SII01S]'I 1"1V "( 0]SS)4d)]~l A'llX]~viql]14 SllOlS]~ 1~1r ,~ Sl*OiS3"l C~t "! ~OIILV31 alSS~I3 S'W~*INV I~11 Ill0AIJ Sdi~H) Ul]NJV]lllJ [90 JlLINIIIJdI3 AUVmmS S'~INV ~lxwv]m-lmoNnA JO s~AoL "6*Q OIW'll "C~ '~*V*ll 9Z ~lnV,,], -0~-

i° • . i O°A.Y, CO. R.A~O DoO, PNOJ~CI JAImJ6 IOrSLS OF Tt~-~E~III~ AN|HiLS EIP(PIq~I41 111 12S (APl, ii.~ 311CIPl CUHIIIOt A[~NT JIOSO] ANIHALS CLASS IF ICAi' 1014 i, H0 LESl~S Z. iLL LCS|0h$ PiInN~MIL! 11~61o~$b[O 3, iLL LESI0~ U~C~IACSEn|SID *o 5U~ L[S|~S PEMNANCN|LY MErd~|S.~0, 1H~ #|NilNI~G LESIO~ UilNG UhCKa~ACIERIStO ~0 Al LiISI IN[ mNl~q IUMU~ flUl NO OlHFJR IUMO~ 6, Al L£ASI Wq[ |U~MJH SHOVING |~ F|BSI SIGNS Of NAL[~ANCYe IQJ[ I~ MUILI6NAN| |lJI4~ 7, a| LEAS/ O/v~ HALIG/e~| |U~U LISIONS CLASSIFICA|I~ h P~llmi~[NILy I~GWESS[0 2. U~.C~A~ACTENI SEO 3, ~ENI~N *. fln~;| SIG~S OF NaLIEa~A~CY ~o M~d. IG~AN! IOTAL L[SIONS -4].- Tk~LK 29 |BIAL $ S I II e )Z SJ lOSII I+ I+ ++ I S+ ISm iiPLACEII[NI MilMALS |NCl.USl[O PltCl[Ml 4t.q S.l I.I I.e 36,4 Ptll4~Nl IT.4 11.1 S.S S~,e Pal( ! 105.44 029 7- +© I-., < I- C) C) I- < Z 7- I 0 L) t-- < C~

>_, (3 t"" ,--] I Z Z ++ >. -,l O >, R @ t" ,-,] C"J > ,--] O. :Z lw ;Itl,ll 0'0 I't 2"!i 8W~I t'EE O*O t'+ I'+ I'I+ IMP+++ l]On1311 l~Nlii l~]~rJ~W]M glllllll ++ +. + CZl | 01 St "wlol m W m II l st + I I IVlOl Stt015]~ ~¥L01 I;l+Olt|l G'l,nllm "11101 A3PlV~gIlVH JO$191g lSalJ "+ ~lm]+ "c olsIHll3im+~3~t "+ NOllv3141s+q13 • i~0~l l~+l~lli+ ]~ ISVll IV "£ HI~iAI I+111m Oi |AI *A~III++ JO ++491+ lSull }+4L ~',II~I~ HflOi411l ~,I+ ISI]~ Iv "+ iflMl +]HIO aN Inll .1411~I I~}INll ]Nil llqll I+ +i 0]SIi+I3INqH311CI ~NI~ INOI{++ ~lqlvm+i }lll °O]SgMM £~Ii~NImWM]A SNIIIS}I )mOl "i 0]$I++131+ SM01S|~ ++V "t SI(OlS~I Itm -| NOIAv31JISSVl) N $1VUlUV + lli0M liOd]i "~0111~3 Id31lf; If+i|" ll "Ligll l+l Ill lli+N|gldi] slvMIIIi l~ll'+IO-lm~l 40 SlVI01 SIWII' I)]I'0M 00"tl 0~V'I "03 "l'V-I • • ,o

> N O I z z > O > F" > O. z 9 ]SV4 8"t S" IC |'6 9"61 IN~JH3d S%I I*! ~'¢ * • LNTJII]d 0~lOnl3lll SlVNIM lli~J'J~dlll ~r115|| ~6 o~oo | 6t 6 II "Itl01 mNm. L0 LI | O I ¢ ( SS "IVlO! SMIS]3 ~Vl01 SHOIS3"I. S'NNINY lv101 JlWN~lllu "S A3NImOI'IvH J0 SNOIS lSdlJ '~ MSlN;R 'C Q~SIS]I3~U~3~q "t OnS~lliJ)lJ A~IN1N~NH~d *| H~llv~lJlSSv~ WIONfll lVffldC)IWN ]~0 iSV)~ IV "l SqSlS lSilJ :Wl ~.l~m~s w~Vml ~lO ISf]l Iv "9 Q]SlI]I:~q'JWI~II]I S~OIS]l ONI~IIM|~ ~H| *@3S511~)~ &~IN]NV~]d SNOIS]l ]NOS *~ 01Sl~313vl~3~l Sq~lS)l 11f "C O31S$:JIN~I AIIU~V~J~I $UOIS]3 11v "t N01LV)IdISSV3) D~m S'IwlNV ItSOll ill0dl~ "IOILM) IA30[ ~11g *lAX] SL0 !£0 IN|N|i|df| " $3vwlNV gOflm)e-ifflo~nl JO SlVlOl 5~V~ l~]~J4J eOe~ ~e~ eO~ ojSV.~

N O ! O > R O N O Z 0 HVd I'IS I'I l'g C'l i'll Iil~lld l'll l*l I'II I*I I'l l'l lSl~ild {|I~II IIVWINi l~IWl3Yldll lllllJll III Ig I I II "llflOI oe,o.~ 90 ~me el l ¢I I C S K "WlOI 5NIll~]l ~IIQI ~M SNOlS]rl S'lWllllW "l~lOl ( A3o~Vo~IIVl JO INII l~lJ "~ IIIIlNQIi lllH~kl~d *I PII IVOI JlIIV~3 PPlmll llvl~llVl Iol lSvll IV *l 10unl lJWO~llwl 0q I~I °'l,~wov,ma~l~ SItOll lllllJ :J*ll ~Dollamllm, ql i~nno,~l%l ]~oO Ilv|'l IV *$ N~l iFINII O~ lf~l *l~l~i ~I91NIi ~NO lSVll IV "h INllll3vln~i~ lql~l fUlllll ONlm01wle ~41 *Oli$l~lN!lil kllNd*Iv~t~]/ Sk~lSll ~),~S *I QISINII31iVN3Oll lUOlll'l ~I~ "t 0lSl]~l lll~lq~PlH~d fulfill "~ "I IUlI$~I O~ ' I NO11131 JlIIVIO w~ 1Ollm llOdlg "lOilNO~ Id)l! Of|! dl "ldYl S~0 ZI0 lHl~lffldX] SIV~INV 9~li~]I-iAOWAI JO SIVA01 l~r 13lrOld "O'O ~kv'l "03 "I'V-I

N O t-~ ! Z Z ++ @ c~ © t-" @. Z el lily,! 9"lS e*ll 2*42 Ioo JleTJNI~ O'e O'O! e'e o'o tt£~ lW]l~]d O]On'131ol $'IVUllff IN]II]3V~3II llllO/l! ISl 40 0 e tE '1VIOl O6 ~mwo o 6 I O 11401 SNOIII1 11101 SNOlS]I lNV+l~ll/k "S 13tiVI~I~w J0 S~JIS £~UlJ *+ HIN~, *¢ 0]ll+NO)k llJN~P~IVdN]d $I MIIv31JlSSv13 S'IVMIPgV lVl01 NfI0,4111 tVlVOqgl'IVll ]NO l.~f?ll II *l ImOml iNvW)l'n, oN inll oJ,3OfVqa1111M JO t;gqglS IIUl+ +ml '~.~IXOm iln~ml )**o IS~+1~ IV "e II/~I U]UlI) 011 IP41 *ml~fll NSlN)II 31410 15111 II "S O~Sb"ltlg~l ~*lllilllVllll]d Slt0|S)'I llY '~ 114011|'1 ON *1 NOl iV3| Jl SS+'i3 SlVMINV I 0SO11 I UOd)ll lOllllq~ Id~llt INfl II 'la"ll IU ill l~3Ml13all] S~VMINI 9*41gI~]~-0,~OIKII J0 SlVI@I S(WVP 13)r011d '0"0 011V.M "0~ *l'V-i p~ o-

-46- T.~LI~ 34 I054450, 4 l-t,V, ¢0. P,AN0 0.|* PJOJ[¢| JANUS TOItLS 0F IUm~-KtlllSGtN|NttS [AP(PII[~| 01a 0|5 lSP|. S| 1~11 6OCP| C~IR4~. ntpNT nNei CLasSIrlCAIION I. I*O L(SIONS Z, ALL L(SIO~SFUN~NILY n[ill[SS[O 3, ALL LI[SIONS I/~CNtRtCTEklSI[O 6. $bM.( L[Si0NS P[k~qMtl(k|L¥ R[GR(SS(O, |lq( N(NtlkiNG L(SIQNS II(IhG UNCHA#ACI(RIS[0 5. t| L[4S| Qtl( fl(N|GN IUI4OUii, UUI NO O|HI[N IUMOUII 6. AI L[AS[ tiN( lU~UR Sh~vlkG It~ FIRST SIGNS Of Na4.IGk~#CY, IKl| hONN,,.ICi~WI IumllU(t 7. aT L[aSI ON#. Nt.,LIWIANI |U#OUW ;OIAL mlNal.S CL&SSIFICAIION I* ;NLAwAw[WILy w[omCSS(O ?. UtJC~tatCTf...qlS(O ), PiNIGN 4. FIRS! SIGkS OF NALIGNANCV S. NAL|GNAN! LESi~ItS IOlAL L(SIGNS IOrAL S] t | Is | J iT |e IOIM. M S Q ]S |llOi#I| BIEPL~(Iq[NI AIIIWALS INCLU0(D P[NCI[NI S9,6 t.t I.t Z,Z 16.9 Ooe 1%1 P(RC(NT 10,S 4,1 41,; 0,0 |i,/ P~ It Z 0 J © < 0 Z Z ! 0 U C0

-47- I054 035 TAIII~ 35 % I~-A.T. CO. M.A~O U.O. PNOJLCl JiMI$ klrPOltl IWS|! /OraLS OF TUNOUil-n[MIkG aJIIM*LS I[xP£nl~[NY 013 e~ ExPf. nl ~lP*6 I~OCPI CmITNOL GLaSS|Ir ICA! ION |, KO L[SIGkS 2, ALL L[SlOIIS I~E~klIIIILMIL'I ll[iil[$5[O ), iLL L(SIO~IS UNC~UACI[IIIS(O 4, SI)ql[ LES|IhS Pf.lqfl/~*f.NILv N[G#[~S[O, I~1[ NLb411*I~*G L[SIONS lil[l~ Ukc)*Ait~Tl[lllS[O ANINiLS ~i, IT LiISI ON[ O[Mllll IUiiOIm, INI NO OIN[A lUllmUII t, IT L(ASl ON! lUNUU*~ SNOulNG IN( FlliSI Sl~S ¥ I*N.|Sl**,<t, ~t H N~.|iNIHI ]I~UI 1. ,1 LF.*SI O*,( .J4.11I~+.N! flJ**Ot~l IOIAL ANIN4LS L[SIPI$ IOIIL L(SIL~HS ¢LASSlFICAIIO~ I, P[aNiJi(MlLY ll[Ollf.SS{O Z. U~CNUlCIEHIS[O 3. ~NIGU 4. ; lnSl Sl(4,S OF NALiON~CV iitillll IOIM. ~S I I l II I II II IOIIL Zl 4, 14 II 4~' q+ IIiPI,A¢I~III AIMIlUM, S 11410.11O10 lll, llCiNl II,l S.l 1,3 I,I) ll,S l,l 15.1 HR¢[Nf IZ.Z 4.4 16,7 I.| 44.1 PAll[ 14 Z 10 F- < @ F-- .J < O < Z Z I F- < )

> ,....] r-' .-1 t~ I Z Z > ,,,--] C) >. + t'-' t,...,l ,-] >_., ©. Z 91 ]'JVd t'l I'L (*St ¢'I::I: i*e I'~T I'# l'l +t'¢ 1141311111 01041"13141 rlVtIIIMV Ilill]3Vl~2d 6111111! N~a OLI IO I $+ 92 "llJOl 11 t le e I ¢ I[ 11101 -pl1- SMOI$]I "WlOl ~omom INVNOI3vM *S A3~IOIlvW J0 5qglS ISblJ *S O]$1H)I3V+VN~ "i O)SS~I~]u A31N]mlkm~d *1 NOIII3|JlSSV~ SlVWllW IVl0l HI't~MIII IMVMilIT. ~ ISY]l Iv *A IIIIOMIll llm4911¥w ON InO *A3NII~I'WN JO SNglS lSulJ ;l~l 9e41nO*4S ,littm~l JIM IRV]] If "V "e~i'~l U3mlOl~ Inll .,m'm+,ml mJIm~l ]NO lSV)l IV "s o]Sli]I+il4il4~4~ 9NI]i +PlOIS]I +mlml+m~e 03SIu)I3VuIH~II SNOI+]I 11+ "¢ O]I~s]MI)I AIlMMNIt]d SNIOiS]3 I"W *~ S~101S]~Oq *! NOIIV31JISSV'II'J l 1~011 o w m S'IV+IHV "IOuIN03 Id3l|! ~liiL I! "l,mt| ese [£I IM+NlaIdV] S~mlNV 9~l~V}i-ul~nl JO S3vlOl lSOd)W srwvP 13~rOIJd "U'O (wv.~ *03 "l'v-I

CO > N O ! Z Z > Q ~0 > O "-1 0 --I O. 2 II 'i~d S'0lp ql'qJ ('ql £*11 AN~O3kl rS~ O'O r/.! e*l) 9*4) qP'6~ IH]lOlfld 0Nnl"~l $1WlW ImelOVld]| e. SI/II/I! IS I |q II (2 ~vAO! tuu (0 lZ o St I C v "WAOA SNOIS3~ ~vtOI I~VNgI~vd "S A3NVI~JI~U JO ~q'Jl~ 1.~.I| "q O~ISIHIL)VNVN3~ "l 0)SS]Pd))d 111N]kw~3d "l NfllIV31JlSSV~3 SPIOIS]I SlV~IXV ~vJOI ~o SUglS lSulJ 3041D~|PO~S H~OiflJ ]NO ISV]~ IV *~ ~l N~IO ON In! *mown] .91.]! )~O i|v]l Iv *; O3SI~]J3V~TH3~I 9N130 SNOIS31 II~lNlV~3~ ]14| *g3S~311cj3U &3IN]NVN~3d SHOIS33 ]Jtoq~ "q O)Sll]J)VW~ SqOl$]l 11v *C O~I~S]IR]II A1JN~VNu)d S~OIS]I 3~f "~ SN01S]~q "1 N011V3IJISSv'D S~Sl~ les~ "I0eLN03 ld3HI I.~L (O "le'f] Sit ¢L0 JN)~Io3¢/3 S3VNIHV ~ldlll~l-~L JO S3vL01 lNOd]l~ ¢~IkVP 13]TOHd "Q'O OkVoH "03 "L*V*O -p/-

( (h 0 -+ | I+ Z Z ++ 0 t~ (3 d3 © O. Z 61 i~d 0°m tgq~ lli~lU]d 0'1 I'$1 i" Pi IM]DW)ld |NN10MI SlVMIMV IHJiI~IldN Illllll2 rain I+lI IQ 41 I qg£ 101 lVl01 iim IlL e'lHlII t 611 ¢ II $uOI+]~ +lvI01 io.~iIW Sl+01S+l S'WII leN "WlOI kOIH~ *( 0]SS)~9)4 ,t'llq~Imlf]d *I NOIIv31Jl SSVl) N~bnl IMVmII3W ~0 ISV]l IV "L ~OM~I lkv~l+U'ON i~ "A)kv~l*l~d JI) SMSIS ISlld ~l+l ~ilmltmS ~+l,ml )1~ j5~)1 IV "9 0KI+iI~I, nI~,411 9NI)O st01S)3 9.lql~sli QKll]I~V~I~ SN01S]I 11V "C 0~SS~gN AIIN~I~tMI~]IISNOIS]~ +'1~ *t sqOlsi~ ~ "I NOIAv)I31SSII+ • S'IIIII MV 10Smi L~O~J~ A.vm+~S SI~,ilW l~llVIe-+il JO S~+lOl S~VP 133PO~ *I*O O~v'~ "03 *£*v-g n( ~lly.t • ' ++0+++GoI

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-51- ~LE 39 ESTIHATES OF WETBUI,L PARAHETERS Tobacco Dose B6 25 30 B6 50 30 B6 75 3O B6 25 6O B6 50 60 B6 75 60 B6 25 120 B6 50 120 B6 75 120 37 25 30 • 7 5O 30 B7 75 30 B7 25 60 17 .5O 6O B7 75 60 $7 25 120 B7 5O 120 B7 75 120 ALL TUHOURS b c.p.f., x 106 k v 1.3198L5 5.242655 4.351070 1.629949 3.989866 3.587721 1.016096 4.149186 4.303343 1.634081 5.361834 4.498700 1.443989 4.569741 5.667275 1.137230 5.939105 4.389773 3.004374 3.OO4374 3.OO4374 3.004374 3.004374 3.004374 3.004374 3.004374 3.004374 3.004374 3.004374 3.004374 3.0O4374 3.0O4374 3.004374 3.004374 3. OO4374 3.004374 17.44824 17.44824 17.46824 17.44824 17.44824 17.44824 17.64824 I7.448Z4 17.44824 17.44824 17.64826 17.44826 17.44824 17.64824 17.64824 17.44824 17.44824 17.44824 ,M:,,. BAT Co LTD - MINNESOTA TOBACCO LITIGATION

-52- TABLE 40 ESTXHATES OF WEIBULL PARAI~TERS MALIGNANT TUMOUES Tobacco Dose c.p.£. B6 25 30 B6 50 30 B6 75 30 B6 25 60 86 50 60 86 75 60 86 25 120 86 50 120 86 75 120 b x 10e k w 1.5&4979 4.011293 38.58548 7.229687 &.011293 38.58548 8.843913 4.011293 38.58548 1.667290 &.OL1293 38.58548 4.184315 4.011293 38.58548 6.715455 4.011293 38.58548 1.077183 4.011293 38.58548 4.961088 4.011293 38.58548 4.829332 4.011293 38.58548 87 25 30 57 5O 3O 87 75 3O 87 25 60 87 50 60 87 75 60 37 25 120 37 5O 120 37 75 120 1.894522 4.011293 38.58548 7.502955 4.011293 38.58548 8.015643 4.011293 38.58548 1.696823 4.011293 38.58548 7.500196 4.011293 38.58548 8.125522 4.011293 38.58548 1.388213 4.011293 38.58548 5.966336 4.011293 38.58548 5.514798 4.011293 38.58548 BAT Co LTD - MINN~TA TOBACCO LITIGATION J 41,

INDEX HAS INDICATED GAP IN BATES RANGE HERE

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-53- TABLE 41 v~o~s oF s ~ v .ERIWD rZOM T~ P~U~S "' OF Z.~ a9 ALL TUMOURS Tobacco Dose c.p.i. S V x 10-6 im i, i B6 25 30 41 31.0650 B6 50 30 36 6.8668 B6 75 30 9 2.0685 36 25 60 42 25.7677 B6 50 60 34 8.5216 36 75 60 21 5.8533 B6 25 120 38 37.3980 36 50 120 41 9.8815 56 75 120 32 7.4361 37 25 30 49 29.9863 ~7 50 30 60 7.488I R7 75 30 29 6.4463 37 25 60 t3 29.7786 37 50 60 63 9.4097 37 75 60 34 6.2188 67 25 I20 35 50.7765 B7 50 120 52 8.7555 m7 75 120 40 9.1121 s- ~ DIi v- Y (nlx ÷D2£)(tx-w)k £ The vtlues of DI~ tnd D2~ are given in T&bles 1 to 38. t'The val~es of k and w are given £~ Table 39. BAT Co LTD - MINNESOTA TOBACCO LITIGATION w k.A

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-54- TABLE 42 V, kT.,I.~S OF S AND V DERIVED FROM THE PARANET~RS OF TABLE 40 HALZG~qNT TUHOURS Tobacco Dose c.p.i. S V x 10-7 = B6 25 30 22 142.3970 B6 50 30 24 33.1965 B6 75 30 5 5.6536 B6 25 60 24 143.9A60 B6 50 60 18 43.O178 B6 75 60 13 19.5583 B6 25 120 19 176.3860 B6 50 120 24 48.3767 B6 75 120 20 41.4136 B7 25 30 32 168.9080 B7 50 30 20 Z6.6562 B7 75 30 17 21.2085 B7 25 bO 26 153.2280 B7 50 60 34 45.3321 B7 75 60 17 ZO.9217 B7 25 120 22 158.6770 B7 50 120 29 48.6060 B7 75 120 22 39.8927 S m ~. DIl - V ,,, ~ (DL:L ÷ D2i)(c:l" - v)k" :L :L The values of DI{ and D24 are S£ven in Tables 1 Co 38. "The valaas of k and w are given in Table 40. mmmmh BAT Co LTD - MINNESOTA TOBACCO LITIGATION

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-55- TABLE 43 GOODNESS-OF-FIT TEST FOR THE PARAMETER VALUES OF TABLE 39 Time Period Observed Expected ×2 4 - 48 49 - 56 57 - 64 65 - 72 73 - 80 81 - 92 93+ 94 75 107 144 70 98 71 ill.6 83.2 98.1 101.4 90.0 94.5 78.8 2.77 O. 80 O.81 17.90 4.45 O.13 0.77 Tocal X2 - 27.63 The cable shows observsd and expected numbers of tumour-bearinS an~naXs. The value of X2 of 27.63 wlcb 6 degrees of freedom iS s£gnlflcanC aC the 99.98Z level of confidence. TABLE 44 GOODNESS-OF-FI"E TEST FOR Tm~- PAEAMETER VALUES OF TABLE 60 Time Period • , ,, ,, 4 - 72 73 - 84 85 - 88 89 - 96 97 - 104 105 - 112 113" Observed J, 47 I00 32 64 44 4O 61 Expected 56.2 83.0 32.7 65.9 57.2 61.8 48.4 J II Tonal X2 = X2 1.50 3.48 O.01 0.06 3.05 0.08 3.25 11.63 The cable shows observed and expected numbers of animals bearinE a ml£ananc Cumour. The value of X2 of 11.43 w£cb 6 desrees of freedom is sianificant at the 88.58Z level of confidence. BAT Co LTD - M1NN~TA TOBACCO LITIGATION ¢...rl O c~

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-56- TABLE 45 NUHBERS OF DEATHS IN THE ZST 8 WEEKS OF EXPERLI4ENT B6/B7 25 mg .5Ou~ 75 ms B6 mm 30 c.p.£. 60 c.p.£. 4 1 39 6O 23 32 120 c.p.£. 3 21 30c.p.i. 6 25 39 60 c.p.i. 3 15 18 120 c.p.J.. 9 14 18 TA.BLE 46 NUHBERS OF DF..ATHS Zlq THE LST 8 WEEKS OF EXPER, XI~HT B6/B7 EXPR~SSZD AS A PEF.CF.I~AGE OF ~ '3~'rTZAL HI.MBER OF Alq~$ ~ EACH GROUP 25 5O mg 75 ms 30 c.p.i. 1.19 41.49 64.52 B6 60 c.p.i. 4.71 26.1A 35.78 120 ¢.p.i. 3.53 23.86 37.78 30 c.p.i. 6.82 29.07 44.83 B7 60 c.p.i. 3.49 16.67 20.22 120 c.p.i. ].0.23 16.09 20.69 BAT Co LTD - MINNF.,SOTA TOBACCO LITIGATION

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-57- TABLE ~7 AIqALYSIS OF VA~ZAI~CE OF THE DATA OF TABLE ~3 Source of Variance BeCwmez~ cobaccos Becween c.p.i, Ke~weext doses Tobacco x c.p.i. Tobacco x dose Sum squ. 272.222 593.444 2613.4~ 14.111 318.111 TOTAL 438.222 27.556 4277.111 d£ 1 2 2 2 2 4 4 17 Mean squ. F S£g. Z 272.22 296.72 1306.72 7.06 159.06 109.56 6,89 39.52 43.07 189.68 1.O2 23.09 15.90 >99.5 >99. $ >99..5 t >99.0 >97.5 The c.p.£, e~£ecc may be parciC£oned as:- C. p. ~ • linear C.p.i. non-linear OX" as : -- C.p.i, 1= linea= C. p.i. In non-l~ear 311.111 282.333 420.083 173.361 3LI,11 282.33 1 4ZO.08 1 173.36 The dose e££ecC amy be parCiC£oued as:- 2512.083 61.361 1 1 2613.41 .03 Dose l£near Dose non--1 inca= O~ atS :- Dose In linear Dose lu z~on-l~esz &5,16 >99.5 40.98 >99,5 60.98 >99.$ 2S.16 >99.0 370.46 >99.5 8.91 >95.0 379.36 >99.5 .O1 BAT Co LTD - MINNESOTA TOBACCO LITIGATION 0

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-58- TABLE 48 ANALYSIS OF VARiaNCE OF THE DATA OF TABLE 4& Source of Varian=e Between tobaccos Between c. p. i. Between domes Tobacco x c. p. i. Tobacco z doge C.p.£. x dose ge s idua 1 TOTAL S,-- squ. 287.Og2 674. 335 3238. 837 8.459 354.178 510.470 18.323 |, | ,, 5091. 694 . Jl, ~m. J u, df Mean squ. 1 287.09 2 337.17 2 1619.42 2 4.23 2 177.O9 4 127.62 4.58 17 J The c.p.i. C.p.i. C.p.i. or aS:- C.p.i. In c.p.i. In i |l egfecc may be linear non-linear linear non-linear jl 35~.177 320.158 partitioned ms:- I 354.18 i 320.16 The dose effect may be Dose line~r Dose uon-li.esr or .8=- Dose in linear Dose In non--lineLr 477.943 196.392 Hi 477.94 196.39 |, i partitioned 316A.133 1 74.704 1 3238.822 1 .O15 1 &&:-- 3164.13 7k. 70 3238.82 .O2 F " 62.67 73.60 353.52 0.92 38.56 27.86 77.32 69.89 104.34 42.87 69o 74 16.31 707.05 .OO S£g. Z ,i >99.5 >99.5 >99.5 e >99.5 >99.5 >99.5 >97.5 >99.5 t w BAT Co LTD - MINNESOTA TOBACCO LITIGATION

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-59- 25 mg 50lag 75 mgI TABLE 49 OBSERVED PERCENTAGES OF TUMOUR-BEAXZNG ANIMALS IN JANUS EXPERZMENT B6/B7. ALL TUMOURS B6 B7 30 c.p.i. 60 c.p.£. 120 c.p.i. 30 c.p.i. 60 c.p.i. 120 c.p.i. m 48.81 38.3O 9.68 49.41 38.64 24.14 44.71 46.59 35.56 55.68 46.51 33.33 50.00 47.78 38.20 39.77 59.77 45.98 TA3LE 50 AGE-STANDAEDISED PERCENTAGES OF ~J~J~UR-~Z2qG A~IZMA/.S IN OANUS EXPERIMENT B6/BT. ALL TIA~URS 2~mg SOmg 75 mg |,, 25 mg 3Oag 75 30 c.p.i. 52.84 82.33 79.70 m6 60 c.p.:L. 120 c.p.i. 58.77 78.84 77.20 48.23 77.32 79.31 30 c.p.i. 60.29 81.38 78.05 5z B7 60 c.p.L. 120 c.p.£. 57.21 77.27 82.82 49.28 84.05 79.89 ,, 30 c.p.:i. 1.08 2.15 8.23 60 c,p.i. 1.19 2.0~ 0 120 c.p.£. 1.08 1.66 2.23 30 ¢.p.i. 1.08 1.75 2.34 B7 60 c.p.i. 120 c.p.i. 1.14 1.62 2.17 |1 i 1.24 1.41 1.74 BAT Co LTD - MINNF_5OTA TOBACCO LITIGATION

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-60- TABLE 52 ANALYSXS OF VAEEANCE OF THE AGE-STANDARD~SED PERCENTAGES OF Tm~OUR-BEARL~C A~LV~LS LN JANUS ~XPERL~r 86/B7 x~ TUMOURS. ~ XZC S~ SqU~ ROOT TRANSFORMATZON WAS USED Source of Variance Between ~obaccos B6/B7 Between ¢.p.i. BeCweendoses Tobacco x c.p.i. Tobacco x dose C.p.i. x dose residual i • TOTAL The c.p.£, effect may C.p.i. linear C.p.£. non-llnear Or aS:" C.p.i. In linear C.p.i. In non-l£near The dose effect may be Dose linear Dose non-1~lear or as:- Dose In linear Dose ln non-llnear Sum squ. df 6.008 1 8. 356 2 999.878 2 1.513 2 O.075 2 32.957 4 24. 023 4 i • m 1072. 810 17 be par t:£cionad 8. 232 1 O. 124 I 7. 567 1 O. 789 partitioned 724.520 275.358 846. 525 153.358 1 mS :-- 1 1 Mean squ. 6.01 4.18 499.94 O. 76 0.04 8.24 6.01 aS: -- 8.23 O. 12 7.57 0.79 m 724.52 275.36 846.53 153.36 ¥ 1.00 O. 70 83.24 O. 13 0.01 1.37 1.37 0.02 1.26 O. 13 J 120.64 45.85 140.95 25.54 S£g. Z >99.9 m o >99.9 >99.5 >99.9 >99.0 ,remain QD BAT Co LTD - MINNESOTA TOBACCO LITIGATION

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-61- I TA.BI~ 53 __ _ |, ANALYSZS OF VARIANCE BASED UPON THZ LZK~LIHOODS OF THE ~:LSULL NODELS OF TUMOUK INCIDENCE IN JAI~US F.XPEKINEI~ Source Between condensate dose levels Between tobaccos B6/B7 Doses Betveen c.p.i, levels Doses and Tobaccos Zo~el Hahn Effects 1so order inceractlons Haln effects 2nd order inceracc£on Main + lsc order I~TAL x2 250.73 3.18 2.02 255.93 6.41 3.74 266.09 df 2 1 2 $ 8 4 17 The between d01e level e~fect .my be perticLoned as:- Dose level e~fffecc (ln-Z£near) 212.79 1 Dose level egfscv (non In-linear) 37.94 1 | The be t'ween c • p. i. m,, level effect may be partitioned Is:- Sig. Z 100.0 92.6 63.6 100.0 39.9 55.8 lO0.O 100.0 100.0 C.p.i. level e~£ect (linear) C.p.i. level effect (non-l£near) 1.98 1 86.1 .04 1 15.4 BAT CO LTD - MINN~TA TOBACCO LITIGATION C~

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-62- TABLE 94 AI~A.L,YSIS OF VAR£AiLqCE BASED UPON THE L'rEELTHOODS OF THE '" ~r.lSULL MODELS O~ 'na4ou~'n~cz~v~CE z~ J~US ZXeE~Z_~4~ SeIBT. ~.r.z~u~T ~4otn~s Source Between condensate dosa levals Between tobaccos B6/B7 Dose levels Between c.p.i, levels Doses and Tobaccos Total Nain Effects 1st order interactions Hain effects 2nd order interacC£c~s Main + Zst order TOTAL J,, ,,, ,, , 182.63 4.11 7.68 19~.A2 2.18 1.97 198.56 df Sig. Z 2 1OO.O 1 95.7 2 97.9 $ 100.0 8 2.5 4 25.8 17 1OO .O The becveen dose levels affect may be partitioned as:- Dose level e~fect (In-linear) 163.64 1 Dose Zevel e~£ecC (non In-linear) 18.99 1 The bscvaen c.p.i, leveZs ef£ecc may be pagt£cioned ae:- C.p.i. level effect (l£near) 7.68 1 C.p.i. level effect (~on-linea:) .OO 1 100.O 1OO.O 99.& 1.6 BAT Co LTD - MINNESOTA TOBACCO LITIGATION r',o

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-63- APPEND IX Included in the JANUS experiment B6/B7 were 4 groups of calibration animals. The anJmmls each received 20 ug of carcinogen in O. 1 ml of acetone:water solution (ratio of acetone to water 9:1 by volume) applied The carcinogens used were 3,4-benz-a-pyrene and 1,2,5,6- The treatments of the four groups was as follows:- 3 times weekly. dibenzanthracene. Group i. Group 2. Group :5. Group 4. D £benzanthracene Dibenzanthracene Benz-a-pyrene Benz-a-pyrene 13 weeks duration 25 weeks duration 13 weeks duration 26 weeks duration The results of these A groups (incidence of tumour-bearlng animals) are shown in Tables LA to 4A. Tables 5A to 9A show summary tabulations of the numbers of Eeslons and the numbers of animals bearing various classes of lesion in these 4 groups. The Welbull discributionwas finted to the data of Tables LA to 4A. The results are shown £n Tables IOA and llA. As can be seen from these t~o tables, the BP and DBA groups were treated separately, co~n values of k and w being used for the 13/26 week groups for each carcinogen. Goodness-of-flt teens were applle~ to the estimates of the Weibull parameters and the results are shown ~ TabLe 12A where it can be seen that the all-tumour data is fitted reasonably well by the Weibull function, but that the maliEnant derma is a poor fit to the function. In view of the fact that the parameter w was at a boundary i.e. the parameter est/Jnation was not at s true maximum of the likelihood gunct~on it Ls perhaps not surprlsing that the da~s do not fit the function with these parameter values. BAT Co LTD - MINNESOTA TOBACCO LITIGATION O',,

( ( TABLE IA t~ N @ t- C~ I z z 0 t" O. Z IF-4.1. ¢0. II.iNO O,O. PIIOJECT JilNU3 INCIOIL'NC[ CNr HEW lruNuA.,N[iUItHO ANImaLS tlUqtet'~Xl' elba It3 KSPT. Ill BoP, 13 W(ItS lrlq iLL ImmuAS MAIN N 01 01 I* 6 tY 0 O i. | tT 0 II e- ti ST e I 13- i6 H I I el* ~ L~J e e ~9- 3! |6 0 e 33- 36 ~ ! I 31- 40 t4 I e LI* 46 ~4 O O 4g* *ka ImQ O I) 4~* 111 84 • I S~* S6 14 I I ST* +e 13 1 l 61+ 41~ L~ I I 6e+ u IS I t 1,9- TI 16 I e ?]* Yl 16 I t TT* M 14 O I It- I+ II I | 15- II IS I I IM- 9Z 14 e 0 +1. ql~ 14 e t +I*III II I 3 llt-lm • I I llm*ll4 I e ] IU-lll 5 I I ll]-lll + • l llY-l+l t I I I+Ioi+4 I I l ILHJ*I+I ! I I 11+'131 I I I t31-13+ I l I II[P~T 110511 PlI.IImAMT Ol DW IF l l Z? l e l? l I Zl O l II e II II l e tl 0 e l+ (J l I$ I l ZO O O d~ l O P i 0 l II I I 15 e o ZS 0 I 13 ILl tl O I tO l O II I I Ee I t in l I IT l l IT l 3 le e I 6 0 I 5 0 l 3 l e 3 o o 3 I I l e e I l I ZZ/ll31711 PIGE PIDIHaNqDflLT Ilf4111rSN[0 Lttl0wS 0mlTY[0 l~PLIC~o~rul JNIMLLS ImaCl..U0t0 TOTIL l II l IS a ell0. 0t lllllNIL5 IT nlsll iT yl~ iit0lllllllll0t I~I[TIN! I~nl00 el .1+0. 0T MII,JLSI[C01+Im0 l't~-g(llfplO0VIllNg ~ Ylatl~nl00 0Z - NO. 0t A~I.IL5 0TIi+0 Pmlm+ rm~ Tim[ Ptnlo0 vlYl+0~T 0[¢0wIPN. tUIm~-0[,alM+ T|mr ptllOOS ImP' or FOUll VI[TNI OUIIIII@N

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C -66- N O I z Z > O >. N 0 ,-.-t c~ > -I O+ 2: I-I-T, qD0, II.llqll IIM, PIH)AE~ ~Oalq~ IEtllOlll elP Illll llllmll-tllllllll mlNdq.I I~PDInDT He 113 EIPT. N O.O.a 12 llnl ILL TllllmlllS ~rnlllt t on OI I- 4 lit O O S- • III o o q- 18 'tv e | 15- |6 I1 O O If* IlO l, lr o I Ill- Iq I!I o o IS- fill 81 o o II~- )l ~T II I 33- 31 !1 I e 31- abe 14 e e ~l- *6 14 0 I Ieo 41 15 l l 64,, II 14 I I II- lip 14 I I In- lO II l l II- II II I I 65- IO II 0 I lie* Vl ~1 o o 13- Ilk tl l l 71- II II I I II- 14 II I I I15- 01 II I lJ II- 91 II I l el* e41 II o l lI-III II I l lli-ll~ s e I IO$-IPO O I ! lll-lll I I I I11-III ) II I liT-Ill I ) I III-III I I t lI5-11l t l t II9-13l I e I II$*1)I I 0 t IIII-II)O I I o I*,1-1*.I I I e I*,!-I*1 I I i TABLE 3A nM.lellllT Itl t~ II I l |Y e e Ilr o • li o O lY o O il 0 I li IJ D IT O I II o l II • I II I I l(, l I ll l I II I I Is O l I! I e I~, I I 13 • l 13 l I 13 • I IT • l IT O II II l + 15 O l 11 I l II I I ll l IP I e t I o + i Ii, I 3 e l I e l I o l I e 0 l B l I 0 e I I I lllll/Tl PIN I~ MItlIIOIIKIL'/ Itllllllllll LEII4~¥1 lUll'TED IIIFLI41"U~H! l~ItlM.S IUCLUI~O L909.171z Ol TOT~ I 12 ~ M N . OlO. Of ~INII.I IT flirt IT THI IIIIWIIIIll mr I'~ IlWl g'llll~ 131 . Nil, or ItllqlLS III¢INIINI lq.~IIUI-I~AIINII 0ulll~ TM[ 511el @lmlN O~P • NO, IW IMIHALS OTIM; 01fill, HI 1141' Yll~ P(J'IOO IIlIIlOUI I~¢OMIJHI TIJ~I~-I~IIIr~ If'It rtllOll5 IL*T l~IT IrmNt kilL'Is l~mLttlOU

> .-4 c"J O t-' ,--I t~ I K z z ,--] > --] © > O t-" ,...1 > ,--] @. Z ,+ II~4 1 @II 311+ Wnl~ qlJl4V'l"131ql 1"lll41Pllt ~"ll'l'JIII O~lJ, lm ImlrJ"l tl31~111 A'll, gq~llWalld .+lllO3Jl InO~llq OQIlI+ Iml+ ~| +I+INI+ I~110 .l'lla,,,t O "~s " t0 ~1141~I 3,411 l'q~ ~41H~O ++IVI~kI'IHWHIll l~llm03l+ :+wslm. A "0+q " I0 00lM~ :nmll J04l J0 ~,,MIP~IO~ ~41 ll MSIa" Jv £~vdlMv +40 "0# a, H arl I ~ + ~ lOz I I I I • I lql-ltl I l I I O I III-+CI I I I I I I It l-oll l O I l O I III-+II I I C I I I "0+I'III I I • I I t llt-lll I I + I I t +ll-Cll I I v l e t lll-ill I I i i i g nl-£11 I I + I i + +ii-Iii l I • I I ) 111-¢i I I I l i I i$ -el I I • I I l II %1 I I I I" I I ' II -M l I II. ae. I II ~,I "II I I CI I l II 01 -¢I I I" +I I l tl ol -tl I l SI • I l spt II "t4 I I II I I II II -$I I I 61 I I II ~,I -lql l l 61 l l II le -IS O I II I I II IS -tl I I 11 I 1 II IS -t+ I I II I I II I',, "~s O l II I l II .+,, -I',1 O I II I I II l~' -I£ I I II I I II II -Ct I I II I I II It "I,I I I tl I O II II -$I I I II I I U t.l -II I I gl I • gl II -II I I £I I I £I II -g I I I Sl I I 14 II ..,(k I I II + I &l I q I I II I I II + -I I0 Ig I m II II 01111U~I m ml'IVll ll~0ulU Till 311lJ. l~l~l II "t'l'g ~I "L~PI+I III III l.]14111.~J I II~II J+lllld3U l~POglWV I~IIlII,~NHNIII AIN Jg 13001311 IIW~P, J.3~lelllld "0"0 0~'nn "03 "l'l~l 890 l t,.qO I VV ~lqllY,l, -I.9-.

( N O t" ! K Z z O 3 I- N © Z 690£P S01 I~A.T. ¢~. I~.ml 0,D. Pn0J[CT ,/mUS Y0T4LS 01r ~m|Nll NlmlL! Ellq[Pln~tml eN Ill Exit, N loP, 13 v~[wS ImSll ¢LAsslrlcATlale I, no LUlO~J |, iLL L[|IqN| Ptlm~Y EW~JSQ ]. iLL lESlmS twcmmicr[mlsEI ** ~ L[I|WIS PtlMIWILrl~LT I~OI~SNB, TIC IIL~IIU|N i[S|l~J R|IqlQ UNCH~MCTN|SO S* ill lEAST ON[ IINllll TWIOWI* lilt He MHElt 5UNIMI~ 6, iT L[AST ~ ~ SlmlN I~ PIHT SIMS OF mIJ~IENHCT, N! NO ~Jd.IGml~! TUIN~ T. iT lEAST N naLllnJNr ;unmm TOTAL ANINJlLS LL~IIOP4 eLaSSlTICATI(H I, ff~LT NinESS~0 |, UNC~niCl[l|S[0 ~, M?IIIN 4, flqS! SIN it ~l.llINCY S, Nl~. IIWMIT T0;AL LESI~S TABLE 5A TOTM~ IT 4 e i L a zy TOT~ 5 O 6 e ! 13 m~l)*gm II[Iq.ICI[II[NT AIilIIII.i IIqCI.IUI)[I PErCEnT 65,i I**| @.e e.I |**l i,I T,4 38,S l,I t,i 11,4 P~J[

N o ! Z Z O m O Z 010 17t7 ;01 a ( i~l.lr, m, ii,jllo i)j. iqloJEcT JMeS l~m.s mr T'.IniWI*KmlU MIIm~.$ I~tmllGNlr N~ 18J [xPy, IN II,P, IiltEK| le t, 3, 4, S, t, lr, CLAIIItlCATI~* IIOLEIImS *I.L LLrSfmeS mU~l~rLT m[In[ssD II[PNI Ilmlll m|nM.s iLL LNIONS WCKUiCTI[I~lSLrll USIOIqlS pLrl~lNL~l.Y ~OIIIE|SEI, MHA|N|Ne LEI|0NS R|Nll UNCHAm&CTEn|SLrO A1 LEAST ON[ II[NION TUo BUT NO OTHLrll TUNW)II 41' LEISY O~ ~ s~owrN Y~ rfnsy sf~ ~r NLIGnANCIt IqlT la) #IILI01WNT 1~ A1 LEAs'r 0~ IIALI~I1 VUNUI~ ¢LJS$I~ ICAll0N t. UNC~mlC~lS~0 i~, ~|~S~ I|~NS Of' 144L|IPlIIW~'Y S, IlK 161MItl ;ev~ ImlMM.S L[II~ TOTAL L[SlmIS -69- TABLE 6A TOY~L s O 't | o e H zv 1OTIL 3 ! l 51 7o s~P~u~[m mills I~LUNO I~@CLTNT I|.S 0.0 Y.6 i,i i.i loi ?4,1 I~,t 1,6 0.11 81,¢ PHI I~

> j o t-- I Z Z > --] O > © > O Z [ LO IzlL O I I-I,T, 4~. II.N |.l, IqlOJ[CT JJlU~ TOTiLS O~ TUMUII.41elUtll ANIHILS EIU~rlt~ENlr elo 813 EI[PT. DO II.O.a 12 VL~LrKS ~1 lIOSO! M|~LS CLHSlF/CATION |, NO LHIIINS |, ill ~Sf401q; Iq~JU~lll.T I~OI~SSEO $, aLL LESIONS U;ICHilIACTLrlIISED 4, N~ Lf$I41M ~V nlPllSlElh R~NM|N|N| L[STGMI Ill|N8 UNCHMaCT[II|R0 g, iT LEAST ON~ OENIIN TUMW, WT NO elrl~ TmO~ 6. iT L|iST N TIWHNM SIIOW~ THE FIRST lift Cr NLII.|III/WlC¥, NT M IlN.IIN/Ilel I. lit UAST II~ NAL leNIN1 TOTAL aNIIL4L| LESIONS ¢Ln$SlrlC*TleO, I. PLqmmLqllLT I~m~lSt8 ~, UqCHilli~ll[n ISEO 3. lLrNtl~ 4, rlflT DIM OF NKIllJIKY S. N~IINaNT IOIAL LESlmq -70- T^BLE 7A ZlsO2p?a~ 1011~. ' 3 I e o TIIaL IO I 11 II ! li fI(PLAC~N~NT MIINiLS IN~.Ug(D FT~CLr~ TO,4~ |1.,I 3,7 tI,EI lr,4) t.o T,4 so.e s.e ff.o OoO. le.e pig[ 13

N o I Z Z @ N © F" m ©. Z ( D,-A.T, M, II,MI0 1.0. Iq~JtCT l~lrmls Of NmUU-OtAm~ ~fN~3 [xlq~nl~l~r eee |H EJPT, N 0.11°J. lqb tRB(S I~mM.| -/L- TABLE 8A q~.*S111rl' ICJT IWi TOTAl. I, NO tl[|ll0i~l 14 ~, aLL t[l|OllS P~DIMILqi~LT IRIN[SS~ I $, ALL L[SIOHS UNCHMaCTLqlIS[| i &. SOlE L[||INS PEMUNENTL¥ IIL'OIMt'IMmo 11 O R[NAIBIN6 L(SlOglS IR|W UNCHAIJCT[RISEO S, AT U[~S5 iN[ KHtill TUI*0~, IIUT NO 0~[~ ~nOUi ! i, air tEilT N TUHmm MIN IN[ ¢II~T S[tl~l Of' t NAL|GllidlCT, BUT NO NALI~U/IT TUNI~ T, LiT L(IST N IqM.llliUINlr ~ 4 ~m~. ~m~LS ZT ItLrPLJCL'n(~ AN][~ALS INCLUO[O ffm~EPT *Jl.5 |9.6 O.O e,o 3,T 41,4 |l).l PaGl[ 3] ) CtJSS/F |¢aT ION TOTAL Io PEImm~iTI.T ~4mESSLm II ~lr.I I~, uNcmnaCl'Lrll/~e q) I.| 2, I~l~ I I1.1 i, F|ILST S|(IIIS {lip NM.IINM~¥ I O.I $, Nk.l~lINl T 41.1~ I'OTM. L[SIOIq IT

BAT Co LTD - MINNESOTA TOBACCO LITIGATION I C ...,..j

C0 N O U ! Z z © N N @ ©1 Z e" P*A.Vo ¢0, II.MI0 0,1). (qnlJl~CY dAmJS 10TaLS IW 11)mNO-I~IlIIN IllmJL$ Slllm~Y I[XI~PlN[NT a6 CALIllltIVl0q InelPS CLJSSIrI¢AY|ON I, NO Lt310iel aNINaL$ |. IlL US|IllS PI[IEAliBtlLY I~CIl~SSLrfl $, ill I.LrSlLrlWl III~LLmKlrI[III~ 6, SON[ LtSle~J ~qlHJl~'NTl.Y I~tllll[Sse'l)o TW Im[K41Wlq LI[Sle~J I~ING UNCNinaclrtlilSI[0 S. iV U[nSV eW MUlU TU~Ut, gUT NO eV~A v~ouw i, iT L[aST O~ ~ suovlrIN 11@ first sims (IF ~k~.lge~T, ~UT U U~I(tNJU~ lr~ouR Y. il~ Ll[dlSy ONE N/il.JGqINr ~ ° CLISSIYlC*Slmt !, fq[NamiTLT m[em[ss[~ ~, UI~aO~T[IIISED $, IENTIPi 4, IrlitST Sidles 0~ ~iLIONRUCY So NAL JOaqdlNy Tolr NL aNlmeLS t[Sle~$ TOYAI. L~SI~S ~ABLE 9A ~TaL SS 15 $ e 7 | m T01~ le 16 e il ~eee nl[PlLJtC[10tm JNIIeJL$ INCLUDED PtWCt~ Si),e I),9 0,0 6.9 i,O ~mmv ~t, lr 0,) o.o si.y Ps~ ?e

-73- TABLE IOA ESTIMATES OF THE PARAMETERS OF THE WEZBULL DISTRIBUTION FOR THE DATA OF TABLES 1a% TO 4A. ALL TUMOUES Group b k DBA 13 weeks DaA 26 weeks 5.58929 x 10-3 4.30786 • 10-2 w S V 0.8852 20 6 1073.48 0.8852 20 22 510.694 5 232.291 5 172.716 s- v- (Dli÷D21)(ti_.)k The valuee of D1. and D2. a~e 8iven in Tables 1A co kA. Note ~hat the valuee of v liven in the above table ere boundary values i e w - ~ima of appearance of let tumour. L/3 BAT Co LTD - MINNESOTA TOBACCO LITIGATION

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-74- TABLE 11A ESTIMATES OF THE PARAMETERS OF THE WETBULL DISTRIBUTION FOR THE DATA OF TABLES IA TO 4A. MALTGNANT TUMOURS Group BP. 13 weeks BP. 26 weeks DBA 13 weeks DKA 26 weeks • | 8.840312 x 10-3 1.336125 x I0-I k w S V | m | 0.5532 44 2 226.235 0.5532 44 20 149.687 0.4407 48 2 142.078 0.4407 48 4 98.076 S- ~DI. Vm i .~ (DIi + D2i)(ci - w)k 1 The values of DI. and D2. are Kiven in Tables IA Co 4A. l 1 Note chat the values of w given in the above Cable are boundary values i.e. w - time of appearanct of lec c,--~ur. BAT Co LTD - MINNESOTA TOBACCO LITIGATION -.O:

INDEX HAS INDICATED GAP IN BATES RANGE HERE

-75- TABLE 12A GOODNESS-OF-FIT TEST OF THE PARAMETER VALUES SHOWN IN TABLES IOA AND llA Group BP. 13 weeks1 BP. 26 weeks o DBA 13 weeks1 DBA 26 weeks All Tumours ×2 8.99 4.74 SiEnif icance Z 73.84 63.57 Malisnanc Tumours X2 17.66 12.69 Significance Z 98.93 92.75 m BAT Co LTD - MINNESOTA TOBACCO LITIGATION

INDEX HAS INDICATED GAP IN BATES RANGE HERE

IrlG, I RD 12~E-R AE V V THE' ARC SIN TIJMOUR RA't'F...~ AGAIN,ST THE $0UARi~ ROOT TRANSF'ORMED AGI~ STANDARDISED AV£'RAG£D OVER THE ¢.p.b, LEVELS ARE: PLOTTED LOG/Id~ITHM5 OF THE CONDENSATE DOSE LEVE/.5 ?0 bO 5O 4O 3.0 ! l I I I I i 3.P. 3.4 3.~ 3.B' 4.0 4--Z 4.4 L,, (: oosE) C:::) BAT Co LTD - MINNESOTA TOBACCO LITIGATION

• ° PLOT OF' £, C b') VERSUS ~n ('CLOSE) ,TANUS ~')(PERIMENT Bb/B'/ ALl.. TUMOUR5 THE: DATA HAVE BEEN AVt:RA~£D OVER THE ¢.p,L, I,.l!Vl~l.5 -IE,O I|.I!, 1~'4 11,6, I1,11. -i!t.0 IIt.P., 13'4" lil.b 3.0 ! 3.1! ! ! I ! 3.4. il.b 3"8 4.0 (oosz) 07 Bk b cZ~ BAT Co LTD - MINNESOTA TOBACCO LITIGATION

MALIGNANT TUMOUR$ .4, HAV£ BE£N AVERAGrD OVER THE ¢.p.L. LEVELS ,b ,g - I1,0, '4 "6 .8 .-I10 .e, 3.0 ! I I I I I I 3'I~ 3'4' 3. b 3'8 4"0 4"P. 4.4 C~ BAT Co LTD - MINNESOTA TOBACCO LITIGATION

FIG. 4 RD =2~a-R PLOT OF" £n {'b'~ VERSUS CUTS PER INCH, ,#ANUS EXPERIMENT ~/B7 MALIGNANT "r'UMOURS .4. .6 ---.8 -r'/. o .p. ,4, 30 60 lEO cuts PER INCH .8 .-18.O ,~- .4. BAT Co LTD - MINNESOTA TOBACCO LITIGATION

FIG.S RD ~2J2-~ PLOT OF" .OnCb~ VERSUS CUTS PER INCH. ,TANU5 EXPERIMENT B/o/B7 ALL TUMOURS £n(b~ °4" '6' m,,7. Ds,.~j • 8- 8b. BAT Co LTD - MINNE._,C~TA TOBACCO LITIGATION CO c..,-i

INDEX HAS INDICATED GAP IN BATES RANGE HERE

BAT Co LTD - MINNESOTA TOBACCO LITIGATION