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jr w: a ~d' Division of loews Theatres, Inc., Research Center, 420 English 8treet, P.O. Box 21!688, Greensboro, North C2rolina 27420 December 1, 1982 Dr. Carol J. Henry Microbiological Associates 5221 River Road Bethesda:, MD 2'0816 Dear Dr. Henry: We have reviewed F'inial ReportsI-172'6.003 and I-1726.004-Gomparative Toxicity of Test Cigarette Smo.ke with Reference Cigarette Smoke After Inhalation in Mice and in Rats, respec- tively. In both reports, Tables 3A-3G did'not designate the groups by treatment (for example, Group 1, Reference Cigarette). Also, in I-1726.0104, Table 4, reference "b" should not appear by 4!/Sham. We have also reviewedI-1725.00'6 - Six Week Repeated Smoke Inhalation in Rats to Compare Histopathology and Short-Term Endpoints Using Test and Reference C'igarettes, and have the following comments and questions: 1. In the title, the word "'and'Vat the end of line 2 should be omitted and inserted at the end ofline 3, after "test". 2. On page 12, under Clinical Chemistry, the word "'serum° after potassium and chloride should be in parentheses. 3. On page 15, last paragraph, the upper limit of the COHb range should be!59.7%. 4. In Table GT7, reference "a" in the title does not have a corresponding footnote. Footnote "'a°' refers to S.D. 5. In Table GT8, the letter ""'c" was omitted beside Standard Deviation at the bottomi. 6. The following abbreviations appear throughout the tables with noreference as to meaning: SC, SNO, ADEQ, MKDEC. 7. On page 18, the text does not discuss the test, which is used'inisome, cases. Kruskal-W'allis 0' 8. On page 18, paragraph 2, line 11, the word "'however"' shou~ld begin a new sentence:. " Q

l w 2 9. In Table H'14, animal #ANQ5201, reference, shows "'0°1 under some parameters and "SNO" under others. What is the difference?' 101. In Table H19', why was a statistical summary done for the reference groupifor a platelet count of zero (Table H14)1?' May we assume from the platelet data in Tables Hi and H14 that the:other da!ta were "adequate"? There were no statistics done on the ones marked "'ADEQ" and "MIKDEC" .. il. In determining levels of significant dif'ferences between groups, why were the Scheffe"s or Kruskal-Wallis, tests done with hematology data, and Tukey"s or. Kruskal-Wallis tests done with clinical chemistry data? Also, inisome cases a Kruskal-Wallis test wa~s done and in some cases aiKruska!l-Wallis Multiple Comparison test was done. Why? 12'. On p'age' 1'9''., paragraph 2',, the text does not cite the Table numbers for serum total protein (,CC'12', CC13, CC14!) . 13. Onipage 19, paragraph 3'., total bilirubin values are incorrectly referred'to Table C33, (the reference shouldd probably be tolTable CC50). Also, an extra parenthesis appears at the:end of'this paragraph., 14. In Table CC'19, the, last coluinn shou~ld indicate that the values represent total bilirubin (if this is the case). Same comment for Table CC2'8. 15. Why wals Tukey"s Multiple Comparison done oniDirect Bilirubin (Table CC31), when the values and means of' values are all zero?= The text indicated'.that Tukey"s Multiple Comparison was done when checking the level of significant difference?' 16. Table CCS'0 (last column) and Table CC60 should indicate that the values represent total bilirubin. 17. On page 2'0,: last paragraph, line 1, one "'the"' should be omitted. If you have!any questions, glease.feel free to call. Sincerely,. . Connie J. tone, Ph.D., D.A.S.T'. CJS/jw: 2