il·1 L
`~ nd· F 1 oo:•
`J1
`lA457
`r ,, ·.c
`=t ")
`(
`' • 1
`
`To Build a Better Mousetrap, Use. Human Parts, M. Miller
`Fil:st Monoclonal AntlOOdy to Treat Cancer Approved
`
`Stress and Immune Respons~ After Surgical Treatment for Regional Breast Cancer,
`B. L Andersen, W. B. Farrar, D. Golden-Kreutz. LA. Kutz. R. MacCall m. et al. .
`Estrogen Receptor Expression in Benign Breast Epithelium and Breast Cancer Risk,
`S. A. Khan, M. A. M. Rogers, K. K. Khurana, M. M. Meguid, P. J. Numann
`Causes of Cervical Cancer in the Philippines: a Case-Control Study, C. Ngelangel, N. Munoz,
`·
`' F. X. Bpsch, ·G. M. Limson, M. R. Festin; J. Deacon, M.Y..[acobs, M. Santamaria, et al . •
`Risk Factors for Cervical Cancer in Thailand: a Case-Control Study, S. Chlchareon,
`R. Herrero, N. Munoz, F. X. Bosch, M. V. Jacobs, J. Deacon, M. Santamaria, et al.
`Folate :{ntake, Alcohol Consumption, Cigarette Smoking, and Risk of Colorectal Adenomas,
`J. A. Baron, R. S. Sandler, R. W. Haile, J. S. Mandel, L A. Mott, E. R. Greenberg
`
`Survivhl of Patients With Colorectal Carcinoma: Effect of Prior Breast Cancert R. Sankila,
`T. Hakulinen
`·
`.
`
`BOOK REVIEW
`
`The Non-Hodgkln's Lymphomas, Second Edition, E. J. Seifter
`
`CORRESPONDENCE Workshop on Hormones, Hormone Metabolism, the Environment, and Breast Cancer,_
`, H. L. Bradlow, D. Davis, C. Pearson, C. Ragovin, L. Sekely, S. M. Sieber, A. Sot()<
`
`Journa l o~ the National
`Cance r Institute : JNCI
`BI'"IL
`)~ ~7~nd Fl oor·s
`UC Sa n . ieqo
`·
`Rec e iv~ d on~ 03-11 - 38
`
`PFIZER EX. 1185
`Page 1
`
`

`

`OF
`
`ISSN 0027-8874
`Volume 90, Number 1
`Pages 1-82
`
`EDITORIAL BOARD
`Barnett S. Kramer
`Editor-in-Chief
`J. Gordon McVie
`European Editor
`
`Eric J. Seifter
`Book Reviews Editor
`
`J. Paul Van Nevel
`News Editor
`
`Frederic J. Kaye
`Douglas L. Weed
`Reviews Editors
`
`Martin L. Brown
`Economics Editor
`
`ASSOCIATE EDITORS
`
`Dan L. Longo
`Reuben Lotan
`Douglas R. Lowy
`Susan G. Nayfield
`David L. Nelson
`Kenneth Olden
`Drew M. Pardoll
`Ross L. Prentice
`Alan S. Rabson
`Robert H. Shoemaker
`Richard M. Simon
`Michael B. Sporn
`Maryalice Stetler-Stevenson
`J. Paul Van Nevel
`Douglas L. Weed
`Noel S. Weiss
`
`Susan G. Arbuck
`Frank M. Balis
`William J. Blot
`Peter M. Blumberg
`John D. Boice, Jr.
`Louise A. Brinton
`Bruce A. Chabner
`Ross C. Donehower
`Susan S. Ellenberg
`Suzanne W. Fletcher
`Michael A. Friedman
`John K. Gohagan
`Frank J. Gonzalez
`Michael M. Gottesman
`Peter Greenwald
`Donald E. Henson
`Susan M. Hubbard
`Frederic J. Kaye
`Hynda K. Kleinman
`Theodore S. Lawrence
`W. Marston Linehan
`Marc E. Lippman
`Scott M. Lippman
`
`INSTITUTE
`
`January 7, 1998
`
`STATISTICAL
`EDITORS
`Janet W. Andersen
`Jacques Benichou
`Donald A. Berry
`Barry W. Brown
`Bernard F. Cole
`Susan S. Ellenberg
`Scott S. Emerson
`Eric Feuer
`Laurence S. Freedman
`Edmund A. Gehan
`Barry I. Graubard
`Sylvan B. Green
`Susan G. Groshen
`Richard A. Olshen
`Philip C. Prorok
`Timothy R. Rebbeck
`Philip S. Rosenberg
`Harland N. Sather
`Daniel J. Schaid
`Richard M. Simon
`Donald M. Stablein
`Robert E. Tarone
`Sholom Wacholder
`
`David Schottenfeld
`Herman A. J. Schut
`Richard K. Severson
`William R. Shapiro
`Roy E. Shore
`Paul M. Sonde!
`Patricia S. Steeg
`Herman D. Suit
`Sandra M. Swain
`Mario Sznol
`Raymond Taetle
`Ian Tannock
`Joel E. Tepper
`J. Tate Thigpen
`Peter R. Twentyman
`Larry M. Weisenthal
`
`EDITORIAL ADVISORY BOARD
`0 ystein Fodstad
`James 0 . Arm itage
`Antonio Fojo
`Bruce C. Baguley
`Lori J. Goldstein
`Laurence H. Baker
`Harvey M. Golomb
`William T. Beck
`Elieser Gorelik
`Clara D. Bloomfield
`Jean L. Grem
`Ben]amin Bonavida
`Arnold H. Greenberg
`George J. Bosl
`Maureen M. Henderson
`C. Norman Coleman
`Gloria H. Heppner
`0 . Michael Colvin
`Ronald B. Herberman
`Thomas H. Corbett
`Pelayo Correa
`Waun Ki Hong
`William J. Hoskins
`Stephen P. Creekmore
`Johanna T. Dwyer
`Alan N. Houghton
`James N. Ingle
`Merrill J. Egorin
`David H. Johnson
`Soldano Ferrone
`V. Craig Jordan
`Isaiah J. Fidler
`John S. Ko vach
`Richard I. Fisher
`Margaret L. Kripke
`David FitzGerald
`
`Richard D. Klausner
`Director, National Cancer Institute
`Susan Molloy Hubbard
`Director, International Cancer Information Center
`Julianne Chappell
`Chief. Scientific Publications Branch; Executive Editor
`
`Mark G. Kris
`Donald W. Kufe
`Bernard Levin
`Brian R. Leyland-Jones
`Allen S. Lichter
`Guy McClung
`FrankL. Meyskens
`Anthony B. Miller
`Malcolm S. Mitchell
`James J. Mule
`C. Kent Osborne
`John J. O'Shea
`David M. Ota
`David F. Paulson
`Henry C. Pitot
`Igor B. Roninson
`Edward A. Sausville
`Thomas J. Sayers
`
`PFIZER EX. 1185
`Page 2
`
`

`

`EDITORIAL STAFF
`Managing Editor: Janet M. Boullin
`Senior Editors: Christopher L. Hatch, David I. Lewin, Richard E.
`Manrow, Lata S. Nerurkar
`Reviews Coordinator/Book Reviews Coordinator: Elaine
`Price Beck
`Technical Editor: Donald Baker
`Senior Production Editor: Elizabeth Horowitz
`Manuscript Editors: Elaine Price Beck, Joan O'Brien Rodriguez
`Publication Specialist: Wayne Bittinger
`Editorial Supervisor: Marla N. Banov
`Editorial Assistants: Jamia V. Capehart, Winona C. Toland
`Printing and Electronic Publishing Specialist/ Advertising
`Coordinator: Edwin A. Haugh
`In This Issue Editor: David I. Lewin
`Press Contact: Ellen A. Scott*
`
`NEWS STAFF
`Editor: J. Paul Van Nevel
`Associate Editors: Kara Smigel, Susan Jenks
`Production Manager: Edwin A. Haugh
`News Correspondents: Betsy Duane, Bob Kuska, Caroline
`McNeil, Nancy J. Nelson, Ann Saphir, Sona S. Thakkar,
`Dorothy A. Tisevich
`Contributing Correspondents: Charles Bankhead, Elaine Blume,
`Peggy Eastman, Jean McCann, Judith Randal, Jan Ziegler
`
`The Journal of the Natianal Cancer Institute is a forum for news, infonna(cid:173)
`tion, and ideas related to cancer research, treatment, prevention, and con(cid:173)
`trol. Accordingly, all articles and items published in the Journal are signed
`and, unless otherwise stated, reflect the individual views of the authors and
`not official points of view held by the National Cancer Institute, any other
`component ofthe U.S. government, Oxford University Press, or the organi(cid:173)
`zations with which the authors are affiliated. The mention of trade names,
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`component of the U.S. government, nor Oxford University Press assumes
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`accuracy of the conclusions reached therein.
`
`The Journal of the National Cancer Institute (ISSN 0027-8874) is published
`semimonthly and is owned by Oxford University Press, 2001 Evans Road,
`Cary, NC 27513.
`
`Subscriptions
`Subscriptions are available on a calendar-year basis. The annual rates (Vol(cid:173)
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`The Journal of the National Cancer Institute is indexed and abstracted by
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`The Journal of the National Cancer Institute (ISSN 0027-8874) is publish(cid:173)
`ed semimonthly by Oxford University P~ess, 2001 Evans Road, Cary, NC
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`
`Manuscript submission
`Authors submitting manuscripts (including letters to the editor) are urged
`to read "Information for Authors" at the back of this issue. Manuscripts
`will be rejected, delayed, or returned if requirements are not met. Ad(cid:173)
`dresses for submissions: P.O. Box 3IIIO, Bethesda, MD 20824-1110; ex(cid:173)
`press mail address: 7550 Wisconsin Ave ., Rm. 114, Bethesda, MD 20814
`(telephone: 301-496-6975 ; fax: 301-402-0212).
`
`News section
`Items for the "Awards, Appointments, Announcements" column of the
`Ne ws, questions about previously published items, and suggestions for
`News stories should be sent to: J. Paul Van Nevel, JOA31 Pepper Building.
`31 Center Drive MSC 2580, Bethesda, MD 20892-2580 (telephone 301-
`496-6631 ; fax: 301-402-4945).
`
`Advertising
`Classified advertising for cancer-related employment openings, fellowshi p
`or grant opportunities, clinical trials, or calls for scientific data to be type(cid:173)
`set in the columns of the "Classified Advertising" section should be submit(cid:173)
`ted to: Advertising Coordinator, P.O. Box 31110, Bethesda, MD 20824-111 0;
`express mail address: 7550 Wisconsin Ave., Rm. 114, Bethesda, MD 20814
`(telephone: 301-496-2621; fax: 301-402-0212). Cost quotes will be provided.
`Items should be typed double spaced. (See also next paragraph.) Camera(cid:173)
`ready, boxed display ads for cancer-related employment openings, fellowship
`or grant opportunities, clinical trials, or calls for scientific data may be submit(cid:173)
`ted to the Advertising Coordinator in full-, half-, third-, or sixth-page sizes.
`Cost quotes and size requirements will be provided. For all other advertising
`(e.g., for products and services), contact PRC Associates, The Annexe,
`Fitznells Manor, Chessington Road, Ewell, Surrey KTl7 ITF, UK (tele(cid:173)
`phone: 44-181-786-7376; fax: 44-181-786-7262); or (U.S. inquiries only)
`Janet M. Boullin (telephone: 301-496-6975; fax: 301-402-0212).
`
`Calendar of events
`Information on cancer-related upcoming events (conferences, symposia,
`short courses, etc.) for the typeset columns of the "Calendar of Events"
`section should be submitted to: Calendar Editor, P.O. Box 31110, Be(cid:173)
`thesda, MD 20824-1110; express mail address: 7550 Wisconsin Ave., Rm.
`114, Bethesda, MD 20814 (telephone: 301-496-2621; fax: 301-402-021 2).
`This service is free of charge. Items should be typed double spaced. (See
`also previous paragraph.)
`
`*Contact by telephone at212-828-3766.
`
`PFIZER EX. 1185
`Page 3
`
`

`

`January 7, 1998
`Volume 90, Number 1
`
`CONTENTS
`
`In This Issue
`
`1 ournal of the
`National Cancer Institute
`
`EDITORIALS
`
`Is Saccharin Safe? Animal Testing Revisited, J. Zurlo. R. A. Squire
`
`Psychologic Stress, Immunity, and Cancer, S. Cohen. B. S. Rabin
`
`Does Estrogen Receptor Expression in Normal Breast Tissue Predict Breast Cancer Risk?
`L. Bernstein, M. F. Press
`
`NEWS
`
`Causes of Childhood Leukemia Beginning to Emerge, T. Reynolds
`
`Prostate Cancer Screening Trials: Fending Off Critics to Recruit Men, C. Vanchieri
`
`Stress Reduction: Three Trials Test Its Impact on Breast Cancer Progression, C. McNeil
`
`ARTICLES
`
`REPORTS
`
`Stat Bite: Age Distribution of Cancer Deaths in the United States
`
`To Build a Better Mousetrap, Use Human Parts, M. Miller
`
`First Monoclonal Antibody to Treat Cancer Approved
`
`A wards, Appointments, Announcements
`
`Long-term Feeding of Sodium Saccharin to Nonhuman Primates: Implications for Urinary
`Tract Cancer, S. Takayama. S. M. Sieber, R. H. Adamson, U. P. Thorgeirsson, D. W. Dalgard,
`L. L. Arnold, M. Cano, S. Eklund, S. M. Cohen
`
`Avidin Targeting of Intraperitoneal Tumor Xenografts, Z. Yew, M. Zhan g, H. Sakahara.
`T. Saga, Y. Arana. J. Konishi
`
`Stress and Immune Responses After Surgical Treatment for Regional Breast Cancer,
`B. L. Andersen, W. B. Farrar, D. Go/den- Kreutz. L.A. Kutz. R. MacCallum, eta/.
`
`Estrogen Receptor Expression in Benign Breast Epithelium and Breast Cancer Risk,
`S. A. Khan, M.A. M. Rogers, K. K. Khurana, M. M. Meguid, P. J. Numann
`
`Cause!\ of Cervical Cancer in the Philippines: a Case-Control Study, C. Ngelangel, N. Munoz.
`F. X. Bosch, G. M. Limson, M. R. Festin, J. Deacon, M. V. Jacobs, M. Santamaria, et al.
`
`Risk Factors for Cervical Cancer in Thailand: a Case-Control Study, S. Chichareon,
`R. Herrero. N. Muiioz, F. X. Bosch. M. V. Jacobs, J. Deacon, M. Santamaria, et al.
`
`Folate Intake, Alcohol Consumption, Cigarette Smoking, and Risk of Colorectal Adenomas,
`J. A. Baron, R. S. Sandler, R. W. Haile, J. S. Mandel, L. A. Molt, E. R. Greenberg
`
`BRIEF
`COMMUNICATION
`
`Survival of Patients With Colorectal Carcinoma: Effect of Prior Breast Cancer, R. Scmkila.
`T. Hakulinen
`
`BOOK REVIEW
`
`The Non-Hodgkin's Lymphomas, Second Edition, E. J. Seifter
`
`Books Received
`
`CORRESPONDENCE Workshop on Hormones, Hormone Metabolism, the Environment, and Breast Cancer,
`H. L. Bradlow, D. Davis, C. Pea rso11, C. Ragovin, L. Sekely, S. M. Sieber, A. Soto
`
`Calendar of Events • Classified Advertising
`
`Information for Authors
`
`• Visit the }oumal's World Wide Web site at http://www.oup.co.ukljnci/ •
`
`2
`3
`
`5
`
`8
`
`10
`
`12
`
`13
`
`14
`16
`17
`
`19
`
`25
`
`30
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`37
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`43
`
`50
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`63
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`66
`66
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`67
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`69
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`80
`
`PFIZER EX. 1185
`Page 4
`
`

`

`INFORMATION
`FOR AUTHORS
`
`Note: The following information is updated
`periodically. Please refer to the most recently
`published version.
`EDITORIAL POLICY
`The Journal of the National Cancer Institute
`publishes manuscripts that describe new findings
`of particular significance in any area relating to
`cancer, as well as associated news items, reviews,
`and opinion pieces. The Journal employs a process
`of rigorous yet rapid review of submitted manu(cid:173)
`scripts so that findings of high scientific and medi(cid:173)
`cal interest can be published with minimum delay.
`Review of manuscripts is conducted by the
`editorial board, with the assistance of external re(cid:173)
`viewers. The editorial board initially reviews all
`submitted manuscripts and, whenever possible, re(cid:173)
`turns to authors within 2 weeks all papers that are
`judged to be of insufficient priority for further
`consideration. Scientific papers of high interest
`will be sent out for external review. Submissions
`describing new results originating from the National
`Cancer Institute will be subject to review by individu(cid:173)
`als outside the institute.
`In most cases, authors will be notified of accep(cid:173)
`tance, rejection, or need for revision within 8
`weeks of submission. Papers sent back to authors
`for revision must be returned to us within the time
`specified in our cover letter or the manuscript will
`be retired from further consideration. Acceptance
`is contingent on author submission of complete and
`consistent data, accurate reference list, and conclu(cid:173)
`sions consistent with results demonstrated in the
`study. Inconsistencies and inaccuracies found after
`acceptance may warrant return of the manuscript for
`resubmission. The decision to publ ish a manuscript
`is solely the responsibility of the editorial board.
`Opinions expressed by the authors are not necessar(cid:173)
`ily those of the publisher or the editors.
`If papers are accepted for publication, manu(cid:173)
`script copy and figures will not be returned. If
`papers are rejected, figures-but not manuscript
`copy-will be returned.
`The Journal endeavors to appeal to a broad,
`multidisciplinary audience. Accordingly , all
`manuscripts submitted for publication should be
`written with clarity and readability in mind. All
`manuscripts are subject to editing to ensure con(cid:173)
`forn1ity with Journal style and editorial stand(cid:173)
`ards. The Journal follows the precepts of the
`International Committee of Medical Journal Edi(cid:173)
`tors (also known as the Vancouver Group). (See
`Uniform requirements for manuscripts submitted
`to biomedical journals. JAMA 1993;269:2282-6.)
`FORMAT
`Articles
`Articles describe new findings of major impor(cid:173)
`tance. An Article should contain 4000 words or
`less, not counting abstract, Methods section, refer(cid:173)
`ence list, tables, footnotes, and figure legends.
`(See "Tables and Figures.")
`Reports
`Reports describe significant findings not re(cid:173)
`quiring a more extensive format. A Report should
`contain 2000 words or less, not counting abstract,
`Methods section, reference list, tables, footnotes,
`and figure legends. (See "Tables and Figures.")
`
`Brief Comm unications
`Brief Communications are concise descrip(cid:173)
`tions of new findings of general interest. A Brief
`Communication should contain 750 words or less,
`not counting reference list, tables, footnotes; and
`figure legends. A Brief Communication should not
`be divided by heads and subheads and should not
`contain an abstract. (See "Tables and Figures.")
`Correspondence
`Letters to the editor may express an opinion
`about material previously published in the Journal
`or express views on topics of current relevance to
`some aspect of cancer. A letter should contain 500
`words or less, not counting reference list (seven
`references maximum), footnotes, and figure leg(cid:173)
`end or table. A letter relating to work published in
`the Journal will ordinarily be referred to the
`author(s) of the original item for a response, which
`may be published along with the letter. Complete
`references should be given if the letter cites the
`work of others; if the letter comments on an item
`published in the Journal, that item must be included
`in the numbered reference list. Letters must be
`submitted both as double-spaced hard copy and on
`disk. (See "Disks" and "Tables and Figures.")
`Editorials
`Editorials convey opinions on any subject rele(cid:173)
`vant to the Journal's concerns. They may discuss
`the significance of a paper in the same issue of the
`Journal, a recent finding published elsewhere, or a
`particular topic of significance. Editorials are usu(cid:173)
`ally solicited by the editors, but unsolicited sub(cid:173)
`missions will be considered. Editorials usually
`contain about 1000 words, not counting reference
`list and footnotes, but length may be negotiated at
`the time of invitation.
`Commenta ry
`Topical items under this heading convey to the
`reader, in relatively nontechnical and informal
`style, a summary of current activities or events that
`bear on some aspect of cancer. Highlights of sci(cid:173)
`enti fie meetings, the intersection of science and
`public policy, or news items of general interest in
`relation to cancer are examples of suitable subject
`areas. Pieces are generally solicited by the editors,
`but unsolicited contributions are welcome. A Com(cid:173)
`mentary usually contains 2000-4000 words, not
`counting reference list, tables, footnotes , and fig(cid:173)
`ure legends. A Commentary should not contain an
`abstract. (See "Tables and Figures.")
`Reviews
`A good Review provides a comprehensive
`overview of an area of cancer biology, epidemiol(cid:173)
`ogy, prevention, treatment, or behavioral science.
`While Reviews should be accessible to knowledge(cid:173)
`able readers not expert in the subject area, Reviews
`should be prepared with the same rigor as a re(cid:173)
`search paper reporting specific results. (See J Nat!
`Cancer lnst 1997;89:6-7 for detailed guidelines on
`preparing reviews for this journal. A copy of the
`guidelines can be obtained by contacting the Jour(cid:173)
`nal Office, P.O. Box 31110, Bethesda, MD 20824-
`1110; telephone: 301-496-6975; fax: 301-402-0212.)
`While most Reviews are solicited by the editors,
`unsolicited submissions are also welcome. A Re(cid:173)
`view should contain 6000 words or less, not count(cid:173)
`ing abstract, reference list, tables, footnotes, and
`figure legends. (See "Tables and Figures.")
`Book Reviews
`Book Reviews are solicited by the book review
`editor and contain I 000 words or less.
`
`SPECIFIC INSTRUCTIONS
`Submission of Manuscripts,
`Including Letters to the Editor
`New submissions of Articles, Reports, and Brief
`Communications originating in Europe (those whose
`corresponding authors have European addresses)
`should be sent to: Prof. J. Gordon Me Vie, European
`Editor of the Journal of the National Cancer Insti(cid:173)
`tute, Cancer Research Campaign, 10 Cambridge
`Terrace, London NWI 4JL, UK. Articles, Reports,
`and Brief Communications from other areas and all
`Editorials, Commentary, Reviews, and letters to the
`editor (Correspondence) should be submitted to:
`Editor-in-Chief, Journal of the National Cancer In(cid:173)
`stitute, P.O. Box31110, Bethesda, MD 20824-1110
`(telephone: 301-496-6975); express mail address:
`7550 Wisconsin Ave., Rm. 114, Bethesda, MD
`20814. All revised manuscripts should be sent to the
`Editor-in-Chief, at Bethesda.
`Manuscript title page, the body of the manu(cid:173)
`script, reference list, footnotes, and figure legends
`must be typed double-spaced; allow sufficient space
`between lines of type so each page contains no more
`than 26 lines (plus page number). Tables may be
`single- or double-spaced, but the type must be large
`enough and the lines of type sufficiently well spaced
`to be easily read. Send an original and three copies
`of the manuscript. Do not staple figures to the manu(cid:173)
`script. Four clear, can1era-ready (reproducible) sets
`of all illustrations must be provided; do not send
`photocopies of photographs, photomicrographs,
`gels, blots, or sin1ilar material. The cover leiter for
`the manuscript must conform to requirements stated
`in the "Cover Letter" section below. Manuscript
`submissions not meeting these requirements (i.e.,
`cover feller statements, number of clear copies of
`illustrations, number of manuscript copies, and
`spacing in hard copy of manuscript} will be returned
`to the author without review.
`Letters to the editor and solicited manuscripts
`must be submitted initially both as double-spaced
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`80 INFORMATION FOR AUTHORS
`
`Journal of the National Cancer Institute, Vol. 90. No. I , January 7, 1998
`
`PFIZER EX. 1185
`Page 5
`
`

`

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`
`For clinical trials, authors should clearly define
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