Instructions to Authors

INSTRUCTIONS TO AUTHORS

GASTROENTEROLOGY publishes clinical and basic studies of allaspects of the digestive system, including the liver andpancreas, as well as nutrition. The types of articles GAS-TROENTEROLOGY publishes include original papers, reviewarticles, case reports, and special category manuscripts.Manuscripts must be prepared in accordance with the“Uniform Requirements for Manuscripts Submitted toBiomedical Journals” developed by the International Com-mittee of Medical Journal Editors (N Engl J Med 1991;324:424-428).

GASTROENTEROLOGY has a total circulation of approximately16,000—about 11,500 in the United States and 4500 inother countries. Forty-five percent of subscribers are AGAInstitute members. In the United States, about 75% ofsubscribers are physicians, and about 25% of subscriptionsgo to residents, medical schools, and libraries. More thanhalf of the papers published originate overseas.

GASTROENTEROLOGY is abstracted and indexed in BiologicalAbstracts, CABS, Chemical Abstracts, Current Contents, Ex-cerpta Medica, Index Medicus, Nutrition Abstracts, and ScienceCitation Index.

Ethical and Legal Considerations

EthicsGASTROENTEROLOGY strongly discourages the submission of

more than one article dealing with related aspects of thesame study. In almost all cases, a single study is bestreported in a single paper.

The journal editors consider research/publication misconductto be a serious breach of ethics and will take action asnecessary to address such misconduct, which includes sub-mission or publication of information that:

(1) Is intentionally erroneous,(2) Has been published elsewhere by a different author with-

out acknowledgment (plagiarism),(3) Has been published elsewhere by the same author without

acknowledgment (duplicate publication), or(4) Is subsequently published elsewhere by the same author

without acknowledgment, attribution, or permission fromthe AGA Institute, as holder of the copyright, to reprint oradapt the material.

Each author who submits a manuscript must complete GAS-TROENTEROLOGY’s Copyright Assignment, Authorship Respon-sibility, NIH Funding, Financial Disclosure, and InstitutionalReview Board/Animal Care Committee Approval form therebyaffirming that:

(1) None of the material in the manuscript is included inanother manuscript, has been published previously, or iscurrently under consideration for publication elsewhere.This includes symposia proceedings, transactions, books,articles published by invitation, and preliminary publica-tions of any kind except an abstract of less than 400 words.If there is any potential overlap with a manuscript previ-ously published by the authors, the related manuscriptsmust be included for editorial evaluation.

(2) Only people who contributed to the intellectual content,the analysis of data, and the writing of the manuscript are

listed as authors and that all authors take public respon-sibility for the research results being reported.

(3) Ethical guidelines were followed by the investigator instudies on humans or animals and described in the paper.The approval of the institutional review board of animalcare committee must be cited in the Methods section ofthe text.

Breaches in these standards may result in proscribed submis-sion for all authors of the concerned manuscript and, whenappropriate, notification of the authors’ institutions. Allauthors are fully responsible for the content of the manu-script.

The publication of abstracts is not considered duplicate pub-lication but should be disclosed in the cover letter accom-panying the manuscript submission.

Conflict of Interest for Authors of Original Articlesand Review ArticlesAuthors of original research articles and review articles should

disclose at the time of submission any financial arrange-ment (e.g., consultancies, stock ownership, equity inter-ests, patent-licensing arrangements, research support, ma-jor honoraria, etc.) they may have with a company whoseproduct figures prominently in the submitted manuscriptor with a company making a competing product (seeCopyright Assignment, Authorship Responsibility, Finan-cial Disclosure, and Institutional Review Board/AnimalCare Committee Approval form). Interactions that occurwithin 2 years before the submission date of an article arepertinent. The conflict of interest form can be found onwww.gastrojournal.org.

Such information will be held in confidence while the paper isunder review and will not influence the editorial decision, butif the article is accepted for publication, the editors willusually discuss with the authors the manner in which suchinformation is to be communicated to the reader.

All funding sources supporting the work and all institutional orcorporate affiliations must be acknowledged in a footnote.

SponsorshipGASTROENTEROLOGY conforms with the standards set forth by the

International Committee of Medical Journal Editors (ICMJE)regarding the relationship between investigators and sponsors(www.icmje.org/sponsor.htm).

ReviewersReviewers of research articles will be disqualified from reviewing

if they:(1) have had an ongoing collaboration, original publications or

grants with the authors within the previous 2 years, except inthe case of being a part of a multicenter group from a differentsite; or

(2) are from the same institution as the authors.Reviewers should disclose at the time of submission any financial

arrangement (e.g., consultancies, stock ownership, equity in-terests, patent-licensing arrangements, research support, ma-jor honoraria, etc.) they may have with a company whoseproduct figures prominently in the submitted manuscript orwith a company making a competing product. Interactions

that occur within 2 years before the submission date of anarticle are pertinent.

Editorialists

Editorialists will be disqualified from writing an editorial if they:(1) have had an ongoing collaboration, original publications or

grants with the authors within the previous 2 years, except inthe case of being a part of a multicenter group from a differentsite; or

(2) are from the same institution as the authors.Editorialists should disclose at the time of submission any finan-

cial arrangement (e.g., consultancies, stock ownership, equityinterests, patent-licensing arrangements, research support,major honoraria, etc.) they may have with a company whoseproduct figures prominently in the submitted manuscript orwith a company making a competing product. Interactionsthat occur within 2 years before the submission date of anarticle are pertinent. If the editorial is accepted for publica-tion, the editors will usually discuss with the authors themanner in which such information is to be communicated tothe reader.

Authorship

Each author must have participated sufficiently in the work totake public responsibility for the content of the paper andmust approve of the final version of the manuscript. Author-ship should be based on substantive contributions to each ofthe following:(1) conception and design of the study;(2) generation, collection, assembly, analysis and/or interpre-

tation of data;(3) drafting or revision of the manuscript;(4) approval of the final version of the manuscript.

National Institutes of Health (NIH) FundingIf a manuscript is accepted for publication and was supported

in part, or in whole, by the NIH, the author may requestthat the manuscript be automatically posted to PubMedCentral (PMC). If the author wishes to make this request,he or she should check the appropriate box located on theCopyright Assignment Form under the NIH Fundingportion of the form. In addition, the author must providethe NIH grant number. If an author makes this request,the manuscript will automatically be entered in the PMCsystem and will be available to the public, free of charge,12 months from the manuscript’s publication date.

Categories of ManuscriptsOriginal Articles

Original Articles are full-length reports of original research andwill be considered for either the Clinical Research sectionor the Basic Research section of the journal. Articles covertopics relevant to clinical and basic studies in these areas ofinterest. They may discuss nutrition, immunology, cellbiology, molecular biology, morphology, physiology,pathophysiology, epidemiology, or therapy. Both adult

and pediatric problems are included. To be published, thework presented in the manuscript must be original; onoccasion, confirmatory studies of timely and importantobservations will also be acceptable. In addition, otherconsiderations for evaluating the acceptability of asubmitted manuscript include its importance, thesoundness of the experimental design, the validity of themethods, the appropriateness of the conclusions, and thequality of presentation.

Reviews in Basic and Clinical Gastroenterology

Each issue of GASTROENTEROLOGY will contain a review articleby two or more collaborating authors that is solicited bythe board of editors (no unsolicited reviews will beconsidered). Each review article will be divided into twosections, Basic and Clinical, with one section to be overseenby a basic science editor and the other by a clinical editor.

Case Reports

Case Reports include case studies of 4 or fewer patients thatdescribe a novel situation or add important insights intomechanisms or diagnosis or treatment of a disease.

Meeting Reports

Meeting Reports are brief synopses of scientific meetings ofpotential interest to readers. No more than 3 journal pagesmust be submitted within 8 weeks of the meeting. Authorshould write or fax a letter to the Editor solicitingpotential interest before submission (preferably, inquiriesregarding potential interest should be made prior to themeeting or conference).

Clinical Challenges and Images in GI

Clinical Challenges and Images in GI presents a strikingclinical image that is meant to challenge and informreaders. The “Image of the Month” is presented as anunknown with the diagnosis hinging on the correctinterpretation and integration of the image and clinicaldata. The answer is presented on a separate page of theJournal. The section is intended to illustrate and teachimportant medical points. If you would like to submit anImage for publication in the Journal, please follow theinstructions below.

1. Images can be either clinical, pathologic (gross ormicroscopic), endoscopic, or radiographic. Theyshould be of high quality and illustrate well thediagnosis. Images for hardcopy submission should beoriginal color or black and white photographic ordigital prints 5 by 7 inches in size and should besubmitted in duplicate.

2. Arrows or other symbols, or label identifiers shouldbe marked only on the second print. The back ofeach print and slide must be labeled with the lastnames of the contributors and an arrow indicatingthe top of image.

3. The case should be described in one typed double-spaced page or less. Format should be as follows:

INSTRUCTIONS TO AUTHORS (Continued)

Short pertinent history, physical exam and laboratoryfindings, and initial clinical course. The image(s)should then be described with all labeled structuresexplained in the text.

4. The answer should discuss the image findings and thediagnosis in no more than one double-spaced typedpage. The diagnosis and discussion should make animportant medical teaching point and include from 1 to3 pertinent references. Information regarding the specificpatient in terms of follow-up and response to therapyshould be given as appropriate.

5. No more than three authors are allowed on eachsubmission. Contributors must provide their names,addresses, phone, and e-mail addresses. Contributorsmust sign and return the copyright form whichassigns copyright to the AGA Institute and attestthat the figure has not been submitted or publishedelsewhere.

6. “Clinical Challenges and Images in GI” submissionsshould be sent to: Image of the Month, AGAInstitute, 4930 Del Ray Avenue, Bethesda, MD20814. fax: (301) 654-1140. Attn: Debra Raden.Electronic submissions are acceptable and should besubmitted as per instructions at www.gastrojournal.org.

Please note that figures and slides will not be returnedto the sender.

Imaging and Advanced Technology

Imaging and Advanced Technology is written by the sectioneditor or, in some instances, by a guest author. Ithighlights developments, both current and anticipated inthe future, in translational science and clinical medicine.Examples include, but are not limited to, chromoendoscopyand detection of aberrant crypt foci, optical imaging andBarrett’s esophagus, endoscopy and confocal imaging,nanotechnology, genomics and discovery of IBD genes, andproteomics.

Correspondence

Correspondence offers opinions on papers published inGASTROENTEROLOGY. Text should not exceed 3 pagesdouble-spaced, and no more than 10 references shouldbe included. All letters become the property ofGASTROENTEROLOGY and are subject to editing by theeditors. Letters commenting on papers are sent to theauthors of those papers for a response. Letters are selectedfor their importance, relevance, and originality; not allletters submitted can be published. GASTROENTEROLOGY

will not publish letters commenting on manuscripts forwhich letters have already been published.

Editorials

Editorials express opinions on current topics of interest orprovide comments on papers published elsewhere in thesame issue. Editorials are usually solicited by the Editor.

Notices

Notices are brief announcements of meetings, seminars, andcourses with only essential information given. Noticesreceived less than 3 months before publication cannot beguaranteed an appropriate publication date.

Continuing Medical Education (CME)

Each issue of GASTROENTEROLOGY will contain two to threecontinuing medical education exams associated witharticles that appear in the issue. AGA members can takethe exams online free of charge. Non-AGA members arerequired to pay a $15 processing fee. For CME exams thataccompany original articles, readers can claim 1.0 AMAPRA Category 1 credit. For CME exams that accompanyAGA Institute medical position statements and technicalreviews, readers can claim 2.0 AMA PRA Category 1credits.

Reviewers of manuscripts can also claim CME credit. Afterreviewing a manuscript on the journal’s manuscripttracking system, Editorial Manager, the reviewer will beprompted to claim up to 3.0 AMA PRA Category 1credits.

This Month in Gastroenterology

This Month in GASTROENTEROLOGY is written by the sectioneditors. It provides general previews of two clinical articlesand two basic articles that appear in the issue andare of particular importance to the GASTROENTEROLOGY

readership.

Selected Summaries

Selected Summaries are concise overviews of articles recentlypublished in other journals that are of potential interest toGASTROENTEROLOGY readers. Contributors are selected by thesection editor. Unsolicited summaries may be submittedto the Selected Summaries Editor for consideration.

Print and Media Reviews

Print and Media Reviews are informative analyses of recentlypublished books or other media relevant to clinicalpractice and research. Reviews are solicited by thesection editor. Unsolicited reviews may be submitted tothe Print and Media Reviews Editor for consideration.

Manuscript PreparationCover Letter

GASTROENTEROLOGY strongly encourages authors to suggest 3to 4 referees (include the mailing address, electronic ad-dress, phone, and fax numbers) and the Associate Editorthey believe best qualified to review their paper. Authorsmay also list a non-preferred Associate Editor and non-preferred referees, but the ultimate selection of an Asso-ciate Editor and referees is at the sole discretion of theEditor and Associate Editor, respectively.


State reasons for deviations, if any, from standard format andclarify any potential conflict related to the exclusive natureof the publication. The cover letter must also categorizethe manuscript into one of the four following groups:ClinicalAlimentary Tract, Clinical Liver/Pancreas/Biliary,Basic Alimentary Tract, or Basic Liver/Pancreas/Biliary.

Electronic SubmissionAll manuscripts submitted to GASTROENTEROLOGY are made

available for online review. Authors may submit their manu-scripts, with figures and tables, electronically via our website,http://www.editorialmanager.com/gastro/. Please note that elec-tronic submission will decrease review time by as much as 2weeks, so authors are encouraged to use this method whenpossible.

Note: If you have submitted your manuscript electronically, youdo not need to submit a hard copy. If your manuscript isaccepted you will be asked to provide the Editorial Officewith hard copies of the missing materials.

Before entering the website, authors are asked to have theirmanuscript saved in Rich Text Format (.rtf) and each figuresaved as a separate electronic file, preferably named as “figure1.tif,” “figure 2.jpg,” etc. Image File Formats: We supportthe following among dozens of file formats: .bmp, .gif, .jpg,.pbm, .pcx, .png, .tif, .eps, and .xbm, along with TARGAand Photoshop files. (ChemDraw, Excel, PowerPoint,SigmaPlot, and Equation Editor formats are not supported atthe time.) Your file formats can be mixed. Tables: Tablesshould be prepared without the use of tabs; most table editorprograms can be uploaded successfully. The word count forelectronic submissions is approximately 5,000-6,000 words.

Manual Submission

Since all manuscripts are made available for online review, if youare unable to submit your manuscript electronically, theEditorial Office can do so on your behalf. However, authorswill incur a nonrefundable charge of $75 for the pro-cessing and uploading of manual and email submis-sions. All manual and email submissions must be accompa-nied by a check, a purchase order, or credit card informationor the submission will not be processed. Checks and purchaseorders must be payable to the “AGA Institute” and creditcard payments must provide the card type, card number, cardholder’s name and address, and the card expiration date.

Note: If you have submitted your manuscript electronically, youdo not need to submit a hard copy. If your manuscript isaccepted you will be asked to provide the Editorial Officewith hard copies of the missing materials.

Submit complete manuscript typed in 12-pt font and doublespaced with 1-inch margins. Limit of 21 pages (approxi-mately 5,000-6,000 words) including tables, figures, andreferences (2 figures � 1 typed page). One diskette contain-ing the text of the manuscript — saved in Rich Text Format(.rtf) — must accompany every manuscript and revision.Also, please include an electronic copy of your cover letter,

and in the case of revisions, your point-by-point response toeditors and reviewers.

Arrange manuscript as follows, each component beginning on aseparate page: (1) title page, (2) abstract, (3) introduction, (4)materials and methods, (5) results, (6) discussion, (7) refer-ences, (8) figures and figure legends, (9) tables.

Place page number and first author’s last name at top of each page.Cite references, tables, and figures consecutively as they appear in

the text.Authors are responsible for applying for permission for both print

and electronic rights for all borrowed materials and are re-sponsible for paying any fees related to the applications ofthese permissions.

Title Page

Title—Include animal species. Use no abbreviations. Limit:120 characters with spaces.

Short Title—Limit: 45 characters.Authors—Include first names of all authors and name and

full location of department and institution where workwas performed.

Grant Support—List grant support and other assistance.Abbreviations—List alphabetically abbreviations not men-

tioned in the Style Guide, which follows the Instruc-tions to Authors. (Note: In general, the use of abbre-viations is discouraged.)

Correspondence—Provide name, complete address, e-mail address,telephone number, and fax number of corresponding author.

Reporting Clinical Trials

In accordance with the policy put forth by the InternationalCommittee of Medical Journal Editors (ICMJE), a clin-ical trial will only be considered for publication if it hasbeen registered in a publicly accessible registry beforethe enrollment of the first patient. The registry must beelectronically searchable and accessible to the public atno charge. It must be open to all registrants and not forprofit. It must have a mechanism to ensure the validityof the registration data.

Randomized controlled trials should be presented accordingto the CONSORT guidelines (JAMA 2001;285:1987-1991 or http://www.consort-statement.org). At manu-script submission, authors must provide the CON-SORT checklist with a diagram that illustrates theprogress of patients through the trial, including recruit-ment, enrollment, randomization, withdrawal and com-pletion, and a detailed description of the randomizationprocedure. The CONSORT checklist can be found onwww.gastrojournal.org under the Instructions to Au-thors. Manuscripts that fail to comply with CONSORTguidelines will not be reviewed for publication.

Abstract

Limit: 250 words. Organize according to the following head-ings: Background & Aims, Methods, Results, and Conclusions.

Do not use abbreviations, footnotes, or references.Authors of clinical research studies should submit a structured


abstract of no more than 250 words organized into thefollowing categories as applicable:

Background & Aims: Describe the importance of the studyand the precise research objective(s) or study question(s).

Methods: Methods should include information on the follow-ing aspects of study design when applicable. The methodssection may employ subheadings at the discretion of theauthor.–Design — describe the basic study design, e.g., random-ized controlled trial, cross sectional study, cohort study,case series, survey, etc. Source of all non-standard reagentsneed to be explicitly stated.–Setting — specify whether the study was conducted ina primary or tertiary care setting, in an ambulatorycare clinic or hospital, in the general community, etc.–Participants — indicate the number of study subjectsand how they were selected, recruited, and assigned to theintervention–Intervention — report the method of administrationand duration of the intervention.

Results: Provide the main outcomes of the study includingconfidence intervals or P values. Report the absolute valuesand risk differences so that readers can determine theabsolute, as well as the relative, impact of the results.

Conclusions: State only conclusions that are directly sup-ported by the evidence and the implications of thefindings.

Body of PaperDescribe ethical guidelines followed (for human or animal stud-

ies); cite approval of institutional human research reviewcommittee or animal welfare committee; describe in detailhazardous procedures or chemicals involved, including pre-cautions observed.

Outline statistical methods used.Identify drugs and chemicals used by generic name (if trademarks

are mentioned, manufacturer name and city are given).

ReferencesCite references in order of appearance in text using superscripted

Arabic numerals.Cite personal communications and unpublished data directly in

text without being numbered.Conform abbreviations to those used in Index Medicus.Conform style and punctuation to GASTROENTEROLOGY require-

ments:Article (list all authors):13. Meltzer SJ, Ahnen DJ, Battifour H, Yokokota J, Cline MJ.

Protooncogene abnormalities in colon cancers and adeno-matous polyps. Gastroenterology 1987;92:1174–1180.

Book:18. Day RA. How to write and publish a scientific paper.

Philadelphia: Institute for Scientific Information, 1979.Article in Book:22. Costa M, Furness JB, Llewellyn-Smith IF. Histochemistry

of the enteric nervous system. In: Johnson LR, ed. Physi-ology of the gastrointestinal tract. Volume 1. 2nd ed. NewYork: Raven, 1987:1–40.

Tables

All tables should be created through a table editor in a wordprocessing function. Do not use spaces or tabs.

Typed and double spaced, each on a separate sheet.Numbered according to order of citation.Table number and title appear above table, explanatory notes

below.

Figure Legends

Typed and double spaced.Numbered according to order of citation.Provide enough information to permit interpretation of figure

without reference to text.

Figures

Electronic Submission: If you submit your manuscript electron-ically, you need not submit figures in hard copy. Figuresmust be at least printer quality (150dpi) to ensure qualityappearance for reviewers.

Manual Submission: Submit 2 complete sets of high-qualitylaser-generated line prints or glossy prints for photographs(either must be at least 300dpi) in 2 separate envelopes. Pleasenote that figures sent with a manual submission will not bereturned to you.

Identify each figure with first author’s last name, figure number,and an arrow indicating the top on a self-adhesive labelaffixed to the back of each figure.

Attach full-page photocopies of each figure to the manuscript. Donot mount multiple-part figures; submit each section indi-vidually. However, you may include a written, suggestedlayout.

Accompany photographs of identifiable patients with writtenpermission to publish from the patient.

Font: If your figures include text, the type should be 8pt orgreater.

Upon Acceptance: Authors of accepted manuscripts will beasked to provide the Editorial Office with 2 sets of glossyprints at publication quality (300dpi).

Cost: Contributors will be required to pay for the printing ofcolor figures ($650 for the first color figure and $100 each foradditional figures). If the manuscript is reviewed with colorfigures, it must be published with color figures with printingfees paid for by the contributor. If the contributor does notwish to pay for printing color figures, then the manuscriptcan only be reviewed containing black and white figures.

Distribution of Material Described in PublishedPapers

Authors are expected to make available materials such as cell lines,cDNA clones, hybridomas, antibodies, biological reagents,unique animals, etc. to any qualified investigator. Prior to thesubmission of newly cloned genes or nucleic acid sequences,the journal requires authors to provide an accession numberto a gene bank. This is to encourage the free exchange ofscientific information and to promote progress in all areas ofgastroenterological investigation.


Manuscript Processing and Review

Submissions. The Editorial Office receives approximately 2000manuscripts a year. Each new manuscript receives a uniquenumber, and information on the manuscript is recorded onthe Editorial Office computer network. The editorial staffreleases information on manuscripts only to authors. TheEditorial Office will email or fax a letter to the correspondingauthor acknowledging receipt of a manuscript, whether newor a resubmission.

Review process. Each manuscript is assigned to an AssociateEditor who has expertise on the subject of the manuscript.After review by the Associate Editor, if the manuscript isjudged to be appropriate and competitive for publication inGASTROENTEROLOGY, it is sent to experts in the appropriatearea for peer review. The Associate Editor chooses 2 or 3reviewers, who remain anonymous. Authors are encouragedto suggest an Associate Editor and 2 to 5 reviewers in thecover letter, though final assignments are at the discretion ofthe editor.

Reviewers provide comments for the editor and for the authors.The Journal expects reviewers to treat manuscripts as confi-dential communications and not to use the content for theirown purposes or make copies of the manuscripts. Reviewersare also expected to declare to the editor any possible conflictsof interest.

Decisions. The single most important criterion for accep-tance is the originality of the work. However, a decisionto accept a manuscript is not based solely on the sci-entific validity of its content. Other factors affectingdecisions include the extent and importance of newinformation in the paper compared with that in otherpapers being considered, the Journal’s need to representa wide range of topics, and the overall suitability forGASTROENTEROLOGY. Decision letters usually, but notalways, convey all factors considered for a particulardecision. Occasionally, the comments to the authorsmay appear to be inconsistent with the editorial deci-sion, which takes into consideration reviewers’ com-ments to the editor, as well as the additional factorslisted above.

Decisions on peer-reviewed papers are sent to the authors anaverage of 6 weeks from the date of submission.

PublicationAccepted manuscripts are sent to the publisher, Elsevier,

soon after acceptance. They will immediately be up-loaded to GASTROENTEROLOGY online (www.gastrojournal.org) under “Articles in Press” for preprint viewing bysubscribers. Authors will still have the opportunity toreview galleys of their manuscripts before they appear inthe print issue of the journal.

Manuscripts are copyedited to make them consistent withJournal style; if a particular section in the manuscript isnot clear or requires additional information, the copyeditor will direct questions to the author. These questions,or “author queries,” will appear in the margins of theproofs that are sent to the author.

The time between acceptance and publication is currentlyabout 3 months. The corresponding author can expectproofs of the article approximately 2 months after accep-tance. Authors receive proofs for the primary purpose ofchecking the accuracy of the typesetting; authors are not torevise or rewrite their articles at this stage. If after accep-tance of their paper, authors become aware of importantinformation they believe should be added to their manu-script, they should contact the editor of GASTROENTEROL-OGY.

Authors are required to return proofs to the publisher within48 hours.

Reprints. Forms for ordering article reprints will be sent withproofs to authors and should be returned with the cor-rected proofs. Authors do not receive free reprints, andtherefore are responsible for ordering their own reprints(minimum order, 100) from the publisher.

Editorial Office

The address for the submission of manuscripts or correspon-dence is: Anil K. Rustgi, MD, Editor, GASTROENTEROLOGY,AGA Institute, 4930 Del Ray Avenue, Bethesda, Maryland20814-3015. Fax: (301)-654-1140. To contact the EditorialOffice, call (301) 941-9781 or e-mail [email protected].

� 2006 by the American Gastroenterological Association Institute


Copyright Assignment, Authorship Responsibility, NIH Funding, Financial Disclosure,Institutional Review Board/Animal Care Committee Approval, and Sponsorship

Copyright Assignment. In consideration of the American Gastroenterological Association Institute (the “AGA Institute”) taking action to reviewand credit the below-identified submission (the “Manuscript”), and for other valuable consideration, the receipt and sufficiency of which is hereby acknowledged,the undersigned authors and/or creators (the “Authors”), jointly and severally, hereby transfer, convey, and assign to the AGA Institute, free and clear of anyliens, licenses or encumbrances, the entire right, title, and interest in and to the Manuscript throughout the world, including without limitation in and to anyand all copyrights for the Manuscript (including but not limited to rights to copy, publish, excerpt, collect royalties and make derivative works) in print,electronic, Internet, broadcast, and all other forms and media now or hereafter known, and for any and all causes of action heretofore accrued in Authors’ favorfor infringement of the aforesaid copyrights, to have and to hold the same unto the AGA Institute, its successors and assigns, for and during the existence ofthe aforesaid copyrights, and all renewals and extensions thereof. At any time and from time to time hereafter, the Authors shall upon the AGA Institute’swritten request take any and all steps and execute, acknowledge and deliver to the AGA Institute any and all further instruments and assurances necessary orexpedient in order to vest the aforesaid copyrights and causes of action more effectively in the AGA Institute. The Authors retain the nonexclusive permissionto use all or part of the Manuscript in future works of their own in a noncompeting way, provided proper copyright credit is given to the AGA Institute. Shouldthe AGA Institute finally determine that it will not publish the Manuscript, the AGA Institute agrees to assign its rights therein back to the Authors. (Note:material prepared by employees of the federal government in the course of their official duties may not be copyrightable.)

Authorship Responsibility. I, the undersigned Author, certify that I have participated sufficiently in the intellectual content, the analysis of data, ifapplicable, and the writing of the Manuscript, to take public responsibility for it. I have reviewed the final version of the Manuscript, believe it represents validwork, and approve it for publication. As an Author of this Manuscript, I certify that, except to the extent expressly credited to others in the text of theManuscript: the entire Manuscript is an original creation of the Authors; and none of the material in the Manuscript has been published previously, is includedin another manuscript, or is currently under consideration for publication elsewhere. I also certify that this Manuscript has not been accepted for publicationelsewhere, and that I have not assigned, licensed, or otherwise transferred any right or interest in the Manuscript to anyone. Moreover, should the AGA Instituteor the editors of GASTROENTEROLOGY request the data upon which the Manuscript is based, I shall produce it. Authors are responsible for applying forpermission for both print and electronic rights for all borrowed materials and are responsible for paying any fees related to the applications of these permissions.

Institutional Review Board/Animal Care Committee Approval. I, the undersigned Author, certify that my institution has approved the protocolfor any investigation involving humans or animals and that all experimentation was conducted in conformity with ethical and humane principles of research.

Sponsorship. I, the undersigned author, certify that I had full access to all of the data in this study, and I take responsibility for the integrity of thedata and the accuracy of the data analysis.

Manuscript title:

Signatures: Each Author must sign and date this statement and assignment. In the case of a work made for hire, the employer(s) must also sign. For example,for any Manuscript including any portion created in the course of employment for another (whether as a regular employee or as an independent contractor)requires the signature of the relevant employer(s).

Print Name: Date: Print Name: Date:



Employer signature(s) as Author (required for works made for hire):

(Employer) (Employer)

By: By:


� If this Manuscript exists in the public domain because it was written as part of the official duties of the Authors as employees of the U.S. government, check this box.

National Institutes of Health (NIH) Funding. My manuscript was supported in part, or in whole, by the NIH. In accordance with the NIH PublicAccess Policy, I would like to request that my manuscript, should it be accepted for publication, be submitted to PubMed Central (PMC). I understandthat my manuscript will therefore be freely accessible by the public via PMC twelve months from the date of its publication.� I would like my manuscript automatically submitted to PMC, should it ultimately be accepted. My NIH grant number is

Financial Disclosure. Check the appropriate box and sign where indicated. All Authors must sign one of the statements below.� I, the undersigned Author, certify that I have no financial arrangements (e.g., consultancies, stock ownership, equity interests, patent-licensing arrangements,research support, major honoraria, etc.) with a company whose product figures prominently in the submitted manuscript or with a company making acompeting product except as disclosed on a separate attachment. All funding sources supporting the work and all institutional or corporate affiliations of mineare acknowledged in a footnote.

Describe potential financial conflict(s) of interest, sign, and date.

Checklist of items to include when reporting a randomized trial (56-58)

PAPER SECTIONAnd topic Item Description

Reportedon page #

TITLE & ABSTRACT 1How participants were allocated to interventions (e.g., “random allocation”, “randomized”,or “randomly assigned”).

INTRODUCTIONBackground

2 Scientific background and explanation of rationale.

METHODSParticipants

3 Eligibility criteria for participants and the settings and locations where the data were collected.

Interventions 4Precise details of the interventions intended for each group and how and when they wereactually administered.

Objectives 5 Specific objectives and hypotheses.

Outcomes 6Clearly defined primary and secondary outcome measures and, when applicable, anymethods used to enhance the quality of measurements (e.g., multiple observations,training of assessors).

Sample size 7How sample size was determined and, when applicable, explanation of any interimanalyses and stopping rules.

Randomization—Sequencegeneration

8Method used to generate the random allocation sequence, including details of anyrestriction (e.g., blocking, stratification)

Randomization—Allocationconcealment

9Method used to implement the random allocation sequence (e.g., numbered containers orcentral telephone), clarifying whether the sequence was concealed until interventions wereassigned.

Randomization—Implementation

10Who generated the allocation sequence, who enrolled participants, and who assignedparticipants to their groups.

Blinding (masking) 11Whether or not participants, those administering the interventions, and those assessingthe outcomes were blinded to group assignment. When relevant, how the success ofblinding was evaluated.

Statistical methods 12Statistical methods used to compare groups for primary outcome(s); Methods for additionalanalyses, such as subgroup analyses and adjusted analyses.

RESULTSParticipant flow

13

Flow of participants through each stage (a diagram is strongly recommended). Specifically, foreach group report the numbers of participants randomly assigned, receiving intendedtreatment, completing the study protocol, and analyzed for the primary outcome. Describeprotocol deviations from study as planned, together with reasons.

Recruitment 14 Dates defining the periods of recruitment and follow-up.

Baseline data 15 Baseline demographic and clinical characteristics of each group.

Numbersanalyzed

16Number of participants (denominator) in each group included in each analysis and whetherthe analysis was by “intention-to-treat”. State the results in absolute numbers whenfeasible (e.g., 10/20, not 50%).

Outcomes andestimation

17For each primary and secondary outcome, a summary of results for each group, and theestimated effect size and its precision (e.g., 95% confidence interval).

Ancillary analyses 18Address multiplicity by reporting any other analyses performed, including subgroup analysesand adjusted analyses, indicating those pre-specified and those exploratory.

Adverse events 19 All important adverse events or side effects in each intervention group.

DISCUSSIONInterpretation

20Interpretation of the results, taking into account study hypotheses, sources of potential bias orimprecision and the dangers associated with multiplicity of analyses and outcomes.

Generalizability 21 Generalizability (external validity) of the trial findings.

Overall evidence 22 General interpretation of the results in the context of current evidence.

To access these links, please visit www.consort-statement.org, click on statement and scroll down to “go directly to checklist”.

Documents

Instructions to Authors