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The New England Journal of Medicine

Instructions for Submitting a NEW Manuscript

Manuscripts containing original material are accepted for consideration if neither the article nor any part of its essential substance, tables, or figures has been or will be published or submitted elsewhere before appearing in the Journal. This restriction does not apply to abstracts or press reports published in connection with scientific meetings. Copies of any closely related manuscripts must be submitted along with the manuscript that is to be considered by the Journal. The Journal discourages the submission of more than one article dealing with related aspects of the same study.

Authors of all types of articles should follow the general instructions given below. Please see Article Types for word counts and instructions. Please abide by the word count guidelines.

These guidelines are in accordance with the “Uniform Requirements for Manuscripts Submitted to Biomedical Journals,” published by the International Committee of Medical Journal Editors at .

For further information regarding manuscripts, please see the editorial policies of the Journal.

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AUTHORSHIP

As stated in the Uniform Requirements, credit for authorship requires substantial contributions to (a) the conception and design or analysis and interpretation of the data, and (b) the drafting of the article or critical revision for important intellectual content. Each author must sign a statement attesting that he or she fulfills the authorship criteria of the Uniform Requirements. At least one person’s name must accompany a group name (e.g., Thelma J. Smith, for the Boston Porphyria Group).

Any change in authorship after submission must be approved in writing by all authors.

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ASSURANCES

In appropriate places in the manuscript, please provide the following items:

• If applicable, a statement that the research protocol was approved by the relevant institutional review boards or ethics committees and that all human participants gave written informed consent

• The identity of those who analyzed the data.

• For clinical trials, the registration number and registry name (see N Engl J Med 2004;351:1250-1).

• For studies containing microarrays, the accession numbers and repository name.

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REQUIRED FORMS

You do not need to send a separate cover letter file with your online submission. Instead, we offer a text box in which you can type your information, or you can cut and paste from a previously written letter. This box can also be left blank, if you wish.

Any change in authorship after submission must be approved in writing by all authors.

Authors of original research articles are not required to submit a formal Financial Disclosure Form at the time of submission. We will request it later, if necessary. However, we do request that you note major conflicts of interest in your cover letter or in the Source of Funding text box.

All authors of review articles are required to submit our Disclosure Form for Review Articles and Editorials.

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ELECTRONIC FILES AND FIGURES

All text, references, figure legends, and tables should be in one double-spaced electronic document (Word Doc or PDF). You may either insert figures in the text file or upload your figures separately. We prefer the former, but this may not work well for complicated graphics, which should be sent separately. It is permissible to send low-resolution images for peer review, although we may ask for high-resolution files at a later stage.

Legends for all figures should be included in the file with the text and should not appear on the figures.

Our preferred file type for new manuscript submissions is Adobe Acrobat portable document format (.pdf) with all figures inserted in the same document. We will also accept Word Doc , WordPerfect (.wpd), text (.txt) documents, and .rtf file format.

Acceptable formats for pictures, photos, and figures are PDF, DOC, PPT, JPG, GIF, TIF.

Please be aware that we will convert all submissions to PDF for peer review.

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ABSTRACT

Provide an abstract of not more than 250 words. It should consist of four paragraphs, labeled Background, Methods, Results, and Conclusions. They should briefly describe, respectively, the problem being addressed in the study, how the study was performed, the salient results, and what the authors conclude from the results.

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TABLES

Double-space tables (including any footnotes) and provide a title for each. Extensive tables or supplementary material may be published on the Journal’s Web site only.

For Original Articles, there is normally a limit of 5 figures and tables (total) per manuscript. Additional figures and tables may be considered as supplements for Web-only publication.

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FIGURES AND ILLUSTRATIONS

Medical and scientific illustrations will be created or redrawn in-house. If an outside illustrator has created a figure, the Journal reserves the right to modify or redraw it to meet our specifications for publication. The author must explicitly acquire all rights to the illustration from the artist in order for us to publish it.

Please describe and clearly indicate all modifications, selective digital adjustments, or electronic enhancements in all digital images. It is permissible to send low-resolution images for peer review, although we may ask for high-resolution files at a later stage.

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PHOTOGRAPHS OF PATIENTS

If photographs of patients are used, either they should not be identifiable or the photographs should be accompanied by written permission to use them. One option is our Release Form for Photographs of Identifiable Patients.

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SPECIAL CASES

Clinical Trials

The ICMJE requires that “any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome” must be registered before the start of patient enrollment. Trials in which the primary goal is to determine pharmacokinetics are exempt. To be acceptable, a registry must be owned by a non-for-profit entity, be publicly accessible, and contain the twenty fields proposed by the World Health Organization. A list of acceptable registries may be found at .

Each manuscript will be checked upon submission to determine whether the study needed registration, and if registered, whether the registration is complete and meaningful. Manuscripts will not enter the editorial process until they have passed this screen.

All studies which began enrolling patients after July 1, 2005, must have been registered before patient enrollment. Any trial which was still seeing patients on September 13, 2005, should have been registered before September 13, 2005. If the trial was complete before September 13, 2005, the study should be registered before submission. Exceptions are granted on a case-by-case basis by the Editor-in-Chief.

Microarray Studies

Data obtained by microarray must be submitted to a repository such as the Gene Expression Omnibus or ArrayExpress prior to submission. The raw and transformed data sets for each microarray experiment must be provided through the repository, and the Accession Number for each experiment or series must be provided in the Methods section. If the data are password-protected, the user name and password must be provided in the cover letter and the Methods section of the manuscript at the time of submission. A criterion of publication is full access to the relevant data sets through a publicly accessible repository.

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JOURNAL STYLE

References

References must be double-spaced and numbered consecutively as they are cited. References first cited in a table or figure legend should be numbered so that they will be in sequence with references cited in the text at the point where the table or figure is first mentioned. List all authors when there are six or fewer; when there are seven or more, list the first three, followed by “et al.” The following are sample references:

1. Shapiro AMJ, Lakey JRT, Ryan EA, et al. Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free immunosuppressive regimen. N Engl J Med 2000;343:230-8.

2. Goadsby PJ. Pathophysiology of headache. In: Silberstein SD, Lipton RB, Dalessio DJ, eds. Wolff's headache and other head pain. 7th ed. Oxford, England: Oxford University Press, 2001:57-72.

3. Kuczmarski RJ, Ogden CL, Grammer-Strawn LM, et al. CDC growth charts: United States. Advance data from vital and health statistics. No. 314. Hyattsville, Md.: National Center for Health Statistics, 2000. (DHHS publication no. (PHS) 2000-1250 0-0431.)

4. U.S. positions on selected issues at the third negotiating session of the Framework Convention on Tobacco Control. Washington, D.C.: Committee on Government Reform, 2002. (Accessed March 4, 2002, at .)

Numbered references to personal communications, unpublished data, or manuscripts either “in preparation” or “submitted for publication” are unacceptable. If essential, such material can be incorporated at the appropriate place in the text.

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Statistical Methods

The basis for these guidelines is described in Bailar JC III, Mosteller F. Guidelines for statistical reporting in articles for medical journals: amplifications and explanations. Ann Intern Med 1988;108:266-73.

• Exact methods should be used as extensively as possible in the analysis of categorical data. For analysis of measurements, nonparametric methods should be used to compare groups when the distribution of the dependent variable is not normal.

• Results should be presented with only as much precision as is of scientific value. For example, measures of association, such as odds ratios, should ordinarily be reported to two significant digits.

• Measures of uncertainty, such as confidence intervals, should be used consistently, including in figures that present aggregated results.

• Except when one-sided tests are required by study design, such as in noninferiority trials, all reported P values should be two-sided. In general, P values larger than 0.01 should be reported to two decimal places, those between 0.01 and 0.001 to three decimal places; P values smaller than 0.001 should be reported as P ................
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