F1000Research Author Guidelines
Overview of the Editorial Process
F1000Research Article Types
Patient Privacy and Informed Consent for Publication
Publication of Materials Relating to Clinical Trials
Overview of the Editorial Process
All submissions to F1000Research will go through a rapid initial check by the in-house editorial team before being published with the status ‘Awaiting Peer Review’. Our editorial team will check the appropriateness of the article (including content, quality, tone and format), ensure it is intelligible and that it is written in good English. Please also ensure you provide the raw data behind all findings in your article (see the section below entitled ‘Submission’ that provides further details on our reasoning behind this request, as well as examples of where this requirement may be waived).
As an author you will be asked to identify 5 potential referees; you may choose from the F1000Research Referee Panel or you may select others of suitable standing. Please avoid suggesting those you have collaborated with in the past 5 years, those from your own institution, or those who are too senior to be likely to undertake such refereeing (they should ideally have authored at least one article in the field as the lead author). Please also try to ensure an international breadth to your choices. All referee suggestions will first be checked in-house to ensure that they meet the above criteria.
We ask referees to inform us whether the work seems scientifically sound, by selecting one of three statuses: ‘Approved’ (similar to approved or minor revisions), ‘Approved with Reservations’ (similar to major revisions) or ‘Not Approved’ (this is not sound science). We will also ask the referees for more detailed comments to support the status they have provided. All statuses and referee responses will be published alongside your article, together with the names of the referees and their affiliations.
You are strongly encouraged to make any amendments to your article suggested by the referees as you deem appropriate. You may also discuss the referee comments openly with the reviewers. All versions of your article will be accessible and can be independently cited, but the latest version will be displayed as the default on F1000Research. When you submit a new version of an article, we also ask you to send us a short summary of the changes that have been made compared with the previous published version. This information will be published at the top of the new version so that readers do not need to re-read the whole article to know what has been changed. Anything requested by the referees that you have chosen not to address should be explained by adding suitable replies directly against the referee responses using the Comment tool.
Once your article receives two ‘Approved’ statuses, or two ‘Approved with Reservations’ statuses and one ‘Approved’ status, your article will be indexed - currently in PubMed, PubMed Central, Scopus, Embase, Google Scholar, CrossRef and the British Library - and the status of your article will change to ‘Indexed’.
F1000Research Article Types
F1000Research publishes the following types of articles:
|Research Articles||Research Articles should present original findings in biology and medicine, such as results of basic and translational research, clinical and epidemiologic studies, or clinical trials.
Null and negative findings and reanalyses of previous studies leading to new results are also encouraged.
(See further details about these articles below in Section 4.1).
|Method Articles||Method Articles describe a new experimental or computational method, test or procedure (basic science or clinical), and should have been well tested. This includes new study methods, substantive modifications to existing methods or innovative applications of existing methods to new models or scientific questions.
We welcome technical articles that describe tools that facilitate the design or performance of experiments, provide data analysis features or assist medical treatment such as drug delivery devices.
|Study Protocols||We welcome protocols for any study design, including epidemiological studies and systematic reviews. All protocols for randomised clinical trials must be registered and follow the CONSORT guidelines; ethical approval for the study must have been already granted.
Study pre-protocols (i.e. discussing provisional study designs) may also be submitted and will be clearly labelled as such when published. Study Protocols for pilot and feasibility studies may also be considered.
(See further details about these articles below in Section 4.2).
|Reviews||Reviews should provide a balanced and comprehensive overview of the latest discoveries in a particular field.|
|Systematic Reviews||Systematic Reviews should usually be based on medical interventions or animal model studies. Systematic Reviews should deal with a clearly formulated question and use systematic and explicit methods to identify, select, and critically assess the relevant research.
We recommend that authors consult the PRISMA guidelines for reporting in Systematic Reviews. As a key feature of these studies is that they are updated periodically to reflect current research and new additions to the published literature, we would welcome regular updates to our Systematic Reviews; this can be done through our novel Update feature.
|Software Tools||A Software Tool article should include the rationale for the development of the tool and details of the code used for its construction. The article should provide examples of suitable input data sets and include an example of the output that can be expected from the tool and how this output should be interpreted.
(See further details about these articles below in Section 4.3)
|Clinical Practice Articles||A short article relating to a specific clinical problem or scenario that discusses issues relating to patient management and treatment pathways using an evidence-based approach. Clinical Practice Articles include case series (i.e. group or series of case reports involving patients who were given similar treatment), but should not be based on a single case (see Case Reports).
(For case series and articles involving patient data, see further details below in Section 4.4)
|Observation Articles||Observation Articles allow the description of a novel observation that may be unexpected, and possibly currently without explanation. An observation can be a phenomenon that has been identified in field work, in the laboratory or through experimental analysis.|
|Opinion Articles||Opinion Articles give the authors’ perspective on a topical issue. Where appropriate, authors should provide a balanced view of different opinions in the field, and make it clear where they are expressing their own personal views and why.|
|Research Notes||Research Notes include single-finding papers that can be reports with one or two illustrations (figures/tables) and lab protocols.
Posters from conferences or internal meetings may be summarised as Research Notes. In many cases, some additional detail, particularly in the methods, description of the results, and/or discussion/conclusions will be required to make sure that readers (and referees) have enough information to understand the description of the work.
|Data Notes||Data Notes are brief descriptions of scientific datasets that include details of why and how the data were created; they do not include any analyses or conclusions.
(See further details about these articles below in Section 4.5).
|Case Reports||A medical Case Report should be original and provide adequate detail of the case. It does not need to describe an especially novel or unusual case as there is benefit from collecting details of many standard cases. Authors should consult the CARE guidelines before preparing their report.
(See further details about these articles below in Section 4.4)
|Correspondence||Correspondence articles are short, peer reviewed comments directly relating to one or more articles published in F1000Research or elsewhere.|
SubmissionAll articles must:
- Not have been published, nor be currently under consideration or review elsewhere, except for on a preprint server such as F1000Posters, ArXiv or PeerJ PrePrints.
- Meet all applicable standards for the ethics of experimentation and research integrity (see below).
- Adhere to appropriate reporting guidelines and community standards for data availability (see below).
Articles can be submitted as Word documents or in rich text format (RTF) using the F1000Research submission system. LaTeX format using the F1000Research template in the WriteLaTeX submission system, or in the Authorea submission system. Users of other word processing packages should save or convert their files to RTF before uploading. Please do not send us hard copies of your manuscript.
Short tables should be submitted as part of the text of the article (preferably at the end), or as an Excel file.
For larger tables or spreadsheets of data, please see the guidelines below under 'Data'.
All figures should be submitted as separate files (with the figure legends at the end of the main article file). Please do not submit any figures that have been previously copyrighted unless you have express written permission from the copyright holder (usually the Publisher unless the publication is open access) to publish under the Creative Commons Attribution License. For clinical photographs, please ensure you have appropriate written consent to publish them from the patient involved.
For all figures, the color mode should be RGB or grayscale, and created using a white background to ensure that they display correctly online.
Line ArtExamples of line art include graphs, diagrams, flow charts and phylogenetic trees. Please make sure that text is at least 8 pt, the lines are thick enough to be clearly seen at the size the image will likely be displayed (between 75-150 mm width, which converts to one or two columns width, respectively), and that the font size and type is consistent between images.
If submitting a graph, either:
- Export the graph as an EPS file using the program you used to create the graph (e.g. SPSS) or, if this is not possible
- Send us the original file in which the graph was created (e.g. if you created the graph in Excel, send us the Excel file with the embedded graph).
- Export the image as an EPS file (e.g. if creating phylogenetic trees with specialized programs), or
- Send us the original file that was used to create the image (e.g. EPS or AI files if Adobe Illustrator was used, or a DOC, PPT or equivalent file if Word or PowerPoint was used).
If none of the above options are possible then we also accept uncompressed TIFFs with a resolution of at least 600dpi at the size they are likely to be displayed at (see above).
Photographs and microscopy imagesThese should be submitted as uncompressed TIFFs with a resolution of at least 300dpi at the size they are likely to be displayed (see above).
Mixed imagesImages that are a mix of half-tone images and line art (e.g. annotated gels or images with scale bars) should be submitted as TIFF files at a resolution of 500dpi or vector files (e.g. EPS or Adobe Illustrator files). Please ensure that the text size is at least 8pt and lines are thick enough to be clearly visible at the size the image is to be displayed at.
Images to be used as dataIf you are submitting photographic images as part of your raw data set, please submit as uncompressed TIFF files.
All research articles should be accompanied by the supporting data. Please include details of how the data were analysed to produce the various results (tables, graphs etc.) shown (i.e. what statistical tests were used); if a piece of software code was used, details of how to access this code (if not proprietary) should be provided.
Please list all authors that played a significant role in the research involved in the article. Please provide full affiliation information (including full institutional address and ZIP code, and e-mail address) for all authors, and identify who is/are the corresponding author(s). All further correspondence relating to the article will be directed through the corresponding author, although for clinical articles, all authors will be contacted just before publication to confirm their authorship on the article and that they all accept direct responsibility for the content of the article.
The involvement of any professional medical writer assistance (or assistance from anyone not directly involved in the research itself) in the preparation of the draft for publicationmust be declared. Criteria for authorship are based on the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, and primarily involves:
- substantial contribution to conception and design, or acquisition, analysis or interpretation of data;
- drafting the article or revising it critically for important intellectual content; and
- final approval of the version to be published.
Anyone who does not meet these criteria (e.g. someone who provided purely technical help, writing assistance, or a department chair who provided only general support) should be listed in the acknowledgements; similarly, everyone who does meet the criteria above should be listed as authors.
When a large, multi-centre group has conducted the work, the group should identify the individuals who accept direct responsibility for the manuscript, and these individuals should fully meet the criteria for authorship as defined above.
2. Article title
The title should be detailed enough for someone to know whether the article would be of interest to them, but also concise. Please ensure the broadness and claims within the title are appropriate to the content of the article itself.
Abstracts should be up to 300 words and provide a succinct summary of the article. Although the abstract should explain why the article might be interesting, care should be taken not to inappropriately over-emphasise the importance of the work describe in the article. Citations should not be used in the abstract and the use of abbreviations should be minimized.
4. Main body of article
The format of the main body of the article is flexible: it should be concise and in a format that is appropriate for displaying the content of the article.
4.1 Research Articles
Research Articles should present primary research findings from any discipline in biology and medicine, such as the results of basic or translational scientific research, clinical or epidemiological studies, clinical trials or other types of research.
We also encourage articles covering null/negative findings, as well as reanalyses of previous datasets and studies leading to new results.
For the majority of Research Articles, the following standard format will be the most appropriate.
F1000Research is committed to serving the research community by ensuring that all publications include sufficient information to allow others to reproduce the work. With this in mind, Methods sections should provide details of the materials and methods used, including a brief discussion of allowances made (if any) for controlling bias or unwanted sources of variability. Any limitations of the datasets should be discussed. When antibodies are used, the species in which the antibody was raised, the manufacturing company or source laboratory, the catalogue or reference number, and whether it is a polyclonal or monoclonal antibody should be included. In addition, when the antibody has been previously validated, a reference to the validation study should be made. If the antibody has not been validated, full details of dilution and use of the antibody should be given in the Methods section.
All research articles should be accompanied by the supporting data.
4.2 Study Protocols
We welcome protocols for any study design, including clinical trials, observational studies and systematic reviews. All protocols for randomised clinical trials must be registered and follow the CONSORT guidelines; ethical approval for the study must have been already granted.
For most Study Protocols, the following standard format will be most appropriate:
- Study Protocol
Articles should include a clear rationale for the study, as well as a detailed description of the protocol, including:
- How the sample was selected
- Interventions to be measured
- Sample size calculation - i.e. expected number of participants to make the outcome significant
- Primary outcomes being measured, as well as a list of secondary outcomes
- Data analysis and statistical plan
- Detail of any ethical issues relating to the study (and of the ethical approval received).
- Plans for dissemination of the study outcome once completed.
Study pre-protocols (i.e. discussing provisional study designs) may also be submitted and will be clearly labelled as such in the title when published. They should contain as much of the above information as possible and also any areas where specific feedback is being requested from reviewers and/or other readers from the community.
Study protocols for pilot and feasibility studies will be considered.
4.3 Software Tools
A Software Tool article should include the rationale for the development of the tool and details of the code used for its construction.
For Software Tool articles, the following standard format will usually be most appropriate:
- Web tool/Results
- Software availability
The main body of the article should include technical details, and different headings can be used for this section. Please include detail of where the source code is located (if open source code) or where the executable file can be downloaded from, and minimum and recommended system requirements to use the. The article should provide examples of suitable input data sets and include an example of the output that can be expected from the tool and how this output should be interpreted.
4.4 Case Reports (and case series)
Case Reports should provide details of an interesting case, but need not necessarily be highly novel to be useful and beneficial to others.
A summary of the background of the case's history and progression, or of the drug's common use and reported adverse events should be provided, together with a brief summary of previous cases in the specific area. Articles describing similar treatment of several patients (‘case series’) are published as Clinical Practice Articles.
Briefly, a case report should include a summary of the background of the case's history and progression, together with a short summary of previous cases in the specific area. The patient information should include demographic details such as age, gender, ethnicity and occupation (without providing details that could lead to patient identification), the main symptoms, medical and family history, and relevant past interventions and their outcomes. The report should include details of the clinical findings, timeline, diagnostic assessment, any therapeutic interventions and information on follow up and outcomes. A discussion of the importance and relevance of the findings and how they may impact our future understanding of disease processes, diagnosis or treatment should also be provided.
Clinical photographs may be included, but they must be accompanied by written consent to publish from the patient involved.
Please ensure that you have obtained written, informed consent from the patient (or their legal guardian for a minor, or next of kin if the patient has deceased) for publication of this Case Report (you can use our consent form, or your own institution's form as you prefer). You also need to include an explicit statement, under a separate heading of 'Consent', at the end of the main text confirming this (we suggest: 'Written informed consent for publication of their clinical details and/or clinical images was obtained from the patient/parent/guardian/relative of the patient.'). This signed consent form should be made available to the F1000Research editorial office if requested.
4.5 Data Notes
Data Articles in F1000Research are brief descriptions of scientific datasets that include details of why and how the data were created; they do not include any new analyses or results.
Benefits of publishing Data Articles:
- Sharing scientific datasets in a discoverable, useable and reproducible way.
- Fostering new collaborations across disciplines.
- Giving appropriate credit to data producers with a citable publication.
- F1000Research helps with deposition in the most appropriate data repository and facilitates rigorous peer review.
A Data Article may be linked to a traditional Research Article reporting analysis of the published dataset, as well as the results and conclusions. Most of the major journals and publishers have confirmed that a Data Article published in F1000Research would not undermine the novelty and value of a Research Article that made use of the published dataset (see list of journal). In instances where you wish to publish the associated Research Article in another journal, we are happy to work with you and the relevant journal to coordinate simultaneous publication of a Data Article and the associated Research Article.
Data Articles typically contain the following sections:
- Abstract: No longer than approximately 300 words; without references.
- Introduction (optional): Rationale for creating the dataset(s) and/or objectives for the experiment resulting in the dataset - why the data were gathered or produced.
- Materials and methods: Detailed account of the protocol used to generate the dataset:
- For standard protocols that have been published elsewhere, a brief description and reference is sufficient.
- Details for the source of all samples, reagents, antibodies etc.
- Details of how samples were selected; what exclusions were made, if any.
- Details of what was being measured;
- For processed data, this section should include details of any software used to process the data, including the version used, details of where the software can be accessed, and any parameters that could impact the outcome of the results.
- Please see our editorial policies for patient data, or for research involving animals.
- Dataset validation (optional): Information about any validation carried out and/or any limitations of the datasets, including any allowances made for controlling bias or unwanted sources of variability.
Data availability: A machine-readable section which will make it possible for the citation and provenance of the dataset(s) to be tracked; this section will be generated by the editorial office.
For articles involving patient data or information (e.g. personal genomics articles, case reports, clinical trials etc), you must ensure you have written informed consent from all the patients involved (or their legal guardian for a minor, or next of kin if the patient is deceased): you can use our consent form or your own institution's form if you prefer. Please be ready to show copies of such consent forms, if requested by the F1000Research editorial team.
Please therefore add a line in your article under this heading stating 'Written informed consent for publication of their clinical details and/or clinical images was obtained from the patient/parent/guardian/ relative of the patient.'
6. Author contributions
In order to give appropriate credit to each author of an article, the individual contributions of each author to the manuscript should be detailed in this section. We recommend using author initials and then stating briefly how they contributed e.g.:
AH, JS and IT conceived the study. MJ designed the experiments. AH, JS and MJ carried out the research. UGT contributed to the design of experiments and provided expertise in genomics. JS and IT prepared the first draft of the manuscript. UGT and MJ contributed to the experimental design and preparation of the manuscript. All authors were involved in the revision of the draft manuscript and have agreed to the final content.
7. Competing interests
All financial, personal, or professional competing interests for any of the authors that could be construed to unduly influence the content of the article must be disclosed and will be displayed alongside the article. Referees are also asked to declare any competing interests and these will be similarly displayed against their reports. Please see more information on what might be construed as a competing interest.
If you do not feel you have any relevant financial or non-financial competing interests to disclose, please include the line: 'No competing interests were disclosed'.
8. Grant information
Please state who funded the work discussed in this article, whether it is your employer, a grant funder etc. Please do not list funding that you have that is not relevant to this specific piece of research. For each funder, please state the funder's name, the grant number where applicable, and the individual to whom the grant was assigned.
If your work was not funded by any grants, please include the line: 'The author(s) declared that no grants were involved in supporting this work'.
This section should acknowledge anyone who contributed to the research or the article but who does not qualify as an author based on the criteria provided above (e.g. someone or an organisation that provided writing assistance). Please state how they contributed; authors should obtain permission to acknowledge from all those mentioned in the Acknowledgements section.
Please do not list grant funding in this section.
References can be listed in any standard referencing style that uses a numbering system (i.e. not Harvard referencing style), and should be consistent between references within a given article. However, key points include:
- Journal abbreviations should follow the Index Medicus/MEDLINE abbreviation approach.
- Datasets should be cited in the reference section and should follow one of these examples.
- Only articles, datasets and abstracts that have been published or are in press, or are available through public e-print/preprint servers/data repositories, may be cited. Unpublished abstracts, papers that have been submitted but not yet accepted, and personal communications should instead be included in the text, and should be referred to as ‘personal communications’ or ‘unpublished reports’ and the researchers involved should be named. It is the responsibility of the authors to ensure they obtain permission to quote any personal communications from the cited individuals.
- Web links, URLs, and links to the authors’ own websites should be included as hyperlinks within the authors' manuscript (e.g. 'Mouse Tumor Biology Database'), and not as references.
- References to trials on a clinical trial database should be as follows:
- [Authors/name of group], [title of the trial], In: ClinicalTrials.gov [cited year month date], Available from [URL of the link from ClinicalTrials.gov]
- e.g. Kovacs Foundation, The Effect of Ozone Therapy for Lumbar Herniated Disc. In: ClinicalTrials.gov [cited 2012 Aug 30], Available from http://clinicaltrials.gov/ct2/show/NCT00566007
11. Figure legends
Figure legends should briefly describe the key messages of the figure such that the figure can stand alone from the main text. However, all figures should also be discussed in the article text. Each figure legend should have a concise title of no more than 15 words. The legend itself should be succinct, while still explaining all symbols and abbreviations. Avoid lengthy descriptions of methods.
For any figures reproduced from another publication (as long as appropriate permission has been obtained from the copyright holder —see under the heading 'Submission'), please include a line in the legend to state that: 'This figure has been reproduced with kind permission from [include original publication citation]'.
All clinical photographs must be accompanied by written consent to publish from the patient(s) involved. Any distinguishing features, medical record numbers or codes that could be used to identify the patient concerned must be removed from clinical images.
For authors whose first language is not English, it may be beneficial to have the manuscript read by a native English speaker with scientific expertise, and there are many editing services that can provide this service at a cost to the authors. Please note that the article will not undergo editing by F1000Research prior to publication and a manuscript may be rejected during the initial checking process if it is deemed unintelligible and not written in good English.
Abbreviations should be used as sparingly as possible, and they should be defined upon first use.
- Use hard returns only to end headings and paragraphs, not to rearrange lines.
- Capitalize only the first word, and proper nouns, in the title.
- Footnotes are not allowed.
- Do not format the text in multiple columns.
- Greek and other special characters may be included. If you are unable to reproduce a particular special character, please type out the name of the symbol in full.
- Species names should be italicized (e.g. Homo sapiens) and the full genus and species must be written out in full, both in the title of the manuscript and at the first mention of an organism in a paper; after that, the first letter of the genus name, followed by the full species name may be used.
- Genes, mutations, genotypes, and alleles should be indicated in italics, and authors are required to use approved gene symbols, names, and formatting. Protein products should be in plain type.
- The Recommended International Non-Proprietary Name (rINN) of drugs should be provided.
- SI units should be used throughout (liter and molar are permitted, however).
For all studies (involving animals or humans), approval must have been obtained for all protocols from the authors' institutional or other relevant ethics committee to ensure they meet national and international guidelines. Details of this approval must be provided on submission, including institution, review board name, and permit number(s).
All studies involving non-human primates must be performed in accordance with the recommendations of the Weatherall report, “The use of non-human primates in research”. If animals were used but ethical approval was not required, a clear statement should be included stating why this approval was unnecessary. In all cases, a statement should be made to confirm that all efforts were made to ameliorate suffering of animals and details of how this was achieved should be provided.
We also strongly encourage all authors to comply with the “Animal Research: Reporting In Vivo Experiments” (ARRIVE) guidelines, developed by NC3Rs to improve standards of reporting to ensure that the data from animal experiments can be fully scrutinized and utilized. The relevant information outlined in these guidelines should be included in the appropriate section of the article (e.g. title, abstract, or method).
Human studies categorized by race/ethnicity, age, disease/disabilities, religion, sex/gender, sexual orientation, or other socially constructed groupings, should include a justification of their choices of definitions and categories, including whether any rules of human categorization were required by the relevant funding agencies. Appropriate non-stigmatizing language should be used when describing different groups.
Patient Privacy and Informed Consent for Publication
For data involving human participation, informed consent must have been obtained, and this should be stated in the article, preferably with a copy of the consent form. If only oral consent was obtained (rather than written), the reasons why should be explained, as well as confirmation of IRB approval that oral consent was adequate, and a statement of how it was documented. Alternatively, if no consent was required (e.g. the data has been anonymised), then this should be clearly stated and authors should confirm that such alterations have not distorted scientific meaning. All clinical investigation must have been conducted according to the principles expressed in the Declaration of Helsinki.
As stated in the Uniform Requirements of the International Committee of Medical Journal Editors:
“Patients have a right to privacy that should not be infringed without informed consent. Identifying information should not be published in written descriptions, photographs, and pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that the patient be shown the manuscript to be published. When informed consent has been obtained it should be indicated in the published article.”
For any articles that include potential identifying information, please ensure that you have obtained written, informed consent from all the patients (or their legal guardians for a minors, or next of kin if the patient is deceased) - you can use our consent form, or your own institution's form as you prefer. You also need to include an explicit statement, under a separate heading of 'Consent', at the end of the main text confirming this (we suggest: 'Written informed consent for publication of their clinical details and/or clinical images was obtained from the patient/parent/guardian/relative of the patient.'). This signed consent form should be made available to the F1000Research editorial office if requested.
Publication of Materials Relating to Clinical Trials
If the data associated with your article relate to a clinical trial then the Trial Registration details must be provided: name of registry, registry number, and URL of the trial in the registry database. We support the public disclosure of all clinical trial results (as mandated in the US FDA Amendments Act, 2007), for example on a public website such as clinicaltrials.gov and this will not affect acceptance to publish such data articles in F1000Research.
What constitutes a clinical trial?
F1000Research uses the WHO definition of a clinical trial to decide which articles fall into this category:
“A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc”.
F1000Research supports the position of the International Committee of Medical Journal Editors (ICMJE) on trial registration and will not publish any trials initiated after 1 July 2005 that have not been registered prospectively in a publicly accessible registry (i.e. before patient recruitment has begun). Trials initiated before this date must be registered before submission to F1000Research. Further information can be found at the ICMJE faq on trial registration and the WHO provides a list of approved registries.
Articles must also adhere to the CONSORT reporting guidelines. Articles must include a copy of the original trial protocol and a completed CONSORT checklist and flow diagram as supporting files which will be published alongside your Data Article. Any deviation from the original trial protocol must be explained in the article. Clarification of details on informed consent must also be discussed in the article, and F1000Research reserves the right to ask for a copy of the patient consent form.