AUTHOR GUIDELINES
1. Types of manuscript and authorship
The Journal of the British Society of Special Care Dentistry is the official journal of the British Society of Special Care Dentistry. The Journal of the British Society of Special Care Dentistry (JBSSCD) is published three times a year and has international scope with comprehensive coverage of disability and oral health in the wider context of dentistry. The Journal is available online at: www.bsscd.org/bsscd-journal-home
1.1 Types of manuscript
The Journal seeks to publish original peer-reviewed articles relating to all aspects relevant to the comprehensive oral care of disabled people and to the dental public health aspects of disability. The Journal publishes:
- Editorials
- Reports of original research (referred papers)
- Case reports
- Reviews and update on topics of relevance (authors are encouraged to contact the Editor to discuss potential topics which could be commissioned)
- A précis of interesting articles relevant to Journal readers and included in other publications
- Prize winning essays
- Book reviews
- Information from the British Society of Special Care Dentistry, including:
- Reports from the Society’s bi-annual conferences
- Reports from the officers of the Society’s Executive Committee
- Society news, announcements and upcoming events
- Continuing Professional Development (CPD)
1.2 Authorship
Authorship
The Journal of the British Society of Special Care Dentistry adheres to the definition of authorship set up by the International Committee of Medical Journal Editors (ICMJE) and is included in the ICMJE list. ICMJE authorship states that authorship criteria should be based on the following:[1]
- Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
- Drafting the work or reviewing it critically for important intellectual content; AND
- Final approval of the version to be published; AND
- Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
- In addition to being accountable for the parts of the work done, ICMJE also states that an author should be able to identify which co-authors are responsible for specific other parts of the work. In addition, authors should have confidence in the integrity of the contributions of their co-authors.
- The Journal of the British Society of Special Care Dentistry also requires that authors ensure their submissions are their own original work, and large language model ‘chatbots’ (such as ChatGPT) must not be used to write their submission.
Authors must meet all six of these conditions.
All authors submitting work to the Journal of the British Society of Special Care Dentistry must have read and must meet the requirements for authorship set out in the International Committee of Medical Journal Editors, Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals (ICMJE Recommendations) as laid out in https://www.icmje.org/recommendations/. Further details are provided in section 7 of these guidelines.
The Editorial Board of the Journal of Disability and Oral Health has applied to become a member of the Committee on Publication Ethics (COPE) and supports and encourages the use of the CONsolidated Standards Of Reporting Trials (CONSORT) checklist.
2. Submission instructions
Your manuscript should be emailed to
2.1 Manuscript
2.1 Manuscript: Send your manuscript in the correct format (see instructions in sections 3 and 4 of these guidelines)
2.2 Covering letter
2.2 Covering letter: A covering letter must be signed by all the authors stating:
The submission is the original work of the author(s) and has not been published, nor being considered for publication, elsewhere.
Authors submitting a paper do so on the understanding that the manuscript has been read and approved by all authors and that all authors agree to the submission of the manuscript to the Journal of the British Society of Special Care Dentistry.
All named authors must have made an active contribution to the:
- conception and design and / or
- analysis and interpretation of the data
- and / or the drafting of the paper.
All named authors must have critically reviewed its content and have approved the final version submitted for publication. Participation solely by virtue of acquisition of funding or the collection of data does not justify authorship.
Up to six authors are accepted without need for justification. In the case of a specific and detailed justification of the role of every author, up to eight authors may be mentioned. It is a requirement that all authors have been accredited as appropriate upon submission of the manuscript.
Contributors who do not qualify as authors should be mentioned under the ‘acknowledgements’ section of the manuscript.
2.3 Disclosure form
2.3 Disclosure Form: a completed ICMJE disclosure form (available here: https://www.icmje.org/disclosure-of-interest/) must be included declaring any potential conflict of interest.
2.4 Ethical approval
2.4 Ethical approval: Where necessary, authors should have received ethical approval for their work and this information should be recorded in the manuscript. See section 8 for further information.
3. Style of manuscripts
Use a clear and concise writing style and avoid jargon or long, complicated sentences that are hard to follow.
Voice: Avoid the passive voice when the active voice may be more appropriate, for example use ‘The authors chose to examine patients because…’ rather than ‘Patients were chosen to be examined by the authors because...’.
Language: Use UK English spelling e.g. ‘ise’ not ‘ize’.
3.1 Formatting
3.1 Formatting:
3.1.1 Line spacing: manuscripts should be double line-spaced with a font size of 12
3.1.2 Margins: a 4 cm margin on the left-hand side of the page should be included
3.1.3 Page numbering: pages should be numbered consecutively in the top right-hand corner
3.1.4 Headings: main headings should be in upper case and bold text, subsidiary headings should be in lower case and bold text
3.2 Title page
3.2 Title page: should be sent as a separate document formatted as page 1 of the submission with the authors’ names and address(es). Qualifications are not necessary. The title page should use the following structure:
- Title: must be descriptive and concise.
- Abstracts: should be included in reports of original research and case reports see sections 4.1.1 and 4.2.3.
- Other submissions must have a short abstract.
- Author(s) name(s): should be written with the surname first and then the initials of each author. Author names should be separated by a comma, and initials should be separated by a space see example title page below.
- Institution and job role / job title: indicate the institution and job role / job title associated with each author by using superscripted numbers see example title page below.
- Correspondence Address: include the email address for the lead author in case of any correspondence.
Example title page:
A review of the dental treatment options for patients with cerebral palsy.
Reid L1, Smith M2, Brown W K3 and Johnson A4.
1Dental Core Trainee, Sheffield Teaching Hospitals NHS Foundation Trust
2Consultant in Special Care Dentistry, Barnsley Hospital NHS Foundation Trust
3,4Consultant in Oral and Maxillofacial surgery, Pennine Care NHS Foundation Trust
Correspondence to: Dr L Bloggs
Email:
3.3 Italics
3.3 Italics:
- Should be used for the names of publications and all Latin (or other language) phrases e.g. et al, in situ, vis-à-vis
- Should be used for the names of books or other publications both in the text and the reference section.
3.4 Abbreviations
3.4 Abbreviations: The JBSSCD does not encourage the use of abbreviations, especially in the abstract or summary sections where they are difficult to interpret. Common abbreviations are accepted but must be written out in full at the first mention in the text e.g. Special Care Dentistry (SCD) or cardiovascular system (CVS). If they are only mentioned infrequently, the words should be written out in full.
3.5 Numbers and units
3.5 Numbers and units: numbers should be spelled out in full at the beginning of a sentence and for all numbers up to and including nine, unless they are followed by a unit of measurement. Numerals should be used from 10 upwards.
Units must conform to the système international d’unités (SI).
3.6 Illustrations
3.6 Illustrations:
- Tables: should be referred to in the text as ‘Table’ and should be numbered in Arabic numbers (1, 2, 3 etc) e.g. ‘As shown in Table 1, the number of patients presenting with…’
Each table should appear on a separate page in Word and have a legend which explains the content of the table without reference to the text. No vertical lines should be included in the tables. Where appropriate, consideration should be given to alternative ways of displaying data other than in tables, for example, as histograms.
- Figures: these should be referred to in the text as ‘Fig.’ and given Arabic numbers e.g. ‘As shown in Fig. 1, the number of patients presenting with…’
Figures should be submitted electronically and in separate files in TIFF or JPEG or EPS format and not inserted into a word processing package. Photographs should be submitted electronically and in separate files in TIFF or JPEG format at high resolution.
- Important note: Patients should not be readily identifiable from their photographs. Their, or their guardian’s, written consent for publication must be obtained by the author and a copy sent to the Journal of the British Society of Special Care Dentistry. It is not sufficient to block out the eyes of the person on the image.
Colour illustrations are permitted.
All figure legends should be written on a separate page in the word processing package.
3.7 Acknowledgements
3.7 Acknowledgements: should be grouped in a paragraph at the end of the text and before the references. Specify contributors to the article other than the authors accredited. Acknowledge only persons who have made substantive contributions to the study.
Authors are responsible for obtaining written permission and approval of the wording from everyone acknowledged by name because readers may infer their endorsement of the data and conclusions.
Where the research project was supported by industry, this should be acknowledged in the covering letter to the Editor on submission of the manuscript.
3.8 Declaration of interests
3.8 Declaration of interests: any possible conflicts of interest must be declared in the manuscript. This includes matters such as:
- Funding from an organisation or company directly for the research;
- Funding you have received (or payment in kind) for any work you have been involved in from an organisation or company that could be linked to the research;
- Consultation or advisory positions you may hold in an organisation or company involved in the research or an organisation involved in similar research;
- Any other situation that could be construed as a conflict of interest.
3.9 References
3.9 References: Authors have responsibility for the accuracy of the references both within the text and in the reference section.
Personal communication should be avoided but where essential will appear in the text only. The Harvard style of references should be used as follows:
- Author(s): family name followed by first name(s) initials. There should be comma after each set of initials, except the last, which is to be followed by a full stop.
- Title: the full title should follow, in sentence case and italicised.
- Journal titles: should be abbreviated to the style of Index Medicus and Index to Dental Literature. See: https://pubmed.ncbi.nlm.nih.gov/10299678/ or https://www.globalindexmedicus.net
- Date, volume and page numbers: list the year of publication, then the volume number and then the first and last pages.
Examples of Reference styles:
Original Scientific Articles: Author(s). Article title. Journal title and year; Journal volume: first and last page number.
Waldman H B, Perlman S P, Swerdloff M. What if dentists did not treat people with disabilities? J Dent Child 1998; 65: 96-101.
Books: Author(s). Book title. Edition. Place of publication: Publisher. Year.
Hennekam R C M, Krantz I D and Allanson J E. Gorlin’s Syndromes of the Head and Neck. Fifth edition. New York: Oxford University Press, 2010.
Chapter in book: Chapter author(s). Title of chapter. In: Book editor ed/eds. Book title. Place of publication: Publisher; Year, chapter page numbers.
Green J, Thorogood N. Analysing qualitative date In: Silverman D ed 2004. Qualitative methods for health research. London: Sage; 2004 pp 173-200.
Report: Author or Editor (if available). Title. Publisher (if available), Place of publication, Year.
Poswillo D. General Anaesthesia, Sedation and Resuscitation in Dentistry. Report of an Expert Working Party for the Standing Dental Advisory Committee. Department of Health, London 1978.
Webpage: Author or Editor (if available). Year. Title [online, if online]. Place of publication: Publisher (if available). Available at: web address of document [Accessed DATE)
NHS England 2022. Special care dentistry: Clinical standard version 2 [online]. Available at: https://www.england.nhs.uk/wp-content/uploads/2022/10/B1641-clincial-standard-special-care-dentistry.pdf [Accessed: 14 November 2024]
Author referencing in main text of the manuscript:
- One author: should be referred to in the text as: (Thompson 2009).
- Two authors: should be referred to in the text as: (Clarkson and O’Mullane, 1989).
- Three or more authors: should be referred to in the text as (Shaw et al., 1995).
- Multiple references need to be listed in chronological order.
- Where an author has published more than one reference in any one year, these should be suffixed as 1987a or 1996a; b.
3.10 Digital Object Identifiers (DOI)
3.10 Digital Object Identifiers (DOI): Authors are responsible for including the DOIs (where available) of all the cited references included in their submission. The DOI should be written at the end of the reference.
E.g. Ummer-Christian R, Iacono T, Grills N, Pradhan A, Hughes N, Gussy M. Access to dental services for children with intellectual and developmental disabilities - A scoping review. Res Dev Disabil 2018; 74: 1-13 DOI: 10.1016/j.ridd.2017.12.022
4. Structure of manuscripts
4.1 Reports of original research
4.1 Reports of original research
4.1.1 Length: as a general guide, contributions should be no more than 3,000 words, including tables and figures which count for 100 to 500 words depending on size.
4.1.2 Abstracts: must be able to stand alone and be structured as indicated below. Abstracts should not include references or abbreviations and may be up to 250 words long.
- Aim and objectives
- Design to include:
- subjects (number of subjects and selection)
- setting
- procedures including the nature of any interventions
- main outcome measures
- Results
- Conclusions
- Key words: list no more than five key words
4.1.3 Main Document should be structured using the following headings:
- Introduction
- Material and Method
- Results
- Discussion
- Conclusions
- Acknowledgements (see section 3.5.5)
- Declaration of interests
- References (see sections 3.5.8 and 3.5.9)
4.2 Case reports
4.2 Case reports
4.2.1 Length: These should be short and concise reports of one or a small series of clinical cases or of a novel technique.
4.2.2 Purpose: There should be a purpose to presenting the case, for example, a cautionary note for other clinicians or a new way of managing a particular situation.
4.2.3 Abstracts: should be short (50 words maximum) and no references should be included.
4.2.4 Structure: the following headings should form the structure of the case report:
- Introduction: should be short and concise
- Report of Case(s): should include details of patient / technique, investigations, differential diagnosis, treatment options and outcomes, ideally over at least six months
- Discussion: should be focussed and describe the importance of the case in regard to implications for oral healthcare and of relevant findings that have not previously been reported
- Conclusion: should be short and concise
- References: there should be a maximum of 10 references
- Key Words: list no more than five key words
4.3 Review articles
4.3 Review articles
4.3.1 Length: The review would usually be approximately 4,000 to 5,000 words of text, excluding references. The review would need to undergo the standard peer review process of the JBSSCD therefore acceptance cannot be guaranteed.
4.3.2 Purpose: A review article should be a structured assessment of the literature using current papers (usually within the last decade) which have a good scientific background.
4.3.2 Structure: the following headings should form the structure of the review article:
- Description of how the articles have been selected and, if appropriate, a full search strategy
- Analysis and comment on the literature reviewed
- A report of the results
- Analysis of the quality of the literature reviewed
5. Review process
5.1 Peer review
5.1 Peer review: All papers will undergo initial screening for suitability for publication in the JBSSCD by the Editor. Papers that are deemed suitable will be sent for peer review by two or one referee. Additional specialist advice may be sought, if necessary, for example from a statistician, before a final decision is made by the Editor.
5.2 Disclaimer
5.2 Disclaimer
The Publisher, Editor cannot be responsible for any errors or any consequences arising from the use of information that is published in the Journal of the British Society of Special Care Dentistry. The views and opinions expressed in the Journal are those of the authors and do not necessarily represent the views of the Publisher, Editor or policies of the British Society of Special Care Dentistry.
6. Additional Points
6.1 Confidentiality
6.1 Confidentiality: The content of all manuscripts under review is kept confidential within the offices of the Editor of the JBSSCD and Hay Green Education Ltd.
Referees are requested to respect confidentiality throughout the peer review process until publication, if the manuscript is accepted. Following acceptance all information relating to a paper will be kept confidential.
6.2 Proofs and offprints / reprints
6.2 Proofs and offprints / reprints: page proofs will be sent to the corresponding author for checking of accuracy and for correction of typographical errors or misprints only. No substantial changes can be made to the paper at this stage. A rapid turnaround is required to keep to the Journal’s deadlines.
6.3 Copyright
6.3 Copyright: is normally signed over to the British Society for Special Care Dentistry at the proof stage.
6.4 Copies
6.4 Copies: Single copies of papers can be made for personal use or education purposes free of charge. Multiple copies can be made only after permission has been granted by the Editor. Permission for multiple copies may be sought by emailing
6.5 Editing
6.5 Editing: the Editor reserves the right to edit manuscripts to improve clarity and in order to conform to the acceptable JBSSCD style and to the limits of space available.
7. Ethical Guidelines
The Journal of the British Society of Special Care Dentistry adheres to the following ethical guidelines for publication and research and manuscripts will only be considered for publication if they meet the highest ethical standards. Authors must read and adhere to the following: International Committee of Medical Journal Editors, Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals (ICMJE Recommendations). The ICMJE Recommendations may be found at: https://www.icmje.org/recommendations/
Disclosure of Financial and Non-Financial Relationships and Activities, and Conflicts of Interest
Disclosure of Financial and Non-Financial Relationships and Activities, and Conflicts of Interest
See: https://www.icmje.org/recommendations/browse/roles-and-responsibilities/author-responsibilities--conflicts-of-interest.html
Public trust in the scientific process and the credibility of published articles depend in part on how transparently an author’s relationships and activities, directly or topically related to a work, are handled during the planning, implementation, writing, peer review, editing, and publication of scientific work.
The potential for conflict of interest and bias exists when professional judgment concerning a primary interest (such as patients' welfare or the validity of research) may be influenced by a secondary interest (such as financial gain). Perceptions of conflict of interest are as important as actual conflicts of interest.
Individuals may disagree on whether an author’s relationships or activities represent conflicts. Although the presence of a relationship or activity does not always indicate a problematic influence on a paper’s content, perceptions of conflict may erode trust in science as much as actual conflicts of interest. Ultimately, readers must be able to make their own judgments regarding whether an author’s relationships and activities are pertinent to a paper’s content. These judgments require transparent disclosures. An author’s complete disclosure demonstrates a commitment to transparency and helps to maintain trust in the scientific process.
Financial relationships (such as employment, consultancies, stock ownership or options, honoraria, patents, and paid expert testimony) are the most easily identifiable, the ones most often judged to represent potential conflicts of interest and thus the most likely to undermine the credibility of the journal, the authors, and of science itself. Other interests may also represent or be perceived as conflicts, such as personal relationships or rivalries, academic competition, and intellectual beliefs.
Authors should avoid entering into agreements with study sponsors, both for-profit and non-profit, that interfere with authors’ access to all of the study’s data or that interfere with their ability to analyse and interpret the data and to prepare and publish manuscripts independently when and where they choose. Policies that dictate where authors may publish their work violate this principle of academic freedom. Authors may be required to provide the journal with the agreements in confidence.
Purposeful failure to report those relationships or activities specified on the journal’s disclosure form is a form of misconduct, as is discussed in section III.B.
Disclosure of potential conflicts of interest is distinct and extends beyond direct support for this work. Within a manuscript, the funding statement should include only direct support of the work described. Support for an individual's contribution for the work should be reported as such. General institutional support for an author's time on the work should be distinguished from direct overall funding of the work. An appropriate funding statement might be: “This study was funded by A; Dr. F's time on the work was supported by B.”
Protection of Research Participants
Protection of Research Participants
See: https://www.icmje.org/recommendations/browse/roles-and-responsibilities/protection-of-research-participants.html
All investigators should ensure that the planning, conduct, and reporting of human research are in accordance with the Helsinki Declaration as revised in 2013. All authors should seek approval to conduct research from an independent local, regional or national review body (e.g., ethics committee, institutional review board), and be prepared to provide documentation when requested by editors. If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the local, regional or national review body explicitly approved the doubtful aspects of the study. Approval by a responsible review body does not preclude editors from forming their own judgment whether the conduct of the research was appropriate.
Patients have a right to privacy that should not be violated without informed consent. Identifying information, including names, initials, or hospital numbers, should not be published in written descriptions, photographs, or 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 an identifiable patient be shown the manuscript to be published. Authors should disclose to these patients whether any potential identifiable material might be available via the Internet as well as in print after publication. Patient consent should be written and archived with the journal, the authors, or both, as dictated by local regulations or laws. Applicable laws vary from locale to locale, and journals should establish their own policies with legal guidance. Since a journal that archives the consent will be aware of patient identity, some journals may decide that patient confidentiality is better guarded by having the author archive the consent and instead providing the journal with a written statement that attests that they have received and archived written patient consent.
Non-essential identifying details should be omitted. Informed consent should be obtained if there is any doubt that anonymity can be maintained. For example, masking the eye region in photographs of patients is inadequate protection of anonymity. If identifying characteristics are deidentified, authors should provide assurance, and editors should so note, that such changes do not distort scientific meaning.
The requirement for informed consent should be included in the journal’s instructions for authors. When informed consent has been obtained, it should be indicated in the published article.
When reporting experiments on animals, authors should indicate whether institutional and national standards for the care and use of laboratory animals were followed.
Responsibilities in the Submission and Peer Review Process
Responsibilities in the Submission and Peer Review Process
See: https://www.icmje.org/recommendations/browse/roles-and-responsibilities/responsibilities-in-the-submission-and-peer-peview-process.html#three
Peer review is the critical assessment of manuscripts submitted to journals by experts who are usually not part of the editorial staff. Because unbiased, independent, critical assessment is an intrinsic part of all scholarly work, including scientific research, peer review is an important extension of the scientific process.
The actual value of peer review is widely debated, but the process facilitates a fair hearing for a manuscript among members of the scientific community. More practically, it helps editors decide which manuscripts are suitable for their journals. Peer review often helps authors and editors improve the quality of reporting.
It is the responsibility of the journal to ensure that systems are in place for selection of appropriate reviewers. It is the responsibility of the editor to ensure that reviewers have access to all materials that may be relevant to the evaluation of the manuscript, including supplementary material for e-only publication, and to ensure that reviewer comments are properly assessed and interpreted in the context of their declared relationships and activities.
A peer-reviewed journal is under no obligation to send submitted manuscripts for review, and under no obligation to follow reviewer recommendations, favourable or negative. The editor of a journal is ultimately responsible for the selection of all its content, and editorial decisions may be informed by issues unrelated to the quality of a manuscript, such as suitability for the journal. An editor can reject any article at any time before publication, including after acceptance if concerns arise about the integrity of the work.
Journals may differ in the number and kinds of manuscripts they send for review, the number and types of reviewers they seek for each manuscript, whether the review process is open or anonymized, and other aspects of the review process. For this reason and as a service to authors, journals should publish a clear, transparent description of their peer-review process for all types of manuscripts.
Journals should notify reviewers of the ultimate decision to accept or reject a paper and should acknowledge the contribution of peer reviewers to their journal. Editors are encouraged to share reviewers’ comments with co-reviewers of the same paper, so reviewers can learn from each other in the review process.
As part of peer review, editors are encouraged to review research protocols, plans for statistical analysis if separate from the protocol, and/or contracts associated with project-specific studies. Editors should encourage authors to make such documents publicly available at the time of or after publication, before accepting such studies for publication. Some journals may require public posting of these documents as a condition of acceptance for publication.
Journal requirements for independent data analysis and for public data availability vary, reflecting evolving views of the importance of data availability for pre- and post-publication peer review. Some journal editors currently request a statistical analysis of trial data by an independent biostatistician before accepting studies for publication. Others ask authors to say whether the study data are available to third parties to view and/or use/reanalyze, while still others encourage or require authors to share their data with others for review or reanalysis. Each journal should establish and publish their specific requirements for data analysis and posting in a place which potential authors can easily access.
Some people believe that true scientific peer review begins only on the date a paper is published. In that spirit, medical journals should have a mechanism for readers to submit comments, questions, or criticisms about published articles, and authors have a responsibility to respond appropriately and cooperate with any requests from the journal for data or additional information should questions about the paper arise after publication (see Section III).
ICMJE believes investigators have a duty to maintain the primary data and analytic procedures underpinning the published results for at least 10 years. The ICMJE encourages the preservation of these data in a data repository to ensure their longer-term availability.
8. Ethical approvals
8.1 Ethics
8.1 Ethics: Articles involving clinical research should conform to the guidelines issued in the World Medical Association’s Declaration of Helsinki where applicable, and in general should have received ethical committee approval.
Experimentation involving human subjects will only be published if such research has been conducted in full accordance with ethical principles, including the World Medical Association Declaration of Helsinki (October 2024 version) and the additional requirements, if any, of the country where the research has been carried out. See: https://www.wma.net/policies-post/wma-declaration-of-helsinki/
Manuscripts must be accompanied by a statement that experiments were undertaken with the understanding and written consent of each subject and according to the above-mentioned principles. A statement regarding the fact that the study has been independently reviewed and approved by an ethical board should also be included. This may be a Local Research Ethics Committee approval and the approval number should be included. The Editor reserves the right to reject manuscripts if there are doubts as to whether appropriate procedures have been used.
8.2 Clinical trials
8.2 Clinical trials
Clinical trials should be reported using the CONSORT guidelines. At the time of writing (November 2024) the CONSORT guidelines were under review. The 2010 CONSORT guidelines can be accessed at: https://www.bmj.com/content/340/bmj.c332. A CONSORT checklist (available at: https://www.consort-spirit.org) and flow diagram should also be included in the submission material
The Journal of the British Society of Special Care Dentistry encourages authors submitting manuscripts reporting from a clinical trial to register the trials in any of the following free, public clinical trials registries: https://clinicaltrials.gov or https://www.isrctn.com. The clinical trial registration number and name of the trial register will then be published with the paper.