Guideline development process
These clinical practice guidelines are a revision and update of the 2008 edition Basal cell carcinoma, squamous cell carcinoma (and related lesions) – a guide to clinical management in Australia. The first edition (Clinical practice guidelines on non-melanoma skin cancer: guidelines for the treatment and management in Australia) was published in 1992.
This current revision and update was commissioned and fully funded by the Australian Government Department of Health.
These guidelines cover all aspects of keratinocyte cancer (KC). The broad areas covered include prevention of KC, epidemiology of the disease, clinical features and pathology, and treatment modalities including surgery, radiotherapy, cryotherapy, topical and photodynamic therapies and systemic therapies. These guidelines also deal with the clinical management of populations at increased risk of KCs, including organ transplant recipients and immunosuppressed patients. Aspects of the cost of treatment are also covered.
The guideline project commenced in July 2017 and in February 2019 the National Health and Medical Research Council (NHMRC) agreed to consider approving the guideline, provided it was developed according to NHMRC procedures and requirements. The guideline was submitted to NHMRC for consideration and approval of the recommendations in August 2019.
Guideline development group
The Management Committee was responsible for the overall management and strategic leadership of the guideline development process. This group acted as a steering committee to establish the scope of the guideline revision and ensure that all deliverables agreed in the project plan were delivered to acceptable standards in accordance with NHMRC requirements, within agreed timeframes and within the approved budget. A wider multidisciplinary Working Party of relevant experts, including the management committee members, section lead authors and GP representatives, was then convened to develop the revised guideline and author specific sections. This approach was taken to ensure that representatives from all specialities and disciplines involved in the care of people with or at risk of KCs were included. Two consumer representatives were invited to be part of the Working Party (see: Working party members and contributors for full details).
Declarations of interests were collated from all nominated individuals and evaluated before the first working party meeting. All working party members were required to forward any further updates to their declarations of interest, in line with Cancer Council Australia's Code of practice for dealing with conflict of interests. Any updates were forwarded for evaluation and the register updated accordingly.
The guideline sections were allocated to specific guideline Working Party members to act as lead authors according to their areas of expertise. Each lead author team was able to co-opt additional experts as co-authors for their allocated questions. The Management Committee assessed the suggestion of any additional co-authors including their declaration of interest.
A project team based at Cancer Council Australia conducted the systematic reviews, which comprised of systematic literature searches, literature screening against pre-determined inclusion and exclusion criteria and critical evaluation and data extraction of the included literature. The project team was responsible for liaising with the Working Party members to draft evidence statements and supporting text, review the content and compile the required documentation.
At the start of the project, members of the Management Committee with expertise in KCs were asked to review the clinical questions and sections of the 2008 guidelines and advise on the currency and relevance of clinical questions, suggested a review approach for updating the topic (systematic literature review or general literature update) and suggest any new clinical questions or topics to be considered. The Clinical question list summarises the included clinical questions updated by systematic review as well as the topic areas that were updated by a general literature review.
When reviewing each question, the Management Committee were asked to consider the following factors:
- whether new, up-to-date guidance is needed due to new evidence requiring a change of practice, and whether there is contested evidence, uncertainty, or unwarranted variation in practice
- the extent to which answering the question would reduce poor outcomes or high disease burden
- whether there is no other current, valid or relevant guidelines available that address this question and are applicable to the Australian context.
The Management Committee decided that new evidence published between 1 January 2008 and 30 November 2018 would be integrated into the existing guideline structure.
The project plan determined that there were enough resources to answer 10 clinical questions systematically (Table A1), and the remainder of content was addressed non-systematically.
|Table A1 Clinical questions selected for systematic review|
|Surgery||What factors need to be considered when determining if surgical treatment modalities are optimal over non-surgical modalities for the management and/or treatment of basal cell carcinoma or cutaneous squamous cell carcinoma?|
|What factors need to be considered when determining the optimal surgical technique for those with basal cell carcinoma?|
|In patients undergoing surgical treatment for cutaneous squamous cell carcinoma, which surgery-related factors (margin width, depth of excision) or tumour-related factors (size, histological features, anatomical site) influence clinical outcomes (cure rate, local recurrence, regional lymph node involvement, metastasis)?|
|What should be the protocol to manage incompletely resected basal cell carcinoma?|
|What should be the protocol to manage rapidly growing tumours?|
|Radiotherapy||When should radiotherapy be used alone, or in combination with surgical excision, to treat those with KCs?|
|In which patients with basal cell carcinoma does a radiotherapy modality achieve equal or better outcomes than conventional surgery?|
|In which patients with cutaneous squamous cell carcinoma does a radiotherapy modality achieve equal or better outcomes than conventional surgery?|
|Metastatic disease and systemic therapies||What should be the protocol to manage or treat locoregionally advanced cutaneous squamous cell carcinoma?|
|Topical treatments and photodynamic therapy||What role does ingenol mebutate gel have in the treatment and management of basal cell carcinoma and/or cutaneous squamous cell carcinoma?|
Steps in preparing clinical practice guidelines to NHMRC criteria
This clinical practice guideline has been developed according to the procedures and requirements for meeting the 2016 NHMRC standard for clinical practice guidelines. The development program has been designed to meet the scientific rigour required by the standard for developing high quality, evidence-based clinical practice guidelines. A series of NHMRC resources and handbooks outlining the major steps and expectations involved in developing guidelines were utilised to guide the process. These documents provided the definitions and protocols for developing research questions and search strategies, conducting systematic literature reviews, summarising and assessing the relevant literature and finally, formulating and grading the recommendations. They also included checklists and templates created to satisfy designated standards of quality and process. For every systematic review question the below steps were followed:
For every question the below steps were followed:
|1. Develop a structured clinical question using the PICO (population, intervention [or exposure], comparison and outcomes) framework|
|2. Search for existing relevant guidelines and systematic reviews|
|3. Process if relevant clinical practice guideline was identified (3a) or not (3b)|
|3a If a relevant clinical practice guideline was found and assessed as suitable for adaption
Conduct systematic literature review update for the question of the existing clinical practice guideline
Screening of literature update results against pre-defined inclusion and exclusion criteria
Critical appraisal and data extraction of each new included article
Update evidence table of evidence review of existing guideline with new literature update results
|3b If no relevant clinical practice guideline was found
Check if an existing systematic review of high quality exists and can be used to inform the systematic review process
Developing the systematic review protocol and systematic literature search strategy for each clinical question
Conducting the systematic literature search according to protocol
Screening of literature results against pre-defined inclusion and exclusion criteria
Critical appraisal and data extraction of each included article
|4. Summarise the relevant data|
|5. Assess the body of evidence and formulate recommendations|
|6. Write the content narrative|
Developing a structured clinical question
During the scoping process the clinical questions included in the 2008 guideline were assessed for clinical importance to the target audience and currency (see Clinical question list).
The included clinical questions were used to develop a PICO framework table for each question to be systematically reviewed. When a clinical question involved risk factors, a population, risk factors and outcomes (PRO) table was used. The lead author and subcommittee members provided the systematic review team with feedback to refine the PICO framework or PRO table.
Search for existing relevant guidelines and systematic reviews
For each clinical question, the National Guideline Clearinghouse (previously accessible via http://guideline.gov) the Guidelines Resource Centre (http://www.cancerview.ca/) as well as the scoping search for the clinical question were scanned for relevant clinical practice guidelines that could potentially be suitable for adaption. No existing guidelines were identified to be suitable for adaption. However, relevant guidelines that did not meet the criteria for adaption were checked for systematic reviews that could be used as a source of relevant references to inform the systematic review process for the clinical question. Full systematic reviews were then performed as outlined in the following sections.
Developing a systematic search strategy
For each clinical question, systematic literature search strategies were developed by the technical team. Search strategies were refined as necessary according to the PICO or PRO framework using keywords or MESH and subject terms. Systematic search strategies were derived from these terms for each included electronic database. The included standard databases searched were PubMed, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects and Health Technology Assessment, CINAHL and PsycINFO databases for all questions.
Conducting the systematic literature search according to NHMRC protocol
Clinical practice guidelines should be based on systematic identification and synthesis of the best available scientific evidence. For each clinical question that required a systematic literature review, literature searches were conducted systematically with the literature cut-off date of 30 November 2018. The following electronic databases were part of the systematic literature search strategy:
- PubMed (US National Library of Medicine): bibliographic references and abstracts to articles in a range of languages on topics such as clinical medical information and biomedicine, and including the allied health fields, biological and physical sciences
- EMBASE: major pharmacological and biomedical database indexing drug information from over 3500 journals
- Database of Abstracts of Reviews of Effects and Health Technology Assessment: contains details of systematic reviews that evaluate the effects of healthcare interventions and the delivery and organisation of health services
- The Cochrane Database of Systematic Reviews: contains systematic reviews of primary research in human health care and health policy, and are internationally recognised as the highest standard in evidence-based health care
- CINAHL: bibliographic references and abstracts to journal articles, book chapters, pamphlets, audiovisual materials, software, dissertations, critical paths, and research instruments on topics including nursing and allied health, biomedicine, consumer health, health sciences librarianship, behavioural sciences, management, and education
- PsycINFO: Bibliographic references and abstracts to journal articles, book chapters, dissertations and technical reports on psychology; social, clinical, cognitive and neuropsychology; psychiatry, sociology, anthropology and education, with source material from a wide range of languages.
A search filter to retrieve relevant literature considering Aboriginal and Torres Strait Islander peoples was added to each question.
Additional relevant papers from reference lists and, where appropriate, clinical trial registries, were also identified for retrieval as part of the snowballing process.
The full detailed systematic literature search strategy for every clinical question is fully documented in the Technical report.
Limitations of searches
A small number of identified articles that met search criteria could not be accessed, and therefore could not be assessed against search criteria. These were excluded.
Screening of literature results against pre-defined inclusion and exclusion criteria
Part of the systematic review process is to screen all retrieved literature results against the pre-defined inclusion and exclusion criteria in two stages:
- First screen – during the first screening round, the titles and abstracts of all retrieved literature were screened by one or two reviewers. All irrelevant, incorrectly identified and duplicate articles were removed.
- Second screen – a second screen was undertaken based on the full article. A reviewer assessed each article for inclusion against the pre-defined inclusion and exclusion criteria for each question. In the case of a disagreement between the reviewers, a third independent reviewer assessed the article against the inclusion and exclusion criteria. Articles that met the inclusion criteria were forwarded for quality assessment and data extraction.
Critical appraisal and data extraction of each included article
Two assessors independently assessed the risk of bias of each of the included studies using a study design specific assessment tool and where necessary pre-specified criteria. The quality assessment tools are listed in the Technical report. Any disagreements were adjudicated by a third reviewer. For all included articles, the relevant data were extracted and summarised in study characteristics and evidence table. Included and excluded articles are documented within each question’s systematic review report within the Technical report.
Summary of the relevant data
For each outcome examined, the results, level of the evidence, the risk of bias due to study design, and the relevance of the evidence for each included study were documented a body of evidence table. Each question was addressed by a systematic review resulting in a systematic review report. All systematic review reports are published in the Technical report of the guideline. Levels of evidence are in Table A2.
Table A2. Designations of levels of evidence according to type of research question
|I||A systematic review of level II studies||A systematic review of level II studies||A systematic review of level II studies||A systematic review of level II studies||A systematic review of level II studies|
|II||A randomised controlled trial||A study of test accuracy with: an independent, blinded comparison with a valid reference standard, among consecutive patients with a defined clinical presentation||A prospective cohort study||A prospective cohort study||A randomised controlled trial|
|III-1||A pseudo-randomised controlled trial (i.e. alternate allocation or some other method)||A study of test accuracy with: an independent, blinded comparison with a valid reference standard, among non-consecutive patients with a defined clinical presentation||All or none||All or none||A pseudo-randomised controlled trial (i.e. alternate allocation or some other method)|
|III-2||A comparative study with concurrent controls:
Non-randomised, experimental trial
Interrupted time series with a control group
|A comparison with reference standard that does not meet the criteria required for Level II and III-1 evidence||Analysis of prognostic factors amongst untreated control patients in a randomised controlled trial||A retrospective cohort study||A comparative study with concurrent controls:
Non-randomised, experimental trial
|III-3||A comparative study without concurrent controls:
Historical control study
Two or more single arm study
Interrupted time series without a parallel control group
|Diagnostic case-control study||A retrospective cohort study||A case-control study||A comparative study without concurrent controls:
Historical control study
Two or more single arm study
|IV||Case series with either post-test or pre-test/post-test outcomes||Study of diagnostic yield (no reference standard)||Case series, or cohort study of patients at different stages of disease||A cross-sectional study||Case series|
Source: National Health and Medical Research Council
Assessment of the body of evidence and formulation of recommendations
The systematic review report and evidence statement for each question was forwarded to each lead author. The authors, in collaboration with their subcommittee members and systematic review team (who conducted the systematic reviews and provided the reports), assessed the body of evidence and completed the NHMRC Evidence Statement form to record the volume of the evidence, its consistency, clinical impact, generalisability and applicability and developed evidence statements (see: Technical report). The process is described in NHMRC additional levels of evidence and grades for recommendations for developers of guidelines (2009).
Following grading of the body of evidence and development of evidence statements, expert authors were asked to formulate evidence-based recommendations that is based on the summarised body of evidence. The method of grading recommendations is shown in Table A3 and the classification of recommendation grades are shown in Table A4.
Table A3. Grading of recommendations
|Component of Recommendation||Recommendation Grade|
|Volume of evidence 1**||one or more level I studies with a low risk of bias or several level II studies with a low risk of bias||one or two level II studies with a low risk of bias or a systematic review/several level III studies with a low risk of bias||one or two level III studies with a low risk of bias, or level I or II studies with a moderate risk of bias||level IV studies, or level I to III studies/systematic reviews with a high risk of bias|
|Consistency 2**||all studies consistent||most studies consistent and inconsistency may be explained||some inconsistency reflecting genuine uncertainty around clinical question||evidence is inconsistent|
|Clinical impact||very large||substantial||moderate||slight or restricted|
|Generalisability||population/s studied in body of evidence are the same as the target population for the guideline||population/s studied in the body of evidence are similar to the target population for the guideline||population/s studied in body of evidence differ to target population for guideline but it is clinically sensible to apply this evidence to target population3||population/s studied in body of evidence different to target population and hard to judge whether it is sensible to generalise to target population|
|Applicability||directly applicable to Australian healthcare context||applicable to Australian healthcare context with few caveats||probably applicable to Australian healthcare context with some caveats||not applicable to Australian healthcare context|
1 Level of evidence determined from level of evidence criteria
2 If there is only one study, rank this component as ‘not applicable’
3 For example results in adults that are clinically sensible to apply children OR psychosocial outcomes for one cancer that may be applicable to patients with another cancer.
**For a recommendation to be graded A or B, the volume and consistency of evidence must also be graded either A or B.
Source: National Health and Medical Research Council
Table A4. Overall recommendation grades
|Body of evidence can be trusted to guide practice|
|Body of evidence can be trusted to guide practice in most situations|
|Body of evidence provides some support for recommendation(s) but care should be taken in its application|
|Body of evidence is weak and recommendation must be applied with caution|
Source: National Health and Medical Research Council
In addition to developing evidence-based recommendations as a result of the systematic review for a question, expert authors could also draft consensus-based recommendations in the absence of evidence after having performed a systematic review, or practice points, when a matter was outside the scope of the search strategy for the systematic review. The NHMRC approved recommendation types and definitions are shown in Table A5.
Table A5. NHMRC approved recommendation types and definitions
|A recommendation formulated after a systematic review of the evidence, indicating supporting references|
|A recommendation formulated in the absence of quality evidence, after a systematic review of the evidence was conducted and failed to identify admissible evidence on the clinical question|
|A point of guidance on a subject that is outside the scope of the search strategy for the systematic review, or guidance on topic not subject to a systematic review, formulated by a consensus process and based on a general literature review, clinical experience and expert opinion|
*NHMRC recommendation. Note: The definition for Practice Points has been adapted from the original NHMRC definition.
Source: National Health and Medical Research Council.
Writing the content
For each clinical question, the assigned lead authors were asked to draft their guideline chapter using the following format:
- general introduction to the clinical question
- background to the clinical question, including its clinical importance and historical evidence, where relevant
- review of the evidence, including the number, quality and findings of studies identified by the systematic review
- evidence summary in tabular form including evidence statements, levels of evidence of included studies and reference citations
- evidence-based recommendation(s) and corresponding grade(s), consensus-based recommendations and practice points
- implications for implementation of the recommendations, including possible effects on usual care, organisation of care and any resource implications
- discussion, including unresolved issues, relevant studies currently underway and future research priorities
For sections not based on systematic review, the lead author was directed to follow a similar process and to draw on high-level evidence, particularly international guidelines, consensus statements and key literature considered to be relevant to Australian practice, to develop information and practice points.
The content draft was then reviewed by subcommittee members who were available. The draft documents often underwent several iterations.
Where contentious issues and areas for debate arose during the development of these guidelines, these are stated in Notes on these recommendations and Unresolved issues sections within each topic.
Review of the draft chapters
A face-to-face meeting with all available Working Party members was held 5 November 2018 to review and finalise the first set of sections ready as a draft guideline for public consultation. Prior to this meeting, the first batch of draft guideline sections were circulated to the Working Party members and posted on Cancer Council Australia’s Clinical Guidelines Network digital platform. The group was asked to review the content and submit feedback. All members were asked to review the content, individual recommendations and practice points in detail, and to identify and note any controversies and points to be discussed at the group meeting.
During the meeting, each section was tabled as an agenda point and key updates, recommendations and practice points were discussed in detail. All clinical guidance was reviewed and approved by consensus. In some cases, the authors agreed on specific actions for the content or discussed further sections or amendments to be added. These were actioned by the authors.
A second face-to-face meeting with all available Working Party members was held 8 April 2019 to finalise the second set of sections ready as a draft guideline for public consultation; any revisions to recommendations from the first set prepared for November 2018 were reviewed again to ensure consensus.
Public consultation and independent expert reviewers
A complete draft of the guideline was sent out for public consultation between 7 June and 8 July 2019 and submitted to NHMRC for an independent review.
Public consultation comments and suggestions received from NHMRC from the independent expert reviewers were considered and integrated in the final draft and submitted to NHMRC for approval.
Submissions were invited from the general public, professional societies and groups and other relevant stakeholders. The consultation was publicised by email to key stakeholders, including contacting professional societies and groups, consumer groups and other relevant parties.
Feedback on the draft received during the consultation and review period was compiled and sent to the relevant author and subcommittee to review their draft content, assessing and considering the submitted comments.
Feedback received during the consultation and review period
The two review stages, public consultation and the NHMRC methodological and expert review, are an integral part of the guideline development process. The feedback was reviewed and incorporated in order to improve the guideline’s quality, legitimacy and acceptability to end users and the public.
All comments received during the consultation and review period were collated in a register and were considered by the relevant section authors.
Additional papers submitted during public consultation were assessed by the methodology team against the systematic review protocol to determine if they could be included.
The Working Party reviewed all feedback received from the public consultation process at a face-to-face meeting on 5 August 2019.
The final face-to-face Working Party meeting was held after the NHMRC review and public consultation period to consider the feedback received and the amended guideline content. Subsequent changes to the draft were agreed by consensus, based on consideration of the evidence. This process followed the same consensus process that was followed prior to public consultation. All changes resulting from the public consultation submission reviews were documented.
The guideline draft was revised in response to review comments and all agreed amendments were documented in the Register of public consultation submissions.
Post-public consultation draft revisions
In response to feedback received during public consultation the definition of a Practice Point (PP) was revised from ‘A recommendation on a subject that is outside the scope of the search strategy for the systematic review, based on expert opinion and formulated by a consensus process’ to ‘A point of guidance …’ in order to make a clearer distinction between PPs and recommendations. The amended definition better conveys the status of PPs as guidance notes that can be utilised by the clinician using their own clinical expertise and judgement.
One significant revision across the whole guideline, in response to feedback, was the reassessment of the PPs and the development of new ‘Key Points’ in each section. Key Points were derived from draft PPs that did not express clinical guidance in the form of actions, but represented important information for clinicians. This process, and a revision to one of the systematic review reports noted below (MS1), reduced the number of PPs compared with the pre-public consultation draft (from 132 to 40) and resulted in a more concise Summary of recommendations in the final draft submitted for Council consideration.
The new Key Points feature appear either below or in place of the original PPs and so can be read within the same sections of the guideline.
Revisions to technical documentation prior to submission of final draft
Post-public consultation revisions included close checking of the systematic review reports and evidence statements to identify and remove any reported clinical trial outcomes that were not specified in the PICO research question and incorrectly included in the draft evidence reports. This process resulted in changes to material based on systematic reviews for four of the clinical questions.
The supporting technical documentation for the following clinical questions was accordingly revised (see the Technical report):
- Clinical question MS1 – all recurrence rate data (local recurrence, time to recurrence, distant recurrence) was removed and within the survival data sections, cause-specific and disease-specific survival data were removed, as these were not an outcome of the PICO for this clinical question. Six studies were excluded from the systematic review based on this correction. Relevant portions of the evidence statement and summary table were updated based on the removal of these outcomes. Two recommendations were affected by this revision: wording of EBR 12.1.1. was changed from “local recurrence” to “locoregional recurrence” for clarity and what was originally the fifth EBR was revised to a Practice Point (now PP 12.1.1.) due to the removal of some supporting evidence.
- Clinical question RT2 – sections reporting response rate were removed as response was not an outcome reported in the PICO table for this systematic review. One study was excluded from the systematic review based on this correction. Relevant portions of the evidence statement were updated based on the removal of these outcomes. This revision resulted in minimal corrections to the evidence summary table. No recommendations were affected by this revision.
- Clinical question RT3 – sections reporting response rates were removed as response was not an outcome reported in the PICO table for this systematic review. Two studies were excluded from the systematic review based on this correction. Relevant portions of the evidence statement were updated based on the removal of these outcome. This revision resulted in minimal corrections to the evidence summary table. No recommendations were affected by this revision.
- Clinical question SX2 – experience of the operator and intervention studies were removed as this PICO was designed to focus on patient risk factors. No evidence was excluded from the systematic review based on this correction. Four evidence statements were removed. No recommendations were affected by this revision; recommendations may have been revised due to public consultation feedback as noted in the register above.
Organisations formally endorsing the guidelines
The following medical colleges and professional bodies may be approached to endorse the guideline after it is finalised:
- Skin Cancer College Australasia (SCCA)
- The Australasian College of Dermatologists (ACOD)
- Australian College of Rural and Remote Medicine (ACRRM)
- Clinical Oncology Society of Australia (COSA)
- Medical Oncology Group of Australia Incorporated (MOGA)
- Royal College of Pathologists of Australia (RCPA)
- Royal Australian College of Physicians (RACP)
- Royal Australian College of Surgeons (RACS)
- Royal Australian College of General Practitioners (RACGP)
- Royal Australian and New Zealand College of Radiologists (RANZCR).
Dissemination and implementation
Cancer Council Australia has created a plan for the dissemination of the guideline in Australia (see: Dissemination plan).
The guideline will be available online via the Cancer Council Australia Clinical Guidelines Network digital platform. The online guideline version increases availability as well as accessibility, and usage will be tracked and analysed with a web analytics solution. Interlinking and listing the guidelines on national and international guideline portal is an important part of the digital dissemination strategy. Important Australian health websites, such as EviQ and healthdirect Australia will be approached to link to the online guideline.
The guideline will also to be listed on national and international guideline portals such as Australia’s Clinical Practice Guidelines Portal.
The Clinical Guidelines Network digital platform is a responsive website that is optimised for mobile and desktop access. When accessing the guidelines with a mobile and tablet device, an icon can be easily added to the home screen of mobile devices, offering easy mobile access.
In addition, the final guideline document will be launched via email alert to professional organisations, interested groups and clinical experts in the field, directing them via URL link to the online guideline and all associated resources.
The Clinical Guidelines Network digital platform is based on semantic web technology, so the guidelines are available in a machine-readable format, which offers the possibility to easily integrate the guideline content with systems and web applications used in the Australian healthcare context.
It is recognised that a planned approach is necessary to overcome specific barriers to implementation clinical settings and to identify appropriate incentives to encourage uptake of guideline recommendations. Implementation of the guidelines will require a combination of effective strategies and may include further continuing medical education/professional development initiatives and interactive learning, the development and promotion of computer-assisted decision aids and electronic decision-support systems, and the creation of audit and other clinical tools.
Lead authors are encouraged to develop journal articles for publication and submit abstracts and posters to conferences out of the guideline as part of the dissemination plan.
The incoming literature updates will continue to be monitored for each systematic review question. If there is strong evidence emerging in a specific area of keratinocyte cancer management, the Management Committee will be reconvened to assess if this warrants a guideline update (full or partial). It is recommended that the guideline be updated after 5 years.
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