and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Dental and Craniofacial Research (NIDCR) |
|
Funding Opportunity Title |
Collaborative Research on the Transition From Acute to Chronic Pain: New Models and Measures in Clinical and Preclinical Pain Research (R01) |
Activity Code |
R01 Research Project Grant |
Announcement Type |
Reissue of RFA-DE-11-001 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-DE-12-003 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.121 |
FOA Purpose |
The overall goal of this FOA is to stimulate preclinical and clinical research that will accelerate our understanding of the biological and behavioral determinants driving the transition from acute pain to chronic pain disorders. An understanding of the mechanisms and risk factors that determine who will transition to a chronic pain state is necessary in order to intervene in this transition and to design new, effective treatments to resolve acute pain before it becomes chronic. The objectives of this FOA are to: 1) assemble research teams with expertise in basic and clinical pain research and related expertise outside the pain field that will provide novel, collaborative, multidisciplinary approaches to answer crucial questions about the transition from acute to chronic pain; 2) discover biological and behavioral mechanisms that drive the transition from an acute pain state to a chronic dysfunctional pain condition; 3) develop new clinical and preclinical models and measures of pain that will be essential to identify and characterize these mechanisms. Studies that involve considerable risk but with the potential for breakthroughs in the field are strongly encouraged. |
Posted Date |
June 28, 2011 |
Open Date (Earliest Submission Date) |
September 27, 2011 |
Letter of Intent Due Date |
September 27, 2011 |
Application Due Date(s) |
(New Date October 28, 2011 per NOT-OD-12-008), Original Date October 27, 2011, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
February/March 2012 |
Advisory Council Review |
May 2012 |
Earliest Start Date(s) |
July 2012 |
Expiration Date |
(New Date October 29, 2011 per NOT-OD-12-008), Original Date October 28, 2011 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Pain conditions are a major health problem in the US and their economic burden approaches $100 billion per year in lost productivity and medical expenses. These conditions lead to medical morbidity and a reduced quality of life for millions of Americans. The NIDCR is committed to supporting research in temporomandibular joint disorders (TMJDs) and other chronic orofacial pain conditions. It is estimated that TMJDs affect approximately 10 million individuals, the majority of them women during their childbearing age. It is currently unclear how many individuals experiencing acute pain in the temporomandibular joint (TMJ) will develop a chronic, persistent pain condition. For the most part, acute TMJ pain resolves with no or minimal treatment. But for those who develop chronic TMJD, the effects can be debilitating. Some pain symptoms can be alleviated by analgesics but there are no effective treatments to completely resolve chronic TMJD or other chronic pain conditions. Some drugs that are used have unwanted side effects that limit their prolonged use or have a low response rate or reduced efficacy. Most current pharmaceutical and behavioral therapies for chronic pain conditions focus on the symptoms, but do not target the underlying mechanisms. Also, these therapies were developed and tested based on our understanding of acute pain mechanisms. None are targeted to prevent the transition to a chronic pain state.
The etiology and pathology of chronic TMJDs and other chronic pain conditions is incompletely understood. A largely unaddressed challenge is the lack of knowledge in identifying who will transition to a chronic pain state and how to treat patients to prevent this transition. There is a need to understand, mechanistically, how pain changes from an acute, high threshold response to a chronic, spontaneous, low threshold, dysfunctional painful condition. It is unknown how acute pain progresses to chronic pain at any level, from the molecular to behavioral.
Current preclinical and clinical models of pain do not replicate all aspects of human chronic pain states. Current measures of pain in both animals and humans usually rely on evoked responses and do not reflect the spontaneous and recurrent pain in chronic conditions. Most basic, preclinical research has focused on mechanisms, molecules, and circuitry involved in acute pain. This knowledge has then been applied to and validated in human studies. While this translational approach is important, little reverse translation has occurred in the pain field, where mechanistic and observational studies in humans are designed to inform animal research in order to validate and examine in more detail the mechanisms underlying pain. Knowledge gained through a combination of human and animal model studies will improve the development of therapeutic approaches for chronic pain conditions.
The unmet need in the pain field is the effective prevention and treatment of chronic pain conditions. In order to begin to meet this need, an emphasis on research at the transition from acute to chronic pain is needed to understand how neurophysiological changes during this period of time lead to chronic pain. In addition, new clinical and preclinical models of pain conditions and new measures of pain designed to better reflect chronic human pain are needed. These measures call for objective, non-invasive, functional approaches and might include brain imaging and behavioral assessments. By changing the research focus and providing new tools to study pain, researchers and clinicians will be able to predict who is at risk of developing chronic pain conditions and to develop novel therapies to prevent the transition to chronicity.
NIDCR and NIH supported basic and clinical pain research is, in large part, addressing the mechanisms of acute nociceptive responses after inflammatory insult or nerve damage has developed into a chronic pain condition, but has not been centered on how the transition to chronicity occurs. In many respects, biological and behavioral changes established at the transition leading to persistent pain represent a disease state of the nervous system and provide our best opportunities to prevent the induction of chronic pain. The overriding concern is that current research is not focused on understanding how chronic pain conditions emerge from an acute painful event or a pain-free state.
This FOA addresses the mission of the NIDCR to improve oral, dental and craniofacial health by performing and supporting basic and clinical research. This Initiative aligns with the NIDCR Strategic Plan 2009-2013 NIDCR Strategic Plan 2009-2013, Goal I, Bring the best science to bear on problems in oral, dental and craniofacial health and Goal III, Identify innovative clinical research avenues to improve oral, dental and craniofacial health. This Initiative also aligns with the NIH Director s research themes of utilizing comprehensive, high throughput technologies to enhance progress in human disease and translating basic science into new and better treatments in order to more rapidly improve diagnostic and therapeutic approaches in medical practice.
The objectives of this FOA are to: 1) assemble research teams with expertise in pain research and related expertise outside the pain field that will provide collaborative, multidisciplinary approaches to answer crucial questions about the transition from acute to chronic pain; 2) discover biological and behavioral mechanisms that drive the transition from an acute, protective pain state to a chronic dysfunctional pain condition; 3) develop new clinical and preclinical models and measures of pain that will be essential to identify and characterize these mechanisms.
To be responsive to this FOA, applications must specifically address mechanisms of transition from acute to chronic pain. These studies can range from underlying molecular mechanisms, cellular and circuit-level analyses, clinical studies, animal and human behavioral research, to epidemiological approaches
The types of research being sought cover the spectrum of biomedicine from basic biological approaches to human behavioral studies to patient-oriented and population research. Comprehensive approaches utilizing new technologies are encouraged. Reverse translational approaches where initial human studies are designed to inform and drive basic mechanistic studies or are designed specifically to develop preclinical validation of mechanisms or therapeutic targets are also being sought.
Funding Instrument |
Grant |
Application Types Allowed |
New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
NIDCR intends to commit $3 million in total costs in FY 2012 to support 6-8 projects. |
Award Budget |
Application budgets are not limited, but need to reflect actual needs of the proposed project. |
Award Project Period |
The total project period for an application submitted in response to this FOA may not exceed five years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the
following registrations.
All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.
Program Directors/Principal Investigators who submitted applications under RFA-DE-11-001 but were not funded may prepare a New application in response to this FOA.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Lynn Mertens King, PhD
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd. Rm 662
Bethesda, MD 20892-4878 (20817 for express deliveries)
Telephone: (301) 594-5006
Fax: (301) 480-8303
Email: [email protected]
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R) Application Guide.
Appendix
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD/PIs must include their eRA Commons ID in the Credential
field of the Senior/Key Person Profile Component of the SF 424(R&R)
Application Package. Failure to register in the Commons and to include a
valid PD/PI Commons ID in the credential field will prevent the successful
submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIDCR, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s)
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable.
Revisions
Not Applicable.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the NIDCR , in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Dental and Craniofacial Research Council. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
In addition all human subjects research is subject to NIDCR Clinical Terms of Award. See the following link for details. NIDCR Clinical Terms of Award.
Cooperative Agreement Terms and Conditions of Award
Not Applicable.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and submission,
downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
John W. Kusiak, PhD
Division of Extramural Research
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd. Rm. 616
Bethesda, MD 20892-4878 (Use 20817 for express deliveries)
Telephone: (301) 594-7984
Fax: (301) 480-8319
Email: [email protected]
Lynn Mertens King, PhD
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd. Rm. 662
Bethesda, MD 20892-4878 (Use 20817 for express deliveries)
Telephone: (301) 594-5006
Fax: (301) 480-8303
Email: [email protected]
Mary Daley Greenwood
Chief Grants Management Officer
National Institute of Dental and Craniofacial Research
Democracy I, Rm. 658
MSC 4878
6701 Democracy Blvd. Rm. 658
Bethesda, MD 20892-4878 (Use 20817 for express deliveries)
Telephone: (301) 594-4808
Fax: (301) 480-3562
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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