Release Date:  January 30, 2001

RFA:  RFA-AI-01-007

National Institute of Allergy and Infectious Diseases

Letter of Intent Receipt Date:  April 20, 2001
Application Receipt Date:       May 22, 2001



The Division of Microbiology and Infectious Diseases of the National 
Institute of Allergy and Infectious Diseases (NIAID), National 
Institutes of Health, invites applications for research grants to 
support multidisciplinary research in the areas such as tropical 
medicine, hematology, immunology, and genetics relevant to 
understanding the pathogenesis of severe malarial anemia. Studies 
should be designed to elucidate the mechanisms underlying severe 
malarial anemia in individuals who are naturally exposed to infection, 
and/or to clarify the pathophysiology of malarial anemia reported in 
non-human primates following immunization and challenge infection. 
Clinical studies will be expected to incorporate substantial research 
at institutions located in areas where malaria is endemic.   
Applications proposing studies to be conducted in murine malaria models 
will not be considered responsive to this Request For Applications 
(RFA)unless they are logically coupled to clinical studies or studies 
in non-human primates, with the clinical and/or primate studies 
comprising the major component of the application.

To enhance capability strengthening for malaria research, NIAID and the 
Fogarty International Center (FIC) have frequently integrated research 
and training programs for foreign investigators. FIC plans to release a 
Request for Applications for a training program on malarial anemia 
complementary to this NIAID RFA for research projects on this subject.  


The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a 
PHS led national activity for setting priority areas. This RFA, 
"Malaria Vaccine Development: Understanding Malarial Anemia" is related 
to one or more of the focus areas. Potential applicants may obtain a 
copy of "Healthy People 2010" at


Applications may be submitted by domestic and foreign for-profit and 
non-profit organizations; public and private institutions, such as 
universities, colleges, hospitals, laboratories, units of State and 
local governments; and eligible agencies of the Federal government. 
Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators.


The mechanism of support will be the individual research project grant 
(R01).  The total requested project period for an application submitted 
in response to this RFA may not exceed four years. Responsibility for 
the planning, direction, and execution of the proposed project will be 
solely that of the applicant.

This RFA is a one-time solicitation.  Future competing renewal 
applications will compete with all investigator-initiated applications 
and will be reviewed according to customary referral and review 

Specific application instructions have been modified to reflect 
"MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined 
by the NIH. Complete and detailed instructions and information on 
Modular Grant applications can be found at

A notice of modification and update (NOT-OD-00-046) regarding modular 
grants was released on 7/24/00 and can be found at


The estimated total funds (direct and facilities and administrative 
(F&A) costs) available for the first year of support for all awards 
made under this RFA will be $1,000,000.  In fiscal year 2002 the NIAID 
plans to fund approximately 3 to 4 awards.  The usual NIH policies 
governing grants administration and management will apply.  Although 
this program is provided for in the financial plans of the NIAID, 
awards pursuant to this RFA are contingent upon the availability of 
funds for this purpose and the receipt of a sufficient number of 
applications of high scientific merit.  Funding beyond the first and 
subsequent years of the grant will be contingent upon satisfactory 
progress during the preceding years and availability of funds.



Malaria is an infectious disease caused by protozoan parasites of 
Plasmodium spp. (primarily P. falciparum and P. vivax).   Malaria 
claims an estimated 1 to 3 million lives annually, and accounts for 
untold morbidity in the approximately 300 to 500 million people 
infected annually.  It is becoming increasingly recognized that severe 
anemia contributes substantially to malaria-related mortality, 
especially in young children living in endemic regions.  

In P. falciparum malaria, anemia may develop acutely or chronically, 
and may range from mild to severe.  In the case of life-threatening 
anemia, a feature of severe and complicated malaria, the only effective 
treatment currently available is blood transfusion, which carries risks 
for transmission of other blood-borne pathogens.  According to the 
World Health Organization (Management of Severe Malaria, 2nd edition), 
need for blood transfusion should be considered in malaria positive 
patients if the packed cell volume falls below 20% or hemoglobin 
concentration falls below 7g/dl.  Children meeting these criteria would 
be considered high-risk if accompanied by respiratory distress, 
impaired consciousness, or hyperparasitemia, or if the packed cell 
volume reaches 12% or hemoglobin concentration reaches 4g/dl.  
Severe malarial anemia is multifactorial, involving increased 
erythrocyte destruction as well as decreased erythrocyte production.  
Factors reported to contribute to severe anemia include hemolysis of 
uninfected as well as parasitized red cells, erythrophagocytosis, bone 
marrow suppression, ineffective erythropoiesis and dyserythropoiesis, 
inadequate erythropoietin production, and concomitant infections.  The 
mechanisms underlying severe malaria anemia are poorly understood, 
apparently involving humoral (e.g. antibody and/or complement) as well 
as cellular (e.g. cytokine) immune responses.  The immunologic basis of 
severe malarial anemia is of particular interest to NIAID because of 
its potential relevance to malaria vaccine development (see NIAID's 
malaria vaccine research activities at  
Recent observations of severe anemia developing in non-human primates (Aotus) 
following vaccination with blood-stage antigens and challenge infection, or 
after repeated P. falciparum infection and drug cure, suggest that improved 
understanding of the pathogenesis of severe malarial anemia will be an important 
factor in the development of safe and effective vaccines. 

Research Objectives and Scope

This RFA seeks to support multidisciplinary research, in areas such as 
tropical medicine, immunology, hematology, and genetics, to increase 
our understanding of the pathogenesis of severe malarial anemia, which 
will contribute to the development of safe and effective vaccines or 
other interventions to reduce morbidity and mortality due to malaria. 
Responsive applications will focus on clinical research involving 
naturally infected individuals living in malaria endemic regions and/or 
preclinical research in non-human primate models of malaria.  
Applications proposing studies to be conducted in murine malaria models 
will not be considered responsive to this RFA unless they are logically 
coupled to clinical studies or studies in non-human primates, as by 
exploration of a common hypothesis, with the clinical and/or primate 
studies comprising the major component of the application. Applications 
for clinical studies will be expected to include substantial 
involvement of institutions and investigators from malaria-endemic 

Applications in response to this RFA will focus on severe, not mild or 
moderate, anemia. The definition of severe malarial anemia is not 
universally agreed upon (see Parasitology Today 16:469, 2000). For 
purposes of this RFA, severe malarial anemia will be clinically defined 
as hemoglobin < 7g/dl or packed cell volume < 20%, in the presence of 
malarial parasitemia of any density. Within the constraint of this 
overall guideline, applicants may choose to apply stricter criteria in 
the context of the particular region or population in which the 
research will be conducted.  Applications for research in non-human 
primates should refer to recent vaccination studies in Aotus monkeys, 
where hematocrit readings less than 50% of the pre-trial level have 
been considered life threatening.

Research proposals submitted in response to this RFA must demonstrate 
that they are relevant to one or more of the following objectives:

o Characterization of the pathogenesis of severe malarial anemia in 
individuals (especially children) living in malaria endemic regions, 
particularly regarding the role of cytokines or other 
immunoregulators, antibody and complement
o Elucidation of the risk factors associated with development of 
severe malarial anemia, particularly with regard to the roles of 
microbial co-infection and genetic predisposition
o Determination of whether prevention of severe anemia would serve as 
a useful clinical endpoint for vaccine efficacy in future malaria 
vaccine trials 
o Characterization of the pathophysiology of severe anemia occurring 
in primate models of malaria following vaccination with malaria 
antigens and challenge infection or multiple reinfection and drug 


Funds for travel of the Principal Investigator to one meeting in the 
Bethesda, MD, area should be included in the budgets for years two and 
four as part of the overall budget request.  This meeting may occur in 
the context of the annual conference of NIAID's International Centers 
for Tropical Disease Research (see 
or in conjunction with another meeting of NIAID-sponsored malaria research 
projects. Inclusion of funds for other key personnel to attend these meetings is 
at the discretion of the applicant.

Sample clinical protocol(s) and consent form(s) must be submitted with 
the application for consideration by the Initial Review Group.  
Protocol documents should include, at minimum, the following sections: 
an introduction, including background and rationale; a statement of the 
study objectives; description of study design; criteria for selection 
of subjects and enrollment procedures; clinical and laboratory 
evaluations to be performed; statistical considerations, including 
general design issues, endpoints, sample size, accrual and power, and 
analysis plan; plans for data collection and management; and, plan for 
data and safety monitoring.  


When clinical studies or trials are a component of the research 
proposed, NIAID policy requires that studies be monitored commensurate 
with the degree of potential risk to study subjects and the complexity 
of the study.  Terms and Conditions of Award will be included with 
awards.  NIAID policy was announced in the NIH Guide on February 24, 
2000 and is available at:  
The full policy, including terms and conditions of award, is available at:  

Please note that NIAID approval of the clinical protocol is required 
prior to initiation of a study. Clinical protocols involving human 
subjects will be reviewed by NIAID for: scientific content, design, 
safety, feasibility, statistical and regulatory issues such as adverse 
experience reporting mechanisms and informed consent. 

It is the policy of the NIH that women and members of minority groups 
and their sub-populations must be included in all NIH supported 
biomedical and behavioral research projects involving human subjects, 
unless a clear, compelling rationale, and justification are provided 
that inclusion is inappropriate with respect to the health of the 
subjects or the purpose of the research.  This policy results from the 
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should 
read the UPDATED "NIH Guidelines For Inclusion of Women and Minorities 
as Subjects in Clinical Research," published in the NIH Guide for 
Grants and Contracts on August 2, 2000 
(; a 
complete copy of the updated Guidelines are available at:  
The revisions relate to NIH-defined Phase III clinical trials and 
require:  a) all applications or proposals and/or protocols to provide 
a description of plans to conduct analyses, as appropriate, to address 
differences by sex/gender and/or racial/ethnic groups, including 
subgroups if applicable; and b) all investigators to report accrual, 
and to conduct and report analyses, as appropriate, by sex/gender 
and/or racial/ethnic group differences.


It is the policy of NIH that children (i.e., individuals under the age 
of 21) must be included in all human subjects research, conducted or 
supported by the NIH, unless there are scientific and ethical reasons 
not to include them.  This policy applies to all initial (Type 1) 
applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines on the Inclusion of Children as 
Participants in Research Involving Human Subjects" that was published 
in the NIH Guide for Grants and Contracts, March 6, 1998, and which is 
available at the following URL address:    

Investigators may obtain copies from these sources or from Dr. 
Stephanie James (listed in INQUIRIES below) who may also provide 
additional relevant information concerning the policy.


All applications and proposals for NIH funding must be self-contained 
within specified page limitations.  Unless otherwise specified in an 
NIH solicitation, Internet addresses (URLs) should not be used to 
provide information necessary to the review because reviewers are under 
no obligation to view the Internet sites.  Reviewers are cautioned that 
their anonymity may be compromised when they directly access an 
Internet site.


Prospective applicants are asked to submit, by April 20, 2001, a letter 
of intent that includes a descriptive title of the overall proposed 
research; the name, address and telephone number of the Principal 
Investigator; and the number and title of this RFA.  Although the 
letter of intent is not required, is not binding, does not commit the 
sender to submit an application, and does not enter into the review of 
a subsequent application, the information that it contains allows NIAID 
staff to estimate the potential review workload and to plan the review.  
The letter of intent is to be sent to Dr. Anna Ramsey-Ewing at the 
address listed under INQUIRIES.


Applicants are strongly encouraged to call NIAID program staff with any 
questions regarding the responsiveness of their proposed project to the 
goals of this RFA.  

Applications are to be submitted on the grant application form PHS 398 
(rev. 4/98) and will be accepted at the standard application deadlines 
as indicated in the application kit. Application kits are available at 
most institutional offices of sponsored research and may be obtained 
from the Division of Extramural Outreach and Information Resources, 
National Institutes of Health, 6701 Rockledge Drive, MSC 7910, 
Bethesda, MD 20892-7910, telephone 301/710-0267, email: In addition, the application kits can be found on 
the following URL:  



Modular Grant applications will request direct costs in $25,000 
modules, up to a total direct cost request of $250,000 per year. 
(Applications that request more than $250,000 direct costs in any year 
must follow the traditional PHS 398 application instructions.)  The 
total direct costs must be requested in accordance with the program 
guidelines and the modifications made to the standard PHS 398 
application instructions described below:

PHS 398

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct 
Costs (in $25,000 increments up to a maximum of $250,000) and Total 
Costs [Modular Total Direct plus Facilities and Administrative  (F&A) 
costs] for the initial budget period Items 8a and 8b should be 
completed indicating the Direct and Total Costs for the entire proposed 
period of support.

Page 4 of the PHS 398. It is not required and will not be accepted with 
the application.

the categorical budget table on Form Page 5 of the PHS 398. It is not 
required and will not be accepted with the application.

o BUDGET NARRATIVE JUSTIFICATION - Prepare a Modular Grant Budget 
Narrative page. (See 
for sample pages.) At the top of the page, enter the total direct costs 
requested for each year.  This is not a Form page.

Under Personnel, provide budget narrative for ALL personnel by 
position, role and level of effort.  This includes consultants and any 
"to be appointed" positions.  No individual salary information should 
be provided. However, the applicant should use the NIH appropriation 
language salary cap and the NIH policy for graduate student 
compensation in developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs 
(direct plus facilities and administrative) for each year, each rounded 
to the nearest $1,000. List the individuals/organizations with whom 
consortium or contractual arrangements have been made, the percent 
effort of all personnel, and the role on the project. Indicate whether 
the collaborating institution is foreign or domestic. The total cost 
for a consortium/contractual arrangement is included in the overall 
requested modular direct cost amount.  Include a Letter of Commitment 
or Intent if there is or is to be a subcontract/consortium.

Provide an additional narrative budget justification for any variation 
in the number of modules requested.

o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information 
used by  reviewers in the assessment of each individual's 
qualifications for a specific role in the proposed project, as well as 
to evaluate the overall qualifications of the research team. A 
biographical sketch is required for all KEY personnel, including 
consultants, following the instructions below. No more than three pages 
may be used for each person. A sample biographical sketch may be viewed 
- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.

o CHECKLIST - This page should be completed and submitted with the 
application. Applicant institutions should calculate the Facilities and 
Administration (F&A) costs using the current negotiated F&A rate, less 
exclusions, for the initial budget period and all future budget 
periods.  It is not necessary to list the exclusions on the Checklist 
nor anywhere in the application.  If the F&A rate agreement has been 
established, indicate the type of agreement and the date. All 
appropriate exclusions must be applied in the calculation of the F&A 
costs for the initial budget period and all future budget years.

o The applicant should provide the name and phone number of the 
individual to contact concerning fiscal and administrative issues if 
additional information is necessary following the initial review.

For purposes of this RFA, in order to accommodate the requirement for 
inclusion of clinical protocols (see SPECIAL REQUIREMENTS), the 
Research Plan section of the application may be expanded beyond the 
standard 25 page limitation, not to exceed 40 pages.  

For purposes of identification and processing, item 2a on the face page 
of the application must be marked "YES" and the RFA number "AI-01-007" 
ANEMIA" must be entered on the face page.

Applications must be received by May 22, 2001.  Applications not 
received as a single package on the receipt date or not conforming to 
the instructions, including page limitations and font size, contained 
in PHS 398 Application Kit (rev. 4/98) (as modified in, and superseded 
by, the special instructions below, for the purposes of this RFA), will 
be judged non-responsive and will be returned to the applicant. 

The RFA label and line 2 of the application should both indicate the 
RFA number.  The RFA label must be affixed to the bottom of the face 
page.  Failure to use this label could result in delayed processing of 
the application such that it may not reach the review committee in time 
for review.

The sample RFA label available at: has been 
modified to allow for this change.  Please note this is in pdf format.

If the application submitted in response to this RFA is
substantially similar to a grant application already
submitted to the NIH for review, but that has not yet been reviewed, 
the applicant will be asked to withdraw either the pending application 
or the new one.  Simultaneous submission of identical applications will 
not be allowed, nor will essentially identical applications be reviewed 
by different review committees.  Therefore, an application that is 
essentially identical to one that has already been reviewed cannot be 
submitted in response to this RFA.  This does not preclude the 
submission of substantial revisions of applications already reviewed, 
but such applications must include an introduction addressing the 
previous critique.

Submit a signed, typewritten original of the application, including the 
checklist, and three signed, exact, single-sided photocopies, in one 
package to:

6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express mail or courier service)

At the time of submission, two additional exact copies of the grant 
application and all five sets of any appendix material must be sent to:

Anna Ramsey-Ewing, Ph.D.  
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Room 2103, MSC-7616
6700-B Rockledge Drive  
Bethesda, MD  20892-7616
Telephone:  (301) 496-8536
FAX:        (301) 402-2638
For express mail carriers use zip code 20817

Applications must be received by the application receipt date listed in 
the heading of this RFA.  If an application is received after that 
date, it will be returned to the applicant without review.

Effective for the receipt dates beginning September 1, 2000, 
applications not in compliance with the modular application 
instructions will be returned to the applicant institution by the 
Center for Scientific Review (CSR).  Applications revised and 
resubmitted to NIH in a timely manner may remain in the intended review 

An application will be considered NON-COMPLIANT if:

1.  The requested direct cost budget is not in modules of $25,000 for 
all years of support for requests up to $250,000 per year.

2.  A detailed itemized categorical budget is provided.

3.  The Budget Narrative Justification page includes an itemized 
justification for one or more of the following: equipment, supplies, 
travel, other expenses, etc. but the number of modules requested in 
each year is the same, or the information is not intended to explain 
the request for a different number of modules in one or more years.

4.  OTHER SUPPORT pages are supplied, in addition to or in the absence 
of the section in the Biographical Sketch identifying "Research 
Projects Ongoing or Completed During the Last Three Years."

5.  The Biographical Sketch lists "Current and Pending Support" instead 
of or in addition to the required information.

Applicants from institutions that have a General Clinical
Research Center (GCRC) funded by the NIH National Center for Research 
Resources may wish to identify the GCRC as a resource for conducting 
the proposed research.  If so, a letter of agreement from either the 
GCRC Program Director or Principal Investigator should be included with 
the application.


Review Considerations

Upon receipt, applications will be reviewed for completeness by the 
Center for Scientific Review and for responsiveness by NIAID staff.

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the Division of Extramural Activities, NIAID 
in accordance with the review criteria stated below. As part of the 
initial merit review, all applications will receive a written critique 
and undergo a process in which only those applications deemed to have 
the highest scientific merit, generally the top half of the 
applications under review, will be discussed, assigned a priority 
score, and receive a second level of review provided by the National 
Advisory Allergy and Infectious Diseases Council.

Review Criteria

The criteria to be used in the evaluation of grant applications are 
listed below.  To put those criteria in context, the following 
information is contained in instructions to the peer reviewers.

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
The reviewers will comment on the following aspects of the application 
in their written critiques in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of 
these goals.  Each of these criteria will be addressed and considered 
by the reviewers in assigning the overall score weighting them as 
appropriate for each application.  Note that the application does not 
need to be strong in all categories to be judged likely to have a major 
scientific impact and thus deserve a high priority score.  For example, 
an investigator may propose to carry out important work that by its 
nature is not innovative but is essential to move a field forward.

1.  Significance.  Does this study address an important problem? If the 
aims of the application are achieved, how will scientific knowledge be 
advanced?  What will be the effect of these studies on the concepts or 
methods that drive this field?

2.  Approach.  Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project?  Does the applicant acknowledge potential problem 
areas and consider alternative tactics? 

3.  Innovation.  Does the project employ novel concepts, approaches or 
method?  Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new methodologies or 

4.  Investigator.  Is the investigator appropriately trained and well 
suited to carry out this work?  Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)?

5.  Environment.  Does the scientific environment in which the work 
will be done contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?  Is there 
evidence of institutional support?

6. Focus.  Does the proposed research emphasize clinical 
research and/or research in non-human primates, and address one or more 
of the specific objectives described above in RESEARCH OBJECTIVES AND 

7.	International Collaboration.  For applications from U.S. 
institutions involving clinical studies, does the proposed research 
incorporate plans for meaningful collaboration with institutions and 
investigators from malaria-endemic regions?    

The initial review group will also examine: the appropriateness of 
proposed project budget and duration; the adequacy of plans to include 
children and both genders and minorities and their subgroups as 
appropriate for the scientific goals of the research and plans for the 
recruitment and retention of subjects; the provisions for the 
protection of human and animal subjects; and the safety of the research 


Letter of Intent Receipt Date:    April 20, 2001 
Application Receipt Date:         May 22, 2001
Scientific Peer Review Date:      October, 2001
Advisory Council Date:            February, 2002
Earliest Anticipated Award date:  April 1, 2002 

Funding decisions will be made on the basis of scientific
and technical merit as determined by peer review, programmatic 
priorities, and the availability of funds. The earliest anticipated 
date of award is April 1, 2002.

Written and telephone inquiries concerning this RFA are encouraged.  
The opportunity to clarify any issues or questions from potential 
applicants is welcome.

Direct inquiries regarding programmatic (research scope and 
eligibility) issues to:

Dr. Stephanie James  
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases  
Room 3101, MSC-7630
6700-B Rockledge Drive
Bethesda, MD  20892-7630
Telephone:  (301) 496-2544
FAX:        (301) 402-0659
Direct inquiries regarding review issues; address the letter of intent 
to; and mail two copies of the application and all five sets of 
appendices to:
Anna Ramsey-Ewing, Ph.D.  
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Room 2103, MSC-7616
6700-B Rockledge Drive  
Bethesda, MD  20892-7616
Telephone:  (301) 496-8536
FAX:        (301) 402-2638
For express mail carriers use zip code 20817

Direct inquiries regarding fiscal matters to:  

Celeste Kerner  
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Room 2248, MSC-7614
6700-B Rockledge Drive  
Bethesda, MD  20892-7614  
Telephone:  (301) 402-6213
Fax:        (301) 480-3780


This program is described in the Catalogue of Federal Domestic 
Assistance No. 93.8__(Use appropriate program number.  NIAID citations 
are Sec. 93.856, Microbiology and Infectious Diseases Research, and No. 
93.855 - Immunology, Allergy, and Transplantation Research.) Awards are 
made under authorization of Sections 301 and 405 of the Public Health 
Service Act as amended (42 USC 241 and 284) and administered under NIH 
grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 
and 92.  This program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review.

The Public Health Service strongly encourages all grant and contract 
recipients to provide a smoke-free workplace and promote the non-use of 
all tobacco products. In addition, Public Law 103-227, the Pro-Children 
Act of 1994, prohibits smoking in certain facilities (or, in some 
cases, any portion of a facility) in which regular or routine 
education, library, day care, health care or early childhood 
development services are provided to children.  This is consistent with 
the PHS mission to protect and advance the physical and mental health 
of the American people.

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