Release date:  November 19, 1998

RFA:  HL-99-005


National Heart, Lung, and Blood Institute

Letter of Intent Receipt Date: January 6, 1999
Application Receipt Date: February 24, 1999



The National Heart, Lung, and Blood Institute (NHLBI) invites research grant
applications to conduct cell biologic, molecular biologic, and molecular
pathologic investigations designed to elucidate the mechanisms underlying airway
remodeling and repair in asthma.  The goal is to understand the pathogenesis,
regulation, and consequences of airway responses in asthma.

Among the disciplines and expertise that are appropriate for this research
program are molecular biology, molecular pathology, cell biology, immunology,
microbiology, biochemistry, allergy, asthma, genetics, pulmonary medicine,
pulmonary physiology, and pediatrics.


The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This Request for Applications (RFA),
"Airway Remodeling and Repair in Asthma," is related to the priority area of
Chronic Disabling Conditions.  Potential applicants may obtain a copy of "Healthy
People 2000" (Full Report:  Stock No.017-001-00474-0 or Summary Report:  Stock
No. 017-001-00473-1) through the Superintendent of Documents, Government Printing
Office, Washington, DC 20402-9325 (telephone 202-512-1800).


Applications may be submitted by domestic and foreign, for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State or 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.

All current policies and requirements that govern the research grant programs of
the National Institutes of Health (NIH) will apply to grants awarded under this
RFA.  Awards under this RFA to foreign institutions will be made only for
research of very unusual merit, need, and promise, and in accordance with PHS
policy governing such awards.


This RFA will use the NIH individual research project grant (R01) mechanism of
support.  However, specific application instructions have been modified to
reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined
by the NIH.  The modular grant concept establishes specific modules in which
direct costs may be requested as well as a maximum level for requested budgets. 
Only limited budgetary information is required under this approach.  The
just-in-time concept allows applicants to submit certain information only when
there is a possibility for an award.  It is anticipated that these changes will
reduce the administrative burden for the applicants, reviewers and Institute

For this RFA, funds must be requested in $25,000 direct cost modules with a
maximum of nine modules ($225,000 direct costs) per R01 per year may be
requested.  A feature of the modular grant concept is that no escalation is
provided for future years, and all anticipated expenses for all years of the
project must be included within the number of modules being requested.  Only
limited budget information will be required and any budget adjustments made by
the Initial Review Group will be in modules of $25,000.  Instructions for
completing the Biographical Sketch have also been modified.  In addition, Other
Support information and the application Checklist page are not required as part
of the initial application.  If there is a possibility for an award, necessary
budget, Other Support and Checklist information will be requested by NHLBI staff
following the initial review.  The APPLICATION PROCEDURES section of this RFA
provides specific details of modifications to standard PHS 398 application kit
instructions.  Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  It is anticipated that
support for this program will begin in September 1999.  Administrative
adjustments in project period and/or amount may be required at the time of the

This RFA is a one-time solicitation.  Future unsolicited competing continuation
applications will compete with all investigator-initiated applications and be
reviewed according to the customary peer review procedures.

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 either from the GCRC program director or principal investigator should
be included with the application.


It is anticipated that for fiscal year 1999, approximately $2,700,000 total costs
will be available for the first year of support for this initiative.  Award of
grants pursuant to this RFA is contingent upon receipt of such funds for this
purpose.  It is anticipated that approximately 8 new grants will be awarded under
this program.  Applicants may request up to 4 years of support.  The specific
number to be funded will, however, depend on the merit and scope of the
applications received and on the availability of funds.  Direct costs will be
awarded in modules of $25,000, less any overlap or other necessary administrative
adjustments.  Facilities and administrative costs will be awarded based on the
negotiated rates.



Chronic airway inflammation and it's consequences play a major role in the
pathogenesis of asthma.  Although the airways obstruction found in asthma has,
until recently, been considered reversible, new data suggests that some patients
with asthma may have permanent abnormalities in lung function.  These permanent
changes are postulated to arise as a consequence of airway injury and repair, a
process felt to represent airway remodeling.  For many years, pathologists have
described basement membrane thickening in asthmatic airways.  It now appears that
the basement membrane is actually normal in asthmatic airways and the thickening
is the result of a sub-epithelial fibrotic response.  More recent studies have
highlighted the importance of other structural alterations in asthmatic airways
including myocyte and myofibroblast hyperplasia and hypertrophy, and epithelial
alterations.  However, the mechanisms responsible for these alterations, their
physiologic and biologic consequences, the role of these changes in the natural
history of asthma, and the amenability of these alterations to therapeutic
intervention have not been adequately investigated.  Study of airway remodeling
and its consequences at cellular, subcellular, and molecular levels will provide
additional insight into the role of airway injury and its abnormal repair in the
pathogenesis of asthma, eventually leading to preventive or therapeutic

Research Scope:

This RFA is designed to stimulate cell biologic, molecular biologic, and
molecular pathologic studies of airway remodeling and repair in asthma, with the
overall goal of elucidating the pathogenesis, regulation, and consequences of
these airway responses in asthma.

Areas of investigation relevant to these objectives include, but are not limited
to, the following:

1. Relationship of the pathologic, ultrastructure and morphometric features of
the remodeled airway to asthma:

Our knowledge of the pathology, ultrastructural features and morphometric
relationships in the remodeled airway in humans and animals is incomplete.  In
addition to large airway involvement, abnormalities in small airways and
associated parenchyma may occur in asthma.  Better definition of these changes
utilizing molecular pathologic approaches is needed.  Although structural changes
(subepithelial fibrosis, matrix accumulation, myocyte and myofibroblast
hyperplasia, mucous gland and goblet cell hyperplasia, and epithelial cell
proliferation) in the airways have been linked to chronic asthma, the spectrum
of pathologic alterations in asthmatic airways has not been well characterized
nor the degree to which these remodeling responses have occurred been determined. 
Information is required about the types of matrix molecules that accumulate and
cellular abnormalities that result, as well as their effects on airway structure. 
For example, what types of collagens are deposited?  What cells produce these
collagens?  Are there specific patterns of elaboration and locations of matrix
metalloproteinases, collagenases and hyaluronidases in the asthmatic airway?  Are
there specific cell types whose location and number are altered?  Does airway
remodeling alter the resident cells of the airway such as dendritic cells and
goblet cells?  What is the relationship of the cellular changes to remodeling of
the airway?  Is remodeling relevant to airflow obstruction?  Does remodeling
compromise airway lumen size or the thickness of the airway between the smooth
muscle layer and lumen?  What are the pathologic correlates of incompletely
reversible asthma?

2.  Role of airway remodeling in the natural history of asthma:

Asthma is thought to be a syndrome comprising multiple different subtypes rather
than a single disease entity.  Each of these may very well have different natural
histories and sequelae.  Airway remodeling in each of these subtypes is likely
to differ in the specific alterations of various structural elements.  Studies
are needed to define the multiple components/locations of the structural
abnormalities which may exist in the different subgroups of asthmatics.  The
relationship between these abnormalities and the deterioration in lung function
and/or diminished reversibility of airway obstruction experienced by some
patients with asthma also needs to be clarified.

3. Pathogenetic events involved in airway remodeling in asthma:

The cellular and molecular events underlying the fibrotic, myocyte/myofibroblast
and epithelial alterations characteristic of the remodeled asthmatic airway are
poorly understood, as well as their exact functional consequences.  It is now
believed that airways hyperresponsiveness, the hallmark of asthma, may be, in a
large part, the consequence of the inflammation and subsequent structural changes
in the airways. Hence, what is the relationship of inflammation and these
structural changes in the airway to the development of airways
hyperresponsiveness?  How is mucous gland and goblet cell differentiation,
proliferation, and secretion regulated in the lung?  What is the relationship of
inflammation to airway remodeling.  Do immune responses contribute to these
processes?  How does airway remodeling contribute to the chronicity, severity,
and physiologic alterations of asthma.  Is oxidantant and/or NO-mediated injury,
chronic antigen exposure, and the interactions of viruses and antigens important
in the mediation of these processes?  Which cytokines and other mediators are
involved in the pathogenesis of the fibrotic/extracellular matrix response and
the myocyte, myofibroblast and epithelial (goblet cell) abnormalities in the
remodeled asthmatic airway?  What role do proteases play in the generation of
airway injury and repair?

It is known that the fibrotic response in the interstitium is heightened by
interventions that block the proliferation of alveolar type II cells and their
eventual differentiation into type I cells.  Is re-epithelialization of the
airway a crucial event that determines the degree of fibrosis that occurs in
response to a given injury?  If so, what are the events involved in epithelial
repair?  Which cytokines and other mediators stimulate epithelial proliferation
and differentiation?  What is the stem cell(s) in the airway, if any?  How does
this stem cell(s) allow epithelial repair to occur with the restoration of an
appropriate frequency and distribution of ciliated vs non-ciliated and goblet

Information is also required concerning the role of development in the generation
of the remodeling response, and the types of interventions that can block it. 
Attention must be directed toward therapeutic interventions against all of the
features of the remodeling response including fibrosis, myocyte and myofibroblast
abnormalities and epithelial alterations.  Additionally, the effects of these
interventions on the physiologic consequences of this response need to be
defined. Since early childhood events play a crucial role in the development of
chronic asthma, it is important to determine whether there are crucial periods
in respiratory development at which injury predisposes to severe remodeling

4.  Genetics factors in airway remodeling:

There is a significant variability in host response to stimuli that cause airway
remodeling.  Recent studies have demonstrated that genetic polymorphisms exist
that can explain variations in host responses to injury and pharmacologic
intervention.  It is important to determine whether there are genetic
explanations for the variations in the extent and severity of airway remodeling. 
For example, are there polymorphisms in the promoters of genes encoding matrix
molecule, matrix degrading enzymes etc., that predict the severity of these
responses?  Are the genes that determine susceptibility to fibrosis in the
pulmonary interstitium ( for example: bleomycin susceptibility) also relevant to
the fibrotic response in the airway?

5.  Development of models for airway remodeling in asthma:

Animal models of asthma have, to date, focused almost exclusively on acute airway
inflammation and physiologic dysregulation.  Very few models that reproduce the
pathologic features of the remodeled asthmatic airway have been developed and
characterized.  There is a particular need for models that investigate the
relationship between immune events and airway remodeling, as well as the relation
between viral infection and airway remodeling.  In addition, models (such as
transgenic models) that allow direct cause and effect relationships to be defined
and allow individual features of airway remodeling (i.e., sub-epithelial
fibrosis, myocyte, myofibroblast abnormalities, epithelial alterations) to be
generated need to be established and characterized.  Also, computerized models
of asthma that explore the impact of the various structural alterations on airway
function need to be developed.

These are examples only.  Investigators should not feel limited to the subjects
mentioned above and are encouraged to submit other topics pertinent to the
objectives of the RFA.

Although studies involving humans and/or human materials are preferable,
investigations with mammalian models that provide convincing evidence they are
relevant to asthma will also be suitable for addressing the mechanistic
information sought in this RFA.


Upon initiation of the program, the NHLBI will sponsor periodic meetings to
encourage exchange of information among investigators who participate in this
program.  Travel funds for a one day meeting each year, most likely to be held
in Bethesda, Maryland, should be included in the modules.  Applicants should also
include a statement in their applications indicating their willingness to
participate in these meetings.

Applications that propose descriptive studies and do not contain hypothesis
driven studies directed at understanding the mechanisms associated with airway
remodeling and repair in asthma will not responsive to the RFA.  Applications
that focus on these mechanisms at the molecular level are of particular interest. 
Studies in human subjects are strongly encouraged, but large clinical studies or
long term (greater than 4 years) epidemiology studies are not within the scope
of this RFA.  Applicants who propose to test hypotheses in animal or in vitro
models must provide a strong rationale for relevance to the human and to asthma. 
This program will not support studies solely directed at development of animal
models unaccompanied by mechanistic studies that address the goals of this RFA.


It is the policy of the NIH that women and members of minority groups and their
subpopulations must be included in all NIH supported biomedical and  behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification is 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 follow the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research", which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513), and in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18,
1994, Volume 23, Number 11.

Investigators also may obtain copies of the policy from the program staff listed
under INQUIRIES.  Program staff may also provide additional relevant information
concerning the policy.


It is the policy of the 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 is available at the following URL address:


Prospective applicants are asked to submit, by January 6, 1999, a letter of
intent that includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the identities of
other key personnel and participating institutions, and the number and title of
the RFA in response to which the application may be submitted.  Although a letter
of intent is not required, is not binding, and does not enter into the review of
subsequent applications, the information that it contains allows NHLBI staff to
estimate the potential review workload and to avoid conflict of interest in the
review.  Applicants without prior R01 support are urged to identify themselves
in the letter of intent.

The letter of intent is to be mailed or faxed to Dr. C. James Scheirer, at the
address listed under INQUIRIES.


The research grant application form PHS 398 (rev. 4/98) is to be used in applying
for these grants, with the modifications noted below.  These forms are available
at most institutional offices of sponsored research; 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:; and on the Internet at

The RFA label available in the PHS 398 (rev. 4/98) application form must be
affixed to the bottom of the face page of the application.  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.  In addition, the RFA title
(Airway Remodeling and Repair in Asthma) and number (HL-99-005) must be typed on
line 2 of the face page of the application form and the YES box must be marked.


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:

As a reminder, Items 7a and 8a should be completed to indicated Modular Direct
Costs requested and Items 7b and 8b should reflect Total Costs (Modular Direct
plus F&A costs).  Item 7 should reflect costs for the Initial Budget Period and
item 8 should reflect costs for the Total Budget Period.

Do not complete Form Page 4 of the PHS 398 (rev 4/98).  It is not required nor
will it be accepted at the time of application.

Do not complete the categorical budget tables on page 5 of the PHS 398 (rev.
4/98) Form.  Only the requested total direct costs line for each year should be
completed based on the number of $25,000 modules being requested.  Applicants may
not request a change in the amount of each module.  A maximum of 9 modules
($225,000 direct cost) per year may be requested for each R01 application. 
Applicants may request for up to four years of support for this RFA.  Direct cost
budgets will remain constant throughout the life of the project (i.e., the same
number of modules requested for all budget periods).  Any necessary escalation
should be considered when determining the number of modules to be requested. 
However, in the event that the number of modules requested must change in any
future year due to the nature of the research proposed, appropriate justification 
must be provided.  Total Direct Costs for the Entire Proposed Project Period
should be shown in the box provided.


o  Budget justifications should be provided under "Justifications" on Form Page
5 of the PHS 398.

o  List the names, role on the project and proposed percent effort for all
project personnel (salaried or unsalaried)and provide a narrative justification
for each person based on his/her role on the project.

o  Identify all consultants by name and organizational affiliation and describe
the services to be performed.

o  Provide a general narrative justification for individual categories
(equipment, supplies, etc.) required to complete the work proposed.  More
detailed justifications should be provided for high cost items.  Any large
one-time purchases, such as large equipment requests, must be accommodated within
these limits.


If collaborations or subcontracts are involved that require transfer of funds
from the grantee to other institutions, it is necessary to establish formal
subcontract agreements with each collaborating institution.  A letter of intent
from each collaborating institution should be submitted with the application. 
Only the percentage of the consortium/contractual TOTAL COSTS (direct and
facilities and administrative costs) relative to the total DIRECT COSTS of the
overall project needs to be stated at this time.  The following example should
be used to indicate the percentage cost of the consortium, "The consortium
agreement represents 27% of overall direct costs requested in the first year." 
A budget justification for the consortium should be provided as described in the
"Budget Justification" section above (no Form Page 5 required for the
consortium).  Please indicate whether the consortium will be in place for the
entire project period and identify any future year changes in the percentage
relative to the parent grant.

If there is a possibility of an award, the applicant will be requested to
identify actual direct and indirect costs for all years of the consortium. Please
note that total subcontract costs need not be calculated in $25,000 modules.
However, when subcontract funds are added to the parent grant budget, the total
direct cost amount must be included in the number of $25,000 modules requested.


A biographical sketch is required for all key personnel, following the modified
instructions below.  Do not exceed the two-page limit for each person.

o Complete the educational block at the top of the form page;

o List current position(s) and those previous positions directly relevant to the

o List selected peer-reviewed publications directly relevant to the proposed
project, with full citation;

o The applicant has the option to provide information on research projects
completed and/or research grants participated in during the last five years that
are relevant to the proposed project.

OTHER SUPPORT - Do not complete the "Other Support" pages (Form Page 7). 
Selected other support information relevant to the proposed research may be
included in the Biographical Sketch as indicated above.  Complete Other Support
information will be requested by NHLBI staff if there is a possibility for an


No "Checklist" page is required as part of the initial application.  A completed
Checklist will be requested by NHLBI staff if there is a possibility for an

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.

Applications not conforming to these guidelines will be considered unresponsive
to this RFA and will be returned without further review.

Submit a signed, typewritten original of the application and three signed,
photocopies, in one package to:

BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must be sent
to Dr. C. James Scheirer, at the address listed under INQUIRIES.

Applications must be received by February 24, 1999.  If an application is
received after that date, it will be returned to the applicant without review. 
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.  The CSR
will not accept any application that is essentially the same as one already
reviewed.  This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an introduction
addressing the previous critique.


Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by NHLBI.  Incomplete and/or unresponsive applications
will be returned to the applicant without further consideration.  Applications
that are complete and responsive to the RFA may be subjected to a streamlined
review process by a Special Emphasis Panel convened by NHLBI Scientific Review
Office to determine their scientific merit relative to other applications
received in response to the RFA.  The roster of reviewers for the RFA will be
available on the NHLBI home page approximately four weeks prior to the scheduled
review date.  Applications determined to be meritorious will be evaluated for
scientific and technical merit by the review committee, be discussed and receive
a priority score.  All other applications will not be discussed or scored. 
Secondary review of the applications will be conducted by the National Heart,
Lung, and Blood Advisory Council (NHLBAC).

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  In the
written review, comments on the following aspects of the application will be made
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 in the assignment of the overall score.

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

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 technologies?

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?

As part of the scientific and technical merit evaluation of the research plan,
reviewers will be instructed to address the adequacy of plans for including both
genders, minorities and their subgroups, and children as appropriate for the
scientific goals of the research, or justification for exclusion.

The personnel category will be reviewed for appropriate staffing based on the
requested percent effort.  The direct costs budget request will be reviewed for
consistency with the proposed methods and specific aims.  Any budgetary
adjustments recommended by the reviewers will be in $25,000 modules.  The
duration of support will be reviewed to determine if it is appropriate to ensure
successful completion of the requested scope of the project.


Applicants should be aware that, in addition to scientific merit, program
priorities and program balance, the total costs of the proposed project and the
availability of funds will be considered by NHLBI staff as well as
NHLBAC in making funding recommendations.  In circumstances in which
applications have similar scientific merit, but vary in cost competitiveness,
NHLBI is likely to select the more cost competitive application for


Letter of Intent Receipt Date:    January 6,1999
Application Receipt Date:         February 24, 1999
Date of Initial Review:           June/July 1999
Review by NHLB Advisory Council:  September 1999
Anticipated Award Date:           September 1999


Inquiries concerning this RFA are encouraged.  Potential applicants may request
sample budget pages.  The opportunity to clarify any issues or questions from
potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Susan Banks-Schlegel, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10018, MSC 7952
Bethesda, MD  20892-7952
Telephone:  (301) 435-0202
FAX:  (301) 480-3557

Direct inquiries regarding review matters, address the letter of intent, and mail
two copies of the application to:

C. James Scheirer, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7220, MSC 7924
Bethesda, MD  20892-7924
Telephone:  (301) 435-0266
FAX:  (301) 480-3541

Direct inquiries regarding fiscal matters to:

Raymond L. Zimmerman
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7154, MSC 7926
Bethesda, MD  20892-7926
Telephone:  (301) 435-0171
FAX:  (301) 480-3310


This program is described in the Catalog of Federal Domestic Assistance, No.
93.838.  Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410, amended by Public Law 99-158, 42 USC 241 and
285) and administered under PHS grants policies and Federal Regulations 42 CFR
52 and 45 CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or a Health Systems Agency Review.

The PHS 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

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