Full Text HD-93-09


NIH GUIDE, Volume 21, Number 28, August 7, 1992

RFA:  HD-93-09

P.T. 34


National Institute of Child Health and Human Development

Application Receipt Date:  January 7, 1993


The Human Learning and Behavior Branch (HLB) of the Center for Research
for Mothers and Children (CRMC) of the National Institute of Child
Health and Human Development (NICHD) invites research grant
applications to develop new knowledge in the area of treatment
effectiveness for learning disabled children who display primary
deficits in oral and written language abilities including disabilities
in listening, speaking, reading, and written language skills.  The
research emphasis must be placed on the identification, development,
and implementation of treatment/intervention conditions that have
effects on specific deficits in component oral language abilities
(e.g., phonology, semantics, syntax), written language abilities (e.g.,
word attack skills, word recognition skills, reading comprehension,
spelling behavior, written expression skills), and the relationships
between them (e.g., compound disabilities in phonology, word attack
skills, spelling, and written expression).  However, children with
comorbid deficits in attention, mathematics, behavioral, and social
competencies should also be studied in the process.

The goal of this Request for Applications (RFA) is to encourage
treatment/intervention research on children with learning disabilities
who are well-defined in terms of age, gender, ethnicity, socio-economic
status, primary learning disability, comorbid disabilities (e.g., ADD;
mathematics disability), severity of disability(ies), intensity and
duration of previous and current interventions, familial and/or genetic
findings, physical/neurological findings, intellectual status,
cognitive-linguistic status, neurophysiological/neuropsychological
status, educational status, and social/behavioral competencies.

Some of the specific research question to be addressed are:

o  Which single treatment/intervention model or combination of models
(e.g.,individualized intervention, small-group intervention,
large-group intervention, computer-assisted instruction) and which
single or multimodal approaches and/or methods (e.g., direct
instruction, mastery learning, phonemic awareness training, alphabetic
methods, analytic phonics methods, process approaches,
neurodevelopmental approaches, whole language approach);

o  provided in which setting or combination of settings (e.g., public
school, private school, clinic,) and under what type of time-on-task
conditions (intensity and duration);

o  have the most effective impact on well-defined domains of child
functioning (e.g., academic, cognitive, social/behavioral,
neurophysiological, neuropsychological);

o  for how long (short vs. long term); and

o  for what reasons (educational, environmental, behavioral,
neurophysiological, psychological processes underlying change and


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.  Of the 3000
such objectives, 170 address the public health needs of children and
adolescents.  This RFA, Research on Treatment Effectiveness for
Learning Disabled (LD) Children, specifically addresses the priorities
that are related to learning problems and psychosocial interventions in
children.  Potential applicants may obtain a copy of "Healthy People
2000" (Full Report:  Stock No. 017-001-474-0, or Summary Report:  Stock
No. 017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone


Applications may be submitted by domestic, public and private,
non-profit and for-profit organizations such as universities, colleges,
hospitals, schools, laboratories, units of State and local governments,
and eligible agencies of the Federal Government.  Women and minority
investigators are encouraged to apply.


The support mechanism for this RFA is the Individual Research Grant
(R01).  Policies that govern are those of the grant-in-aid award
programs covered by the PHS.  Responsibility for the planning,
direction, and execution of the proposed project will be solely that of
the applicant.  The total project period for applications submitted in
response to this RFA may not exceed five years.


The NICHD has set aside $600,000 for direct costs for the first year of
support.  It is anticipated that two awards will be made.  This level
of support is dependent on the receipt of a sufficient number of
applications of high scientific merit.  Although this program is
provided for in the financial plan of the NICHD, awards pursuant to
this RFA are contingent upon the availability of funds for this



The NICHD has had a long standing interest in the study of learning
disabilities and disorders that adversely affect the development of
listening, speaking, reading, and writing abilities in approximately 10
to 15 percent of children in the United States.  Since its inception in
1963, the NICHD has funded research to delineate the basic biological
and behavioral mechanisms that underlie specific deficits in attention,
perception, language, cognition, and academic skills, particularly
reading.  In January of 1987, a National Conference on Learning
Disabilities, co-sponsored by the Interagency Committee on Learning
Disabilities (of which the NICHD was designated as the lead agency) and
the Foundation for Children with Learning Disabilities, was held on the
NIH campus.  The proceedings of this conference were combined with
other sources to provide a comprehensive document titled Learning
Disabilities:  A Report to the U.S. Congress (1987).  A major
recommendation included in this report called for a systematic effort
to develop rigorous research strategies and intervention trials to
examine the response of learning disabled children to different forms
of treatment.

In 1990, the NICHD supported a planning conference in Racine, Wisconsin
to review ongoing NICHD-supported comprehensive longitudinal studies
designed to classify and define learning disabilities.  In addition,
efforts at this conference were made to conceptualize the scope, goals,
and objectives for research programs to identify and/or develop
treatment intervention programs that could enhance the development of
oral and written language abilities in well-defined groups and
subgroups of LD children.  This RFA can be thought of as an expression
of both the NICHDs long-standing commitment to learning disabilities in
general, as well as the NICHDs specific commitment to the 1990 planning
of intervention studies.


The specific focus of this RFA on treatment/intervention studies with
LD children between the ages of six and twelve who manifest primary
deficits in oral and written language, is related to the current
understanding of the developmental nature of reading and writing
disabilities.  The past decade has seen a significant increase in
knowledge related to the relationship between deficits in component
oral language abilities (e.g., phonology, semantics, syntax),
orthographic capabilities, and reading (e.g., word attack/decoding word
recognition, comprehension) and written language (spelling,
formulation/composition, expression) deficits.  More specifically, a
great deal is now known about which linguistic, perceptual, and word
recognition (orthographic) mechanisms are related to the development of
accurate and fluent reading and writing abilities.  Moreover, there now
exists a substantial body of information related to how best to account
for the heterogeneity and levels of severity within samples of LD
readers and writers.  This progress will allow investigators to define
their samples for study according to rigorous criteria related to
critical marker variables.  In addition, a review of current prevalence
studies suggest that 60 to 80 percent of identified LD children
manifest primary deficits in language-based reading deficits.  In
contrast, current knowledge related to the developmental course and
diagnostic characteristics of children who display primary deficits in
mathematics and/or social competencies is less well developed, and
intervention research at the proposed level of complexity within this
RFA must await a broadening and strengthening of the scientific footing
upon which treatments for these primary domain deficits could be based.

Research Population

Learning Disabled children between the ages of six and twelve with
primary deficits in component oral and written language abilities that
are related to well-defined disabilities or combinations of
disabilities in phonological skills, semantic skills, syntactic skills,
word-attack skills, orthographic skills, spelling abilities, and
written composition skills should constitute the population of interest
for this research program.  It is expected that not all children within
the samples selected for study will manifest the entire range of oral
and written language deficits mentioned above.  More specifically,
within any sample chosen for study, there are likely to be subgroups
with significantly different patterns of comorbidity, levels of
severity, and psychological processing deficits.  As such, applicants
should consider research protocols that are capable of identifying
well-defined subgroups and subtypes that exist within the sample.
Investigators should also consider casting the sampling net wide enough
to ensure a representative number of subtypes and contrast groups
within the study population.  For example, of interest are subtypes of
dyslexic children of varying intellectual abilities, with primary
deficits in word attack/decoding and/or comprehension skills, who
display a single comorbid deficit or a combination of comorbid deficits
in attention, oral language, mathematics, behavioral, and social
competencies; subtypes of dyslexic children without comorbid deficits,
and subtypes of children with and without comorbid deficits whose
reading and writing deficits are associated with known
pathophysiological factors or neuroencephalopathic events (e.g., head
injury, neoplasm, post surgical complications).

Subject Selection Criteria

The samples for study should be rigorously defined so that complete
replication at another site can be accomplished.  Within this context,
applicants should provide clearly documented and operationalized
definitions for their subject selection criteria.  These definitions
and criteria must be specified in an a priori manner.  The selection of
"school-identified" or "clinic-identified" learning disabled children
is clearly discouraged unless the diagnostic characteristics in these
cases matches the applicant's a priori established selection criteria.
Likewise, criteria for selection of contrast group(s) should be
specified in an a priori manner.

All children selected for study must be defined with reference to age,
gender, grade level, length of time in special education placement,
type of current special education placement, previous special education
placement(s) including intensity and duration, ethnicity,
socio-economic status, primary learning disability, comorbid
disabilities, severity of disability, familial and/or genetic findings,
physical/neurological findings, intellectual status,
cognitive-linguistic status, neurophysiological/neuropsychological
status, levels of academic achievement in reading, mathematics, and
written language, and presence or absence of attention deficit

Measurement Criteria

Standardized tests, laboratory tasks, observational measures, and other
assessment procedures (e.g., dynamic assessment procedures) must be
selected on the basis of known reliability and validity and
appropriateness for the population under study.  If reliability and
validity characteristics are not yet known for a particular assessment
or measurement procedure, the application should contain specific plans
for establishing these features.  The valid measurement of change over
time is critical to the research called for in this RFA since treatment
effectiveness is of primary concern.  As such, applicants should be
aware of, and utilize robust procedures for, separating treatment
effects from the effects of development in general.  The use of growth
models and longitudinal data are encouraged as is the collection of
sufficient data prior to the onset of treatment(s) to allow estimation
of pre- and post-treatment growth curves.  Measurement should also be
carried out across several time points.


Review of the literature related to dyslexia and other learning
disabilities suggests that no single treatment/intervention approach or
method is likely to yield clinically significant, long-term,
therapeutic gains in heterogeneous groups of LD children.  Likewise,
even in homogeneous groups of disabled readers (dyslexics) matched on
well-defined criteria such as age, IQ, socio-economic status, and
opportunity to learn, members differ significantly in their development
of requisite skills (e.g., phonological awareness) that are
significantly related to the development of fluent and automatic basic
reading and written language skills.  This suggests that not all
children fail to develop oral and written language skills for the same
reasons and, as such, will not respond equally well to the same
treatment or multi-modality approach.

Unfortunately, to date, there exists scant scientific support for the
use of particular treatment/interventions or combination of treatments
with different types of oral and written language disabilities.  There
are several factors that contribute to limitations in documented
treatment efficacy for LD children, and these factors should be
considered in the design of subsequent treatment studies:

First, many studies addressing the efficacy of different
treatment/intervention methods and approaches for LD individuals have
studied heterogeneous groups of children who were identified according
to vague and inconsistent criteria, and who demonstrated unaccounted
for differences in demographic background features, number and degree
of comorbid disabilities, and severity of primary and comorbid
disabilities. As such, not only have replication efforts been negated,
but it has been impossible to determine specific treatment effects and
outcomes due to the possible influence of uncontrolled nuisance
variables.  Moreover, this lack of description with respect to the
children's background and academic and information processing
characteristics have made it difficult to identify which
treatment/intervention methods are indicated and/or contra-indicated
for which children, under what conditions.

Second, many studies of LD children's response to treatment models,
approaches, and methods have employed intervention procedures that are
poorly described and defined.  For instance, few intervention studies
critically describe how and why treatment/intervention stimuli are
represented to the child.  In addition, the type of response that the
treatment/intervention procedure requires of the child is rarely
defined in detail.  In treatment/intervention investigations involving
reading disorders, few studies have provided sufficient detail with
respect to the following critical questions:  What is the nature of the
vocabulary?  Is vocabulary controlled?  On what basis were the words
used in the treatment protocol selected?  Do the word stimuli possess
a consistent phoneme-grapheme relationship?  How many meaningful nouns
and verbs are used?  What is the nature of the sentence structure?  Is
the sentence structure similar to the child's language?  What is the
nature of the content of the reading material?  Is the material
relevant to the child's background?  Are the sound and word decoding
strategies that are utilized analytic or synthetic in nature?  Does the
treatment/intervention require deductive or inductive cognitive
operations, or both?

Unless sufficient descriptive data are available to answer these types
of questions, replication and an understanding of the critical
variables necessary for positive response to treatment/intervention
will be difficult to ascertain.

Third, treatment/intervention studies that employ models, approaches,
or methods that have several components or procedures rarely report
which component or procedure or which combination of procedures are
most critical to promoting gains in learning at different developmental
stages during the learning process for different types of youngsters
with LD.  Likewise, treatment studies employing multimodal
interventions frequently fail to identify how and why the different
interventions are selected and the roles that the different
interventions play in achieving treatment gains.  This information is
critical since some children with LD may require a stronger emphasis on
particular components of the intervention program given their
particular array of cognitive, linguistic, neuropsychological,
behavioral, and attentional characteristics.

Fourth, the majority of treatment/intervention studies conducted with
youngsters with LD have been relatively short-term in duration.  As
such, when limited effects of a treatment or combination of treatments
are reported, it is not clear whether the limited efficacy is due to
the treatment itself or to the fact that it was employed for a duration
that was too short to promote long-term change, no matter how robust
the intervention.  Moreover, it is likely that even the most powerful
treatments or combination of treatments may not result in measurable
effects during or immediately following specific durations of
intervention, if such effects are assessed by static measures or within
too short a timeframe.  As such, measurement methodologies must be
employed that are capable of assessing fine grained changes in child
functioning across several domains over a well defined period of time.

Fifth, many treatment studies assessing the effectiveness of different
interventions may have been confounded by the effects of previous and
concurrent interventions.  It is unclear whether a history of a
particular type of treatment(s) significantly influences response to an
ongoing intervention.  It is also not well understood whether
concurrent interventions or programs being conducted in regular or
special classroom settings influence response to ongoing experimental
treatments.  These issues must be addressed in order to separate
specific treatment effects from contaminating practice or inhibitory
effects produced by historical or concomitant interventions.

Sixth, a significant number of treatment studies involving children
with LD have not separated specific intervention or program effects
from clinician or teacher effects.  That is, limited attention has been
paid to delineating those teacher and environmental variables that can
account for change within any treatment program.  What content,
assessment, teaching and behavior management capabilities do successful
clinicians and teachers possess that less successful ones do not?  How
do these clinician/teacher characteristics interact with the magnitude
and generalization of change?

Seventh, it is not clear from the existing treatment literature whether
or not gains in oral and written language skills developed under highly
controlled intervention conditions generalize to less controlled
naturalistic settings.  As such, follow-up studies of treatment
benefits have typically shown a decrease in treatment gains,
particularly when measurements are taken in settings that are different
from those employed in the original treatment trials.  Issues related
to the generalization and maintenance of treatment effects should be

Rationale and Research Questions

A critical public health task confronting the field of learning
disabilities is to understand and define the treatment/intervention
variables and factors that have to be considered when addressing the
oral and written language needs of children with LD.  There exists an
immediate and compelling need to develop intervention protocols that
increase the probability that individuals with well-defined LD will
acquire proficient reading and written language skills as well as the
skills that are related to these developmental learning processes.  To
this end, examples of research questions and areas that need to be
addressed are provided below.  These examples are illustrative but not

1.  How do deficits in information processing abilities (e.g.,
phonological processing, listening comprehension, visual perception,
orthographic processing and memory, spatial and temporal processing)
interact with well-defined treatment/interventions to develop specific
skills, concepts, and/or strategies?  Are certain interventions more
efficacious with certain processing profiles?  Can type and severity of
processing deficit predict response to intervention?

2.  How does comorbidity affect response to different treatment models,
approaches, methods?  For example, do children with dyslexia and
attention deficit disorder show a different response to treatment(s)
than dyslexic children without attention deficit disorder?  Do children
with combined deficits in oral language (e.g., phonology), written
language (reading, spelling), and other academic skills (e.g.,
mathematics) require different types of intervention, levels of
intensity, and greater duration in treatment than children without such

3.  Are different deficits in component oral language skills (e.g.,
phonology, semantics, syntax) related to different reading and written
language disabilities?  For example, do phonological deficits predict
deficits in word attack skills or word recognition skills or both?  Are
semantic deficits more related to word recognition deficits than are
phonological deficits?  Are different treatment/interventions required
to produce maximum benefits with these different constellations of oral
and written language deficits?

4.  Is there differential treatment response by gender?  By
socio-economic status?  By comorbidity?  Do type and level of severity
of processing deficit, comorbidity, SES, and gender interact with
treatment response?

5.  Are combined or tailored treatment/intervention approaches more
efficacious than "packaged" programs?  If so, with which types of
children and at what age?

6.  Are synthetic phonics approaches more efficacious than analytic
phonics approaches in the treatment of dyslexia?  Do these different
approaches have different probabilities of success depending on the
background, demographic, and diagnostic features of the child?

7.  Are code-emphasis treatment approaches (e.g., alphabetic
approaches) more efficacious than meaning-emphasis approaches (e.g.,
whole language approaches) in the treatment of dyslexia?  If so, do
different subtypes respond differentially to these approaches?  Is a
combination of these approaches warranted?

8.  How is generalization of treatment effects best accomplished across
settings?  What critical conditions must be in place in order to
transfer skills learned in highly intensive treatment settings to less
intensive settings?

9.  How do affective variables relate to the acquisition of oral and
written language skills?  Likewise, how do motivational factors
interact with response to treatment?

10.  How do previous and concurrent treatments affect response to

11.  What correlations exist between type of processing deficits,
severity of deficits, degree of comorbidity, response to intervention,
and neurophysiological and neuropsychological status?

12.  Are positive responses to treatment for component oral and written
language deficits accompanied by changes in neurophysiological,
neuropsychological, affective, social, and attentional status?

13.  What declarative and procedural knowledge must clinicians and
teachers possess to maximize treatment response in children with LD?
How is this knowledge best developed?

14.  Are there decision making frameworks or clinical heuristics that
can be used to guide treatment and to enhance efficacy?  How are these
frameworks best developed and implemented?

15.  How can treatment success and efficacy best be measured?  How are
growth curves best assessed?  Are static or dynamic measures best
suited for the monitoring of treatment effects?

16.  It is likely that treatments will involve several components.  How
and when are component analyses developed and used to interpret
treatment effects?

17.  Are well-defined treatments for oral and written language
disorders manifested by children with LD equally efficacious for
children whose oral and written language deficits are related to
head-injury?  Lower cognitive ability?  SES?  Lack of exposure to



The research subjects will be boys and girls between the ages of six
and twelve years-of-age.  Investigators are encouraged to study male
and female children varying in their racial and socio-economic

NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be required to include
minorities and women in study populations so that research findings can
be of benefit to all persons at risk of the disease, disorder or
condition under study; special emphasis should be placed on the need
for inclusion of minorities and women in studies of diseases, disorders
and conditions which disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of the
study.  This information should be included in the form PHS 398 in
Sections 1-4 of the Research Plan AND summarized in Section 5, Human

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However, NIH
recognizes that it may not be feasible or appropriate in all research
projects to include representation of the full array of United States
racial/ethnic minority populations (i.e., Native Americans (including
American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks,

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology, prevention
(and preventive strategies), diagnosis, or treatment of diseases,
disorders or conditions, including but not limited to clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the selected
study population is inadequate, it will be considered a scientific
weakness or deficiency in the study design and will be reflected in
assigning the priority score to the application.

All applications for clinical research submitted to NIH are required to
address these policies.  NIH funding components will not award grants
or cooperative agreements that do not comply with these policies.


Applications are to be submitted on PHS form 398 (rev. 9/91).  This
application form is available in the business or grants and contracts
office at most academic and research institutions and from the Office
of Grants Inquiries, Division of Research Grants, NIH, Westwood
Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441.  The
receipt deadline for applications prepared in response to this RFA is
January 7, 1993.  Late applications will not be accepted.

The RFA label available in the PHS 398 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, Research on Treatment Effectiveness for Learning
Disabled (LD) Children, and the RFA number must be typed on line 2a of
the face page of the application form and the YES box must be marked.

The original and three copies of the application must be sent or
delivered to:

Office of Grants Inquiries
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two copies of the application must be sent
under separate cover to:

Laurance Johnston, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
9000 Rockville Pike
Bethesda, MD  20892


Upon receipt, applications will be reviewed by staff of the NICHD for
responsiveness to the RFA.  Applications deemed non-responsive will be
returned to the applicant.  In the event that an application is
returned, the applicant has the option to resubmit the application to
the Division of Research Grants as an unsolicited application during
one of the three yearly review cycles (February 1, June 1, October 1).
If the application submitted in response to this RFA is substantially
similar to a grant application already submitted to the NIH for review,
but 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 cannot be submitted in response to this RFA
that is essentially identical to one that has already been 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.

Responsive applications may be evaluated by preliminary triage in a
peer review group to determine the scientific merit relative to other
applications received in connection with this RFA.  Applications judged
to be non-competitive will not be considered further.  The Principal
Investigator and his/her institutional business official will be
notified in such instances.  Those applications judged to be
competitive will be further evaluated for technical and scientific
merit by a peer review panel convened for this purpose by the Division
of Scientific Review, NICHD.

Review criteria will be those customarily used by the NIH to evaluate
investigator-initiated R01 applications, including:

o  Thorough knowledge of the scientific literature in appropriate

o  Scientific, technical, or medical significance and originality of
the proposed research;

o  Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  Qualifications and research experience of the Principal

o  Appropriateness of the proposed budget and duration in relation to
the proposed research.

Following evaluation by the initial review group, all applications will
be reviewed by the National Advisory Child Health and Human Development


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

Requests for additional programmatic information may be addressed to:

G. Reid Lyon, Ph.D.
Human Learning and Behavior Branch
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
9000 Rockville Pike
Bethesda, MD  20892
Telephone:  (301) 496-6591

Direct inquiries regarding fiscal and administrative matters to:

E. Douglas Shawver
Office of Grants and Contracts
National Institute of Child Health and Human Development
9000 Rockville Pike
Bethesda, MD  20892
Telephone:  (301) 496-1303


This program is described in the Catalog of Federal Domestic Assistance
No. 93.865, Research for Mothers and Children.  Awards are made under
authorization of the Public Health Service Act, Title IV, Part A
(Public Law 78-410, as 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.  Awards are also made under authorization
of PHS Act, Title V, Part B.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health System Agency review.


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