This Program Announcement expires on October 5, 2004, unless renewed.


Release Date:  October 11, 2001

PA NUMBER:  PA-02-012

National Institute on Alcohol Abuse and Alcoholism (NIAAA)



The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking 
research grant applications on the clinical use of behavioral therapies for 
alcoholism treatment.  The term “behavioral therapy” is used broadly to 
include a range of nonpharmacological therapies including cognitive-behavioral 
therapy, motivational enhancement therapy, twelve-step facilitation, marital 
and family therapy, community-reinforcement approach, contingency management, 
and brief intervention. To further advance the field of behavioral therapies, 
several research areas have been identified and include developing new 
innovative therapies; creating or refining behavioral techniques for the 
engagement, retention, and adherence of patients in treatment; developing 
therapies to manage precipitants of relapse; investigating the effectiveness 
of behavioral therapies in group settings; and combining and sequencing of 
behavioral and pharmacological treatments. It is recommended that the 
development and formulation of new therapies or the refinement of existing 
therapies be first tested as small-scale pilot studies prior to conducting 
clinical efficacy trials. All applications submitted in response to this 
program announcement should be conducted in humans.


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 Program Announcement (PA) is 
related to one or more of the priority 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, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government.  Faith-based organizations are eligible to 
apply for these grants.  Racial/ethnic minority individuals, women, and 
persons with disabilities are encouraged to apply as principal investigators.


This PA will use the National Institutes of Health (NIH) research project 
grant (R01), exploratory/developmental grant (R21), and small grant (R03)award 
mechanisms.  Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant.  The total project 
period for an application submitted in response to this PA may not exceed five 
(5) years.  Facilities and Administrative (F&A) costs will be awarded based on 
the negotiated rate at the time of the award.  More detailed information on 
the R21 mechanism can be found at 

Applications requesting direct costs of $500,000 or more in any one year must 
obtain written agreement from the NIAAA that the application will be accepted 
for consideration of award, in accordance with NIH policy, which is available 
at Currently, 
small grants (R03) are limited to 2 years for up to $50,000 per year for 
direct costs, and exploratory/developmental grants (R21) are limited to 
$100,000 per year for direct costs for up to 3 years. 
Exploratory/developmental grants cannot be renewed: however, a no-cost 
extension of up to one year may be granted prior to expiration of the project 
period.  Investigators are encouraged to seek continued support after 
completing an exploratory/developmental grant project through a research 
project grant (R01).

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



Most of the treatments available in the U.S. for alcoholism have been 
behavioral in nature.  A large number of clinical trials conducted over the 
past 15 years have demonstrated effectiveness for several types of behavioral 
therapies, including cognitive behavioral therapy, motivation enhancement 
therapy, marital family therapy, brief interventions, and community-
reinforcement approach (Hester and Miller, 1995; Fuller and Hiller-Sturmhofel, 
1999; National Institute on Alcohol Abuse and Alcoholism, 2000). 

Cognitive behavioral coping-skills therapy which aims to improve the patient’s 
skills for changing their problematic drinking behavior, has been successful 
in improving treatment outcome in alcoholic patients (Longabaugh and 
Morgenstern, 1999). Nonetheless, it has been suggested that its effectiveness 
can be increased by integrating it with components of other treatment 
approaches, such as motivational interviewing (Longabaugh and Morgenstern, 
1999).  This strategy is currently being implemented and tested by COMBINE, an 
ongoing 11-site randomized clinical trial, conducted as a cooperative 
agreement by NIAAA. 

Motivational enhancement therapy was developed in Project MATCH and involves 
strategies to motivate patients to stop or reduce their drinking. 
Surprisingly, motivational enhancement therapy proved nearly as effective as 
the more intensive cognitive behavioral and twelve-step facilitation therapies 
in reducing the frequency and amount of drinking in alcohol dependent patients 
(Project MATCH Research Group, 1998).  Motivational interviewing, a component 
of the motivational enhancement therapy, also appears to aid engagement and 
retention of patients in treatment (DiClemente et al., 1999; Miller, 1995).

Twelve-step facilitation interventions have been demonstrated to be effective 
in promoting abstinence and in increasing patient’s involvement in Alcoholics 
Anonymous (AA) programs (Humphreys, 1999).  Results from Project MATCH showed 
that AA attendance was associated with more favorable treatment outcomes in 
all three therapies (Project MATCH Research Group, 1998).

Brief interventions have been successful in reducing drinking levels in 
patients at risk for or experiencing alcohol-related problems (Fleming and 
Manwell, 1999; Wilk et al., 1997; Bien et al., 1993). The therapy consists of 
providing brief counseling to patients by a physician or nursing staff in five 
or less office visits.  

Marital family therapy appears helpful in enhancing treatment retention and 
improving drinking outcome.  For example, behavioral couple therapy which 
employs a “sobriety contract” with the spouse, teaches marital communication, 
and emphasizes shared activities and positive feelings, increased abstinence 
and reduced couple separations and domestic violence (O’Farrell and Fals-
Stewart, 2000).

The community reinforcement approach provides positive reinforcement for 
sobriety, eliminates reinforcers for drinking, and teaches new coping 
behavior.  Studies have demonstrated that the community reinforcement approach 
is more successful in reducing drinking than traditional outpatient treatments 
(Miller et al., 1999).  Integrating the community reinforcement approach with 
family therapy also appears promising (Smith et al., 2001).   
Contingency management encourages behavioral change in drinking by either 
presenting patients with positive reinforcements (e.g., money, vouchers, and 
prizes) for meeting treatment goals or employing adverse consequences when 
patients relapse to drinking (e.g., withholding of vouchers and writing an 
unfavorable report to a parole officer).  Although contingency management has 
been successfully used to reduce illicit drug use, researchers have only 
recently applied this technique to alcoholism.  So far, results have been 
positive in retaining alcohol dependent patients in treatment and in reducing 
their drinking behavior (Higgins and Petry, 1999).

Finally, cue-exposure therapy involves exposing a patient to alcohol-related 
cues during therapy.  Although few studies have investigated its effectiveness 
for alcoholism treatment, the results, so far, have been promising (Monti and 
Rohsenow, 1999).  

Thus, progress has been made in a broad range of behavioral interventions to 
treat alcohol abuse and dependence.  Still, many alcoholics do not respond 
adequately to currently available behavioral therapies.  The purpose of this 
program announcement is to improve the overall effectiveness of behavioral 
interventions in the engagement, retention, adherence, and outcome of 
alcoholism treatment across various populations of alcohol dependent and abuse 

Specific Areas of Interest

Examples of research opportunities exist in the following areas:

- New and innovative therapies.  Since current alcoholism treatments have 
modest effects, new therapies and enhancement of existing therapies are 
needed.  New therapies can be based on promising findings from basic 
behavioral and cognitive research, interventions found effective in changing 
other problematic behaviors, and theory-driven models of behavioral sciences. 

- Engagement and retention of patients in treatment.  Treatment providers 
consistently state that, from their perspective, research improving retention 
should be the number one priority. A beginning has been made to develop 
promising behavioral techniques to engage reluctant/ambivalent patients in 
treatment using a motivational interviewing model. A behavioral technique that 
has shown promise in improving retention is contingency management. But 
further research is needed in this important area. 

- Patient compliance.  Compliance has been shown to be a key determinant of 
outcome with medications, with relapse rates lower in those who comply with 
the prescribed regimen.  At the same time, medical studies often report 
noncompliance to medication as a major problem, with as many as 50% of 
patients failing to take the medication as prescribed within the first few 
weeks of treatment. There is a critical need to develop practical, effective 
means to improve patient compliance. 

- Precipitants of relapse.  Relapse to drinking is common after treatment. 
Patients have identified multiple precipitants of relapse including stress, 
social pressure, insomnia, anger, depression, anxiety, and environmental cues 
associated with prior drinking experiences. Better behavioral techniques to 
enable patients to manage these precipitants without resorting to drinking are 
needed to improve the long-term treatment of alcoholism. 

- Behavioral therapies in group settings.  Group therapies are the most 
commonly used approach in the treatment of alcoholism.  Little research, 
however, exists in this area, particularly on how group therapy compares with 
individual counseling.  Behavioral dynamics and modeling of group sessions and 
evaluation of its effectiveness with subtypes of alcoholics in diverse 
treatment settings need to be investigated.  Research from social psychology 
would be informative for studying group therapy.

- Combinations and sequences of treatment.  Current alcoholism treatments 
yield modest effects.  By combining or sequencing treatments, it may be 
possible to enhance outcomes, particularly for nonresponders.  Combined 
interventions can include behavioral therapies as broadly defined in this 
program announcement and pharmacotherapies.  They might also be focused as 
tailored interventions for special populations (see below).

- Natural resolution of alcohol problems.  Many problem drinkers, 
particularly, those with mild to moderate severity, recover outside of the 
formal alcohol treatment system.  Identifying the factors involved in natural 
resolutions might provide insight into structuring new effective behavioral 

- Special populations.  In this program announcement, special populations 
refer to important, often understudied populations with special treatment 
needs, such as minorities, the elderly, and women, especially those who are 
pregnant.  The following are examples of research topics relevant to four 
additional special populations:

-- Alcohol abusing and dependent patients with co-occurring psychiatric 
disorders.  Individuals with alcohol use disorders have high rates of co-
occurring psychiatric comorbidity. Interestingly, this population is more 
likely to seek alcoholism treatment than noncomorbid alcoholics are but also 
more likely to drop out of treatment.  In addition, the prognosis is generally 
poorer. Limited research has been conducted in the treatment of this 
population.  In particular, research is needed to develop specialized 
behavioral therapies for comorbid patients. The effects of treating the 
concurrent disorders on alcoholism treatment outcomes also needs to be 
determined. The intervention strategy to address both the alcoholism and the 
psychiatric condition might depend on the kind of comorbidity and perhaps, the 
subtype of comorbid alcoholic patient. 

-- Develop effective interventions for adolescents with alcohol problems.  
Drinking as well as adverse alcohol-related consequences increase year by year 
as adolescents approach adulthood.  Critical consequences of adolescent 
alcohol abuse include impaired social and academic functioning, psychiatric 
problems, and high-risk problem behaviors that include polydrug use and 
smoking.  There is a clear need for behavioral interventions that specifically 
focus on the issues and problems of adolescence.  Examples of behavioral 
therapies that may hold promise but require further research include cognitive 
behavioral therapy, motivation enhancement therapy, and family therapy.  
Optimal combinations and sequencing of behavioral and pharmacological 
interventions need to be investigated for the treatment of the more severely 
affected adolescents.  

-- Individuals with alcohol use disorders in the criminal justice system. 
Approximately 80 percent of the prison and jail inmates are involved in 
alcohol and drug use.  Limited research, however, exists on understanding 
their behavioral complexities and appropriate treatment. 

-- Professional health care personnel suffering from alcohol use disorder.  
Little research currently exists on treating physicians, nurses, and other 
professional health care personnel who have a problem with alcohol.

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 and 
compelling rationale and justification are provided indicating 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 is available at the following URL 

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


NIH policy requires education on the protection of human subject participants 
for all investigators submitting NIH proposals for research involving human 
subjects.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website:


As of the October 2000 receipt date, applicants must supply a general 
description of the Data and Safety Monitoring Plan for ALL clinical trials; 
this must be included in the application 
( The 
degree of monitoring should be commensurate with risk. NIH Policy for Data and 
Safety Monitoring requires establishment of formal Data and Safety Monitoring 
Boards for multi-site clinical trials involving interventions that entail 
potential risk to the participants. The absence of this information will 
negatively affect your priority score.


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.


The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) cited 
publicly and officially by a Federal agency in support of an action that has 
the force and effect of law (i.e., a regulation) may be accessed through FOIA.  
It is important for applicants to understand the basic scope of this 
amendment.  NIH has provided guidance at:

Applicants may wish to place data collected under this PA in a public archive, 
which can provide protections for the data and manage the distribution for an 
indefinite period of time.  If so, the application should include a 
description of the archiving plan in the study design and include information 
about this in the budget justification section of the application. In 
addition, applicants should think about how to structure informed consent 
statements and other human subjects procedures given the potential for wider 
use of data collected under this award.


The PHS 398 research grant application instructions and forms (rev. 5/2001) at must be used in 
applying for these grants and will be accepted at the standard application 
deadlines ( as indicated in the 
application kit.  This version of the PHS 398 is available in an interactive, 
searchable format. Although applicants are encouraged to begin using the 
5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to 
accept applications prepared using the 4/1998 revision until January 9, 2002. 
Beginning January 10, 2002, however, the NIH will return applications that are 
not submitted on the 5/2001 version.  For further assistance contact 
GrantsInfo, Telephone 301/710-0267, Email:

Applicants planning to submit an investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any amended/revised 
version of the preceding grant application types requesting $500,000 or more 
in direct costs for any year are advised that he or she must contact the 
Institute or Center (IC) program staff before submitting the application, 
i.e., as plans for the study are being developed.  Furthermore, the 
application must obtain agreement from the IC staff that the IC will accept 
the application for consideration for award.  Finally, the applicant must 
identify, in a cover letter sent with the application, the staff member and 
Institute or Center who agreed to accept assignment of the application.

This policy requires an applicant to obtain agreement for acceptance of the 
original application as well as any subsequent revisions.  Refer to the NIH 
Guide for Grants and Contracts, March 20, 1998 at 


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 NIH staff.  
The research grant application form PHS 398 (rev. 5/2001) at is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions.  Applicants are permitted, however, 
to use the 4/1998 revision of the PHS 398 for scheduled application receipt 
dates until January 9, 2002.  If you are preparing an application using the 
4/1998 version, please refer to the step-by-step instructions for Modular 
Grants available at  
Additional information about Modular Grants is also available on this site.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the 
NIH. Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/2001).  
Additional information on Modular Grants can be found at

The title and number of the program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

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

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


Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be evaluated for scientific and technical merit 
by an appropriate scientific review group convened in accordance with the 
standard NIH peer review procedures.  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 applications under review, will be discussed, assigned a 
priority score, and receive a second level review by the appropriate national 
advisory council or board.

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 comments reviewers will be asked to discuss the following aspects 
of the application 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 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 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 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 

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research

o  The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project  
proposed in the application.

o  The adequacy of the proposed plan to share data, if appropriate.


Award criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities.


Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Cherry Lowman, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 505
6000 executive Blvd. (MSC-7003)
Bethesda, MD  20892-7003
(For express mail use:
Rockville, MD  20852)
Telephone:  (301) 443-0637
FAX:  (301)443-8774

Direct inquiries regarding fiscal matters to:

Judy Fox Simons
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 505
6000 executive Blvd. (MSC-7003)
Bethesda, MD  20892-7003
(For express mail use:
Rockville, MD  20852)
Telephone:  (301) 443-2434


This program is described in the Catalog of Federal Domestic Assistance No. 
93.273.  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 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, and 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.


Bien, T.H., Miller, W.R., & Tonigan, J.S. (1993)  Brief interventions for 
alcohol problems: A review.  Addiction 88:315-336

DiClemente, C.C., Bellino, L.E., & Neavins, T.M. (1999)  Motivation for change 
and alcoholism treatment. Alcohol Research & Health 23:86-92.

Fleming, M., & Manwell, J.B. (1999)  Brief intervention in primary care 
settings. Alcohol Research & Health 23:128-137.

Fuller, R.K., & Hiller-Sturmhofel, S. (1999)  Alcoholism treatment in the 
United States: An overview.  Alcohol Research & Health 23:69-77.

Hester, R.K. and Miller, W.R. (1995) Handbook of Alcoholism Treatment 
Approaches, Second Edition, Boston: Allyn and Bacon. 

Higgins, S.T. and Petry, N.P. (1999) Contingency management: Incentives for 
sobriety.  Alcohol Research & Health 23:122-127.

Humphreys, K. (1999)  Professional interventions that facilitate 12-step self-
help group involvement. Alcohol Research & Health 23:93-98.

Longabaugh, R., & Morgenstern, J. (1999)  Current status and future 
directions.  Alcohol Research & Health 23:79-85.

Miller, W.R. (1995)  Increasing motivation for change.  In R.K. Hester & W.R. 
Miller (editors), Handbook of Alcoholism Treatment Approaches: Effective 
Alternatives, 2nd Edition, Needham Hights, Massachusetts: Allyn & Bacon, pp. 

Miller, W.R., Meyers, R.J., & Hiller-Sturmhofel, S. (1999)  The community-
reinforcement approach. Alcohol Research & Health 23:116-127.

Monti, P.M. & Rohsenow, D.J. (1999) Coping-skills training and cue-exposure 
therapy in the treatment of alcoholism.  Alcohol Research & Health 23: 107-

National Institute on Alcohol Abuse and Alcoholism (2000)  New Advances in 
Alcoholism Treatment.  Alcohol Alert  49:1-4. 

O’Farrell, T.J., & Fals-Stewart, W. (2000)  Behavioral couples therapy for 
alcoholism and drug abuse.  Journal of Substance Abuse Treatment 18:51-54.

Project MATCH Research Group (1998)  Matching patients with alcohol disorders 
to treatments: Clinical implications from Project MATCH.  Journal of Mental 
Health 7:589-602.

Smith, J.E., Meyers, R.J., & Miller, W.R. (2001) The Community reinforcement 
approach to the treatment of substance use disorders.  The American Journal on 
Addictions 10(Supplement): 51-59.

Wilk, A.I., Jensen, N.M., & Havighurst, T.C. (1997)  Meta-analysis of 
randomized control trials addressing brief interventions in heavy alcohol 
drinkers.  Journal of General Internal Medicine 12:274-283.

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