Sequenced Treatment Alternatives to Relieve Depression (STAR*D)

Depression Clinical Trial

Official title:

Sequenced Treatment Alternatives to Relieve Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00021528
• Other study ID #: N01MH90003
• Secondary ID: DSIR AT
• Status: Completed
• Phase: Phase 4
• First received: July 20, 2001
• Last updated: September 24, 2009
• Start date: July 2001
• Est. completion date: September 2006

Study information

• Verified date: September 2006
• Source: National Institute of Mental Health (NIMH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

STAR*D focuses on non-psychotic major depressive disorder in adults who are seen in outpatient settings. The primary purpose of this research study is to determine which treatments work best if the first treatment with medication does not produce an acceptable response. Participants will first receive citalopram, an SSRI medication; if symptoms remain after 8-12 weeks of treatment, up to four other levels of treatment will be offered, including cognitive therapy and other medications. There are no placebo treatments. Some patients may require a combination of two or more treatments to obtain full benefit. Participation could last from 15 to 27 months and involve up to 30 clinic visits. Participants will be interviewed by telephone throughout the study about their symptoms, daily functioning, treatment side effects, use of the health care system, and satisfaction with treatment. There will be a one-year follow up for participants once their depression has been successfully treated

Description:

The STAR*D project will enroll 4,000 outpatients (ages 18 -75) diagnosed with nonpsychotic Major Depressive Disorder. Participants will be initially treated (open label) with citalopram, the Level 1 treatment, for a minimum of 8 weeks. Patients who experience minimal benefit will be strongly encouraged to complete 12 weeks of treatment in order to maximize the chances of symptom remission (unless no benefit at all is seen after 8 weeks). All participants will also receive a brief depression educational program.

At each level change, participants will be asked to indicate the unacceptability of the potential treatment strategies (e.g, to augment or to switch medications). Participants will then be eligible for random assignment to one of the acceptable and medically safe treatment options.

Level 2: Participants who either did not have an adequate response to or could not tolerate citalopram are eligible for Level 2. The Level 2 treatment strategies are:

i) Medication and Psychotherapy Switch: switch to sertraline, venlafaxineXR, bupropionSR, or cognitive therapy (CT).

ii) Medication and Psychotherapy Augmentation: add to citalopram either a) buspirone, b) bupropionSR, or c) CT.

iii) Medication Only Switch or Medication Only Augmentation options are available for participants for whom CT is unacceptable.

iv)Psychotherapy Only Switch or Psychotherapy Only Augmentation options are available for participants for whom additional medication is unacceptable at this point in the study (participants must be willing to continue citalopram)

Level 2A: Participants without a satisfactory response to their Level 2 treatment are eligible for random assignment to additional treatment at Level 2A (if medically safe and acceptable). Level 2A is included so that all participants entering Level 3 have had an opportunity to respond to at least 2 medications. Level 2A consists of Medication Switch to one of two antidepressant medications (venlafaxineXR or bupropion SR).

Level 3: Participants without satisfactory response to Level 2 and,if appropriate Level 2A, are eligible for random assignment to one of the following treatments (if acceptable and medically safe):

i) Medication Switch to: a) mirtazapine or b) nortriptyline, a tricyclic antidepressant.

ii) Medication Augmentation: Add (to current Level 2 or Level 2A medication) either: a) lithium or b) thyroid hormone (T3).

Level 4: Participants without an adequate response to Level 3 are eligible for random assignment to Level 4 treatment (if acceptable and medically safe). Level 4 includes two Medication Switch options: to tranylcypromine [a monoamine oxidase inhibitor (MAOI)], or to mirtazapine plus venlafaxineXR.

After Level 4, participants without an adequate response will discuss other acceptable treatment options with their physician.

Once an adequate response is achieved at Levels 2, 2A, 3 or 4, participants are eligible to enter the 12-month follow-up, during which time they will remain on their current treatment(s) and will be asked about their symptoms and other relevant information monthly by telephone. ONLY PATIENTS BEING TREATED AT THE PARTICIPATING CLINICS ARE ELIGIBLE FOR THIS STUDY.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

• Outpatients aged 18 to 75 years old with nonpsychotic major depressive disorder (HAMD score 14 or greater)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• citalopram

• BuproprionSR

• buspirone

• Lithium

• mirtazapine

• nortriptyline

• sertraline

• tranylcypromine

• VenlafaxineXR

Behavioral:
• Cognitive Therapy

Drug:
• T3 (Triiodothyronine)

Locations

Country	Name	City	State
United States	Briarwood Family Practice Clinic	Ann Arbor	Michigan
United States	General Psychiatric Ambulatory Clinic	Ann Arbor	Michigan
United States	Birmingham VA Medical Center	Birmingham	Alabama
United States	Internal Medicine Associates	Boston	Massachusetts
United States	Swampscott Family Doctors	Boston	Massachusetts
United States	UNC Chapel Hill Adult Diagnostic & Treatment Clinic	Chapel Hill	North Carolina
United States	UNC Chapel Hill Family Practice Clinic	Chapel Hill	North Carolina
United States	UNC Chapel Hill General Medicine Clinic	Chapel Hill	North Carolina
United States	MGH/Charlestown Clinic	Charlestown	Massachusetts
United States	Northwestern Outpatient Treatment Care Center	Chicago	Illinois
United States	University of Illinois at Chicago Clinic	Chicago	Illinois
United States	Psychiatric Centers at San Diego	Chula Vista	California
United States	The Holiner Psychiatric Group	Dallas	Texas
United States	UT Southwestern Family Medicine Clinic	Dallas	Texas
United States	Evanston Outpatient Clinic	Evanston	Illinois
United States	LIJ/Zucker Hillside Adult Ambulatory Care Center	Glen Oaks	New York
United States	Harbor UCLA Family Health Care Center	Harbor City	California
United States	LIJ North Shore Medical Group	Lake Success	New York
United States	UCLA General Outpatient Psychiatry Clinic	Los Angeles	California
United States	UCLA Internal Medicine Clinic	Los Angeles	California
United States	Centerstone/Luton Mental Health Services	Nashville	Tennessee
United States	Psychiatric Consultants, P.C.	Nashville	Tennessee
United States	Vanderbilt University Medical Center-Mental Health Center	Nashville	Tennessee
United States	Vine Hill Community Clinic	Nashville	Tennessee
United States	Bellefield Clinic of WPIC	Pittsburgh	Pennsylvania
United States	Diversified Human Services Clinic	Pittsburgh	Pennsylvania
United States	Latterman Family Health Center	Pittsburgh	Pennsylvania
United States	MCV Family Counseling	Richmond	Virginia
United States	MCV Primary Care Clinic	Richmond	Virginia
United States	MGH/Salem Professional	Salem	Massachusetts
United States	UCSD Outpatient Psychiatric Services	San Diego	California
United States	Veterans Affairs Medical Center/FIRM Primary Care Clinic	San Diego	California
United States	Harbor UCLA Medical Center	Torrance	California
United States	Laureate Psychiatric Clinic & Hospital	Tulsa	Oklahoma
United States	Springer Family Medicine	Tulsa	Oklahoma
United States	Warren Clinic	Tulsa	Oklahoma
United States	Tuscaloosa VA Mental Health Clinic - Veterans Only	Tuscaloosa	Alabama
United States	Tuscaloosa VA Primary Care Center	Tuscaloosa	Alabama
United States	AMPN Corkery, Heise & Dainesi	Upper St. Clair	Pennsylvania
United States	COMCARE of Sedgwick County	Wichita	Kansas
United States	Psychiatric Outpatient Clinic	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (50)

Adli M, Rush AJ, Möller HJ, Bauer M. Algorithms for optimizing the treatment of depression: making the right decision at the right time. Pharmacopsychiatry. 2003 Nov;36 Suppl 3:S222-9. Review. — View Citation

Alpert JE, Biggs MM, Davis L, Shores-Wilson K, Harlan WR, Schneider GW, Ford AL, Farabaugh A, Stegman D, Ritz AL, Husain MM, Macleod L, Wisniewski SR, Rush AJ; STAR*D Investigators. Enrolling research subjects from clinical practice: ethical and procedura — View Citation

Claassen CA, Trivedi MH, Rush AJ, Husain MM, Zisook S, Young E, Leuchter A, Wisniewski SR, Balasubramani GK, Alpert J. Clinical differences among depressed patients with and without a history of suicide attempts: findings from the STAR*D trial. J Affect D — View Citation

Davis LL, Frazier E, Husain MM, Warden D, Trivedi M, Fava M, Cassano P, McGrath PJ, Balasubramani GK, Wisniewski SR, Rush AJ. Substance use disorder comorbidity in major depressive disorder: a confirmatory analysis of the STAR*D cohort. Am J Addict. 2006 Jul-Aug;15(4):278-85. — View Citation

Davis LL, Rush JA, Wisniewski SR, Rice K, Cassano P, Jewell ME, Biggs MM, Shores-Wilson K, Balasubramani GK, Husain MM, Quitkin FM, McGrath PJ. Substance use disorder comorbidity in major depressive disorder: an exploratory analysis of the Sequenced Treatment Alternatives to Relieve Depression cohort. Compr Psychiatry. 2005 Mar-Apr;46(2):81-9. — View Citation

Fava M, Alpert JE, Carmin CN, Wisniewski SR, Trivedi MH, Biggs MM, Shores-Wilson K, Morgan D, Schwartz T, Balasubramani GK, Rush AJ. Clinical correlates and symptom patterns of anxious depression among patients with major depressive disorder in STAR*D. Psychol Med. 2004 Oct;34(7):1299-308. — View Citation

Fava M, Rush AJ, Alpert JE, Carmin CN, Balasubramani GK, Wisniewski SR, Trivedi MH, Biggs MM, Shores-Wilson K. What clinical and symptom features and comorbid disorders characterize outpatients with anxious major depressive disorder: a replication and ext — View Citation

Fava M, Rush AJ, Trivedi MH, Nierenberg AA, Thase ME, Sackeim HA, Quitkin FM, Wisniewski S, Lavori PW, Rosenbaum JF, Kupfer DJ. Background and rationale for the sequenced treatment alternatives to relieve depression (STAR*D) study. Psychiatr Clin North Am. 2003 Jun;26(2):457-94, x. Review. — View Citation

Fava M, Rush AJ, Wisniewski SR, Nierenberg AA, Alpert JE, McGrath PJ, Thase ME, Warden D, Biggs M, Luther JF, Niederehe G, Ritz L, Trivedi MH. A comparison of mirtazapine and nortriptyline following two consecutive failed medication treatments for depress — View Citation

Fava M, Rush AJ. Current status of augmentation and combination treatments for major depressive disorder: a literature review and a proposal for a novel approach to improve practice. Psychother Psychosom. 2006;75(3):139-53. Review. — View Citation

Friedman EF, Thase ME, Biggs MM, Carmin C, Hollon SD, Kornblith SJ, Petersen T, Veenstra G, Wisniewski SR, and Rush AJ. The implementation of cognitive therapy in STAR*D. Cognitive Therapy and Research, 28:819-833, 2004.

Friedman EF, Thase ME, Biggs MM, Carmin C, Hollon SD, Kornblith SJ, Petersen T, Veenstra G, Wisniewski SR, Rush AJ. The implementation of cognitive therapy in STAR*D. Cognit Ther Res 2004;28:819-33.

Gaynes BN, Davis L, Rush AJ, Trivedi MH, Fava M, Wisniewski SR. The aims and design of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. Primary Psychiatry 2005;12(2):36-41. http://www.primarypsychiatry.com/pdf/art_4845.pdf

Gaynes BN, Rush AJ, Trivedi M, Wisniewski SR, Balasubramani GK, Spencer DC, Petersen T, Klinkman M, Warden D, Schneider RK, Castro DB, Golden RN. A direct comparison of presenting characteristics of depressed outpatients from primary vs. specialty care settings: preliminary findings from the STAR*D clinical trial. Gen Hosp Psychiatry. 2005 Mar-Apr;27(2):87-96. — View Citation

Gaynes, B.N., Davis, L., Rush A.J., Trivedi, M., Fava, M., Wisniewski, S.R. The aims and design of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. Primary Psychiatry, 12(2):36-41, 2005.

Gilmer WS, Kemp DE. STAR*D: What Have We Learned Thus Far? International Drug Therapy Newsletter 41:75-82, 2006.

Gilmer WS, Trivedi MH, Rush AJ, Wisniewski SR, Luther J, Howland RH, Yohanna D, Khan A, Alpert J. Factors associated with chronic depressive episodes: a preliminary report from the STAR-D project. Acta Psychiatr Scand. 2005 Dec;112(6):425-33. — View Citation

Hollon SD, Shelton RC, Wisniewski S, Warden D, Biggs MM, Friedman ES, Husain M, Kupfer DJ, Nierenberg AA, Petersen TJ, Shores-Wilson K, Rush AJ. Presenting characteristics of depressed outpatients as a function of recurrence: preliminary findings from the STAR*D clinical trial. J Psychiatr Res. 2006 Feb;40(1):59-69. Epub 2005 Oct 21. — View Citation

Husain MM, Rush AJ, Sackeim HA, Wisniewski SR, McClintock SM, Craven N, Holiner J, Mitchell JR, Balasubramani GK, Hauger R. Age-related characteristics of depression: a preliminary STAR*D report. Am J Geriatr Psychiatry. 2005 Oct;13(10):852-60. — View Citation

Khan AY, Carrithers J, Preskorn SH, Lear R, Wisniewski SR, John Rush A, Stegman D, Kelley C, Kreiner K, Nierenberg AA, Fava M. Clinical and demographic factors associated with DSM-IV melancholic depression. Ann Clin Psychiatry. 2006 Apr-Jun;18(2):91-8. — View Citation

Kornstein SG, Harvey AT, Rush AJ, Wisniewski SR, Trivedi MH, Svikis DS, McKenzie ND, Bryan C, Harley R. Self-reported premenstrual exacerbation of depressive symptoms in patients seeking treatment for major depression. Psychol Med. 2005 May;35(5):683-92. — View Citation

Lavori PW, Rush AJ, Wisniewski SR, Alpert J, Fava M, Kupfer DJ, Nierenberg A, Quitkin FM, Sackeim HA, Thase ME, Trivedi M. Strengthening clinical effectiveness trials: equipoise-stratified randomization. Biol Psychiatry. 2001 Nov 15;50(10):792-801. — View Citation

Lesser IM, Leuchter AF, Trivedi MH, Davis LL, Wisniewski SR, Balasubramani GK, Petersen T, Stegman D, Rush AJ. Characteristics of insured and noninsured outpatients with depression in STAR(*)D. Psychiatr Serv. 2005 Aug;56(8):995-1004. — View Citation

Marcus SM, Young EA, Kerber KB, Kornstein S, Farabaugh AH, Mitchell J, Wisniewski SR, Balasubramani GK, Trivedi MH, Rush AJ. Gender differences in depression: findings from the STAR*D study. J Affect Disord. 2005 Aug;87(2-3):141-50. — View Citation

McGrath PJ, Stewart JW, Fava M, Trivedi MH, Wisniewski SR, Nierenberg AA, Thase ME, Davis L, Biggs MM, Shores-Wilson K, Luther JF, Niederehe G, Warden D, Rush AJ. Tranylcypromine versus venlafaxine plus mirtazapine following three failed antidepressant me — View Citation

McMahon FJ, Buervenich S, Charney D, Lipsky R, Rush AJ, Wilson AF, Sorant AJ, Papanicolaou GJ, Laje G, Fava M, Trivedi MH, Wisniewski SR, Manji H. Variation in the gene encoding the serotonin 2A receptor is associated with outcome of antidepressant treatm — View Citation

Murphy SA, Oslin DW, Rush AJ, Zhu J; MCATS. Methodological challenges in constructing effective treatment sequences for chronic psychiatric disorders. Neuropsychopharmacology. 2007 Feb;32(2):257-62. Epub 2006 Nov 8. — View Citation

Nierenberg AA, Fava M, Trivedi MH, Wisniewski SR, Thase ME, McGrath PJ, Alpert JE, Warden D, Luther JF, Niederehe G, Lebowitz B, Shores-Wilson K, Rush AJ. A comparison of lithium and T(3) augmentation following two failed medication treatments for depress — View Citation

Nierenberg AA, Trivedi MH, Fava M, Biggs MM, Shores-Wilson K, Wisniewski SR, Balasubramani GK, Rush AJ. Family history of mood disorder and characteristics of major depressive disorder: a STAR*D (sequenced treatment alternatives to relieve depression) stu — View Citation

Nierenberg AA, Trivedi MH, Ritz L, Burroughs D, Greist J, Sackeim H, Kornstein S, Schwartz T, Stegman D, Fava M, Wisniewski SR. Suicide risk management for the sequenced treatment alternatives to relieve depression study: applied NIMH guidelines. J Psychiatr Res. 2004 Nov-Dec;38(6):583-9. — View Citation

Novick JS, Stewart JW, Wisniewski SR, Cook IA, Manev R, Nierenberg AA, Rosenbaum JF, Shores-Wilson K, Balasubramani GK, Biggs MM, Zisook S, Rush AJ; STAR*D investigators. Clinical and demographic features of atypical depression in outpatients with major depressive disorder: preliminary findings from STAR*D. J Clin Psychiatry. 2005 Aug;66(8):1002-11. — View Citation

Perlis RH, Fraguas R, Fava M, Trivedi MH, Luther JF, Wisniewski SR, Rush AJ. Prevalence and clinical correlates of irritability in major depressive disorder: a preliminary report from the Sequenced Treatment Alternatives to Relieve Depression study. J Clin Psychiatry. 2005 Feb;66(2):159-66; quiz 147, 273-4. — View Citation

Pilowsky DJ, Wickramaratne PJ, Rush AJ, Hughes CW, Garber J, Malloy E, King CA, Cerda G, Sood AB, Alpert JE, Wisniewski SR, Trivedi MH, Talati A, Carlson MM, Liu HH, Fava M, Weissman MM. Children of currently depressed mothers: a STAR*D ancillary study. J — View Citation

Rush AJ, Bernstein IH, Trivedi MH, Carmody TJ, Wisniewski S, Mundt JC, Shores-Wilson K, Biggs MM, Woo A, Nierenberg AA, Fava M. An evaluation of the quick inventory of depressive symptomatology and the hamilton rating scale for depression: a sequenced treatment alternatives to relieve depression trial report. Biol Psychiatry. 2006 Mar 15;59(6):493-501. Epub 2005 Sep 30. — View Citation

Rush AJ, Fava M, Wisniewski SR, Lavori PW, Trivedi MH, Sackeim HA, Thase ME, Nierenberg AA, Quitkin FM, Kashner TM, Kupfer DJ, Rosenbaum JF, Alpert J, Stewart JW, McGrath PJ, Biggs MM, Shores-Wilson K, Lebowitz BD, Ritz L, Niederehe G; STAR*D Investigators Group. Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design. Control Clin Trials. 2004 Feb;25(1):119-42. — View Citation

Rush AJ, Trivedi M, Fava M. Depression, IV: STAR*D treatment trial for depression. Am J Psychiatry. 2003 Feb;160(2):237. — View Citation

Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring on — View Citation

Rush AJ, Trivedi MH, Wisniewski SR, Stewart JW, Nierenberg AA, Thase ME, Ritz L, Biggs MM, Warden D, Luther JF, Shores-Wilson K, Niederehe G, Fava M; STAR*D Study Team. Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. N E — View Citation

Rush AJ, Zimmerman M, Wisniewski SR, Fava M, Hollon SD, Warden D, Biggs MM, Shores-Wilson K, Shelton RC, Luther JF, Thomas B, Trivedi MH. Comorbid psychiatric disorders in depressed outpatients: demographic and clinical features. J Affect Disord. 2005 Jul;87(1):43-55. — View Citation

Trivedi MH, Fava M, Wisniewski SR, Thase ME, Quitkin F, Warden D, Ritz L, Nierenberg AA, Lebowitz BD, Biggs MM, Luther JF, Shores-Wilson K, Rush AJ; STAR*D Study Team. Medication augmentation after the failure of SSRIs for depression. N Engl J Med. 2006 M — View Citation

Trivedi MH, Rush AJ, Wisniewski SR, Nierenberg AA, Warden D, Ritz L, Norquist G, Howland RH, Lebowitz B, McGrath PJ, Shores-Wilson K, Biggs MM, Balasubramani GK, Fava M; STAR*D Study Team. Evaluation of outcomes with citalopram for depression using measur — View Citation

Trivedi MH, Rush AJ, Wisniewski SR, Warden D, McKinney W, Downing M, Berman SR, Farabaugh A, Luther JF, Nierenberg AA, Callan JA, Sackeim HA. Factors associated with health-related quality of life among outpatients with major depressive disorder: a STAR*D — View Citation

Warden D, Rush AJ, Trivedi M, Ritz L, Stegman D, Wisniewski SR. Quality improvement methods as applied to a multicenter effectiveness trial--STAR*D. Contemp Clin Trials. 2005 Feb;26(1):95-112. Epub 2005 Jan 27. — View Citation

Weissman MM, Pilowsky DJ, Wickramaratne PJ, Talati A, Wisniewski SR, Fava M, Hughes CW, Garber J, Malloy E, King CA, Cerda G, Sood AB, Alpert JE, Trivedi MH, Rush AJ; STAR*D-Child Team. Remissions in maternal depression and child psychopathology: a STAR*D — View Citation

Wisniewski SR, Eng H, Meloro L, Gatt R, Ritz L, Stegman D, Trivedi M, Biggs MM, Friedman E, Shores-Wilson K, Warden D, Bartolowits D, Martin JP, Rush AJ. Web-based communications and management of a multi-center clinical trial: the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project. Clin Trials. 2004;1(4):387-98. — View Citation

Wisniewski SR, Leon AC, Otto MW, Trivedi MH. Prevention of missing data in clinical research studies. Biol Psychiatry. 2006 Jun 1;59(11):997-1000. Epub 2006 Mar 29. Review. — View Citation

Wisniewski SR, Stegman D, Trivedi M, Husain MM, Eng H, Shores-Wilson K, Luther J, Biggs MM, Burroughs D, Ritz AL, Fava M, Quitkin F, Rush AJ; STAR*D Investigators. Methods of testing feasibility for sequenced treatment alternatives to relieve depression (STAR*D). J Psychiatr Res. 2004 May-Jun;38(3):241-8. — View Citation

Yates WR, Mitchell J, Rush AJ, Trivedi MH, Wisniewski SR, Warden D, Hauger RB, Fava M, Gaynes BN, Husain MM, Bryan C. Clinical features of depressed outpatients with and without co-occurring general medical conditions in STAR*D. Gen Hosp Psychiatry. 2004 Nov-Dec;26(6):421-9. — View Citation

Zisook S, Rush AJ, Albala A, Alpert J, Balasubramani GK, Fava M, Husain M, Sackeim H, Trivedi M, Wisniewski S. Factors that differentiate early vs. later onset of major depression disorder. Psychiatry Res. 2004 Dec 15;129(2):127-40. — View Citation

Zisook S, Rush AJ, Lesser I, Wisniewski SR, Trivedi M, Husain MM, Balasubramani GK, Alpert JE, Fava M. Preadult onset vs. adult onset of major depressive disorder: a replication study. Acta Psychiatr Scand. 2007 Mar;115(3):196-205. — View Citation

* Note: There are 50 references in all — Click here to view all references

External Links

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