An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

NCT01592786 | Completed Phase 2 Results

• 1 other identifier: MEM-MD-91
• Study Type: interventional
• Target: 906
• Locations: 17 countries
• Sites: 114

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in a follow-up randomized withdrawal study.

Conditions

Autism Spectrum Disorder (ASD); Autism; Autistic Disorder; Asperger's Disorder; Asperger's; Pediatric Autism; Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Keywords

Autism Spectrum Disorder (ASD); Autism; Autistic Disorder; Asperger's Disorder; Asperger's; Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS); Memantine; Pediatric Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Confirmed Social Responsiveness Scale (SRS) Responders

  A confirmed SRS responder was defined as a patient who had at least 12 weeks of exposure to memantine, and a ≥ 10-point reduction in the SRS total raw score relative to baseline at 2 consecutive visits separated by at least 2 weeks. The SRS is a 65-item, caregiver-rated assessment scale that measures observable items on social behavior and social language use, as well as characteristics of autism in a naturalistic social setting. Each item is rated on a scale from 0 (never true) to 3 (almost always true). The SRS total raw score ranges from 0 to 195; a higher score indicates greater severity of social impairment.

  Visit 1 (Baseline) to Visit 8 (week 48/Final Visit)

Study Arms (1)

Memantine Hydrochloride (HCl)

EXPERIMENTAL

Once daily oral administration of open-label memantine for up to 48 weeks: 6-week dose-titration period followed by up to 42-week maintenance period.

Drug: Memantine Hydrochloride (HCl)

Interventions

Memantine Hydrochloride (HCl) DRUG

Memantine extended release 3-mg capsules; the dosages studied ranged from 3 - 15 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for up to 48 weeks.

Also known as: Namenda

Memantine Hydrochloride (HCl)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female outpatients.
• Age of 6-12.
• Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
• Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study

You may not qualify if:

• Have enrolled in Study MEM-MD-57A
• Medical conditions that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well-being.
• Participation in any other clinical investigation using an experimental drug within 30 days of screening.
• Having any primary psychiatric (Axis I) diagnosis other than autism, Asperger's Disorder, and PDD-NOS.
• Meeting DSM-IV-TR criteria for bipolar I disorder, psychotic disorder not otherwise specified, posttraumatic stress disorder, schizophrenia, or major depressive disorder within the past 6 months

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (118)

Forest Investigative Site 068

Dothan, Alabama, 36303, United States

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Forest Investigative Site 005

Phoenix, Arizona, 85006, United States

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Forest Investigative Site 055

Tucson, Arizona, 85718, United States

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Forest Investigative Site 077

Little Rock, Arkansas, 72202-3591, United States

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Forest Investigative Site 054

Glendale, California, 91206, United States

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Forest Investigative Site 109

Imperial, California, 92251, United States

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Forest Investigative Site 066

Irvine, California, 92612, United States

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Forest Investigative Site 096

Los Angeles, California, 90024, United States

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Forest Investigative Site 021

San Francisco, California, 94143-0984, United States

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Forest Investigative Site 026

Santa Ana, California, 92701, United States

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Forest Investigative Site 002

Stanford, California, 94305-5719, United States

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Forest Investigative Site 078

Boulder, Colorado, 80304, United States

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Forest Investigative Site 073

Centennial, Colorado, 80112, United States

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Forest Investigative Site 052

Washington D.C., District of Columbia, 20010-2970, United States

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Forest Investigative Site 075

Bradenton, Florida, 32751, United States

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Forest Investigative Site 080

Gainesville, Florida, 32607, United States

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Forest Investigative Site 117

Jacksonville, Florida, 32216, United States

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Forest Investigative Site 065

Maitland, Florida, 32751, United States

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Forest Investigative Site 118

Miami, Florida, 33155, United States

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Forest Investigative Site 085

Oakland Park, Florida, 33334, United States

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Forest Investigative Site 115

Orange City, Florida, 32763, United States

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Forest Investigative Site 124

Orlando, Florida, 32803, United States

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Forest Investigative Site 125

Orlando, Florida, 32803, United States

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Forest Investigative Site 062

Orlando, Florida, 32806, United States

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Forest Investigative Site 114

Orlando, Florida, 32839, United States

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Forest Investigative Site 067

Tampa, Florida, 33612, United States

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Forest Investigative Site 101

Wellington, Florida, 33414, United States

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Forest Investigative Site 102

Libertyville, Illinois, 60048, United States

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Forest Investigative Site 023

Naperville, Illinois, 60563, United States

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Forest Investigative Site 082

Evansville, Indiana, 47713, United States

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Forest Investigative Site 123

Fort Wayne, Indiana, 46805, United States

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Forest Investigative Site 056

Indianapolis, Indiana, 46260, United States

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Forest Investigative Site 084

Indianapolis, Indiana, 46260, United States

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Forest Investigative Site 106

Wichita, Kansas, 67214-3199, United States

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Forest Investigative Site 061

Louisville, Kentucky, 40202, United States

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Forest Investigative Site 074

Owensboro, Kentucky, 42301, United States

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Forest Investigative Site 095

Lake Charles, Louisiana, 70605, United States

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Forest Investigative Site 091

New Orleans, Louisiana, 70112, United States

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Forest Investigative Site 086

Rockville, Maryland, 20852, United States

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Forest Investigative Site 059

Newton, Massachusetts, 02459, United States

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Forest Investigative Site 108

Springfield, Massachusetts, 01199, United States

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Forest Investigative Site 116

Lincoln, Nebraska, 68516, United States

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Forest Investigative Site 097

Lincoln, Nebraska, 68526, United States

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Forest Investigative Site 130

Henderson, Nevada, 89052, United States

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Forest Investigative Site 104

Las Vegas, Nevada, 89128, United States

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Forest Investigative Site 136

Neptune City, New Jersey, 07753, United States

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Forest Investigative Site 127

Toms River, New Jersey, 08755, United States

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Forest Investigative Site 081

Albuquerque, New Mexico, 87108-5129, United States

Location

Forest Investigative Site 107

Albuquerque, New Mexico, 87109, United States

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Forest Investigative Site 098

The Bronx, New York, 10467, United States

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Forest Investigative Site 072

Chapel Hill, North Carolina, 27514, United States

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Forest Investigative Site 069

Avon Lake, Ohio, 44012, United States

Location

Forest Investigative Site 001

Columbus, Ohio, 43210, United States

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Forest Investigative Site 019

Oklahoma City, Oklahoma, 73116, United States

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Forest Investigative Site 092

Tulsa, Oklahoma, 74104, United States

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Forest Investigative Site 053

Gresham, Oregon, 97030, United States

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Forest Investigative Site 132

Johnstown, Pennsylvania, 15904, United States

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Forest Investigative Site 131

McMurray, Pennsylvania, 15317, United States

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Forest Investigative Site 100

Media, Pennsylvania, 19063, United States

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Forest Investigative Site 105

Charleston, South Carolina, 29407, United States

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Forest Investigative Site 090

Memphis, Tennessee, 38119, United States

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Forest Investigative Site 057

Nashville, Tennessee, 37232, United States

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Forest Investigative Site 051

Houston, Texas, 77090, United States

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Forest Investigative Site 070

The Woodlands, Texas, 77381, United States

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Forest Investigative Site 028

Clinton, Utah, 84015, United States

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Forest Investigative Site 141

Ogden, Utah, 84405, United States

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Forest Investigative Site 029

Salt Lake City, Utah, 84106, United States

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Forest Investigative Site 064

Charlottesville, Virginia, 22903, United States

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Forest Investigative Site 113

Norfolk, Virginia, 23507, United States

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Forest Investigative Site 071

Bothell, Washington, 98011, United States

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Forest Investigative Site 119

Charleston, West Virginia, 25304, United States

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Forest Investigative Site 063

Middleton, Wisconsin, 53562, United States

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Forest Investigative Site 177

Camperdown, New South Wales, 2050, Australia

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Forest Investigative Site 204

Brussels, 1020, Belgium

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Forest Investigative Site 203

Brussels, 1090, Belgium

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Forest Investigative Site 202

Hoboken, 2660, Belgium

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Forest Investigative Site 201

Leuven, 3000, Belgium

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Forest Investigative Site 155

Toronto, Ontario, M5B 1T8, Canada

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Forest Investigative Site 227

Barranquilla, Colombia

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Forest Investigative Site 228

Bello, Colombia

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Forest Investigative Site 226

Bogotá, Colombia

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Forest Investigative Site 276

Tallinn, 10617, Estonia

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Forest Investigative Site 329

Bron, Rhone, 69500, France

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Forest Investigative Site 326

Paris, 75935, France

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Forest Investigative Site 379

Budapest, 1021, Hungary

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Forest Investigative Site 381

Budapest, 1026, Hungary

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Forest Investigative Site 376

Budapest, 1083, Hungary

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Forest Investigative Site 378

Budapest, 1089, Hungary

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Forest Investigative Site 382

Gyula, 5700, Hungary

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Forest Investigative Site 380

Szeged, 6725, Hungary

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Forest Investigative Site 401

Kopavogur, 200, Iceland

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Forest Investigative Site 453

Roma, Roma, 165, Italy

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Forest Investigative Site 452

Siena, Siena, 53100, Italy

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Forest Investigative Site 526

Wellington, 6012, New Zealand

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Forest Investigative Site 579

Gdansk, 80-542, Poland

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Forest Investigative Site 578

Gdansk, 80-952, Poland

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Forest Investigative Site 580

Kielce, 25-317, Poland

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Forest Investigative Site 576

Kobierzyce, 55-040, Poland

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Forest Investigative Site 577

Warsaw, 02-957, Poland

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Forest Investigative Site 626

Belgrade, 11000, Serbia

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Forest Investigative Site 627

Belgrade, 11000, Serbia

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Forest Investigative Site 629

Niš, 18000, Serbia

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Forest Investigative Site 628

Novi Sad, 21000, Serbia

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Forest Investigative Site 651

Singapore, 539747, Singapore

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Forest Investigative Site 676

Cape Town, Western Cape, 7530, South Africa

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Forest Investigative Site 704

Yangsan, Gyeongsangnam-do, 626-770, South Korea

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Forest Investigative Site 702

Seoul, 110744, South Korea

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Forest Investigative Site 703

Seoul, 120-752, South Korea

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Forest Investigative Site 701

Seoul, 138-736, South Korea

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Forest Investigative Site 729

Barcelona, Barcelona, 8221, Spain

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Forest Investigative Site 728

Sabadell, Barcelona, 8208, Spain

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Forest Investigative Site 727

Madrid, Madrid, 28031, Spain

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Forest Investigative Site 730

Torremolinos, Málaga, 29620, Spain

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Forest Investigative Site 802

Kherson, Vil. Stepanivka, 73488, Ukraine

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Forest Investigative Site 803

Donetsk, 83008, Ukraine

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Forest Investigative Site 807

Kharkiv, 61153, Ukraine

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Forest Investigative Site 804

Kyiv, 4080, Ukraine

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Forest Investigative Site 801

Odesa, 65014, Ukraine

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MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Asperger Syndrome

Interventions

Memantine

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Joel Trugman, MD
• Organization: Forest Research Institute

Joel.Trugman@frx.com

201-427-8000

Study Officials

• Jordan Lateiner, MS, MBA

  Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 7, 2012
• Study Start: June 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 7, 2014
• Results First Posted: August 7, 2014

Record last verified: 2014-07

Locations

KR (4); SG (1); IC (1); BE (4); ZA (1); AU (1); HU (6); UA (5); IT (2); NZ (1); FR (2); PL (5); ES (1); US (72); SE (4); CO (3); CA (1)