An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis

NCT00751881 | Completed Phase 3 Results DMC

• 2 other identifiers: EFC105312007-004452-36
• Study Type: interventional
• Target: 1,169
• Locations: 22 countries
• Sites: 176

Brief Summary

The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS. Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression. Other secondary objectives were:

• To assess the effect of the two doses of teriflunomide in comparison to placebo on:
• Fatigue;
• Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.
• To evaluate the safety and tolerability of teriflunomide.

Conditions

Multiple Sclerosis

Keywords

relapsing multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate

  ARR is obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of treatment durations. Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale (EDSS) score or Functional System scores. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as "offset" variable; treatment group, region of enrollment and baseline EDSS stratum as covariates).

  Core treatment period between 48 - 152 weeks depending on time of enrollment

Secondary Outcomes (11)

• Core Treatment Period: Time to Disability Progression

  Core treatment period between 48 - 152 weeks depending on time of enrollment

• Core Treatment Period: Time Without Relapse

  Core treatment period between 48 - 152 weeks depending on time of enrollment

• Core Treatment Period: Change From Baseline to Week 48 in EDSS Total Score

  Baseline (before randomization), Week 12, Week 24, Week 36 and Week 48

• Core Treatment Period: Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score

  Baseline (before randomization), Week 12, Week 24 and Week 48

• Core Treatment Period: Change From Baseline to Last Visit in Fatigue Impact Scale (FIS) Total Score

  Baseline (before randomization) and up to Week 152

Other Outcomes (1)

• Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)

  From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first

Study Arms (3)

Teriflunomide 7 mg / 14 mg

EXPERIMENTAL

Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.

Drug: Teriflunomide

Teriflunomide 14 mg / 14 mg

EXPERIMENTAL

Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.

Drug: Teriflunomide

Placebo / Teriflunomide 14 mg

PLACEBO COMPARATOR

Core treatment period: Placebo (for teriflunomide) once daily. Extension treatment period: Teriflunomide 14 mg once daily.

Drug: Placebo; Drug: Teriflunomide

Interventions

Placebo DRUG

Film-coated tablet Oral administration

Placebo / Teriflunomide 14 mg

Teriflunomide DRUG

Film-coated tablet Oral administration

Also known as: HMR1726

Placebo / Teriflunomide 14 mg; Teriflunomide 14 mg / 14 mg; Teriflunomide 7 mg / 14 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Relapsing multiple sclerosis,
• Two relapses in prior 2 years or one relapse in prior year.

You may not qualify if:

• Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
• Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia,
• Pregnant or nursing woman,
• Alcohol or drug abuse,
• Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate,
• Human immunodeficiency virus (HIV) positive,
• Any known condition or circumstance that would prevent, in the investigator's opinion, compliance or completion of the study.
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (193)

Sanofi-Aventis Investigational Site Number 840041

Phoenix, Arizona, 85060, United States

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Sanofi-Aventis Investigational Site Number 840084

Tucson, Arizona, 85741-3537, United States

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Sanofi-Aventis Investigational Site Number 840008

Loma Linda, California, 92354, United States

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Sanofi-Aventis Investigational Site Number 840034

Modesto, California, 95355, United States

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Sanofi-Aventis Investigational Site Number 840090

Fort Collins, Colorado, 80528, United States

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Sanofi-Aventis Investigational Site Number 840011

Fairfield, Connecticut, 06430, United States

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Sanofi-Aventis Investigational Site Number 840013

Maitland, Florida, 32761, United States

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Sanofi-Aventis Investigational Site Number 840083

Ocala, Florida, 34474, United States

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Sanofi-Aventis Investigational Site Number 840086

Ormond Beach, Florida, 32174, United States

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Sanofi-Aventis Investigational Site Number 840025

Sarasota, Florida, 34239, United States

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Sanofi-Aventis Investigational Site Number 840015

St. Petersburg, Florida, 33606, United States

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Sanofi-Aventis Investigational Site Number 840033

Sunrise, Florida, 33351, United States

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Sanofi-Aventis Investigational Site Number 840063

Elk Grove Village, Illinois, 60007, United States

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Sanofi-Aventis Investigational Site Number 840064

Flossmoor, Illinois, 60402, United States

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Sanofi-Aventis Investigational Site Number 840039

Fort Wayne, Indiana, 46804, United States

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Sanofi-Aventis Investigational Site Number 840012

Indianapolis, Indiana, 46256, United States

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Sanofi-Aventis Investigational Site Number 840016

Des Moines, Iowa, 50314, United States

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Sanofi-Aventis Investigational Site Number 840069

Clinton Township, Michigan, 48035, United States

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Sanofi-Aventis Investigational Site Number 840075

Grand Rapids, Michigan, 49503, United States

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Sanofi-Aventis Investigational Site Number 840061

Traverse City, Michigan, 49684, United States

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Sanofi-Aventis Investigational Site Number 840076

Minneapolis, Minnesota, 55455, United States

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Sanofi-Aventis Investigational Site Number 840079

Tupelo, Mississippi, 38801, United States

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Sanofi-Aventis Investigational Site Number 840088

St Louis, Missouri, 63131, United States

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Sanofi-Aventis Investigational Site Number 840060

Syracuse, New York, 13210, United States

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Sanofi-Aventis Investigational Site Number 840029

Charlotte, North Carolina, 28204, United States

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Sanofi-Aventis Investigational Site Number 840074

Bismarck, North Dakota, 58501, United States

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Sanofi-Aventis Investigational Site Number 840026

Cincinnati, Ohio, 45219, United States

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Sanofi-Aventis Investigational Site Number 840078

Dayton, Ohio, 45409, United States

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Sanofi-Aventis Investigational Site Number 840066

Tulsa, Oklahoma, 74137, United States

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Sanofi-Aventis Investigational Site Number 840024

Portland, Oregon, 97225, United States

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Sanofi-Aventis Investigational Site Number 840073

Philadelphia, Pennsylvania, 19102, United States

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Sanofi-Aventis Investigational Site Number 840022

Philadelphia, Pennsylvania, 19107, United States

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Sanofi-Aventis Investigational Site Number 840068

Greenville, South Carolina, 29615, United States

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Sanofi-Aventis Investigational Site Number 840071

Cordova, Tennessee, 38018, United States

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Sanofi-Aventis Investigational Site Number 840036

Nashville, Tennessee, 37232, United States

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Sanofi-Aventis Investigational Site Number 840007

San Antonio, Texas, 78229, United States

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Sanofi-Aventis Investigational Site Number 840006

Bennington, Vermont, 05201, United States

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Sanofi-Aventis Investigational Site Number 840089

Seattle, Washington, 98122, United States

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Sanofi-Aventis Investigational Site Number 840020

Charleston, West Virginia, 25301, United States

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Sanofi-Aventis Investigational Site Number 036005

Bedford Park, 5042, Australia

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Sanofi-Aventis Investigational Site Number 036006

Chatswood, 2067, Australia

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Fitzroy, 3065, Australia

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Geelong, 3220, Australia

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Heidelberg, 3084, Australia

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New Lambton, 2305, Australia

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Sanofi-Aventis Investigational Site Number 036001

Sydney, 2050, Australia

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Sanofi-Aventis Investigational Site Number 040001

Vienna, 1010, Austria

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Sanofi-Aventis Investigational Site Number 112105

Grodno, Belarus

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Sanofi-Aventis Investigational Site Number 112102

Minsk, 220226, Belarus

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Sanofi-Aventis Investigational Site Number 112101

Minsk, Belarus

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Minsk, Belarus

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Vitebsk, Belarus

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Sanofi-Aventis Investigational Site Number 056004

Bruges, 8000, Belgium

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Leuven, 3000, Belgium

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Melsbroek, Belgium

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Sijsele-Damme, Belgium

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Sanofi-Aventis Investigational Site Number 124004

Gatineau, J9J 0A5, Canada

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Sanofi-Aventis Investigational Site Number 124002

Kingston, K7L 2V7, Canada

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Sanofi-Aventis Investigational Site Number 124007

Montreal, H1T 2M4, Canada

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Sanofi-Aventis Investigational Site Number 124008

Ottawa, K2G 6E2, Canada

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Sanofi-Aventis Investigational Site Number 124001

Québec, G1J 1Z4, Canada

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Sanofi-Aventis Investigational Site Number 124003

Regina, S4T 1A5, Canada

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Sanofi-Aventis Investigational Site Number 124006

Saint John, E2L 3L6, Canada

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Sanofi-Aventis Investigational Site Number 152006

Santiago, Chile

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Santiago, Chile

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Viña del Mar, Chile

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Sanofi-Aventis Investigational Site Number 156023

Baotou, 014010, China

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Sanofi-Aventis Investigational Site Number 156031

Beijing, 100034, China

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Sanofi-Aventis Investigational Site Number 156006

Beijing, 100050, China

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Beijing, 100050, China

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Beijing, 100053, China

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Sanofi-Aventis Investigational Site Number 156032

Beijing, 100068, China

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Sanofi-Aventis Investigational Site Number 156024

Beijing, 100088, China

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Sanofi-Aventis Investigational Site Number 156030

Beijing, 100191, China

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Sanofi-Aventis Investigational Site Number 156001

Beijing, 100730, China

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Sanofi-Aventis Investigational Site Number 156008

Beijing, 100853, China

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Changchun, 130021, China

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Sanofi-Aventis Investigational Site Number 156002

Chengdu, 610041, China

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Sanofi-Aventis Investigational Site Number 156025

Guangzhou, 510260, China

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Sanofi-Aventis Investigational Site Number 156012

Guangzhou, 510630, China

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Sanofi-Aventis Investigational Site Number 156027

Haikou, 570102, China

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Sanofi-Aventis Investigational Site Number 156021

Hangzhou, 310016, China

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Sanofi-Aventis Investigational Site Number 156033

Jinan, 250033, China

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Sanofi-Aventis Investigational Site Number 156034

Nanjing, 210008, China

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Sanofi-Aventis Investigational Site Number 156011

Nanjing, 210029, China

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Sanofi-Aventis Investigational Site Number 156019

Qingdao, 266003, China

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Sanofi-Aventis Investigational Site Number 156029

Shanghai, 200003, China

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Sanofi-Aventis Investigational Site Number 156016

Shanghai, 200040, China

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Sanofi-Aventis Investigational Site Number 156009

Shenyang, 110001, China

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Sanofi-Aventis Investigational Site Number 156022

Shijiazhuang, 050051, China

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Sanofi-Aventis Investigational Site Number 156018

Suzhou, 215006, China

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Sanofi-Aventis Investigational Site Number 156028

Taiyuan, 030001, China

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Sanofi-Aventis Investigational Site Number 156003

Tianjin, 300052, China

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Sanofi-Aventis Investigational Site Number 156035

Tianjin, 300211, China

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Sanofi-Aventis Investigational Site Number 156017

Wenzhou, 325000, China

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Sanofi-Aventis Investigational Site Number 156004

Wuhan, 430030, China

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Sanofi-Aventis Investigational Site Number 156014

Xi'an, 710032, China

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Sanofi-Aventis Investigational Site Number 156015

Xi'an, 710061, China

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Sanofi-Aventis Investigational Site Number 203001

Brno, 65691, Czechia

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Sanofi-Aventis Investigational Site Number 203002

Ostrava - Poruba, 70852, Czechia

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Sanofi-Aventis Investigational Site Number 203004

Teplice, 415 29, Czechia

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Sanofi-Aventis Investigational Site Number 233002

Tallinn, 10617, Estonia

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Sanofi-Aventis Investigational Site Number 233001

Tartu, 50406, Estonia

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Sanofi-Aventis Investigational Site Number 250005

Besançon, 25030, France

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Sanofi-Aventis Investigational Site Number 250008

Dijon, 21033, France

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Sanofi-Aventis Investigational Site Number 250001

Lyon, 69394, France

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Sanofi-Aventis Investigational Site Number 250007

Nantes, 44093, France

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Sanofi-Aventis Investigational Site Number 250006

Nice, 06002, France

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Sanofi-Aventis Investigational Site Number 250002

Nîmes, 30029, France

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Sanofi-Aventis Investigational Site Number 250003

Poissy, 78300, France

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Sanofi-Aventis Investigational Site Number 276010

Bamberg, 96047, Germany

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Sanofi-Aventis Investigational Site Number 276003

Bayreuth, 95445, Germany

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Sanofi-Aventis Investigational Site Number 276005

Berlin, 10713, Germany

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Sanofi-Aventis Investigational Site Number 276001

Erlangen, 91054, Germany

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Sanofi-Aventis Investigational Site Number 276006

Giessen, 35385, Germany

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Sanofi-Aventis Investigational Site Number 276004

Hanover, 30625, Germany

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Sanofi-Aventis Investigational Site Number 276007

Leipzig, 04157, Germany

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Sanofi-Aventis Investigational Site Number 276009

Magdeburg, 39120, Germany

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Sanofi-Aventis Investigational Site Number 276002

Wiesbaden, 65191, Germany

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Sanofi-Aventis Investigational Site Number 300001

Athens, 11527, Greece

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Sanofi-Aventis Investigational Site Number 300006

Thessaloniki, 57010, Greece

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Sanofi-Aventis Investigational Site Number 484003

México, 06726, Mexico

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Sanofi-Aventis Investigational Site Number 484005

Monterrey, 64460, Mexico

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Sanofi-Aventis Investigational Site Number 528003

's-Hertogenbosch, 5211 NL, Netherlands

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Sanofi-Aventis Investigational Site Number 528001

Breda, 4818 CK, Netherlands

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Sanofi-Aventis Investigational Site Number 528002

Groesbeek, 6561 KE, Netherlands

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Sanofi-Aventis Investigational Site Number 528004

Nieuwegein, 3435 CM, Netherlands

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Sanofi-Aventis Investigational Site Number 528006

Sittard-Geleen, 6162 BG, Netherlands

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Sanofi-Aventis Investigational Site Number 608004

Cebu City, Philippines

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Sanofi-Aventis Investigational Site Number 608002

Makati City, 1229, Philippines

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Sanofi-Aventis Investigational Site Number 608001

Manila, Philippines

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Sanofi-Aventis Investigational Site Number 608003

Quezon City, 1102, Philippines

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Sanofi-Aventis Investigational Site Number 616002

Gdansk, 80-803, Poland

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Sanofi-Aventis Investigational Site Number 616005

Lodz, 90-549, Poland

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Sanofi-Aventis Investigational Site Number 616001

Lublin, 20-718, Poland

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Sanofi-Aventis Investigational Site Number 616004

Szczecin, 70-215, Poland

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Sanofi-Aventis Investigational Site Number 616003

Warsaw, 04-141, Poland

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Sanofi-Aventis Investigational Site Number 642006

Bacau, 600114, Romania

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Sanofi-Aventis Investigational Site Number 642005

Brasov, 500123, Romania

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Sanofi-Aventis Investigational Site Number 642001

Bucharest, 010584, Romania

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Sanofi-Aventis Investigational Site Number 642007

Oradea, 410154, Romania

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Sanofi-Aventis Investigational Site Number 703003

Bratislava, 82606, Slovakia

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Sanofi-Aventis Investigational Site Number 703005

Bratislava, 82606, Slovakia

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Sanofi-Aventis Investigational Site Number 703001

Martin, 03659, Slovakia

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Sanofi-Aventis Investigational Site Number 703006

Prešov, 08181, Slovakia

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Sanofi-Aventis Investigational Site Number 724001

Barcelona, 08035, Spain

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Sanofi-Aventis Investigational Site Number 724007

Getafe, 28905, Spain

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Sanofi-Aventis Investigational Site Number 724002

Girona, 17007, Spain

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Sanofi-Aventis Investigational Site Number 724004

Madrid, 28040, Spain

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Sanofi-Aventis Investigational Site Number 724003

Seville, 41071, Spain

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Sanofi-Aventis Investigational Site Number 752002

Stockholm, 141 86, Sweden

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Sanofi-Aventis Investigational Site Number 752001

Stockholm, 171 76, Sweden

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Sanofi-Aventis Investigational Site Number 752003

Stockholm, 182 88, Sweden

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Sanofi-Aventis Investigational Site Number 764001

Bangkok, 10330, Thailand

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Sanofi-Aventis Investigational Site Number 764002

Bangkok Noi, 10700, Thailand

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Sanofi-Aventis Investigational Site Number 788003

Manouba, 2010, Tunisia

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Sanofi-Aventis Investigational Site Number 788004

Sfax, 3029, Tunisia

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Sanofi-Aventis Investigational Site Number 788002

Tunis, 1006, Tunisia

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Sanofi-Aventis Investigational Site Number 788001

Tunis, 1007, Tunisia

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Sanofi-Aventis Investigational Site Number 792011

Edirne, Turkey (Türkiye)

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Sanofi-Aventis Investigational Site Number 792009

Istanbul, 34147, Turkey (Türkiye)

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Sanofi-Aventis Investigational Site Number 792001

Istanbul, 34390, Turkey (Türkiye)

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Sanofi-Aventis Investigational Site Number 792007

Istanbul, Turkey (Türkiye)

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Sanofi-Aventis Investigational Site Number 792010

Istanbul, Turkey (Türkiye)

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Sanofi-Aventis Investigational Site Number 792012

Izmir, 35380, Turkey (Türkiye)

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Kocaeli, 41380, Turkey (Türkiye)

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Manisa, Turkey (Türkiye)

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Samsun, Turkey (Türkiye)

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Trabzon, 61080, Turkey (Türkiye)

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Sanofi-Aventis Investigational Site Number 804101

Chernihiv, 14025, Ukraine

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Dnipropetrovsk, 49027, Ukraine

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Donetsk, 83003, Ukraine

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Donetsk, 83099, Ukraine

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Ivano-Frankivsk, 76008, Ukraine

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Kharkiv, 61018, Ukraine

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Kharkiv, 61068, Ukraine

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Kiev, 04050, Ukraine

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Kiev, 04112, Ukraine

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Kiev, Ukraine

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Lutsk, 43005, Ukraine

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Lutsk, 43024, Ukraine

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Lviv, 79010, Ukraine

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Lviv, 79010, Ukraine

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Poltava, 36011, Ukraine

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Vinnytsia, 21005, Ukraine

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Zaporizhya, 69035, Ukraine

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Zaporizhzhia, 69600, Ukraine

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Zaporizhzhya, 69000, Ukraine

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Sanofi-Aventis Investigational Site Number 826002

Edinburgh, EH4 2XU, United Kingdom

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Sanofi-Aventis Investigational Site Number 826004

Haywards Heath, RH16 4EX, United Kingdom

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Irvine, KA12 8SS, United Kingdom

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Leeds, LS1 3EX, United Kingdom

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Salford, M6 8HD, United Kingdom

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Related Publications (6)

• Confavreux C, O'Connor P, Comi G, Freedman MS, Miller AE, Olsson TP, Wolinsky JS, Bagulho T, Delhay JL, Dukovic D, Truffinet P, Kappos L; TOWER Trial Group. Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014 Mar;13(3):247-56. doi: 10.1016/S1474-4422(13)70308-9. Epub 2014 Jan 23.

  PMID: 24461574 RESULT

• Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.

  PMID: 33023488 DERIVED

• Miller AE, Olsson TP, Wolinsky JS, Comi G, Kappos L, Hu X, Xu X, Lublin AL, Truffinet P, Chavin J, Delhay JL, Benamor M, Purvis A, Freedman MS; TOWER investigators. Long-term safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis: Results from the TOWER extension study. Mult Scler Relat Disord. 2020 Nov;46:102438. doi: 10.1016/j.msard.2020.102438. Epub 2020 Aug 1.

  PMID: 32911306 DERIVED

• Qiu W, Huang DH, Hou SF, Zhang MN, Jin T, Dong HQ, Peng H, Zhang CD, Zhao G, Huang YN, Zhou D, Wu WP, Wang BJ, Li JM, Zhang XH, Cheng Y, Li HF, Li L, Lu CZ, Zhang X, Bu BT, Dong WL, Fan DS, Hu XQ, Xu XH; TOWER Trial Chinese Group. Efficacy and Safety of Teriflunomide in Chinese Patients with Relapsing Forms of Multiple Sclerosis: A Subgroup Analysis of the Phase 3 TOWER Study. Chin Med J (Engl). 2018 Dec 5;131(23):2776-2784. doi: 10.4103/0366-6999.246067.

  PMID: 30511679 DERIVED

• Freedman MS, Morawski J, Thangavelu K. Clinical efficacy of teriflunomide over a fixed 2-year duration in the TOWER study. Mult Scler J Exp Transl Clin. 2018 May 16;4(2):2055217318775236. doi: 10.1177/2055217318775236. eCollection 2018 Apr-Jun.

  PMID: 29796289 DERIVED

• Freedman MS, Wolinsky JS, Comi G, Kappos L, Olsson TP, Miller AE, Thangavelu K, Benamor M, Truffinet P, O'Connor PW; TEMSO and TOWER Study Groups. The efficacy of teriflunomide in patients who received prior disease-modifying treatments: Subgroup analyses of the teriflunomide phase 3 TEMSO and TOWER studies. Mult Scler. 2018 Apr;24(4):535-539. doi: 10.1177/1352458517695468. Epub 2017 Mar 17.

  PMID: 28304217 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

teriflunomide

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2008
• First Posted: September 12, 2008
• Study Start: August 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: August 1, 2015
• Last Updated: July 7, 2016
• Results First Posted: June 26, 2013

Record last verified: 2016-05

Locations

BE (5); ES (5); SE (3); TU (4); GB (5); TH (2); DE (9); FR (7); US (39); PH (4); SL (4); CL (3); CA (7); NL (5); AU (7); RO (4); UA (19); CZ (3); GR (2); ME (2); CN (32); PL (5)