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| ID | Type | Description | Link |
|---|---|---|---|
| R092670PSY3012 | Other Identifier | Janssen Research & Development, LLC | |
| 2011-004676-11 | EudraCT Number | ||
| U1111-1135-1969 | Other Identifier | Universal Trial Number |
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The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.
This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), placebo-controlled (an inactive substance is compared with a drug to test whether the drug has a real effect in a clinical trial) multicenter study. The study consists of 4 phases: a Screening Phase (up to 3 weeks); a 17-week flexible dose open-label Transition Phase (open-label phase means that all people know the identity of the intervention); a 12-week fixed dose open-label Maintenance Phase; and a randomized, double-blind, fixed dose, placebo-controlled relapse prevention phase (referred to as the Double-blind Phase). Patients who meet specific stabilization criteria will enter the Double-blind Phase at Week 29. Patients will be randomly assigned, in a 1:1 ratio, to receive either a fixed dose of PP3M or placebo. The Double-blind Phase will be of variable duration; patients will remain in the study until they experience a relapse event or meet discontinuation criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paliperidone palmitate 3-month (PP3M) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PP3M 175 mg eq. | Drug | Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Relapse During the Double-Blind Phase | Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event. Median time to relapse was estimated by the Kaplan-Meier method. | Approximately Week 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase | The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated 1 (absent) to 7 (extreme). The total score ranging from 30 to 210. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32606705 | Derived | Mathews M, Gopal S, Singh A, Nuamah I, Pungor K, Tan W, Soares B, Kim E, Savitz AJ. Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies. Neuropsychiatr Dis Treat. 2020 Jun 19;16:1533-1542. doi: 10.2147/NDT.S221242. eCollection 2020. | |
| 30994855 |
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A total of 509 participants were enrolled in to the study and 506 participants were entered the Open-label Transition and received at least one dose of study drug (PP1M). 2 participants were enrolled but not received study drug and 1 participant was screen failure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-Label Transition Phase: Paliperidone Palmitate 1-Month | Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| TRANSITION PHASE |
|
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| PP3M 263 mg eq. | Drug | Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria. |
|
| PP3M 350 mg eq. | Drug | Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria. |
|
| PP3M 525 mg eq. | Drug | Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria. |
|
| Placebo (20% Intralipid emulsion) | Drug | Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria. |
|
| Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60) |
| Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase | The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). | Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60) |
| Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase | The PSP scale measures personal and social functioning in the domains of: a) Socially useful activities, b) Personal and social relationships, c) Self-care, and d) Disturbing and aggressive behavior. The results of the assessment were converted to a numerical score which ranges from 1 to 100. A score lying between 71 and 100 indicates a mild degree of dysfunction; scores between 31 and 70 indicate varying degrees of difficulty, and a participant with a score of <=30 had functioning so poor that he or she required intensive supervision. | Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60) |
| San Fran Cisco |
| California |
| United States |
| Washington D.C. | District of Columbia | United States |
| Lauderhill | Florida | United States |
| Chicago | Illinois | United States |
| Hoffman Estates | Illinois | United States |
| Topeka | Kansas | United States |
| Baltimore | Maryland | United States |
| Flowood | Mississippi | United States |
| Marlton | New Jersey | United States |
| Cedarhurst | New York | United States |
| Oklahoma City | Oklahoma | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| Salt Lake City | Utah | United States |
| Barranquilla | Colombia |
| Bogotá | Colombia |
| Medellín | Colombia |
| Pereira | Colombia |
| Johor Bahru | Malaysia |
| Kuala Lumpur | Malaysia |
| Tanjong Rambutan | Malaysia |
| Guadajalara | Mexico |
| Mexico City | Mexico |
| Monterrey | Mexico |
| San Luis Potosí City | Mexico |
| Zapopan | Mexico |
| Arad | Romania |
| Craiova | Romania |
| Iași | Romania |
| Sibiu | Romania |
| Tg Mures | Romania |
| Deajun | South Korea |
| Gyeongsangnam-Do | South Korea |
| Incheon | South Korea |
| Seongnam | South Korea |
| Diyarbakır | Turkey (Türkiye) |
| Sakarya | Turkey (Türkiye) |
| Donetsk | Ukraine |
| Evpatoriya | Ukraine |
| Hlevakha | Ukraine |
| Ivano-Frankivsk | Ukraine |
| Kerch | Ukraine |
| Kharkiv | Ukraine |
| Kherson | Ukraine |
| Kiev | Ukraine |
| Lviv | Ukraine |
| Odesa | Ukraine |
| Poltava | Ukraine |
| Smila | Ukraine |
| Ternopil | Ukraine |
| Uzhhorod | Ukraine |
| Vinnitsa | Ukraine |
| Derived |
| Savitz AJ, Xu H, Gopal S, Nuamah I, Mathews M, Soares B. Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies. Braz J Psychiatry. 2019 Nov-Dec;41(6):499-510. doi: 10.1590/1516-4446-2018-0153. |
| 28640988 | Derived | Weiden PJ, Kim E, Bermak J, Turkoz I, Gopal S, Berwaerts J. Does Half-Life Matter After Antipsychotic Discontinuation? A Relapse Comparison in Schizophrenia With 3 Different Formulations of Paliperidone. J Clin Psychiatry. 2017 Jul;78(7):e813-e820. doi: 10.4088/JCP.16m11308. |
| 27743205 | Derived | Magnusson MO, Samtani MN, Plan EL, Jonsson EN, Rossenu S, Vermeulen A, Russu A. Population Pharmacokinetics of a Novel Once-Every 3 Months Intramuscular Formulation of Paliperidone Palmitate in Patients with Schizophrenia. Clin Pharmacokinet. 2017 Apr;56(4):421-433. doi: 10.1007/s40262-016-0459-3. |
| 26306819 | Derived | Gopal S, Vermeulen A, Nandy P, Ravenstijn P, Nuamah I, Buron Vidal JA, Berwaerts J, Savitz A, Hough D, Samtani MN. Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia. Curr Med Res Opin. 2015 Nov;31(11):2043-54. doi: 10.1185/03007995.2015.1085849. Epub 2015 Oct 2. |
| 25820612 | Derived | Berwaerts J, Liu Y, Gopal S, Nuamah I, Xu H, Savitz A, Coppola D, Schotte A, Remmerie B, Maruta N, Hough DW. Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Aug;72(8):830-9. doi: 10.1001/jamapsychiatry.2015.0241. |
| Open-Label Maintenance Phase: Paliperidone Palmitate 3-Month |
Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase. |
| FG002 | Double-Blind Phase: Placebo | Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. |
| FG003 | Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M) | Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase. |
| COMPLETED |
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| NOT COMPLETED |
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| MAINTENANCE PHASE |
|
|
| DOUBLE BLIND PHASE |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Double-Blind Phase: Placebo | Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. |
| BG001 | Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M) | Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Relapse During the Double-Blind Phase | Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event. Median time to relapse was estimated by the Kaplan-Meier method. | The intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during the Double-blind Phase and received at least one dose of Double-blind study agent. | Posted | Median | 95% Confidence Interval | Days | Approximately Week 60 |
|
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| ||||||||||||||||||||||||||||
| Secondary | Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase | The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated 1 (absent) to 7 (extreme). The total score ranging from 30 to 210. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. | Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60) |
| ||||||||||||||||||||||||||||||
| Secondary | Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase | The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). | Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60) |
| ||||||||||||||||||||||||||||||
| Secondary | Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase | The PSP scale measures personal and social functioning in the domains of: a) Socially useful activities, b) Personal and social relationships, c) Self-care, and d) Disturbing and aggressive behavior. The results of the assessment were converted to a numerical score which ranges from 1 to 100. A score lying between 71 and 100 indicates a mild degree of dysfunction; scores between 31 and 70 indicate varying degrees of difficulty, and a participant with a score of <=30 had functioning so poor that he or she required intensive supervision. | Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60) |
|
Up to Week 92
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open-Label Phase: PP1M + PP3M | PP1M= Paliperidone Palmitate 1 Month and PP3M= Paliperidone Palmitate 3 Month. Open-Label Transition Phase: Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64. Open-Label Maintenance Phase: Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase. | 33 | 506 | 317 | 506 | ||
| EG001 | Double-Blind Phase: Placebo | Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. | 15 | 145 | 77 | 145 | ||
| EG002 | Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M) | Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase. | 4 | 160 | 98 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis Erosive | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Megacolon | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Pyelonephritis Chronic | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hallucination, Auditory | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hallucination, Visual | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Schizophrenia, Paranoid Type | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Substance-Induced Psychotic Disorder | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Calculus Urinary | Renal and urinary disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Venous Thrombosis Limb | Vascular disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Injection Site Swelling | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. if requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Research | Janssen Research & Development, LLC | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
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| Failed Randomization Criteria |
|
| Other |
|
| Lost to Follow-up |
|
| Pregnancy |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Other |
|
| Male |
|
| Malaysia |
|
| Mexico |
|
| Romania |
|
| South Korea |
|
| Turkey |
|
| Ukraine |
|
| United States |
|
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|
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