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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003566-41 | EudraCT Number | ||
| U1111-1133-0958 | Other Identifier | WHO | |
| PIP no. be confirmed | Other Identifier | EMA |
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This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals in children and adolescents with type 1 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin degludec/insulin aspart | Experimental |
| |
| Insulin detemir | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/insulin aspart | Drug | Administered subcutaneously (s.c., under the skin) once daily with a main meal. Dose individually adjusted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) | Percentage point change in glycosylated haemoglobin A1c (HbA1c) from baseline (week 0) to 16 Weeks. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment. | Week 0 to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose | Change from baseline in FPG after 16 weeks of treatment. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment. | week 0, week 16 |
| Incidence of Treatment Emergent Adverse Events (TEAEs) |
Not provided
Inclusion Criteria: - Informed consent obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Subjects diagnosed with type 1 diabetes mellitus - HbA1c below or equal to 11.0% Exclusion Criteria: - Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the investigator - More than 1 episode of diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1 (Screening) - Any chronic disorder or significant concomitant disease, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Phoenix | Arizona | 85053 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30666772 | Background | Thalange N, Deeb L, Klingensmith G, Franco DR, Bardtrum L, Tutkunkardas D, Danne T. The rate of hyperglycemia and ketosis with insulin degludec-based treatment compared with insulin detemir in pediatric patients with type 1 diabetes: An analysis of data from two randomized trials. Pediatr Diabetes. 2019 May;20(3):314-320. doi: 10.1111/pedi.12821. Epub 2019 Feb 10. | |
| 30014589 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
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The trial was conducted at 63 sites in 14 countries as follows: Belgium: 3 sites; Brazil: 1 sites; Canada:
3 sites; Czech Republic 3 sites; Croatia: 2 sites; Israel: 6 sites; Macedonia: 2 sites; Poland: 3 sites; Russia: 5 sites; Serbia: 4 sites; Slovenia: 1 sites; South Africa: 2 sites; Spain: 5 sites; and United States: 23 sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | IDegAsp OD | Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks. |
| FG001 | IDet OD/BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| insulin aspart | Drug | Administered s.c. with the remaining meals. Dose individually adjusted. |
|
| insulin detemir | Drug | Administered s.c. once or twice daily. Dose individually adjusted. Subjects will continue with their pre-trial dosing scheme (once (OD) or twice daily (BID)) and will be allowed to switch from OD to BID dosing. |
|
| insulin aspart | Drug | Administered s.c. at meal-times. Dose individually adjusted. |
|
A Treatment Emergent Adverse Event (TEAE) was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day on randomised treatment. |
| After 16 weeks of treatment |
| Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia) | Treatment emergent hypoglycaemic episodes (PG < 3.1 mmol/L (56 mg/dL) or severe hypoglycaemia). Confirmed hypoglycaemic episodes were defined as episodes that were either:
| After 16 weeks of treatment |
| Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes | The confirmed hypoglycaemic episodes occurring between 23:00 and 07:00 were considered for this endpoint | After 16 weeks of treatment |
| Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill | The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill. | After 16 weeks of treatment |
| Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill With Ketosis (Blood Ketones Above 1.5 mmol/L) | The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill. The ketone meaurement involved an additional finger prick and ketosis was considered present if blood ketones were higher than 1.5mmol/L | After 16 weeks of treatment |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Novo Nordisk Investigational Site | Sacramento | California | 95816 | United States |
| Novo Nordisk Investigational Site | Aurora | Colorado | 80045 | United States |
| Novo Nordisk Investigational Site | Jacksonville | Florida | 32207 | United States |
| Novo Nordisk Investigational Site | Maitland | Florida | 32751 | United States |
| Novo Nordisk Investigational Site | Melbourne | Florida | 32901 | United States |
| Novo Nordisk Investigational Site | Tallahassee | Florida | 32308 | United States |
| Novo Nordisk Investigational Site | Tampa | Florida | 33612 | United States |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30322 | United States |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30339 | United States |
| Novo Nordisk Investigational Site | Idaho Falls | Idaho | 83404-7596 | United States |
| Novo Nordisk Investigational Site | Springfield | Illinois | 62703 | United States |
| Novo Nordisk Investigational Site | Indianapolis | Indiana | 46202 | United States |
| Novo Nordisk Investigational Site | Iowa City | Iowa | 52242 | United States |
| Novo Nordisk Investigational Site | Lexington | Kentucky | 40503 | United States |
| Novo Nordisk Investigational Site | Baltimore | Maryland | 21229 | United States |
| Novo Nordisk Investigational Site | Worcester | Massachusetts | 01655 | United States |
| Novo Nordisk Investigational Site | Kansas City | Missouri | 64111 | United States |
| Novo Nordisk Investigational Site | Buffalo | New York | 14203 | United States |
| Novo Nordisk Investigational Site | Tulsa | Oklahoma | 74135 | United States |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75231 | United States |
| Novo Nordisk Investigational Site | Brussels | 1090 | Belgium |
| Novo Nordisk Investigational Site | Brussels | 1200 | Belgium |
| Novo Nordisk Investigational Site | Leuven | 3000 | Belgium |
| Novo Nordisk Investigational Site | Curitiba | Paraná | 80810-040 | Brazil |
| Novo Nordisk Investigational Site | Porto Alegre | Rio Grande do Sul | 91350-250 | Brazil |
| Novo Nordisk Investigational Site | São Paulo | São Paulo | 01228-200 | Brazil |
| Novo Nordisk Investigational Site | Vancouver | British Columbia | V6H 3V4 | Canada |
| Novo Nordisk Investigational Site | London | Ontario | N6A 5W9 | Canada |
| Novo Nordisk Investigational Site | Mississauga | Ontario | L5B 1B8 | Canada |
| Novo Nordisk Investigational Site | Montreal | Quebec | H3T 1C5 | Canada |
| Novo Nordisk Investigational Site | Montreal | Quebec | HIT 2M4 | Canada |
| Novo Nordisk Investigational Site | Zagreb | 10 000 | Croatia |
| Novo Nordisk Investigational Site | Zagreb | 10000 | Croatia |
| Novo Nordisk Investigational Site | Olomouc | 779 00 | Czechia |
| Novo Nordisk Investigational Site | Pardubice | 53203 | Czechia |
| Novo Nordisk Investigational Site | Prague | 15018 | Czechia |
| Novo Nordisk Investigational Site | Hyderabad | Andhra Pradesh | 500034 | India |
| Novo Nordisk Investigational Site | Bangalore | Karnataka | 560034 | India |
| Novo Nordisk Investigational Site | Mumbai | Maharashtra | 400008 | India |
| Novo Nordisk Investigational Site | Mumbai | Maharashtra | 400012 | India |
| Novo Nordisk Investigational Site | New Dehli | New Delhi | 110029 | India |
| Novo Nordisk Investigational Site | Chennai | Tamil Nadu | 600086 | India |
| Novo Nordisk Investigational Site | Beersheba | 84101 | Israel |
| Novo Nordisk Investigational Site | Haifa | 31096 | Israel |
| Novo Nordisk Investigational Site | Petah Tikva | 49202 | Israel |
| Novo Nordisk Investigational Site | Tel Aviv | Israel |
| Novo Nordisk Investigational Site | Tel Litwinsky | 52621 | Israel |
| Novo Nordisk Investigational Site | Ẕerifin | 70300 | Israel |
| Novo Nordisk Investigational Site | Skopje | 1000 | North Macedonia |
| Novo Nordisk Investigational Site | Gdansk | 80-952 | Poland |
| Novo Nordisk Investigational Site | Warsaw | 04-730 | Poland |
| Novo Nordisk Investigational Site | Warsaw | 04-736 | Poland |
| Novo Nordisk Investigational Site | Moscow | 125373 | Russia |
| Novo Nordisk Investigational Site | Novosibirsk | 630048 | Russia |
| Novo Nordisk Investigational Site | Saint Petersburg | 191144 | Russia |
| Novo Nordisk Investigational Site | Tomsk | 634050 | Russia |
| Novo Nordisk Investigational Site | Ufa | 450106 | Russia |
| Novo Nordisk Investigational Site | Belgrade | 11070 | Serbia |
| Novo Nordisk Investigational Site | Niš | 18 000 | Serbia |
| Novo Nordisk Investigational Site | Novi Sad | 21000 | Serbia |
| Novo Nordisk Investigational Site | Ljubljana | 1525 | Slovenia |
| Novo Nordisk Investigational Site | Johannesburg | Gauteng | 2193 | South Africa |
| Novo Nordisk Investigational Site | Pretoria | Gauteng | 0181 | South Africa |
| Novo Nordisk Investigational Site | Mayville | KwaZulu-Natal | 4058 | South Africa |
| Novo Nordisk Investigational Site | Barcelona | 08035 | Spain |
| Novo Nordisk Investigational Site | Esplugues Llobregat(Barcelona) | 08950 | Spain |
| Novo Nordisk Investigational Site | Leganés | 28911 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28034 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28046 | Spain |
| Battelino T, Deeb LC, Ekelund M, Kinduryte O, Klingensmith GJ, Kocova M, Kovarenko M, Shehadeh N. Efficacy and safety of a fixed combination of insulin degludec/insulin aspart in children and adolescents with type 1 diabetes: A randomized trial. Pediatr Diabetes. 2018 Nov;19(7):1263-1270. doi: 10.1111/pedi.12724. Epub 2018 Aug 16. |
Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks |
| Exposed |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Full Analysis set (FAS) included all randomised subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | IDegAsp OD | Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks. |
| BG001 | IDet OD/BID | Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks |
| 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 |
| ||||||||||||||||
| HbA1c | Mean | Standard Deviation | percentage (%) |
| |||||||||||||||
| Fasting plasma Glucose (FPG) | Capillary blood samples for fasting plasma glucose (FPG) were taken either at home or at the clinic in the morning on the day of visits 2, 14 and 18 by use of a home blood sampling kit. At baseline FPG assessment: IDegAsp OD: 172 subjects, IDet: 166 subjects. In total: 338 subjects | Mean | Standard Deviation | mmol/L |
|
| 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 | Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) | Percentage point change in glycosylated haemoglobin A1c (HbA1c) from baseline (week 0) to 16 Weeks. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment. | The FAS included all randomised subjects. 20 subjects were withdrawn and only 4 subjects though completed the study did not have assesments. | Posted | Mean | Standard Deviation | percentage (%) | Week 0 to week 16 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose | Change from baseline in FPG after 16 weeks of treatment. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment. | The FAS included all randomised subjects. 338 subjects had assessment at baseline, 326 had assessment at week 16, 2 subjects were withdrawn before exposure and 22 subjects week 16 assessment was not done. | Posted | Mean | Standard Deviation | mmol/L | week 0, week 16 |
|
| |||||||||||||||||||||||||||||
| Secondary | Incidence of Treatment Emergent Adverse Events (TEAEs) | A Treatment Emergent Adverse Event (TEAE) was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day on randomised treatment. | The Safety analysis set (SAS) included all subjects receiving at least one dose of the trial product or its comparator | Posted | Number | number of events | After 16 weeks of treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia) | Treatment emergent hypoglycaemic episodes (PG < 3.1 mmol/L (56 mg/dL) or severe hypoglycaemia). Confirmed hypoglycaemic episodes were defined as episodes that were either:
| The SAS included all subjects receiving at least one dose of the trial product or its comparator | Posted | Number | episodes | After 16 weeks of treatment |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes | The confirmed hypoglycaemic episodes occurring between 23:00 and 07:00 were considered for this endpoint | The SAS included all subjects receiving at least one dose of the trial product or its comparator | Posted | Number | episodes | After 16 weeks of treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill | The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill. | The SAS included all subjects receiving at least one dose of the trial product or its comparator | Posted | Number | episodes | After 16 weeks of treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill With Ketosis (Blood Ketones Above 1.5 mmol/L) | The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill. The ketone meaurement involved an additional finger prick and ketosis was considered present if blood ketones were higher than 1.5mmol/L | The SAS included all subjects receiving at least one dose of the trial product or its comparator | Posted | Number | episodes | After 16 weeks of treatment |
|
|
Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IDegAsp OD | Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks. | 11 | 181 | 96 | 181 | ||
| EG001 | IDet OD/BID | Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks | 7 | 179 | 97 | 179 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Fibula Fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypoglycaemic seizure | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Developmental glaucoma | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
Novo Nordisk maintains the right to be informed of plans by any investigator to publish and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to Novo Nordisk before submission for comments. Comments will be given within four weeks from receipt of the planned communication
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C578220 | insulin degludec, insulin aspart drug combination |
| D061267 | Insulin Aspart |
| D000069057 | Insulin Detemir |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D049528 | Insulin, Long-Acting |
Not provided
Not provided
| Male |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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