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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002962-15 | EudraCT Number | ||
| U1111-1284-2216 | Other Identifier | World Health Organization (WHO) |
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The purpose of this extension trial is to evaluate the long-term safety of delgocitinib.
Subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until Week 36. A final follow-up phone call is planned on Week 38.
Subject who completed 16 weeks of treatment with delgocitinib cream 20 mg/g or vehicle cream twice daily in trials DELTA 1 or DELTA 2 will be offered to roll-over to this extension trial.
Subjects will be treated with delgocitinib cream 20 mg/g twice daily only if they need it to control their chronic hand eczema. In the periods when the disease is controlled, no treatment will be administered.
Clinic visits every 4 weeks are planned (with the possibility of unscheduled visits) to investigate safety and efficacy of treatment, as well as its effect on patient-reported outcomes (PROs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| As-needed treatment with delgocitinib | Experimental | Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delgocitinib | Drug | Delgocitinib cream 20 mg/g |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-emergent Adverse Events From Baseline up to Week 38 | An AE will be considered treatment emergent if it started after the baseline visit | From baseline up to Week 38 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36 | The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). | From baseline up to Week 38 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEO Investigational Site | Brussels | 1000 | Belgium | |||
| LEO Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40081663 | Derived | Gooderham M, Molin S, Bissonnette R, Worm M, Crepy MN, Stingeni L, Warren RB, Schliemann S, Schuttelaar ML, Ferrucci S, Serra-Baldrich E, Silverberg JI, Balita-Crisostomo CL, Osterdal ML, Plohberger U, Agner T. Long-term safety and efficacy of delgocitinib cream for up to 52 weeks in adults with Chronic Hand Eczema: Results of the phase 3 open-label extension DELTA 3 trial following the DELTA 1 and 2 trials. J Am Acad Dermatol. 2025 Jul;93(1):95-103. doi: 10.1016/j.jaad.2025.03.008. Epub 2025 Mar 11. |
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This trial enrolled subjects who completed one of the 2 pivotal phase 3 trials with delgocitinib cream 20 mg/g or cream vehicle (parent trials - Trial 1401 [NCT04871711] or Trial 1402 [NCT04872101]).
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| ID | Title | Description |
|---|---|---|
| FG000 | As-needed Treatment With Delgocitinib | Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed. > > Delgocitinib: Delgocitinib cream 20 mg/g |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2023 |
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| Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36. | The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). | From baseline up to Week 38 |
| HECSI Score at Each Scheduled Visit From Baseline up to Week 36 | The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). | From baseline up to Week 38 |
| Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36 | The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-75 is defined as at least 75% improvement in HECSI score from parent trial baseline. | From baseline up to Week 38 |
| Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36 | The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-90 is defined as at least 90% improvement in HECSI score from parent trial baseline. | From baseline up to Week 38 |
| Ghent |
| 9000 |
| Belgium |
| LEO Investigational Site | Kortrijk | 8500 | Belgium |
| LEO Investigational Site | Leuven | 3000 | Belgium |
| LEO Investigational Site | Loverval | 6280 | Belgium |
| LEO Investigational Site | Maldegem | 9990 | Belgium |
| LEO Investigational Site | Calgary | Alberta | T2J 7E1 | Canada |
| LEO Investigational Site | Calgary | Alberta | T3E 0B2 | Canada |
| LEO Investigational Site | Edmonton | Alberta | T5J 3S9 | Canada |
| LEO Investigational Site | Edmonton | Alberta | T6G 1C3 | Canada |
| LEO Investigational Site | Surrey | British Columbia | V3R 6A7 | Canada |
| LEO Investigational Site | Vancouver | British Columbia | V6 4E1 | Canada |
| LEO Investigational Site | Fredericton | New Bruswick | E3B 1G9 | Canada |
| LEO Investigational Site | Ajax | Ontario | L1S 7K8 | Canada |
| LEO Investigational Site | Cobourg | Ontario | K9A 4J9 | Canada |
| LEO Investigational Site | Etobicoke | Ontario | M8X 1Y9 | Canada |
| LEO Investigational Site | Hamilton | Ontario | L8S 1G5 | Canada |
| LEO Investigational Site | Kingston | Ontario | K7L 2V7 | Canada |
| LEO Investigational Site | London | Ontario | N6A 3H7 | Canada |
| LEO Investigational Site | Markham | Ontario | L3P 1X3 | Canada |
| LEO Investigational Site | Toronto | Ontario | M2M 4J5 | Canada |
| LEO Investigational Site | Toronto | Ontario | M3H 5Y8 | Canada |
| LEO Investigational Site | Waterloo | Ontario | N2J 1C4 | Canada |
| LEO Investigational Site | Windsor | Ontario | N8W 1E6 | Canada |
| LEO Investigational Site | Montreal | Quebec | H2X 2V1 | Canada |
| LEO Investigational Site | Aarhus N | 8200 | Denmark |
| LEO investigational Site | Copenhagen | 2400 | Denmark |
| LEO Pharma Investigational Site | Hellerup | 2900 | Denmark |
| LEO Investigational Site | Bordeaux | 33000 | France |
| LEO Investigational Site | Dijon | 21000 | France |
| LEO Investigational Site | Le Mans | 72037 | France |
| LEO Investigational Site | Lille | 5900 | France |
| LEO Investigational Site | Martigues | 13500 | France |
| LEO Pharma Investigational Site | Nantes | 44093 | France |
| LEO Investigational Site | Nice | 06000 | France |
| LEO Investigational Site | Nice | 06202 | France |
| LEO Investigational Site | Paris | 75014 | France |
| LEO Investigational Site | Reims | 51100 | France |
| LEO Investigational Site | Toulouse | 31000 | France |
| LEO Investigational Site | Aachen | 52074 | Germany |
| LEO Investigational Site | Bad Bentheim | 48455 | Germany |
| LEO Investigational Site | Berlin | 10115 | Germany |
| LEO Investigational Site | Bretzenheim | 55128 | Germany |
| LEO Investigational Site | Dresden | 01307 | Germany |
| LEO Investigational Site | Frankfurt am Main | 60590 | Germany |
| LEO Investigational Site | Friedrichshafen | 88045 | Germany |
| LEO Investigational Site | Gera | 07548 | Germany |
| LEO Investigational Site | Göttingen | 37073 | Germany |
| LEO Investigational Site | Hamburg | 22391 | Germany |
| LEO Investigational Site | Hanover | 30159 | Germany |
| LEO Investigational Site | Haßfurt | 97437 | Germany |
| LEO Investigational Site | Jena | 07743 | Germany |
| LEO Investigational Site | Lübeck | 23538 | Germany |
| LEO Investigational Site | Mahlow | 15831 | Germany |
| LEO Pharma Investigational Site | Memmingen | 87700 | Germany |
| LEO Investigational Site | München | 80802 | Germany |
| Leo Investigational Site | Münster | 48149 | Germany |
| LEO Investigational Site | Osnabrück | 49074 | Germany |
| LEO Investigational Site | Stuttgart | 70178 | Germany |
| LEO Investigational Site | Brescia | 25123 | Italy |
| LEO Investigational Site | L’Aquila | 67100 | Italy |
| LEO Investigational Site | Rome | 00168 | Italy |
| LEO Investigational Site | Vicenza | 36100 | Italy |
| LEO Investigational Site | Amsterdam | 1105 AZ | Netherlands |
| LEO Investigational Site | Bergen op Zoom | 4614 VT | Netherlands |
| LEO Investigational Site | Groningen | 9713 GZ | Netherlands |
| LEO Investigational Site | Hoofddorp | 2134 TM | Netherlands |
| LEO Investigational Site | Utrecht | 3584 CX | Netherlands |
| LEO Investigitional Site | Bialystok | 15-375 | Poland |
| LEO Investigational Site | Bialystok | 15-794 | Poland |
| LEO Investigational Site | Gdansk | 80-546 | Poland |
| LEO Investigational Site | Krakow | 30-033 | Poland |
| LEO Investigational Site | Krakow | 31-011 | Poland |
| LEO Investigational Site | Lodz | 90-436 | Poland |
| LEO Investigational Site | Lublin | 20-081 | Poland |
| LEO Investigational Site | Lublin | 20-406 | Poland |
| LEO Investigational Site | Osielsko | 86-031 | Poland |
| LEO Pharma Investigational Site | Rzeszów | 35-055 | Poland |
| LEO Investigational Site | Warsaw | 02-507 | Poland |
| LEO Investigational Site | Warsaw | 02-625 | Poland |
| LEO Investigational Site | Warsaw | 02-953 | Poland |
| LEO Investigational Site | Warsaw | 02-962 | Poland |
| LEO Investigational Site | Wroclaw | 50-566 | Poland |
| LEO Investigational Site | Wroclaw | 51-318 | Poland |
| LEO Investigational Site | Alicante | 03010 | Spain |
| LEO Investigational Site | Badalona | 08915 | Spain |
| LEO Investigitional Site | Barcelona | 08041 | Spain |
| LEO Investigational Site | Bilbao | 48013 | Spain |
| LEO Investigational Site | Madrid | 28031 | Spain |
| LEO Investigational Site | Mieres | 33611 | Spain |
| LEO Investigational Site | Seville | 41009 | Spain |
| LEO Investigational Sites | Redhill | Surrey | RH1 5RH | United Kingdom |
| LEO Investigational Site | London | SE1 7EH | United Kingdom |
| LEO Investigational Site | Middlesbrough | TS4 3BW | United Kingdom |
| LEO Investigational Site | Salford | M6 8HD | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | As-needed Treatment With Delgocitinib | Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed.> > Delgocitinib: Delgocitinib cream 20 mg/g |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Number of Treatment-emergent Adverse Events From Baseline up to Week 38 | An AE will be considered treatment emergent if it started after the baseline visit | Posted | Number | events | From baseline up to Week 38 |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36 | The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). | Posted | Count of Participants | Participants | From baseline up to Week 38 |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36. | The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). | Posted | Count of Participants | Participants | From baseline up to Week 38 |
|
| ||||||||||||||||||||||||||||
| Secondary | HECSI Score at Each Scheduled Visit From Baseline up to Week 36 | The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). | Posted | Mean | Standard Deviation | score on a scale | From baseline up to Week 38 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36 | The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-75 is defined as at least 75% improvement in HECSI score from parent trial baseline. | Posted | Count of Participants | Participants | From baseline up to Week 38 |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36 | The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-90 is defined as at least 90% improvement in HECSI score from parent trial baseline. | Posted | Count of Participants | Participants | From baseline up to Week 38 |
|
|
From baseline to week 36
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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 | As-needed Treatment With Delgocitinib | As-needed treatment with Delgocitinib cream 20 mg/g (N=801) | 3 | 801 | 27 | 801 | 329 | 801 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Abdominal incarcerated hernia | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Death | General disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Contrast media allergy | Immune system disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Chronic sinusitis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Complicated appendicitis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Paranasal sinus abscess | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Peritonsillar abscess | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Sinusitis aspergillus | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Non-systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.0 | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Non-systematic Assessment |
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| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Non-systematic Assessment |
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| Lipofibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Non-systematic Assessment |
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| Oesophageal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Non-systematic Assessment |
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| Pyogenic granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Non-systematic Assessment |
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| Facial paralysis | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Alcoholism | Psychiatric disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Adnexal torsion | Reproductive system and breast disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
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The sponsor seeks publication of all clinical trials in peer-reviewed journals within 12 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 12 months, the investigator has the right to publish the results from clinical trial generated by him/herself.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure | LEO Pharma | +4544945888 | disclosure@leo-pharma.com |
| Jun 17, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C000621572 | delgocitinib |
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| Unknown or Not Reported |
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