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This study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir (LPV/r) + lamivudine (3TC)) in treatment-experienced human immunodeficiency virus 1 (HIV-1) infected participants with an undetectable plasma HIV-1 (ribonucleic acid) RNA level (for at least 6 months) at the 48 week time point of treatment in the routine clinical settings of the Russian Federation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-1 infected participants | HIV-1-infected participants on any triple highly active antiretroviral therapy (HAART) with plasma HIV-1 ribonucleic acid (RNA) level < 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to lopinavir with ritonavir plus lamivudine (LPV/r+3TC) as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lopinavir/ritonavir | Drug | tablet |
| |
| lamivudine |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48 | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24 | Week 24 | |
| Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data) | Baseline, Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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HIV-1 infected participants on any triple HAART with undetectable plasma HIV-1 RNA level for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r + 3TC in the routine clinical settings.
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| Name | Affiliation | Role |
|---|---|---|
| Andrey Strugovschikov, MD | AbbVie | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Human Immunodeficiency Virus 1 (HIV-1) Infected Participants | HIV-1-infected participants on any triple highly active antiretroviral therapy (HAART) with plasma HIV-1 ribonucleic acid (RNA) level < 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to lopinavir with ritonavir plus lamivudine (LPV/r+3TC) as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HIV-1 Infected Participants | HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level < 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48 | Participants with an assessment at given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 48 |
|
|
Up to Week 48
This study is non-interventional. Therefore, adverse events were not recorded in a solicited manner as in an interventional trial, but were recorded by spontaneous reporting in line with the requirements described in EMA Guideline on GVP module VI and local pharmacovigilance practice of the Russian Federation.
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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 | HIV-1 Infected Participants | Treatment-experienced HIV-1 infected participants with an undetectable plasma HIV-1 RNA level lopinavir/ritonavir: tablet Lamivudine: tablet |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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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 | Aug 17, 2015 | May 15, 2018 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D061466 | Lopinavir |
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
tablet |
|
| Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data) | Baseline, Week 24 |
| Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data) | Statistics for absolute HIV-1 RNA viral load, where all participants with undetectable HIV-1-RNA viral load data were included into calculations with half of the lower indication limit (50/2 copies/mL, or 25.00 copies/mL). | Baseline, Week 48 |
| Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data) | Baseline, Week 48 |
| Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24 | Baseline, Week 24 |
| Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48 | Baseline, Week 48 |
| Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24 | Baseline, Week 24 |
| Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48 | Baseline, Week 48 |
| Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs) | Week 48 |
| Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24 | Baseline, Week 24 |
| Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48 | Baseline, Week 48 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L) | Baseline, Week 24 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L) | Baseline, Week 48 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L) | Baseline, Week 24 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L) | Baseline, Week 48 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L) | Baseline, Week 24 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L) | Baseline, Week 48 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L) | Baseline, Week 24 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L) | Baseline, Week 48 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose | Baseline, Week 24 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose | Baseline, Week 48 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL | Baseline, Week 24 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL | Baseline, Week 48 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin | Baseline, Week 24 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin | Baseline, Week 48 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL | Baseline, Week 24 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL | Baseline, Week 48 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine | Baseline, Week 24 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine | Baseline, Week 48 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol | Baseline, Week 24 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol | Baseline, Week 48 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides | Baseline, Week 24 |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides | Baseline, Week 48 |
| Number of Participants With Adverse Events | Adverse events were not recorded in a solicited manner as in an interventional trial, but were recorded by spontaneous reporting in line with the requirements described in European Medicines Agency (EMA) Guideline on Good Pharmacovigilance Practices (GVP) module VI and local pharmacovigilance practice of the Russian Federation. | up to Week 48 |
| Pregnancy |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Absolute HIV-1 RNA Viral Load (Untransformed Data) | Statistics for absolute HIV-1 RNA viral load, where all participants with undetectable HIV-1-RNA viral load data were included into calculations with half of the lower indication limit (50/2 copies/mL, or 25.00 copies/mL). | Mean | Standard Deviation | copies/mL |
|
| HIV-1 RNA Viral Load (Log10-Transformed Data) | Mean | Standard Deviation | log10 copies/mL |
|
| CD4+T-Cell Counts (%) | Mean | Standard Deviation | percentage of lymphocytes that are CD4+ |
|
| CD4+T-Cell Counts (cells/mm^3) | Mean | Standard Deviation | cells/mm^3 |
|
| Arm Circumference | Mean | Standard Deviation | cm |
|
| Hip Circumference | Mean | Standard Deviation | cm |
|
| Waist Circumference | Mean | Standard Deviation | cm |
|
| Alanine Aminotransferase (U/L) | participants with an evaluable baseline assessment | Mean | Standard Deviation | U/L |
|
| Alanine Aminotransferase (µmol/L) | participants with an evaluable baseline assessment | Mean | Standard Deviation | µmol/L |
|
| Aspartate Aminotransferase (U/L) | participants with an evaluable baseline assessment | Mean | Standard Deviation | U/L |
|
| Aspartate Aminotransferase (µmol/L) | participants with an evaluable baseline assessment | Mean | Standard Deviation | µmol/L |
|
| Glucose | Mean | Standard Deviation | mmol/L |
|
| High Density Lipoprotein (HDL) | participants with an evaluable baseline assessment | Mean | Standard Deviation | mmol/L |
|
| Insulin | participants with an evaluable baseline assessment | Mean | Standard Deviation | µEq/mL |
|
| Low Density Lipoprotein (LDL) | participants with an evaluable baseline assessment | Mean | Standard Deviation | mmol/L |
|
| Serum Creatinine | participants with an evaluable baseline assessment | Mean | Standard Deviation | µmol/L |
|
| Total Cholesterol | participants with an evaluable baseline assessment | Mean | Standard Deviation | mmol/L |
|
| Triglycerides | participants with an evaluable assessment at baseline | Mean | Standard Deviation | mmol/L |
|
| Participants |
|
|
| Secondary | Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24 | Participants with an assessment at given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
|
|
|
| Secondary | Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data) | Participants with data on HIV-1 RNA viral load at given time point. | Posted | Mean | Standard Deviation | copies/mL | Baseline, Week 24 |
|
|
|
| Secondary | Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data) | Participants with data on HIV-1 RNA viral load at given time point. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline, Week 24 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data) | Statistics for absolute HIV-1 RNA viral load, where all participants with undetectable HIV-1-RNA viral load data were included into calculations with half of the lower indication limit (50/2 copies/mL, or 25.00 copies/mL). | Participants with data on HIV-1 RNA viral load at given time point. | Posted | Mean | Standard Deviation | copies/mL | Baseline, Week 48 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data) | Participants with data on HIV-1 RNA viral load at given time point. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline, Week 48 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24 | Participants with valid measurements at given time point. | Posted | Mean | Standard Deviation | percentage of lymphocytes that are CD4+ | Baseline, Week 24 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48 | Participants with valid measurements at given time point. | Posted | Mean | Standard Deviation | percentage of lymphocytes that are CD4+ | Baseline, Week 48 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24 | Participants with valid measurements at given time point. | Posted | Mean | Standard Deviation | cells/mm^3 | Baseline, Week 24 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48 | Participants with valid measurements at given time point. | Posted | Mean | Standard Deviation | cells/mm^3 | Baseline, Week 48 |
|
|
|
| Secondary | Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs) | Participants with HIV-1 RNA viral load detected levels of ≥ 50 copies/mL up to Week 24. | Posted | Count of Participants | Participants | Week 48 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24 | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | cm | Baseline, Week 24 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48 | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | cm | Baseline, Week 48 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L) | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | U/L | Baseline, Week 24 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L) | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | U/L | Baseline, Week 48 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L) | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | µmol/L | Baseline, Week 24 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L) | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | µmol/L | Baseline, Week 48 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L) | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | U/L | Baseline, Week 24 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L) | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | U/L | Baseline, Week 48 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L) | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | µmol/L | Baseline, Week 24 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L) | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | µmol/L | Baseline, Week 48 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 24 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 48 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 24 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 48 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | µEq/mL | Baseline, Week 24 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | µEq/mL | Baseline, Week 48 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 24 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 48 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | µmol/L | Baseline, Week 24 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | µmol/L | Baseline, Week 48 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 24 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 48 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 24 |
|
|
|
| Secondary | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides | Participants with measurements at given time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 48 |
|
|
|
| Secondary | Number of Participants With Adverse Events | Adverse events were not recorded in a solicited manner as in an interventional trial, but were recorded by spontaneous reporting in line with the requirements described in European Medicines Agency (EMA) Guideline on Good Pharmacovigilance Practices (GVP) module VI and local pharmacovigilance practice of the Russian Federation. | Posted | Count of Participants | Participants | No | up to Week 48 |
|
|
|
| 0 |
| 216 |
| 0 |
| 216 |
| 3 |
| 216 |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D016047 |
| Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| Title | Measurements |
|---|
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|
| Change from BL: hip circumference |
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| Absolute values: waist circumference |
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| Change from BL: waist circumference |
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| Change from BL: hip circumference |
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| Absolute values: waist circumference |
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| Change from BL: waist circumference |
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