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The main purpose of the study is to evaluate the safety, reactogenicity, and the immunogenicity of mRNA-1010 vaccine candidate variations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1010 Dose C | Experimental | Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1. |
|
| mRNA-1010.4 Dose B | Experimental | Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1. |
|
| mRNA-1010.4 Dose C | Experimental | Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1. |
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| mRNA-1010.6 Dose A | Experimental | Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1. |
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| mRNA-1010.6 Dose B | Experimental | Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1. |
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| mRNA-1010.6 Dose C | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1010 | Biological | Sterile liquid for injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. | 7 days post-vaccination |
| Number of Participants With Unsolicited Adverse Events (AEs) | An unsolicited AE was an AE that was not solicited using a participant diary and that was communicated by a participant who has signed the informed consent. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure. | Up to 28 days post-vaccination |
| Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation | An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or coronavirus disease 2019 [COVID-19] and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 181) are reported in this outcome measure. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains | Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. 95% CI was calculated based on the t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel RCA | Hollywood | Florida | 33024 | United States | ||
| Suncoast Research Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | mRNA-1010 | Participants received a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1. |
| FG001 | mRNA-1010.4 Low Dose | Participants received mRNA-1010.4 at a low dose level by IM injection on Day 1. |
| 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 | Yes | No | No | Study Protocol | Apr 12, 2023 | Nov 27, 2024 |
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Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.
|
| mRNA-1010.4 |
| Biological |
Sterile liquid for injection |
|
| mRNA-1010.6 | Biological | Sterile liquid for injection |
|
| Day 1 to Day 181 (end of study [EOS]) |
| Days 1 (Baseline), 8, 29, 91, and 181 |
| Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains | The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% confidence interval (CI) for GMFR was calculated based on the t distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. | Baseline, Days 8, 29, 91, and 181 |
| Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains | Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroresponse was defined as (a) a post-vaccination antibody titer ≥ 4 * lower limit of quantification (LLOQ) if baseline (Day 1) antibody titer was < LLOQ or (b) a post-vaccination antibody titer ≥ 4-fold of baseline antibody titer if baseline antibody titer was ≥ LLOQ. | Days 8, 29, 91, and 181 |
| Miami |
| Florida |
| 33135 |
| United States |
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | United States |
| Rockville Internal Medicine | Rockville | Maryland | 20854 | United States |
| DM Clinical Research | Southfield | Michigan | 48076 | United States |
| Meridian Clinical Research | Hastings | Nebraska | 68901 | United States |
| Meridian Clinical Research | Lincoln | Nebraska | 68510 | United States |
| United Medical Associates | Binghamton | New York | 13905 | United States |
| DM Clinical Research | Sugar Land | Texas | 77478 | United States |
| Texas Center for Drug Development | Tomball | Texas | 77375 | United States |
| FG002 | mRNA-1010.4 High Dose | Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1. |
| FG003 | mRNA-1010.6 Low Dose | Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1. |
| FG004 | mRNA-1010.6 Medium Dose | Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1. |
| FG005 | mRNA-1010.6 High Dose | Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1. |
| Received Injection |
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| Safety Set | All participants who received 1 dose of study intervention. Participants were included in the study arm corresponding to the study intervention that they received. |
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| Solicited Safety Set | All participants who received 1 dose of study intervention and contributed any solicited AR data (that is, had at least 1 post baseline solicited safety [eDiary] assessment). Participants were included in the study arm corresponding to the study intervention that they received. |
|
| Per-Protocol Set | All randomized participants who received the study intervention, complied with the injection schedule, timing of immunogenicity blood sampling to have a baseline (Day 1), had at least 1 post injection assessment, had a Day 29 assessment that was within 22 days to 43 days after injection, had no important protocol deviations which impacted the immune response, and did not use prohibited medication or nonstudy vaccines against influenza. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Full Analysis Set included all randomized participants who received the study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | mRNA-1010 | Participants received a single dose of mRNA-1010 by IM injection on Day 1. |
| BG001 | mRNA-1010.4 Low Dose | Participants received mRNA-1010.4 at a low dose level by IM injection on Day 1. |
| BG002 | mRNA-1010.4 High Dose | Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1. |
| BG003 | mRNA-1010.6 Low Dose | Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1. |
| BG004 | mRNA-1010.6 Medium Dose | Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1. |
| BG005 | mRNA-1010.6 High Dose | Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1. |
| BG006 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. | Solicited Safety Set included all participants who received 1 dose of study intervention and contributed any solicited AR data (that is, had at least 1 post baseline solicited safety [eDiary] assessment). Participants were included in the study intervention group corresponding to the study intervention that they received. | Posted | Count of Participants | Participants | 7 days post-vaccination |
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| |||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Unsolicited Adverse Events (AEs) | An unsolicited AE was an AE that was not solicited using a participant diary and that was communicated by a participant who has signed the informed consent. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure. | Safety Set included all participants who received 1 dose of study intervention. Participants were included in the study arm corresponding to the study intervention that they received. | Posted | Count of Participants | Participants | Up to 28 days post-vaccination |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation | An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or coronavirus disease 2019 [COVID-19] and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 181) are reported in this outcome measure. | Safety Set included all participants who received 1 dose of study intervention. Participants were included in the study arm corresponding to the study intervention that they received. | Posted | Count of Participants | Participants | Day 1 to Day 181 (end of study [EOS]) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains | Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. 95% CI was calculated based on the t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation. | Per-Protocol Set: all randomized participants who received study drug, complied with injection schedule, timing of immunogenicity blood sampling to have a baseline (Day 1), had at least 1 post injection assessment, had a Day 29 assessment that was within 22 days to 43 days after injection, had no important protocol deviations which impacted immune response, and did not use prohibited medication/nonstudy vaccines against influenza. 'Number analyzed'= participants evaluable for specified category. | Posted | Geometric Mean | 95% Confidence Interval | titer | Days 1 (Baseline), 8, 29, 91, and 181 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains | The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% confidence interval (CI) for GMFR was calculated based on the t distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. | Per-Protocol Set: all randomized participants who received study drug, complied with injection schedule, timing of immunogenicity blood sampling to have a baseline (Day 1), had at least 1 post injection assessment, had a Day 29 assessment that was within 22 days to 43 days after injection, had no important protocol deviations which impacted immune response, and did not use prohibited medication/nonstudy vaccines against influenza. 'Number analyzed'= participants evaluable for specified category. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Baseline, Days 8, 29, 91, and 181 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains | Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroresponse was defined as (a) a post-vaccination antibody titer ≥ 4 * lower limit of quantification (LLOQ) if baseline (Day 1) antibody titer was < LLOQ or (b) a post-vaccination antibody titer ≥ 4-fold of baseline antibody titer if baseline antibody titer was ≥ LLOQ. | Per-Protocol Set: all randomized participants who received study drug, complied with injection schedule, timing of immunogenicity blood sampling to have a baseline (Day 1), had at least 1 post injection assessment, had a Day 29 assessment that was within 22 days to 43 days after injection, had no important protocol deviations which impacted immune response, and did not use prohibited medication/nonstudy vaccines against influenza. 'Number analyzed'= participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Days 8, 29, 91, and 181 |
|
Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants.
Participants were included in the study arm corresponding to the study intervention that they received.
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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 | mRNA-1010 | Participants received a single dose of mRNA-1010 by IM injection on Day 1. | 0 | 60 | 1 | 60 | 0 | 60 |
| EG001 | mRNA-1010.4 Low Dose | Participants received mRNA-1010.4 at a low dose level by IM injection on Day 1. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | mRNA-1010.4 High Dose | Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1. | 0 | 60 | 2 | 60 | 0 | 60 |
| EG003 | mRNA-1010.6 Low Dose | Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1. | 0 | 30 | 1 | 30 | 0 | 30 |
| EG004 | mRNA-1010.6 Medium Dose | Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG005 | mRNA-1010.6 High Dose | Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1. | 0 | 59 | 1 | 59 | 3 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Moderna Clinical Trials Support Center | ModernaTX, Inc. | 1-877-777-7187 | clinicaltrials@modernatx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 27, 2024 | Nov 27, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000722747 | mRNA-1010 influenza vaccine |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Grade 1 |
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| Grade 2 |
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| Grade 3 |
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| Grade 4 |
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| OG002 |
| mRNA-1010.4 High Dose |
Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1 |
| OG003 | mRNA-1010.6 Low Dose | Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1. |
| OG004 | mRNA-1010.6 Medium Dose | Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1. |
| OG005 | mRNA-1010.6 High Dose | Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1. |
|
|
Participants received mRNA-1010.4 at a low dose level by IM injection on Day 1.
| OG002 | mRNA-1010.4 High Dose | Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1 |
| OG003 | mRNA-1010.6 Low Dose | Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1. |
| OG004 | mRNA-1010.6 Medium Dose | Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1. |
| OG005 | mRNA-1010.6 High Dose | Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1. |
|
|
Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1 |
| OG003 | mRNA-1010.6 Low Dose | Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1. |
| OG004 | mRNA-1010.6 Medium Dose | Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1. |
| OG005 | mRNA-1010.6 High Dose | Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1. |
|
|
| OG002 | mRNA-1010.4 High Dose | Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1 |
| OG003 | mRNA-1010.6 Low Dose | Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1. |
| OG004 | mRNA-1010.6 Medium Dose | Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1. |
| OG005 | mRNA-1010.6 High Dose | Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1. |
|
|
| mRNA-1010.4 High Dose |
Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1 |
| OG003 | mRNA-1010.6 Low Dose | Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1. |
| OG004 | mRNA-1010.6 Medium Dose | Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1. |
| OG005 | mRNA-1010.6 High Dose | Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1. |
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