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| ID | Type | Description | Link |
|---|---|---|---|
| PT11-37 | Other Identifier | Consumer Health Care | |
| P08712 | Other Identifier | Merck |
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The purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (Loratadine and
Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom Complex (MSC) score will then receive drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| loratadine | Experimental | Participants will receive one dose of loratadine following randomization at 120 minutes of exposure during visit 4. |
|
| fexofenadine | Experimental | Participants will receive one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. |
|
| placebo | Placebo Comparator | Participants will receive one dose of placebo following randomization at 120 minutes of exposure during visit 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| loratadine | Drug | loratadine, one 10 mg tablet, orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) | The MSC Score is calculated as the sum of 5 individual symptom scores for Runny Nose, Itchy Nose, Sneezing, Watery Eyes, and Itchy Eyes. Each individual symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The total MSC score ranges from 0 - 25. Increasing scores are associated with increasing severity. | From time of sensitization (time 0) to end of visit (~8 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | The individual symptom score for Runny Nose was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Runny Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. |
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Inclusion Criteria:
urine pregnancy test at Screening (Visit 1) and Visit 4 (prior to randomization) and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the Screening visit and throughout the study.
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Loratadine | Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4. |
| FG001 | Fexofenadine | Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. |
| FG002 | Placebo | Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Loratadine | Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4. |
| BG001 | Fexofenadine | Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. |
| 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 | Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) | The MSC Score is calculated as the sum of 5 individual symptom scores for Runny Nose, Itchy Nose, Sneezing, Watery Eyes, and Itchy Eyes. Each individual symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The total MSC score ranges from 0 - 25. Increasing scores are associated with increasing severity. | Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point. | Posted | Mean | Standard Deviation | units on a scale | From time of sensitization (time 0) to end of visit (~8 hours) |
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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 | Loratadine | Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017336 | Loratadine |
| C093230 | fexofenadine |
| ID | Term |
|---|---|
| D003533 | Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| fexofenadine | Drug | fexofenadine, one 180 mg tablet, orally |
|
| placebo to loratadine | Drug | one tablet, orally |
|
| placebo to fexofenadine | Drug | one tablet, orally |
|
| From time of sensitization (time 0) to end of visit (~8 hours) |
| Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | The individual symptom score for Itchy Nose was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. | From time of sensitization (time 0) to end of visit (~8 hours) |
| Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | The individual symptom score for Sneezing was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Sneezing symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. | From time of sensitization (time 0) to end of visit (~8 hours) |
| Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | The individual symptom score for Water Eyes was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Watery Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. | From time of sensitization (time 0) to end of visit (~8 hours) |
| Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | The individual symptom score for Itchy Eyes was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. | From time of sensitization (time 0) to end of visit (~8 hours) |
| Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | The individual symptom score for Nasal Congestion was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Nasal Congestion symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. | From time of sensitization (time 0) to end of visit (~8 hours) |
| Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | The individual symptom score for Itchy Mouth/Throat/Ears was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Mouth/Throat/Ears symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. | From time of sensitization (time 0) to end of visit (~8 hours) |
| BG002 | Placebo | Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Loratadine | Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4. |
| OG001 | Fexofenadine | Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. |
| OG002 | Placebo | Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4. |
|
|
| Secondary | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | The individual symptom score for Runny Nose was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Runny Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. | Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point. | Posted | Mean | Standard Deviation | units on a scale | From time of sensitization (time 0) to end of visit (~8 hours) |
|
|
|
| Secondary | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | The individual symptom score for Itchy Nose was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. | Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point. | Posted | Mean | Standard Deviation | units on a scale | From time of sensitization (time 0) to end of visit (~8 hours) |
|
|
|
| Secondary | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | The individual symptom score for Sneezing was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Sneezing symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. | Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point. | Posted | Mean | Standard Deviation | units on a scale | From time of sensitization (time 0) to end of visit (~8 hours) |
|
|
|
| Secondary | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | The individual symptom score for Water Eyes was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Watery Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. | Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point. | Posted | Mean | Standard Deviation | units on a scale | From time of sensitization (time 0) to end of visit (~8 hours) |
|
|
|
| Secondary | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | The individual symptom score for Itchy Eyes was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. | Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point. | Posted | Mean | Standard Deviation | units on a scale | From time of sensitization (time 0) to end of visit (~8 hours) |
|
|
|
| Secondary | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | The individual symptom score for Nasal Congestion was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Nasal Congestion symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. | Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point. | Posted | Mean | Standard Deviation | units on a scale | From time of sensitization (time 0) to end of visit (~8 hours) |
|
|
|
| Secondary | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | The individual symptom score for Itchy Mouth/Throat/Ears was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Mouth/Throat/Ears symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. | Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point. | Posted | Mean | Standard Deviation | units on a scale | From time of sensitization (time 0) to end of visit (~8 hours) |
|
|
|
| 0 |
| 85 |
| 0 |
| 85 |
| EG001 | Fexofenadine | Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. | 0 | 85 | 0 | 85 |
| EG002 | Placebo | Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4. | 0 | 85 | 0 | 85 |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| 30 minutes |
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| 45 minutes |
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| 60 minutes |
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| 75 minutes |
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| 90 minutes |
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| 105 minutes |
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| 120 minutes |
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| 135 minutes |
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| 150 minutes |
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| 180 minutes |
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| 195 minutes |
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| 240 minutes |
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| 255 minutes |
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| 270 minutes |
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| 285 minutes |
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| 300 minutes |
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| 315 minutes |
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| 330 minutes |
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| 345 minutes |
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| 360 minutes |
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| 30 minutes |
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| 90 minutes |
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| 135 minutes |
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| 165 minutes |
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| 180 minutes |
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| 195 minutes |
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| 210 minutes |
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| 255 minutes |
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| 285 minutes |
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| 300 minutes |
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| 315 minutes |
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| 330 minutes |
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| 345 minutes |
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| 360 minutes |
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| 30 minutes (n=85, n=85, n=85) |
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| 45 minutes (n=85, n=85, n=85) |
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| 60 minutes (n=85, n=85, n=85) |
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| 75 minutes (n=85, n=85, n=85) |
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| 90 minutes (n=85, n=85, n=85) |
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| 105 minutes (n=85, n=85, n=85) |
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| 210 minutes (n=85, n=85, n=85) |
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| 225 minutes (n=85, n=85, n=85) |
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| 240 minutes (n=85, n=85, n=85) |
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| 255 minutes (n=85, n=85, n=85) |
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| 270 minutes (n=85, n=85, n=85) |
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| 285 minutes (n=85, n=85, n=85) |
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| 300 minutes (n=84, n=85, n=85) |
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| 315 minutes (n=84, n=85, n=85) |
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| 330 minutes (n=85, n=85, n=85) |
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| 345 minutes (n=84, n=85, n=85) |
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| 360 minutes (n=85, n=85, n=85) |
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| 255 minutes |
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| 270 minutes |
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| 285 minutes |
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| 300 minutes |
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| 315 minutes |
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| 330 minutes |
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| 345 minutes |
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| 360 minutes |
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| 30 minutes (n=85, n=85, n=85) |
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| 45 minutes (n=85, n=85, n=85) |
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| 60 minutes (n=85, n=85, n=85) |
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| 75 minutes (n=85, n=85, n=85) |
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| 135 minutes (n=85, n=85, n=85) |
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| 150 minutes (n=85, n=85, n=85) |
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| 165 minutes (n=85, n=85, n=85) |
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| 180 minutes (n=85, n=85, n=85) |
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| 195 minutes (n=85, n=85, n=85) |
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| 210 minutes (n=85, n=85, n=85) |
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| 225 minutes (n=85, n=85, n=85) |
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| 240 minutes (n=84, n=85, n=85) |
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| 255 minutes (n=85, n=85, n=85) |
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| 270 minutes (n=85, n=85, n=85) |
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| 285 minutes (n=85, n=85, n=85) |
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| 300 minutes (n=85, n=85, n=85) |
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| 315 minutes (n=85, n=85, n=85) |
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| 330 minutes (n=85, n=85, n=85) |
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| 345 minutes (n=85, n=85, n=85) |
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| 360 minutes (n=85, n=85, n=85) |
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| 30 minutes (n=85, n=85, n=85) |
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| 45 minutes (n=85, n=85, n=85) |
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| 60 minutes (n=85, n=85, n=85) |
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| 75 minutes (n=85, n=85, n=85) |
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| 90 minutes (n=85, n=85, n=85) |
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| 105 minutes (n=85, n=85, n=85) |
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| 120 minutes (n=85, n=85, n=85) |
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| 135 minutes (n=85, n=85, n=85) |
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| 150 minutes (n=85, n=85, n=85) |
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| 165 minutes (n=85, n=85, n=85) |
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| 180 minutes (n=85, n=85, n=85) |
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| 195 minutes (n=85, n=85, n=85) |
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| 210 minutes (n=85, n=85, n=85) |
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| 225 minutes (n=85, n=85, n=85) |
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| 240 minutes (n=85, n=85, n=85) |
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| 255 minutes (n=85, n=85, n=84) |
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| 270 minutes (n=85, n=85, n=84) |
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| 285 minutes (n=85, n=85, n=85) |
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| 300 minutes (n=85, n=85, n=85) |
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| 315 minutes (n=85, n=85, n=85) |
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| 330 minutes (n=85, n=85, n=85) |
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| 345 minutes (n=85, n=85, n=85) |
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| 360 minutes (n=85, n=85, n=85) |
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| 30 minutes (n=85, n=85, n=85) |
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| 45 minutes (n=85, n=85, n=85) |
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| 60 minutes (n=85, n=85, n=85) |
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| 75 minutes (n=85, n=85, n=85) |
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| 90 minutes (n=85, n=85, n=85) |
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| 105 minutes (n=85, n=85, n=85) |
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| 120 minutes (n=85, n=85, n=85) |
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| 135 minutes (n=85, n=85, n=85) |
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| 150 minutes (n=85, n=85, n=85) |
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| 165 minutes (n=85, n=85, n=85) |
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| 180 minutes (n=85, n=85, n=85) |
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| 195 minutes (n=85, n=85, n=85) |
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| 210 minutes (n=85, n=85, n=85) |
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| 225 minutes (n=85, n=85, n=85) |
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| 240 minutes (n=85, n=85, n=85) |
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| 255 minutes (n=85, n=85, n=84) |
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| 270 minutes (n=85, n=85, n=85) |
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| 285 minutes (n=85, n=85, n=85) |
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| 300 minutes (n=85, n=85, n=85) |
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| 315 minutes (n=85, n=85, n=85) |
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| 330 minutes (n=85, n=85, n=85) |
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| 345 minutes (n=85, n=85, n=85) |
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| 360 minutes (n=85, n=85, n=85) |
|