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This is a double-blind, single center, parallel group, placebo and active comparator, controlled study to characterize the wake promoting effects of single doses of SPD489 in healthy adult male undergoing acute sleep deprivation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPD489 20 mg | Experimental |
| |
| SPD489 50 mg | Experimental |
| |
| SPD489 70 mg | Experimental |
| |
| Armodafinil | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPD489 20 mg | Drug | Single oral dose of 20 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of Wakefulness Test (MWT) | The MWT was conducted to determine the subjects' ability to stay awake. Subjects sat in a darkened room and were told to "stay awake as long as possible" during the 30 minute session. This is an indicator of how well you are able to function and remain alert in quiet times of inactivity. Higher times are better. | Over a period of 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Karolinska Sleepiness Scale (KSS) Scores | The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better. | Over a period of 15 hours |
| KSS Scores by Timepoint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinilabs, Inc. | New York | New York | 10019 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SPD489 20 mg | A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation |
| FG001 | SPD489 50 mg | A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation |
| FG002 | SPD489 70 mg | A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation |
| FG003 | Armodafinil 250 mg | A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation |
| FG004 | Placebo | A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SPD489 20 mg | A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation |
| BG001 | SPD489 50 mg | A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation |
| 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 | Maintenance of Wakefulness Test (MWT) | The MWT was conducted to determine the subjects' ability to stay awake. Subjects sat in a darkened room and were told to "stay awake as long as possible" during the 30 minute session. This is an indicator of how well you are able to function and remain alert in quiet times of inactivity. Higher times are better. | Full Analysis Set (FAS) is defined as all randomized subjects with any primary efficacy assessment. | Posted | Least Squares Mean | Standard Error | Minutes | Over a period of 8 hours |
|
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Safety Analysis Set
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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 | SPD489 20 mg | A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
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| SPD489 50 mg | Drug | Single oral dose of 50 mg |
|
|
| SPD489 70 mg | Drug | Single oral dose of 70 mg |
|
|
| Armodafinil | Drug | Single oral dose of 250 mg |
|
| Placebo | Drug | Single oral dose |
|
The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.
| Over a period of 15 hours |
| Psychomotor Vigilance Task (PVT) Scores | PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses. | Over a period of 12 hours |
| PVT Scores by Timepoint | PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses. | Over a period of 12 hours |
| BG002 | SPD489 70 mg | A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation |
| BG003 | Armodafinil 250 mg | A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation |
| BG004 | Placebo | A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation |
| OG002 | SPD489 70 mg | A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation |
| OG003 | Armodafinil 250 mg | A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation |
| OG004 | Placebo | A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation |
|
|
|
| Secondary | Karolinska Sleepiness Scale (KSS) Scores | The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better. | FAS | Posted | Least Squares Mean | Standard Error | Units on a scale | Over a period of 15 hours |
|
|
|
|
| Secondary | KSS Scores by Timepoint | The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better. | FAS | Posted | Least Squares Mean | Standard Error | Units on a scale | Over a period of 15 hours |
|
|
|
|
| Secondary | Psychomotor Vigilance Task (PVT) Scores | PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses. | FAS | Posted | Least Squares Mean | Standard Error | msec | Over a period of 12 hours |
|
|
|
|
| Secondary | PVT Scores by Timepoint | PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses. | FAS | Posted | Least Squares Mean | Standard Error | msec | Over a period of 12 hours |
|
|
|
|
| 0 |
| 27 |
| 1 |
| 27 |
| EG001 | SPD489 50 mg | A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation | 0 | 27 | 5 | 27 |
| EG002 | SPD489 70 mg | A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation | 0 | 27 | 4 | 27 |
| EG003 | Armodafinil 250 mg | A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation | 0 | 27 | 3 | 27 |
| EG004 | Placebo | A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation | 0 | 27 | 1 | 27 |
| Nausea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D005021 |
| Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Mean Difference (Final Values) |
| -1.2 |
| 2-Sided |
| 95 |
| -1.8 |
| -0.6 |
| Superiority or Other (legacy) |
| Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -1.6 | 2-Sided | 95 | -2.2 | -1.0 | Superiority or Other (legacy) |
| Mixed Models Analysis | 0.0947 | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -1.1 | 0.1 | Superiority or Other (legacy) |
| Mixed Models Analysis | 0.9393 | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.6 | 0.6 | Superiority or Other (legacy) |
| Mixed Models Analysis | 0.0297 | Mean Difference (Final Values) | -0.7 | 2-Sided | 95 | -1.3 | -0.1 | Superiority or Other (legacy) |
| Mixed Models Analysis | 0.0004 | Mean Difference (Final Values) | -1.1 | 2-Sided | 95 | -1.7 | -0.5 | Superiority or Other (legacy) |
| 8:50pm |
|
| 9:50pm |
|
| 10:50pm |
|
| 11:50pm |
|
| 12:50am |
|
| 1:50am |
|
| 2:50am |
|
| 3:50am |
|
| 4:50am |
|
| 5:50am |
|
| 6:50am |
|
| 7:50am |
|
| 8:50am |
|
| 9:50am |
|
| 10:50am |
|
| 0.1798 |
| Mean Difference (Final Values) |
| 0.4 |
| 2-Sided |
| 95 |
| -0.2 |
| 0.9 |
| Superiority or Other (legacy) |
| 7:50pm | Mixed Models Analysis | 0.6090 | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -0.4 | 0.7 | Superiority or Other (legacy) |
| 7:50pm | Mixed Models Analysis | 0.1169 | Mean Difference (Final Values) | 0.4 | 2-Sided | 95 | -0.1 | 1.0 | Superiority or Other (legacy) |
| 7:50pm | Mixed Models Analysis | 0.3028 | Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -0.8 | 0.3 | Superiority or Other (legacy) |
| 7:50pm | Mixed Models Analysis | 0.9831 | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.5 | 0.5 | Superiority or Other (legacy) |
| 7:50pm | Mixed Models Analysis | 0.2887 | Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -0.8 | 0.2 | Superiority or Other (legacy) |
| 8:50pm | Mixed Models Analysis | 0.4395 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.8 | 0.3 | Superiority or Other (legacy) |
| 8:50pm | Mixed Models Analysis | 0.9019 | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.5 | 0.6 | Superiority or Other (legacy) |
| 8:50pm | Mixed Models Analysis | 0.3419 | Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -0.8 | 0.3 | Superiority or Other (legacy) |
| 8:50pm | Mixed Models Analysis | 0.9581 | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.6 | 0.5 | Superiority or Other (legacy) |
| 8:50pm | Mixed Models Analysis | 0.2572 | Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -0.9 | 0.2 | Superiority or Other (legacy) |
| 8:50pm | Mixed Models Analysis | 0.8085 | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -0.6 | 0.5 | Superiority or Other (legacy) |
| 8:50pm | Mixed Models Analysis | 0.3678 | Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -0.8 | 0.3 | Superiority or Other (legacy) |
| 9:50pm | Mixed Models Analysis | 0.3732 | Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -0.9 | 0.4 | Superiority or Other (legacy) |
| 9:50pm | Mixed Models Analysis | 0.4924 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.9 | 0.4 | Superiority or Other (legacy) |
| 9:50pm | Mixed Models Analysis | 0.9798 | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.7 | 0.6 | Superiority or Other (legacy) |
| 9:50pm | Mixed Models Analysis | 0.8557 | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -0.6 | 0.7 | Superiority or Other (legacy) |
| 9:50pm | Mixed Models Analysis | 0.0998 | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -1.2 | 0.1 | Superiority or Other (legacy) |
| 9:50pm | Mixed Models Analysis | 0.1479 | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -1.1 | 0.2 | Superiority or Other (legacy) |
| 9:50pm | Mixed Models Analysis | 0.8358 | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -0.7 | 0.6 | Superiority or Other (legacy) |
| 10:50pm | Mixed Models Analysis | 0.0199 | Mean Difference (Final Values) | -0.9 | 2-Sided | 95 | -1.6 | -0.1 | Superiority or Other (legacy) |
| 10:50pm | Mixed Models Analysis | 0.7625 | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -0.9 | 0.6 | Superiority or Other (legacy) |
| 10:50pm | Mixed Models Analysis | 0.1936 | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -1.2 | 0.3 | Superiority or Other (legacy) |
| 10:50pm | Mixed Models Analysis | 0.4534 | Mean Difference (Final Values) | 0.3 | 2-Sided | 95 | -0.5 | 1.0 | Superiority or Other (legacy) |
| 10:50pm | Mixed Models Analysis | 0.0012 | Mean Difference (Final Values) | -1.2 | 2-Sided | 95 | -2.0 | -0.5 | Superiority or Other (legacy) |
| 10:50pm | Mixed Models Analysis | 0.2072 | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -1.2 | 0.3 | Superiority or Other (legacy) |
| 10:50pm | Mixed Models Analysis | 0.0413 | Mean Difference (Final Values) | -0.8 | 2-Sided | 95 | -1.5 | 0.0 | Superiority or Other (legacy) |
| 11:50pm | Mixed Models Analysis | 0.1086 | Mean Difference (Final Values) | -0.7 | 2-Sided | 95 | -1.5 | 0.1 | Superiority or Other (legacy) |
| 11:50pm | Mixed Models Analysis | 0.5843 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -1.0 | 0.6 | Superiority or Other (legacy) |
| 11:50pm | Mixed Models Analysis | 0.0571 | Mean Difference (Final Values) | -0.8 | 2-Sided | 95 | -1.6 | 0.0 | Superiority or Other (legacy) |
| 11:50pm | Mixed Models Analysis | 0.3965 | Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -1.2 | 0.5 | Superiority or Other (legacy) |
| 11:50pm | Mixed Models Analysis | 0.0009 | Mean Difference (Final Values) | -1.4 | 2-Sided | 95 | -2.2 | -0.6 | Superiority or Other (legacy) |
| 11:50pm | Mixed Models Analysis | 0.0211 | Mean Difference (Final Values) | -1.0 | 2-Sided | 95 | -1.8 | -0.1 | Superiority or Other (legacy) |
| 11:50pm | Mixed Models Analysis | 0.2863 | Mean Difference (Final Values) | -0.4 | 2-Sided | 95 | -1.2 | 0.4 | Superiority or Other (legacy) |
| 12:50am | Mixed Models Analysis | 0.0428 | Mean Difference (Final Values) | -0.8 | 2-Sided | 95 | -1.7 | 0.0 | Superiority or Other (legacy) |
| 12:50am | Mixed Models Analysis | 0.3757 | Mean Difference (Final Values) | 0.4 | 2-Sided | 95 | -0.5 | 1.2 | Superiority or Other (legacy) |
| 12:50am | Mixed Models Analysis | 0.0002 | Mean Difference (Final Values) | -1.6 | 2-Sided | 95 | -2.4 | -0.8 | Superiority or Other (legacy) |
| 12:50am | Mixed Models Analysis | 0.3535 | Mean Difference (Final Values) | -0.4 | 2-Sided | 95 | -1.2 | 0.4 | Superiority or Other (legacy) |
| 12:50am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -1.9 | 2-Sided | 95 | -2.7 | -1.1 | Superiority or Other (legacy) |
| 12:50am | Mixed Models Analysis | 0.1131 | Mean Difference (Final Values) | -0.7 | 2-Sided | 95 | -1.5 | 0.2 | Superiority or Other (legacy) |
| 12:50am | Mixed Models Analysis | 0.0039 | Mean Difference (Final Values) | -1.2 | 2-Sided | 95 | -2.0 | -0.4 | Superiority or Other (legacy) |
| 1:50am | Mixed Models Analysis | 0.1302 | Mean Difference (Final Values) | -0.7 | 2-Sided | 95 | -1.5 | 0.2 | Superiority or Other (legacy) |
| 1:50am | Mixed Models Analysis | 0.6138 | Mean Difference (Final Values) | 0.2 | 2-Sided | 95 | -0.6 | 1.1 | Superiority or Other (legacy) |
| 1:50am | Mixed Models Analysis | 0.0008 | Mean Difference (Final Values) | -1.5 | 2-Sided | 95 | -2.3 | -0.6 | Superiority or Other (legacy) |
| 1:50am | Mixed Models Analysis | 0.1643 | Mean Difference (Final Values) | -0.6 | 2-Sided | 95 | -1.5 | 0.3 | Superiority or Other (legacy) |
| 1:50am | Mixed Models Analysis | 0.0002 | Mean Difference (Final Values) | -1.7 | 2-Sided | 95 | -2.5 | -0.8 | Superiority or Other (legacy) |
| 1:50am | Mixed Models Analysis | 0.0782 | Mean Difference (Final Values) | -0.8 | 2-Sided | 95 | -1.6 | 0.1 | Superiority or Other (legacy) |
| 1:50am | Mixed Models Analysis | 0.0441 | Mean Difference (Final Values) | -0.9 | 2-Sided | 95 | -1.7 | 0.0 | Superiority or Other (legacy) |
| 2:50am | Mixed Models Analysis | 0.0193 | Mean Difference (Final Values) | -1.2 | 2-Sided | 95 | -2.2 | -0.2 | Superiority or Other (legacy) |
| 2:50am | Mixed Models Analysis | 0.7071 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -1.2 | 0.8 | Superiority or Other (legacy) |
| 2:50am | Mixed Models Analysis | 0.0002 | Mean Difference (Final Values) | -1.9 | 2-Sided | 95 | -2.9 | -0.9 | Superiority or Other (legacy) |
| 2:50am | Mixed Models Analysis | 0.0611 | Mean Difference (Final Values) | -0.9 | 2-Sided | 95 | -1.9 | 0.0 | Superiority or Other (legacy) |
| 2:50am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -2.2 | 2-Sided | 95 | -3.2 | -1.2 | Superiority or Other (legacy) |
| 2:50am | Mixed Models Analysis | 0.0160 | Mean Difference (Final Values) | -1.2 | 2-Sided | 95 | -2.2 | -0.2 | Superiority or Other (legacy) |
| 2:50am | Mixed Models Analysis | 0.0480 | Mean Difference (Final Values) | -1.0 | 2-Sided | 95 | -2.0 | 0.0 | Superiority or Other (legacy) |
| 3:50am | Mixed Models Analysis | 0.0234 | Mean Difference (Final Values) | -1.2 | 2-Sided | 95 | -2.2 | -0.2 | Superiority or Other (legacy) |
| 3:50am | Mixed Models Analysis | 0.5624 | Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -1.3 | 0.7 | Superiority or Other (legacy) |
| 3:50am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -2.5 | 2-Sided | 95 | -3.5 | -1.5 | Superiority or Other (legacy) |
| 3:50am | Mixed Models Analysis | 0.0022 | Mean Difference (Final Values) | -1.6 | 2-Sided | 95 | -2.6 | -0.6 | Superiority or Other (legacy) |
| 3:50am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -2.7 | 2-Sided | 95 | -3.7 | -1.6 | Superiority or Other (legacy) |
| 3:50am | Mixed Models Analysis | 0.0008 | Mean Difference (Final Values) | -1.8 | 2-Sided | 95 | -2.8 | -0.8 | Superiority or Other (legacy) |
| 3:50am | Mixed Models Analysis | 0.0883 | Mean Difference (Final Values) | -0.9 | 2-Sided | 95 | -1.9 | 0.1 | Superiority or Other (legacy) |
| 4:50am | Mixed Models Analysis | 0.3093 | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -1.5 | 0.5 | Superiority or Other (legacy) |
| 4:50am | Mixed Models Analysis | 0.8871 | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -0.9 | 1.1 | Superiority or Other (legacy) |
| 4:50am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -2.2 | 2-Sided | 95 | -3.2 | -1.2 | Superiority or Other (legacy) |
| 4:50am | Mixed Models Analysis | 0.0022 | Mean Difference (Final Values) | -1.6 | 2-Sided | 95 | -2.6 | -0.6 | Superiority or Other (legacy) |
| 4:50am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -2.4 | 2-Sided | 95 | -3.4 | -1.4 | Superiority or Other (legacy) |
| 4:50am | Mixed Models Analysis | 0.0006 | Mean Difference (Final Values) | -1.8 | 2-Sided | 95 | -2.8 | -0.8 | Superiority or Other (legacy) |
| 4:50am | Mixed Models Analysis | 0.2462 | Mean Difference (Final Values) | -0.6 | 2-Sided | 95 | -1.6 | 0.4 | Superiority or Other (legacy) |
| 5:50am | Mixed Models Analysis | 0.4427 | Mean Difference (Final Values) | -0.4 | 2-Sided | 95 | -1.4 | 0.6 | Superiority or Other (legacy) |
| 5:50am | Mixed Models Analysis | 0.4405 | Mean Difference (Final Values) | 0.4 | 2-Sided | 95 | -0.6 | 1.4 | Superiority or Other (legacy) |
| 5:50am | Mixed Models Analysis | 0.0003 | Mean Difference (Final Values) | -2.0 | 2-Sided | 95 | -3.0 | -0.9 | Superiority or Other (legacy) |
| 5:50am | Mixed Models Analysis | 0.0279 | Mean Difference (Final Values) | -1.2 | 2-Sided | 95 | -2.2 | -0.1 | Superiority or Other (legacy) |
| 5:50am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -2.5 | 2-Sided | 95 | -3.5 | -1.5 | Superiority or Other (legacy) |
| 5:50am | Mixed Models Analysis | 0.0015 | Mean Difference (Final Values) | -1.7 | 2-Sided | 95 | -2.7 | -0.7 | Superiority or Other (legacy) |
| 5:50am | Mixed Models Analysis | 0.1246 | Mean Difference (Final Values) | -0.8 | 2-Sided | 95 | -1.8 | 0.2 | Superiority or Other (legacy) |
| 6:50am | Mixed Models Analysis | 0.3067 | Mean Difference (Final Values) | -0.6 | 2-Sided | 95 | -1.6 | 0.5 | Superiority or Other (legacy) |
| 6:50am | Mixed Models Analysis | 0.8940 | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -1.0 | 1.1 | Superiority or Other (legacy) |
| 6:50am | Mixed Models Analysis | 0.0034 | Mean Difference (Final Values) | -1.6 | 2-Sided | 95 | -2.7 | -0.5 | Superiority or Other (legacy) |
| 6:50am | Mixed Models Analysis | 0.0708 | Mean Difference (Final Values) | -1.0 | 2-Sided | 95 | -2.0 | 0.1 | Superiority or Other (legacy) |
| 6:50am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -2.5 | 2-Sided | 95 | -3.6 | -1.4 | Superiority or Other (legacy) |
| 6:50am | Mixed Models Analysis | 0.0006 | Mean Difference (Final Values) | -1.9 | 2-Sided | 95 | -2.9 | -0.8 | Superiority or Other (legacy) |
| 6:50am | Mixed Models Analysis | 0.2476 | Mean Difference (Final Values) | -0.6 | 2-Sided | 95 | -1.7 | 0.4 | Superiority or Other (legacy) |
| 7:50am | Mixed Models Analysis | 0.2310 | Mean Difference (Final Values) | -0.7 | 2-Sided | 95 | -1.8 | 0.4 | Superiority or Other (legacy) |
| 7:50am | Mixed Models Analysis | 0.8369 | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -1.2 | 1.0 | Superiority or Other (legacy) |
| 7:50am | Mixed Models Analysis | 0.0035 | Mean Difference (Final Values) | -1.6 | 2-Sided | 95 | -2.7 | -0.5 | Superiority or Other (legacy) |
| 7:50am | Mixed Models Analysis | 0.0498 | Mean Difference (Final Values) | -1.1 | 2-Sided | 95 | -2.2 | 0.0 | Superiority or Other (legacy) |
| 7:50am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -2.5 | 2-Sided | 95 | -3.6 | -1.4 | Superiority or Other (legacy) |
| 7:50am | Mixed Models Analysis | 0.0007 | Mean Difference (Final Values) | -1.9 | 2-Sided | 95 | -3.0 | -0.8 | Superiority or Other (legacy) |
| 7:50am | Mixed Models Analysis | 0.3198 | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -1.6 | 0.5 | Superiority or Other (legacy) |
| 8:50am | Mixed Models Analysis | 0.3750 | Mean Difference (Final Values) | 0.5 | 2-Sided | 95 | -0.6 | 1.7 | Superiority or Other (legacy) |
| 8:50am | Mixed Models Analysis | 0.7978 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -1.3 | 1.0 | Superiority or Other (legacy) |
| 8:50am | Mixed Models Analysis | 0.5197 | Mean Difference (Final Values) | -0.4 | 2-Sided | 95 | -1.5 | 0.8 | Superiority or Other (legacy) |
| 8:50am | Mixed Models Analysis | 0.0751 | Mean Difference (Final Values) | -1.1 | 2-Sided | 95 | -2.2 | 0.1 | Superiority or Other (legacy) |
| 8:50am | Mixed Models Analysis | 0.1079 | Mean Difference (Final Values) | -1.0 | 2-Sided | 95 | -2.1 | 0.2 | Superiority or Other (legacy) |
| 8:50am | Mixed Models Analysis | 0.0065 | Mean Difference (Final Values) | -1.6 | 2-Sided | 95 | -2.8 | -0.5 | Superiority or Other (legacy) |
| 8:50am | Mixed Models Analysis | 0.2529 | Mean Difference (Final Values) | 0.7 | 2-Sided | 95 | -0.5 | 1.8 | Superiority or Other (legacy) |
| 9:50am | Mixed Models Analysis | 0.6364 | Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -1.3 | 0.8 | Superiority or Other (legacy) |
| 9:50am | Mixed Models Analysis | 0.9417 | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -1.1 | 1.0 | Superiority or Other (legacy) |
| 9:50am | Mixed Models Analysis | 0.0200 | Mean Difference (Final Values) | -1.3 | 2-Sided | 95 | -2.3 | -0.2 | Superiority or Other (legacy) |
| 9:50am | Mixed Models Analysis | 0.0527 | Mean Difference (Final Values) | -1.1 | 2-Sided | 95 | -2.1 | 0.0 | Superiority or Other (legacy) |
| 9:50am | Mixed Models Analysis | 0.0107 | Mean Difference (Final Values) | -1.4 | 2-Sided | 95 | -2.5 | -0.3 | Superiority or Other (legacy) |
| 9:50am | Mixed Models Analysis | 0.0303 | Mean Difference (Final Values) | -1.2 | 2-Sided | 95 | -2.2 | -0.1 | Superiority or Other (legacy) |
| 9:50am | Mixed Models Analysis | 0.6889 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -1.3 | 0.8 | Superiority or Other (legacy) |
| 10:50am | Mixed Models Analysis | 0.9552 | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -1.2 | 1.1 | Superiority or Other (legacy) |
| 10:50am | Mixed Models Analysis | 0.7558 | Mean Difference (Final Values) | 0.2 | 2-Sided | 95 | -1.0 | 1.3 | Superiority or Other (legacy) |
| 10:50am | Mixed Models Analysis | 0.1824 | Mean Difference (Final Values) | -0.8 | 2-Sided | 95 | -1.9 | 0.4 | Superiority or Other (legacy) |
| 10:50am | Mixed Models Analysis | 0.3323 | Mean Difference (Final Values) | -0.6 | 2-Sided | 95 | -1.7 | 0.6 | Superiority or Other (legacy) |
| 10:50am | Mixed Models Analysis | 0.0413 | Mean Difference (Final Values) | -1.2 | 2-Sided | 95 | -2.4 | 0.0 | Superiority or Other (legacy) |
| 10:50am | Mixed Models Analysis | 0.0925 | Mean Difference (Final Values) | -1.0 | 2-Sided | 95 | -2.2 | 0.2 | Superiority or Other (legacy) |
| 10:50am | Mixed Models Analysis | 0.7133 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -1.4 | 0.9 | Superiority or Other (legacy) |
| Mean Difference (Final Values) |
| -35.4 |
| 2-Sided |
| 95 |
| -45.5 |
| -25.4 |
| Superiority or Other (legacy) |
| Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -26.7 | 2-Sided | 95 | -36.7 | -16.6 | Superiority or Other (legacy) |
| Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -26.5 | 2-Sided | 95 | -36.6 | -16.5 | Superiority or Other (legacy) |
| Mixed Models Analysis | 0.9945 | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -10.1 | 10.0 | Superiority or Other (legacy) |
| Mixed Models Analysis | 0.0814 | Mean Difference (Final Values) | -8.9 | 2-Sided | 95 | -18.9 | 1.1 | Superiority or Other (legacy) |
| Mixed Models Analysis | 0.9743 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -10.2 | 9.9 | Superiority or Other (legacy) |
| 11:15pm |
|
| 1:15am |
|
| 3:15am |
|
| 5:15am |
|
| 7:15am |
|
| 9:15am |
|
| 0.4410 |
| Mean Difference (Final Values) |
| -3.8 |
| 2-Sided |
| 95 |
| -13.6 |
| 6.0 |
| Superiority or Other (legacy) |
| 9:15pm | Mixed Models Analysis | 0.1046 | Mean Difference (Final Values) | -8.1 | 2-Sided | 95 | -17.9 | 1.7 | Superiority or Other (legacy) |
| 9:15pm | Mixed Models Analysis | 0.6467 | Mean Difference (Final Values) | -2.3 | 2-Sided | 95 | -12.0 | 7.5 | Superiority or Other (legacy) |
| 9:15pm | Mixed Models Analysis | 0.1971 | Mean Difference (Final Values) | -6.4 | 2-Sided | 95 | -16.2 | 3.4 | Superiority or Other (legacy) |
| 9:15pm | Mixed Models Analysis | 0.9052 | Mean Difference (Final Values) | -0.6 | 2-Sided | 95 | -10.4 | 9.2 | Superiority or Other (legacy) |
| 9:15pm | Mixed Models Analysis | 0.2420 | Mean Difference (Final Values) | -5.8 | 2-Sided | 95 | -15.6 | 4.0 | Superiority or Other (legacy) |
| 11:15pm | Mixed Models Analysis | 0.0001 | Mean Difference (Final Values) | -16.7 | 2-Sided | 95 | -25.1 | -8.3 | Superiority or Other (legacy) |
| 11:15pm | Mixed Models Analysis | 0.4321 | Mean Difference (Final Values) | 3.3 | 2-Sided | 95 | -5.0 | 11.6 | Superiority or Other (legacy) |
| 11:15pm | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -18.4 | 2-Sided | 95 | -26.7 | -10.1 | Superiority or Other (legacy) |
| 11:15pm | Mixed Models Analysis | 0.6999 | Mean Difference (Final Values) | 1.6 | 2-Sided | 95 | -6.7 | 9.9 | Superiority or Other (legacy) |
| 11:15pm | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -18.1 | 2-Sided | 95 | -26.4 | -9.8 | Superiority or Other (legacy) |
| 11:15pm | Mixed Models Analysis | 0.6566 | Mean Difference (Final Values) | 1.9 | 2-Sided | 95 | -6.4 | 10.2 | Superiority or Other (legacy) |
| 11:15pm | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -20.0 | 2-Sided | 95 | -28.3 | -11.7 | Superiority or Other (legacy) |
| 1:15am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -25.2 | 2-Sided | 95 | -36.1 | -14.3 | Superiority or Other (legacy) |
| 1:15am | Mixed Models Analysis | 0.7824 | Mean Difference (Final Values) | -1.5 | 2-Sided | 95 | -12.4 | 9.4 | Superiority or Other (legacy) |
| 1:15am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -25.1 | 2-Sided | 95 | -36.0 | -14.3 | Superiority or Other (legacy) |
| 1:15am | Mixed Models Analysis | 0.7867 | Mean Difference (Final Values) | -1.5 | 2-Sided | 95 | -12.4 | 9.4 | Superiority or Other (legacy) |
| 1:15am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -26.5 | 2-Sided | 95 | -37.4 | -15.6 | Superiority or Other (legacy) |
| 1:15am | Mixed Models Analysis | 0.6029 | Mean Difference (Final Values) | -2.9 | 2-Sided | 95 | -13.7 | 8.0 | Superiority or Other (legacy) |
| 1:15am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -23.6 | 2-Sided | 95 | -34.5 | -12.8 | Superiority or Other (legacy) |
| 3:15am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -37.1 | 2-Sided | 95 | -50.1 | -24.1 | Superiority or Other (legacy) |
| 3:15am | Mixed Models Analysis | 0.8684 | Mean Difference (Final Values) | 1.1 | 2-Sided | 95 | -11.9 | 14.1 | Superiority or Other (legacy) |
| 3:15am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -53.3 | 2-Sided | 95 | -66.3 | -40.3 | Superiority or Other (legacy) |
| 3:15am | Mixed Models Analysis | 0.0228 | Mean Difference (Final Values) | -15.1 | 2-Sided | 95 | -28.1 | -2.1 | Superiority or Other (legacy) |
| 3:15am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -40.0 | 2-Sided | 95 | -53.0 | -27.0 | Superiority or Other (legacy) |
| 3:15am | Mixed Models Analysis | 0.7852 | Mean Difference (Final Values) | -1.8 | 2-Sided | 95 | -14.8 | 11.2 | Superiority or Other (legacy) |
| 3:15am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -38.2 | 2-Sided | 95 | -51.2 | -25.2 | Superiority or Other (legacy) |
| 5:15am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -38.2 | 2-Sided | 95 | -51.3 | -25.1 | Superiority or Other (legacy) |
| 5:15am | Mixed Models Analysis | 0.5528 | Mean Difference (Final Values) | 3.9 | 2-Sided | 95 | -9.1 | 17.0 | Superiority or Other (legacy) |
| 5:15am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -53.9 | 2-Sided | 95 | -67.0 | -40.9 | Superiority or Other (legacy) |
| 5:15am | Mixed Models Analysis | 0.0747 | Mean Difference (Final Values) | -11.8 | 2-Sided | 95 | -24.9 | 1.2 | Superiority or Other (legacy) |
| 5:15am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -49.2 | 2-Sided | 95 | -62.2 | -36.1 | Superiority or Other (legacy) |
| 5:15am | Mixed Models Analysis | 0.2868 | Mean Difference (Final Values) | -7.1 | 2-Sided | 95 | -20.1 | 6.0 | Superiority or Other (legacy) |
| 5:15am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -42.1 | 2-Sided | 95 | -55.2 | -29.1 | Superiority or Other (legacy) |
| 7:15am | Mixed Models Analysis | 0.0007 | Mean Difference (Final Values) | -37.6 | 2-Sided | 95 | -59.1 | -16.2 | Superiority or Other (legacy) |
| 7:15am | Mixed Models Analysis | 0.9089 | Mean Difference (Final Values) | -1.2 | 2-Sided | 95 | -22.7 | 20.2 | Superiority or Other (legacy) |
| 7:15am | Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | -52.9 | 2-Sided | 95 | -74.3 | -31.4 | Superiority or Other (legacy) |
| 7:15am | Mixed Models Analysis | 0.1307 | Mean Difference (Final Values) | -16.5 | 2-Sided | 95 | -37.9 | 5.0 | Superiority or Other (legacy) |
| 7:15am | Mixed Models Analysis | 0.0011 | Mean Difference (Final Values) | -36.3 | 2-Sided | 95 | -57.7 | -14.8 | Superiority or Other (legacy) |
| 7:15am | Mixed Models Analysis | 0.9903 | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -21.3 | 21.6 | Superiority or Other (legacy) |
| 7:15am | Mixed Models Analysis | 0.0010 | Mean Difference (Final Values) | -36.4 | 2-Sided | 95 | -57.8 | -14.9 | Superiority or Other (legacy) |
| 9:15am | Mixed Models Analysis | 0.1655 | Mean Difference (Final Values) | -21.4 | 2-Sided | 95 | -51.7 | 9.0 | Superiority or Other (legacy) |
| 9:15am | Mixed Models Analysis | 0.8975 | Mean Difference (Final Values) | -2.0 | 2-Sided | 95 | -32.4 | 28.5 | Superiority or Other (legacy) |
| 9:15am | Mixed Models Analysis | 0.0199 | Mean Difference (Final Values) | -36.2 | 2-Sided | 95 | -66.5 | -5.8 | Superiority or Other (legacy) |
| 9:15am | Mixed Models Analysis | 0.2785 | Mean Difference (Final Values) | -16.8 | 2-Sided | 95 | -47.2 | 13.7 | Superiority or Other (legacy) |
| 9:15am | Mixed Models Analysis | 0.5048 | Mean Difference (Final Values) | -10.3 | 2-Sided | 95 | -40.6 | 20.1 | Superiority or Other (legacy) |
| 9:15am | Mixed Models Analysis | 0.5533 | Mean Difference (Final Values) | 9.1 | 2-Sided | 95 | -21.3 | 39.6 | Superiority or Other (legacy) |
| 9:15am | Mixed Models Analysis | 0.2098 | Mean Difference (Final Values) | -19.4 | 2-Sided | 95 | -49.9 | 11.1 | Superiority or Other (legacy) |