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This study will investigate any improvement in alertness and performance based on cognitive function and mood assessment in subjects suffering the common cold, when taking a novel paracetamol and caffeine combination verses paracetamol alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| highest dose Paracetamol + caffeine | Active Comparator | highest dose of Paracetamol and caffeine |
|
| low-dose Paracetamol + caffeine | Active Comparator | lowest dose of Paracetamol and caffeine |
|
| high dose paracetamol | Active Comparator | highest dose paracetamol |
|
| low dose paracetamol | Active Comparator | lowest dose paracetamol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paracetamol + caffeine | Drug | paracetamol with caffeine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test | The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated. | Baseline to 60 minutes post treatment administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test | The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated. |
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Common Cold Centre | Cardiff | Wales | United Kingdom |
Out of 244 participants screened, 4 did not meet the study criteria. Remaining 240 were randomized into the study.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paracetamol + Caffeine Combination (1000/130) | Two paracetamol (500 milligrams [mg] ) and caffeine (65 mg) tablets were dissolved in 200 milliliter (mL) of water and administered orally. |
| FG001 | Paracetamol (1000) | Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally. |
| FG002 | Paracetamol + Caffeine Combination (500/65) | One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally. |
| FG003 | Paracetamol (500) | One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paracetamol + Caffeine Combination (1000/130) | Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally. |
| BG001 | Paracetamol (1000) |
| 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 | Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test | The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated. | Intent to Treat (ITT) population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | Posted | Least Squares Mean | Standard Error | Correct responses | Baseline to 60 minutes post treatment administration |
Adverse events were collected from the start of the treatment, and until 5 days following administration of the last dose of investigational product.
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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 | Paracetamol + Caffeine Combination (1000/130) | Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| paracetamol | Drug | paracetamol |
|
| Baseline to 120 minutes post treatment administration |
| Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task | The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs). | Baseline, 60 minutes and upto 120 minutes post treatment administration |
| Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task | The no. of inaccurate responses to RVIP was determined from cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of screen. They responded to consecutive sequences of 3 odd or even numbers by pressing the corresponding response button. This was identified in the output file by a value of '1' in the 'TARGET=1' column. If a subject responded incorrectly to stimuli (pressed the response button at the wrong time), this was identified by a value of '-1' in the 'CORRECT=1' column. The no. of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button within 600 msecs of being presented with a string of 3 consecutive even or odd numbers), this was considered a missed response and was calculated as the no. of records where there was a value of '1' in the 'TARGET=1' column and a value of '0' in the 'CORRECT=1' column. | Baseline, 60 minutes and up to 120 minutes post treatment administration |
| Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test | Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained auditory attention task, participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones. This was identified in the output file by a value of '8' in the 'NUMBER' column. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appeared in a continuous stream of letters presented on a screen. This was identified in the output file by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. | Baseline, 60 minutes and up to 120 minutes post treatment administration |
| Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task | The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs). | Baseline, 30 minutes and up to 60 minutes post treatment administration |
| Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test | For sustained auditory attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones. It was identified in output file by a value of '8' in 'NUMBER' column. For sustained visual attention task, participants responded to letter 's' every time it appeared in a continuous stream of letters presented on screen. This was identified in output file by a value of 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), it was identified by a value of '-1' in 'CORRECT=1' column. The no. of incorrect responses was calculated as total no. of records where 'CORRECT=1' had a value of '-1'. The no. of missed responses (when subject failed to press the response button on hearing the number '8' or seeing the letter 's'), was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in the 'LETTER' column and a value of '0' in the 'CORRECT=1' column. | Baseline, 60 minutes and up to 120 minutes post treatment administration |
| Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test | Auditory and visual attention of participants was evaluated using a validated Divided Attention task. Participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones or saw a letter 's' on the screen . This was identified in the output file by a value of '8' in the 'NUMBER' column or by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. | Baseline, 60 minutes and up to 120 minutes post treatment administration |
| Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test | The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs). | Baseline, 60 minutes and up to 120 minutes post treatment administration |
| Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test | For the Divided Attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones or seeing a letter 's' on screen. This was identified in the output file by a value of '8' in 'NUMBER' column or 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), this was identified by a value of '-1' in 'CORRECT=1' column. The number of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button on hearing the no. '8' or seeing the letter 's'), this was considered a missed response. The number of missed responses was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in 'LETTER' column and a value of '0' in the 'CORRECT=1' column. | Baseline, 60 minutes and up to 120 minutes post treatment administration |
Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
| BG002 | Paracetamol + Caffeine Combination (500/65) | One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally. |
| BG003 | Paracetamol (500) | One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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|
|
|
| Secondary | Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test | The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated. | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | Posted | Least Squares Mean | Standard Error | Correct responses | Baseline to 120 minutes post treatment administration |
|
|
|
|
| Secondary | Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task | The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs). | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | Posted | Median | Full Range | milliseconds (msec) | Baseline, 60 minutes and upto 120 minutes post treatment administration |
|
|
|
| Secondary | Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task | The no. of inaccurate responses to RVIP was determined from cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of screen. They responded to consecutive sequences of 3 odd or even numbers by pressing the corresponding response button. This was identified in the output file by a value of '1' in the 'TARGET=1' column. If a subject responded incorrectly to stimuli (pressed the response button at the wrong time), this was identified by a value of '-1' in the 'CORRECT=1' column. The no. of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button within 600 msecs of being presented with a string of 3 consecutive even or odd numbers), this was considered a missed response and was calculated as the no. of records where there was a value of '1' in the 'TARGET=1' column and a value of '0' in the 'CORRECT=1' column. | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Error | inaccurate and missed responses | Baseline, 60 minutes and up to 120 minutes post treatment administration |
|
|
|
| Secondary | Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test | Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained auditory attention task, participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones. This was identified in the output file by a value of '8' in the 'NUMBER' column. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appeared in a continuous stream of letters presented on a screen. This was identified in the output file by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | Posted | Median | Full Range | Correct responses | Baseline, 60 minutes and up to 120 minutes post treatment administration |
|
|
|
| Secondary | Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task | The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs). | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | Posted | Least Squares Mean | Standard Error | msec | Baseline, 30 minutes and up to 60 minutes post treatment administration |
|
|
|
| Secondary | Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test | For sustained auditory attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones. It was identified in output file by a value of '8' in 'NUMBER' column. For sustained visual attention task, participants responded to letter 's' every time it appeared in a continuous stream of letters presented on screen. This was identified in output file by a value of 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), it was identified by a value of '-1' in 'CORRECT=1' column. The no. of incorrect responses was calculated as total no. of records where 'CORRECT=1' had a value of '-1'. The no. of missed responses (when subject failed to press the response button on hearing the number '8' or seeing the letter 's'), was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in the 'LETTER' column and a value of '0' in the 'CORRECT=1' column. | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Error | incorrect and missed responses | Baseline, 60 minutes and up to 120 minutes post treatment administration |
|
|
|
| Secondary | Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test | Auditory and visual attention of participants was evaluated using a validated Divided Attention task. Participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones or saw a letter 's' on the screen . This was identified in the output file by a value of '8' in the 'NUMBER' column or by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | Posted | Median | Full Range | Correct responses | Baseline, 60 minutes and up to 120 minutes post treatment administration |
|
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|
| Secondary | Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test | The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs). | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | Posted | Least Squares Mean | Standard Error | msec | Baseline, 60 minutes and up to 120 minutes post treatment administration |
|
|
|
| Secondary | Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test | For the Divided Attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones or seeing a letter 's' on screen. This was identified in the output file by a value of '8' in 'NUMBER' column or 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), this was identified by a value of '-1' in 'CORRECT=1' column. The number of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button on hearing the no. '8' or seeing the letter 's'), this was considered a missed response. The number of missed responses was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in 'LETTER' column and a value of '0' in the 'CORRECT=1' column. | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Error | incorrect and missed responses | Baseline, 60 minutes and up to 120 minutes post treatment administration |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Paracetamol (1000) | Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally. | 0 | 45 | 0 | 45 |
| EG002 | Paracetamol + Caffeine Combination (500/65) | One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally. | 0 | 74 | 0 | 74 |
| EG003 | Paracetamol (500) | One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally. | 0 | 75 | 0 | 75 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP. | ANCOVA | From ANCOVA model with factors for treatment group and season, and baseline score as a covariate. | A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p<0.05). | LS Mean Difference | 2.7 | 2-Sided | 95 | 0.3 | 5.2 | A positive difference favored the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP. | ANCOVA | From ANCOVA model with factors for treatment group and season, and baseline score as a covariate. | A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p<0.05). | LS Mean Difference | 1.1 | 2-Sided | 95 | -1.7 | 3.9 | A positive difference favored the first named treatment. | No | Superiority or Other |
| 120 minutes |
|
| Incorrect responses at 120 minutes |
|
| Missed responses at 60 minutes |
|
| Missed responses at 120 minutes |
|
| Number of Accurate Responses to SAT at 120 mins |
|
| 120 minutes |
|
| Incorrect responses at 120 minutes |
|
| Missed responses at 60 minutes |
|
| Missed responses at 120 minutes |
|
| 120 minutes |
|
| 120 minutes |
|
| Incorrect responses at 120 minutes |
|
| Missed responses at 60 minutes |
|
| Missed responses at 120 minutes |
|