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This study aims to determine whether in-bed cycle ergometry, early in the hospital course after a brain hemorrhage could balance damaging and reparative inflammation in the brain. Inflammatory factors of two groups of patients with brain hemorrhage will be compared, one group will receive in-bed cycling beginning 3 days after hemorrhage plus usual care and the other group will receive usual care only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supine cycle ergometry of the lower extremities | Experimental | Patients will receive two 20 minute cycle ergometry sessions separated by at least 4 hours in addition to usual care. The cycle will be set to a gear of zero and will begin in passive mode, the patient will be able to actively cycle if patients are able. |
|
| Control | No Intervention | Patients will receive usual care only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supine cycle ergometry of the lower extremities | Device | The cycle ergometer allows for movement of the lower extremities by a motor if a patient is experiencing a disorder of consciousness or is otherwise unable to move one or both legs. If a patient is able to cycle actively the device allows the patient to move patient's legs without support of the motor. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Interleukin-1beta Level in Blood (Picogram/Milliliter) | Day 1, day 3 and day 7 of study | |
| Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter) | Day 1, day 3 and day 7 of study | |
| Change in Tumor Necrosis Factor-alpha Level in Blood (Picogram/Milliliter) | Day 1, day 3 and day 7 of study | |
| Change in C Reactive Protein Level in Blood (Nanogram/Milliliter) | Day 1, day 3 and day 7 of study | |
| Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter) | Day 1, day 3 and day 7 of study | |
| Change in Interleukin-1beta Level in Cerebrospinal Fluid (Picogram/Milliliter) | Cerebrospinal fluid (CSF) will be collected only in patients with an external ventricular drain as part of patients' care. | Day 1, day 3 and day 7 of study |
| Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter) | CSF will be collected only in patients with an external ventricular drain as part of patients' care. | Day 1, day 3 and day 7 of study |
| Change in Tumor Necrosis Factor (TNF) -Alpha Level in CSF (Picogram/Milliliter) | CSF will be collected only in patients with an external ventricular drain as part of patients' care. TNF-alpha normal range (1.45 pg/mL to 1073.41 pg/mL) |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Hand-held Dynamometry Score (Pounds) | An average of three hand-held dynamometry measurements will be calculated for each measurement episode and the change over time will be measured. Grip strength is reported in pounds and compared against population and sex-based normative values. | Study days 1, 3, 7, day of transfer from the ICU or discharge, whichever comes first, assessed up to 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth K Zink | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University, Department of Neurology | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23817823 | Background | Amidei C, Sole ML. Physiological responses to passive exercise in adults receiving mechanical ventilation. Am J Crit Care. 2013 Jul;22(4):337-48. doi: 10.4037/ajcc2013284. | |
| 17535998 | Background | Arafah BM, Nishiyama FJ, Tlaygeh H, Hejal R. Measurement of salivary cortisol concentration in the assessment of adrenal function in critically ill subjects: a surrogate marker of the circulating free cortisol. J Clin Endocrinol Metab. 2007 Aug;92(8):2965-71. doi: 10.1210/jc.2007-0181. Epub 2007 May 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Supine Cycle Ergometry of the Lower Extremities | Patients will receive two 20 minute cycle ergometry sessions separated by at least 4 hours in addition to usual care. The cycle will be set to a gear of zero and will begin in passive mode, the patient will be able to actively cycle if patients are able. Supine cycle ergometry of the lower extremities: The cycle ergometer allows for movement of the lower extremities by a motor if a patient is experiencing a disorder of consciousness or is otherwise unable to move one or both legs. If a patient is able to cycle actively the device allows the patient to move patient's legs without support of the motor. |
| FG001 | Control | Patients will receive usual care only. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Supine Cycle Ergometry of the Lower Extremities | Patients will receive two 20 minute cycle ergometry sessions separated by at least 4 hours in addition to usual care. The cycle will be set to a gear of zero and will begin in passive mode, the patient will be able to actively cycle if patients are able. Supine cycle ergometry of the lower extremities: The cycle ergometer allows for movement of the lower extremities by a motor if a patient is experiencing a disorder of consciousness or is otherwise unable to move one or both legs. If a patient is able to cycle actively the device allows the patient to move patient's legs without support of the motor. |
| 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 in Interleukin-1beta Level in Blood (Picogram/Milliliter) | Samples collected did not meet the threshold for analysis, therefore this outcome measure could not be assessed. | Posted | Day 1, day 3 and day 7 of study |
|
Up to 90 days
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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 | Supine Cycle Ergometry of the Lower Extremities | Patients will receive two 20 minute cycle ergometry sessions separated by at least 4 hours in addition to usual care. The cycle will be set to a gear of zero and will begin in passive mode, the patient will be able to actively cycle if patients are able. Supine cycle ergometry of the lower extremities: The cycle ergometer allows for movement of the lower extremities by a motor if a patient is experiencing a disorder of consciousness or is otherwise unable to move one or both legs. If a patient is able to cycle actively the device allows the patient to move patient's legs without support of the motor. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| systolic blood pressure above goal | Cardiac disorders | Non-systematic Assessment |
Data from the first 25 patients enrolled in this study was analyzed. However, recruitment was thought to be affected by the COVID-19 pandemic. The investigator intended to resume recruitment of the remainder of the sample, however additional funding was not available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Department of Neurology | Johns Hopkins University | 410-955-2228 | ezink1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2020 | Feb 20, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 4, 2019 | Feb 20, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Pilot randomized parallel group design
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The clinician assessing outcomes will not have been involved in the care of the patient and will not be aware of the group assignment.
|
| Day 1, day 3 and day 7 of study |
| Change in C Reactive Protein Level in CSF (Nanogram/Milliliter) | CSF will be collected only in patients with an external ventricular drain as part of patients' care | Day 1, day 3 and day 7 of study |
| Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter) | CSF will be collected only in patients with an external ventricular drain as part of patients' care | Day 1, day 3 and day 7 of study |
| Change in Salivary Cortisol Level (Microgram/Deciliter) | Day 1, day 3 and day 7 of study |
| Global Pre-morbid Physical Health Status as Measured by the Promis Scale v1.2 | The global physical health status subscale of the Promis scale v1.2 will be used to measure pre-morbid physical health status. A 5-point Likert scale is used to score each of the four items. The scores for each item are summed as a raw score and are converted to T scores using a standardized table with higher T scores indicating better physical health status. An average t score representing the population is 50. 10 points is equal to 1 standard deviation, thus a score of 60 means that one is one standard deviation better than the general population. | Day 1 of study |
| Global Pre-morbid Mental Health Status as Measured by the Promis Scale v1.2 | The global mental health status subscale of the Promis scale will be used to measure pre-morbid mental health status. A 5-point Likert scale is used to score each of the four items. The scores for each item are summed as a raw score and are converted to T scores using a standardized table with higher T scores indicating better physical health status. An average t score representing the population is 50. Ten points is equal to 1 standard deviation, thus a score of 60 means that one is one standard deviation better than the general population. | Day 1 of study |
| Functional Status as Assessed by the Modified Rankin Score (mRS) | The modified Rankin score will be used to measure function in terms of activities of daily living after stroke. A six-point ordinal scale (0-6) with lower scores indicating less disability and higher scores indicating increasingly severe disability. A score of 6 indicates death. Reporting the frequency of each score category. | Standard of care 90-day assessment |
| Change in the Functional Status as Assessed by the Modified Rankin Score | The modified Rankin score will be used to measure function in terms of activities of daily living after stroke. A six-point ordinal scale (0-6) with lower scores indicating less disability and higher scores indicating increasingly severe disability. A score of 6 indicates death. Change in functional status was calculated by subtracting the first score (discharge) from the second score (90 day assessment). | Day of ICU transfer or discharge, 90 day assessment |
| Change in Muscle Strength as Assessed by the Medical Research Council Sum (MRCS) Score | The MRCS will be used to measure muscle strength over time. The instrument is a 60 point scale indicating muscle strength in 6 muscle groups. Three muscle groups each on the right and left upper extremities and three each in the right and left lower extremities. Each muscle group is scored from 0-5 out of a possible 5 points. A composite score with a maximum of 60 is produced, 30 points can be achieved for each side of the body. | Study days 1, 3, 7, On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days, 30-day follow-up visit |
| Ability to Perform Activities of Daily Living as Assessed by the Barthel Index | The Barthel index will be used to measure a participant's ability to perform activities of daily living in detail. The instrument is a 10-item scale with a range of 0 -100 points. Higher scores indicate higher levels of function. | On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days, 30-day follow-up visit |
| Health Status as Assessed by the Stroke Impact Scale Version 3.0 | This is a 59-item questionnaire that will measure health status in 8 domains following the stroke. A 5-point Likert scale is used to score each item with higher scores indicating higher perceived health status. | During the 30-day follow up visit |
| Perception of Stroke Recovery as Assessed by the Stroke Impact Scale Version 3.0 | The last question of the instrument measures a participant's perception of stroke recovery using a 0-100 scale with higher scores representing higher levels of recovery and lower scores representing less recovery. | During the 30-day follow up visit |
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| 25328080 | Background | Zhao X, Sun G, Ting SM, Song S, Zhang J, Edwards NJ, Aronowski J. Cleaning up after ICH: the role of Nrf2 in modulating microglia function and hematoma clearance. J Neurochem. 2015 Apr;133(1):144-52. doi: 10.1111/jnc.12974. Epub 2014 Nov 24. |
| BG001 | Control | Patients will receive usual care only. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type of Stroke | Count of Participants | Participants |
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| OG001 |
| Control |
Patients will receive usual care only. |
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| Primary | Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter) | One participant was withdrawn for safety reasons in the intervention arm. All timepoints collected are reported. | Posted | Median | Inter-Quartile Range | picogram/milliliter | Day 1, day 3 and day 7 of study |
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| Primary | Change in Tumor Necrosis Factor-alpha Level in Blood (Picogram/Milliliter) | Samples collected did not meet the threshold for analysis, therefore this outcome measure could not be assessed. | Posted | Day 1, day 3 and day 7 of study |
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| Primary | Change in C Reactive Protein Level in Blood (Nanogram/Milliliter) | C reactive protein was not performed due to lack of funding. | Posted | Day 1, day 3 and day 7 of study |
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| Primary | Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter) | Participants who were able to have samples drawn are reported. | Posted | Median | Inter-Quartile Range | picograms/mL | Day 1, day 3 and day 7 of study |
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| Primary | Change in Interleukin-1beta Level in Cerebrospinal Fluid (Picogram/Milliliter) | Cerebrospinal fluid (CSF) will be collected only in patients with an external ventricular drain as part of patients' care. | Samples collected did not meet the threshold for analysis, therefore this outcome measure could not be assessed. | Posted | Day 1, day 3 and day 7 of study |
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| Primary | Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter) | CSF will be collected only in patients with an external ventricular drain as part of patients' care. | 4 participants had an external ventricular drain and had CSF collected (2 intervention, 2 control) | Posted | Number | picograms/mL | Day 1, day 3 and day 7 of study |
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| Primary | Change in Tumor Necrosis Factor (TNF) -Alpha Level in CSF (Picogram/Milliliter) | CSF will be collected only in patients with an external ventricular drain as part of patients' care. TNF-alpha normal range (1.45 pg/mL to 1073.41 pg/mL) | Samples collected did not meet the threshold for analysis, therefore this outcome measure could not be assessed. | Posted | Day 1, day 3 and day 7 of study |
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| Primary | Change in C Reactive Protein Level in CSF (Nanogram/Milliliter) | CSF will be collected only in patients with an external ventricular drain as part of patients' care | C Reactive Protein assay was not performed due to lack of funding. | Posted | Day 1, day 3 and day 7 of study |
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| Primary | Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter) | CSF will be collected only in patients with an external ventricular drain as part of patients' care | 4 participants had an external ventricular drain and had CSF collected (2 intervention, 2 control) | Posted | Number | picograms/mL | Day 1, day 3 and day 7 of study |
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| Primary | Change in Salivary Cortisol Level (Microgram/Deciliter) | Samples not collected | Posted | Day 1, day 3 and day 7 of study |
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| Secondary | Absolute Change in Hand-held Dynamometry Score (Pounds) | An average of three hand-held dynamometry measurements will be calculated for each measurement episode and the change over time will be measured. Grip strength is reported in pounds and compared against population and sex-based normative values. | Six participants, 3 in each group had dynamometry values collected. | Posted | Number | pounds | Study days 1, 3, 7, day of transfer from the ICU or discharge, whichever comes first, assessed up to 60 days |
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| Secondary | Global Pre-morbid Physical Health Status as Measured by the Promis Scale v1.2 | The global physical health status subscale of the Promis scale v1.2 will be used to measure pre-morbid physical health status. A 5-point Likert scale is used to score each of the four items. The scores for each item are summed as a raw score and are converted to T scores using a standardized table with higher T scores indicating better physical health status. An average t score representing the population is 50. 10 points is equal to 1 standard deviation, thus a score of 60 means that one is one standard deviation better than the general population. | Participants who completed the survey are reported. | Posted | Mean | Inter-Quartile Range | T-score | Day 1 of study |
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| Secondary | Global Pre-morbid Mental Health Status as Measured by the Promis Scale v1.2 | The global mental health status subscale of the Promis scale will be used to measure pre-morbid mental health status. A 5-point Likert scale is used to score each of the four items. The scores for each item are summed as a raw score and are converted to T scores using a standardized table with higher T scores indicating better physical health status. An average t score representing the population is 50. Ten points is equal to 1 standard deviation, thus a score of 60 means that one is one standard deviation better than the general population. | Participants who completed the survey are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Day 1 of study |
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| Secondary | Functional Status as Assessed by the Modified Rankin Score (mRS) | The modified Rankin score will be used to measure function in terms of activities of daily living after stroke. A six-point ordinal scale (0-6) with lower scores indicating less disability and higher scores indicating increasingly severe disability. A score of 6 indicates death. Reporting the frequency of each score category. | 17 patients had the modified Rankin assessed per standard of care at 90 days. | Posted | Count of Participants | Participants | Standard of care 90-day assessment |
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| Secondary | Change in the Functional Status as Assessed by the Modified Rankin Score | The modified Rankin score will be used to measure function in terms of activities of daily living after stroke. A six-point ordinal scale (0-6) with lower scores indicating less disability and higher scores indicating increasingly severe disability. A score of 6 indicates death. Change in functional status was calculated by subtracting the first score (discharge) from the second score (90 day assessment). | Only 4 patients had scores at discharge or transfer and at the 90 day assessment per standard of care (1 in the treatment group and 3 in the control group). Change in scores are reported. | Posted | Number | score on a scale | Day of ICU transfer or discharge, 90 day assessment |
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| Secondary | Change in Muscle Strength as Assessed by the Medical Research Council Sum (MRCS) Score | The MRCS will be used to measure muscle strength over time. The instrument is a 60 point scale indicating muscle strength in 6 muscle groups. Three muscle groups each on the right and left upper extremities and three each in the right and left lower extremities. Each muscle group is scored from 0-5 out of a possible 5 points. A composite score with a maximum of 60 is produced, 30 points can be achieved for each side of the body. | Resource limitations precluded collection of this data. | Posted | Study days 1, 3, 7, On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days, 30-day follow-up visit |
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| Secondary | Ability to Perform Activities of Daily Living as Assessed by the Barthel Index | The Barthel index will be used to measure a participant's ability to perform activities of daily living in detail. The instrument is a 10-item scale with a range of 0 -100 points. Higher scores indicate higher levels of function. | Due to resource constraints this assessment was only performed at discharge and only in 14 patients, 7 each in the intervention and control arms. | Posted | Median | Inter-Quartile Range | score on a scale | On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days, 30-day follow-up visit |
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| Secondary | Health Status as Assessed by the Stroke Impact Scale Version 3.0 | This is a 59-item questionnaire that will measure health status in 8 domains following the stroke. A 5-point Likert scale is used to score each item with higher scores indicating higher perceived health status. | Resource constraints precluded collection of this data. | Posted | During the 30-day follow up visit |
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| Secondary | Perception of Stroke Recovery as Assessed by the Stroke Impact Scale Version 3.0 | The last question of the instrument measures a participant's perception of stroke recovery using a 0-100 scale with higher scores representing higher levels of recovery and lower scores representing less recovery. | Resource constraints precluded collection of this data. | Posted | During the 30-day follow up visit |
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| 1 |
| 14 |
| 0 |
| 14 |
| 2 |
| 14 |
| EG001 | Control | Patients will receive usual care only. | 3 | 11 | 0 | 11 | 0 | 11 |
| cramping | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020521 | Stroke |
| Day 3 |
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| Day 7 |
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| Day 3 |
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| Day 7 |
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| First participant in each arm, day 3 |
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| First participant in each arm, day 7 |
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| Second participant in each arm, day 1 |
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| Second participant in each arm, day 3 |
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| Second participant in each arm, day 7 |
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| First participant in each arm, day 3 |
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| First participant in each arm, day 7 |
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| Second participant in each arm, day 1 |
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| Second participant in each arm, day 3 |
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| Second participant in each arm, day 7 |
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| First participant in each arm, day 3 |
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| First participant in each arm, day 7 |
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| First participant in each arm, discharge |
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| Second participant in each arm, day 1 |
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| Second participant in each arm, day 3 |
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| Second participant in each arm, day 7 |
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| Second participant in each arm, discharge |
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| Third participant in each arm, day 1 |
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| Third participant in each arm, day 3 |
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| Third participant in each arm, day 7 |
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| Third participant in each arm, discharge |
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| mRS 2 |
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| mRS 3 |
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| mRS 4 |
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| mRS 5 |
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| mRS 6 |
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| Second participant, change in score |
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| Third participant, change in score |
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