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NCT Number: NCT04369976

Short Arm Human Centrifuge Therapeutic Training and Rehabilitation (GRACER1)

The study is a single blind randomized controlled trial (RCT) designed to examine the benefit of a short arm human centrifuge intervention program (SAHC) combined with exercise, compared to a standard of care (SOC) rehabilitation program in physically impaired patients with MS, stroke, severe chronic obstructive pulmonary disease (COPD) and elderly people with balance and gait disorders (risk of falls).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

The patients will be randomly assigned to the short arm human centrifuge training (SAHC intervention), standard of care (SOC training) or a passive control. The SAHC intervention consists of 3 sessions per week. The session duration is 1 hour. The intervention will last 3 months.

Aiming to estimate the minimum number of participants required for obtaining reliable results, the investigators performed power analysis. It was conducted in g-power 3.1 to determine a sufficient sample size using an alpha of 0.05, a power of 0.80, and a medium effect size (f = 0.21). Based on the aforementioned assumptions, a total sample size of 26 participants per group was computed.

The passive control group will abstain from any exercise. Initially, there will be one session serving as an evaluation and familiarization of the SAHC group participants on the centrifuge. Its aim besides familiarization will be also to individually assess the optimal according to the participant's cardiovascular functioning with cardiac output (CO), stroke volume (SV) mean arterial pressure (MAP) diastolic blood pressure (DBP), systolic blood pressure (SBP), and heart rate (HR). These criteria are monitored at each training session and are used to dynamically adapt the intervention intensity. More specifically, after 6 training sessions (2 weeks), the centrifugation load will be increased and considering the cardiovascular criteria, centrifugation will be combined with either aerobic exercise (through an ergometer) or resistance training through elastic training bands. Further verification of the dynamic configuration of the intervention will be provided by the electroencephalographic (EEG) assessment. More specifically, resting state EEG (eyes open & closed condition, lying in horizontal position) and centrifugation in three different intensities, mild (corresponding to 0.5,0.7, and 1 g), medium (corresponding to 1.2 and 1.5 g) and high intensity (corresponding to 1.7 and 2 g). Functional connectivity and cortical-network features derived from graph theory will be used by deep learning algorithms (convolutional neural networks) in order to define the optimal centrifuge training.

A set of core outcomes as described below will be collected at the following experimental time instances: a) baseline, b) after 4 weeks, c) 8 weeks, d) 3 months, e) 6-month follow-up, g) 12-month follow-up. The outcomes will be collected across the domains of body structure and function, activity, and participation as classified by the world health organization international classification of functioning (ICF), disability and health.

The primary outcomes are the following:

  • A set of cardiovascular biosignal sensors described above,
  • Electroencephalographic (EEG) recordings,
  • The functional gait assessment (FGA) and
  • The functioning differences assessed by changes in summary ordinal score on the short physical performance battery (SPPB). The battery consists of three tests: balance, gait ability and leg strength. The score for each test is given in categorical modality (0-4) based on run time intervals, and the total score will range from 0 (worst) to 12 points (best). The SPPB has been shown to be a valid instrument for screening frailty and predicting disability, institutionalization and mortality. A total score of less than 10 points indicates frailty and a high risk of disability and falls. 1 point change in the total score has demonstrated to be of clinical relevance.

More primary outcomes include other measures of gaze and postural stability, fatigue, and functional mobility, isokinetic strength and muscle oxygen consumption. Additionally, a set of biomarkers in blood and urine will be collected.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • both male and female
  • height less than 2 m,
  • healthy or
  • with gait disorder or
  • impaired mobility from multiple sclerosis or
  • stroke,
  • chronic obstructive pulmonary disease (COPD) or
  • elderly

Exclusion criteria

  • Neurological or psychiatric disorder,
  • vertigo,
  • nausea or
  • chronic pain,
  • participants with a height greater than 2 meters,
  • participants with chronic use of substances or alcoholism,
  • with recent (within 6 months) surgery,
  • current arrhythmia,
  • severe migraines,
  • pregnancy,
  • epilepsy,
  • cholelithiasis or
  • kidney stones,
  • dehydration,
  • recent wounds from surgery,
  • recent fractures (unless recommended by a doctor),
  • acute inflammation or
  • pain and
  • newly inserted metal pins or plates, newly implanted stents .

Treatment and study plan

ARTIFICIAL GRAVITY COMBINED WITH EXERCISE

Device

The passive control group will abstain from any exercise. Recordings of the participant's will include cardiovascular functioning cardiac output (CO), stroke volume (SV) mean arterial pressure (MAP) diastolic blood pressure (DBP), systolic blood pressure (SBP), and heart rate (HR), Electroencephalography ( EEG) as well as dynamic force and stance and muscle oxygenation. More specifically, after 6 training sessions (2 weeks), the centrifugation load will be increased and will be combined with either aerobic exercise (through an ergometer) or resistance training through elastic training bands. Functional connectivity and cortical-network features will be used by deep learning algorithms in order to define the optimal centrifuge training .

Other names: standard of care (SOC) rehabilitation program

Primary outcomes

  1. Cardiovascular physiological parameter 1 cardiac output (CO) 1-standing

    Time frame: The time frame will include: changes from baseline up to 6 months

    Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes standing condition

  2. Cardiovascular physiological parameter 1 cardiac output (CO) 2-lying

    Time frame: The time frame will include: changes from baseline up to 6 months

    Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes lying condition

  3. Cardiovascular physiological parameter 1 cardiac output (CO) 3-mild intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes mild intensity centrifugation condition

  4. Cardiovascular physiological parameter 1 cardiac output (CO) 4-medium intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes medium intensity centrifugation condition

  5. Cardiovascular physiological parameter 1 cardiac output (CO) 5-high intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes high intensity centrifugation condition

  6. Cardiovascular physiological parameter 2, Stroke volume (SV) 1-standing

    Time frame: The time frame will include: changes from baseline up to 6 months

    Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes standing position

  7. Cardiovascular physiological parameter 2, Stroke volume (SV) 2-lying

    Time frame: The time frame will include: changes from baseline up to 6 months

    Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes lying position

  8. Cardiovascular physiological parameter 2, Stroke volume (SV) 3-mild intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of mild intensity (from 0,5 g to 1 g

  9. Cardiovascular physiological parameter 2, Stroke volume (SV) 4-medium intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of medium intensity (from 1,2g to1,5 g

  10. Cardiovascular physiological parameter 2, Stroke volume (SV) 5-high intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of high intensity (from 1,7g to 2 g)

  11. Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 1-standing

    Time frame: The time frame will include: changes from baseline up to 6 months

    Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger at standing position

  12. Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 2-lying

    Time frame: The time frame will include: changes from baseline up to 6 months

    Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger at lying position

  13. Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 3-mild intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after centrifugation with mild intensity (from 0,5 g to 1 g)

  14. Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 4-medium intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after centrifugation with medium intensity (from 1,2g to1,5 g)

  15. Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 5-high intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after centrifugation with high intensity (from 1,7g to 2 g).

  16. Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 1-standing

    Time frame: The time frame will include: changes from baseline up to 6 months

    Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after 5 minutes standing position

  17. Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 2-lying

    Time frame: The time frame will include: changes from baseline up to 6 months

    Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after 5 minutes lying position

  18. Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 3-low intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after centrifugation of mild intensity (from 0,5 g to 1 g).

  19. Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 4-medium intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after centrifugation with medium intensity (from 1,2g to1,5 g).

  20. Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 5-high intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after centrifugation of high intensity (from 1,7g to 2 g).

  21. Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 1-standing

    Time frame: The time frame will include: changes from baseline up to 6 months

    Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes at standing position

  22. Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 2;lying

    Time frame: The time frame will include: changes from baseline up to 6 months

    Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes at lying position

  23. Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 3-mild intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation with mild intensity (from 0,5 g to 1 g).

  24. Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 4-medium intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation with medium intensity (from 1,2g to1,5 g)

  25. Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 5-high intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation with high intensity (from 1,7g to 2 g)

  26. Cardiovascular physiological parameter 6, heart rate (HR) 1-standing

    Time frame: The time frame will include: changes from baseline up to 6 months

    Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes at standing position

  27. Cardiovascular physiological parameter 6, heart rate (HR) 2-lying

    Time frame: The time frame will include: changes from baseline up to 6 months

    Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes at lying position

  28. Cardiovascular physiological parameter 6, heart rate (HR) 3-mild intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of mild intensity (from 0,5 g to 1 g).

  29. Cardiovascular physiological parameter 6, heart rate (HR) 4-medium intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation with medium intensity (from 1,2g to1,5 g).

  30. Cardiovascular physiological parameter 6, heart rate (HR) 5-high intensity

    Time frame: The time frame will include: changes from baseline up to 6 months

    Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of high intensity (from 1,7g to 2 g).

  31. Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 1

    Time frame: The time frame will include: changes from baseline up to 6 months

    Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used .

    The recording involves the subject with eyes open.

  32. Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 2

    Time frame: The time frame will include: changes from baseline up to 6 months

    Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used .

    The recording involves the subject with eyes closed.

  33. Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 3

    Time frame: The time frame will include: changes from baseline up to 6 months

    Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used .

    The recording involves the subject in standing position.

  34. Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 4

    Time frame: The time frame will include: changes from baseline up to 6 months

    Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used .

    The recording involves the subject in lying position.

  35. Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 5

    Time frame: The time frame will include: changes from baseline up to 6 months

    Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used .

    The recording involves the subject in centrifugation with mild intensity (from 0,5 g to 1 g).

  36. Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 6

    Time frame: The time frame will include: changes from baseline up to 6 months

    Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used .

    The recording involves the subject in centrifugation with medium intensity (from 1,2g to1,5 g).

  37. Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 7

    Time frame: The time frame will include: changes from baseline up to 6 months

    Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used .

    The recording involves the subject in centrifugation of high intensity (from 1,7g to 2 g).

  38. The Short Physical Performance Battery assessment score

    Time frame: The time frame will include: changes from baseline up to 6 months

    The functioning differences assessed by changes in summary ordinal score on Balance, gait ability and leg strength.

    The score for each test is given in categorical modality (0-4) based on run time intervals, and the total score will range from 0 (worst) to 12 points (best).

  39. The Functional Gait Assessment (FGA)

    Time frame: changes in 3 months

    questionnaire

  40. Gastrocnemius muscle oxygenation

    Time frame: The time frame will include: changes in 3 months

    Oxygen saturation (SmO2 (%)) of the gastrocnemius medialis muscle measured with muscle oxygen monitor" (MOXY) placed in the gastrocnemius muscle of the dominant leg during centrifugation

  41. Biological samples 1: CATECHOLAMINES

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: μmol from urine and saliva samples will be collected

  42. Biological samples 2: ADIPONECTINE

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: μg/mL from serum

  43. Biological samples 3:BDNF

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: ng/ml from serum

  44. Biological samples 4:MELATONINE

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: pg/mL from saliva

  45. Biological samples 5:ADENOSINE

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: µM from saliva

  46. Biological samples 5:TNF-α

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: pg/mL from serum

  47. Biological samples 6:IL-1β

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: pg/mL from serum

  48. Biological samples 7:High-sensitivity C-reactive Protein (hs-CRP)

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: mg/L from serum

  49. Biological samples 8:Total leucocyte number:

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: number of cells x 10^3/μL from serum

  50. Biological samples 9:sTNF-RII

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: pg/ml from serum

  51. Biological samples 10:D-creatinine

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: mmol/l from serum

  52. Biological samples 11:alpha-amylase

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: IU, from serum

  53. Biological samples 12:secretory immunoglobulin A (sIgA)

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: mg/dL, from serum

  54. Biological samples 13: cortisol (SC) mg/dL

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: mg/dL, from saliva

  55. Biological samples 14: Glucose

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: mg/dL, from serum

  56. Biological samples 15: ACTH

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: ng/liter, from plasma

  57. Biological samples 16: Transcortin (mg/liter)

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: mg/liter, from serum

  58. Biological samples 17: Total antioxidant capacity (TAC)

    Time frame: The time frame will include: changes in 3 months

    Unit of measurement: mM Trolox equivalent/l , from saliva

  59. weight in kilograms, height in meters), as appropriate, or to clarify how multiple measurements will be aggregated to arrive at one reported value (e.g., weight

    Time frame: changes in 3 months

    unit: Kg

  60. Height

    Time frame: Day 1only

    Unit:meters

  61. Body Mass Index

    Time frame: changes in 3 months

    Unit: kg/m^2).

Sponsors and collaborators

Lead sponsor

Greek Aerospace Medical Association and Space Research

Other

Registry information

Official study title

Estimating the Optimal G Level for Training and Rehabilitation on a Short Arm Human Centrifuge

Acronym: GRACER1

Important dates

Study start
2020
Primary completion
2021
Study completion
2025
First posted
Apr 30, 2020
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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