Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis

A Randomized, Double-Blind, Single-Center, Phase 2, Efficacy and Safety Study of Autologous HB-adMSCs vs Placebo for the Treatment of Patients With Multiple Sclerosis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05116540

Acronym

HBMS01

Enrollment

Registered

2021-11-11

Start date

2021-11-24

Completion date

2024-06-04

Last updated

2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Mesenchymal Stem Cells, MS, RRMS, stem cells, MSCs, Relapsing, Remitting

Brief summary

Randomized Double-Blind Efficacy and safety study of Autologous HB-adMSCs versus placebo for the treatment of Multiple Sclerosis. This study will be for 24 subjects with 6 infusions over a 52 week period. Study participants will continue their established concomitant medications during participation in this investigation.

Detailed description

Each eligible study subject will receive a total of 6 intravenous infusions of HB-adMSCs or placebo. Study infusions will be administered with the following regimen, Week 0, 4, 8, 16, 24, and 32. There will be one follow-up visit and end of study at week 52.

Interventions

BIOLOGICALHB-adMSCs

Autologous product

DRUGPlacebo

Normal Saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double-Blinded Randomized Study

Intervention model description

Randomized, Double-Blind

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Male and female participants 18 - 75 years of age. 2. Study participants must have been diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS) for at least 6 months before study participation. 3. Study participants must be stabilized on any MS therapy for at least 6 months prior to randomization. 4. Study participants must agree not to increase or begin any Diseases Modifying Therapies for MS during participation in the clinical trial. 5. Study participants must have an EDSS score between 3.0 to 6.5. (Patient must be able to walk). 6. Study participants must have previously banked their mesenchymal stem cells with Hope Biosciences. 7. Study participants should be able to read, understand, and provide written consent. 8. Before any clinical-trial-related procedures are performed, informed consent must be obtained from the participants voluntarily. 9. Female study participants should not be pregnant or plan to become pregnant during study participation and for 6 months after last investigational product administration. \* 10. Male participants, if their sexual partners can become pregnant, should use a method of contraception during study participation and for 6 months after the last administration of the investigated product. \* 11. Study participant is able and willing to comply with the requirements of this clinical trial. 12. Participants in the study should have evidence of disease, as shown by MRIs of the brain or spinal cord, with the most recent being within 1 year of the screening date, and no other signs of relapse.

Exclusion criteria

1. Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take effective contraceptive measures. \* 2. Study participants with other types of multiple sclerosis, such as progressive relapsing, primary or secondary progressive. 3. Study participant has any active malignancy, including but not limited to evidence of cutaneous basal, squamous cell carcinoma, or melanoma. 4. Study participant has known addiction or dependency or has current substance use or abuse. 5. Study participant has 1 or more significant concurrent medical conditions (verified by medical records), including the following: * Poorly controlled diabetes mellitus (PCDM) defined as history of deficient standard of care treatment and/or pre-prandial glucose \>130mg/dl during screening visit or post-prandial glucose \>200mg/dl. * Medical History of Chronic kidney disease (CKD) diagnosis and/or screening results of eGFR \< 59mL/min/1.73m2. * Presence of New York Heart Association (NYHA) Class III/IV heart failure during screening visit. * Any medical history of myocardial infarction in any of the different types, such as ST-elevation myocardial infarction (STEMI) or non-ST-elevated myocardial infarction (NSTEMI), coronary spasm, or unstable angina. * Medical history of uncontrolled high blood pressure defined as a deficient standard of care treatment and/or blood pressure \> 180/120 mm/Hg during screening visit.Medical history of diseases such as, inherited thrombophilias, cancer of the lung, brain, lymphatic, gynecologic system (ovary or uterus), or gastrointestinal tract (like pancreas or stomach). * Medical history of conditions, such as recent major general surgery, (within 12 months before the Screening), lower extremity paralysis due to spinal cord injury, fracture of the pelvis, hips, or femur. 6. Study participant has received any stem cell treatment within 12 months before first dose of investigational product other than stem cells produced by Hope Biosciences. 7. The study participant has received any experimental drug within 12 months before the first dose of the investigational product. (Except for COVID-19 vaccinations) 8. Study participant has a laboratory abnormality during screening, including the following: * White blood cell count \< 3000/mm3 * Platelet count \< 80,000mm3 * Absolute neutrophil count \< 1500/mm3 * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 10 upper limit of normal (ULN) x 1.5 9. Study participant has any other laboratory abnormality or medical condition which, in the opinion of the investigator poses a safety risk or will prevent the subject from completing the study. 10. The study participant has any concurrent neurologic disease, including hereditary conditions that the principal investigator considers could interfere with the study participation. Some of these neurologic diseases could be Charcot-Marie-Tooth (CMT) or Spinocerebellar Ataxia (SCA). 11. Study participant has any ongoing infection, including TB, CMV, EBV, HSV, VZV, hepatitis virus, toxoplasmosis, HIV, or syphilis infections, as well as hepatitis B surface antigen positive, and or/ hepatitis C PCR positivity. 12. Study participant is unlikely to complete the study or adhere to the study procedures. 13. Study participant has a previously diagnosed psychiatric condition which in the opinion of the investigator may affect self-assessments. 14. Study participants with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product. 15. Male study participants who plan to donate sperm during the study or within 6 months after the last dose. Female patients who plan to donate eggs or undergo in vitro fertilization treatment during the study or within 6 months after the last dose. 16. Study participants who are determined by the Investigator to be unsuitable for study enrollment for other reasons. 17. Participants' life expectancy must not have been considerably limited by other comorbidities, a history of previous myelodysplasia, or hematologic illness. * Acceptable reversible and permanent methods of birth control include: 1\. True sexual abstinence (abstaining from sexual activity during the entire period of risk). 2\. Surgery (occlusion bilateral tubal ligation, vasectomized partner). 3. Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable patch, or intravaginal). 4. Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument	Baseline to Week 52	The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. The developers used the SF-36 as a base and added 18 questions to address MS-specific problems, including fatigue and cognitive function. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life).
Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Baseline to Week 52	The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. The developers used the SF-36 as a base and added 18 questions to address MS-specific problems, including fatigue and cognitive function. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life).
Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Baseline to Week 52	The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Cognitive Function subscale. The score ranges from 0 to 100 percent, and is 15% of the total Mental Health Composite Score.
Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Baseline to Week 52	The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Emotional Wellbeing sub-scale. The score ranges from 0 to 100 percent, and is 29% of the total Mental Health Composite Score.
Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Baseline to Week 52	The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Health Distress sub-scale. The score ranges from 0 to 100 percent, and is 14% of the total Mental Health Composite Score and 11% of the total Physical Health Composite Score.
Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Baseline to Week 52	The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Role Limitation/Emotional sub-scale. The score ranges from 0 to 100 percent, and is 24% of the total Mental Health Composite Score.
Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Baseline to Week 52	The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Overall Quality of Life sub-scale. The score ranges from 0 to 100 percent, and is 18% of the total Mental Health Composite Score.
Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Baseline to Week 52	The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Energy/Fatigue sub-scale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score.
Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Baseline to Week 52	The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Health Perception sub-scale. The score ranges from 0 to 100 percent, and is 17% of the total Physical Health Composite Score.
Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Baseline to Week 52	The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Physical Function sub-scale. The score ranges from 0 to 100 percent, and is 17% of the total Physical Health Composite Score.
Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Baseline to Week 52	The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Role Limitations - Physical sub-scale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score.
Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Baseline to Week 52	The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Pain subscale. The score ranges from 0 to 100 percent, and is 11% of the total Physical Health Composite Score.
Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Baseline to Week 52	The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Social Function subscale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score.
Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Baseline to Week 52	The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Sexual Function subscale. The score ranges from 0 to 100 percent, and is 8% of the total Physical Health Composite Score.
Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54	Baseline to Week 52	Analysis of covariance (ANCOVA) is a statistical model that combines linear regression and ANOVA to analyze the results of different treatments. In this outcome measure, ANCOVA was used to analyze change in the physical health composite score in treatment versus placebo. The ANCOVA model was used to compare HB-adMSC patients with placebo patients on Change from Baseline to Week 52 with a fixed factor of treatment, fixed stratification factors of MS severity, age and gender, and a covariate of the baseline value for the score on the corresponding outcome measure. This model allows us to test the significance of the effects of the treatment at Week 52. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately.
Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54 Composite Score	Baseline to Week 52	Analysis of covariance (ANCOVA) is a statistical model that combines linear regression and ANOVA to analyze the results of different treatments. In this outcome measure, ANCOVA was used to analyze change in the mental health composite score in treatment versus placebo. The ANCOVA model was used to compare HB-adMSC patients with placebo patients on Change from Baseline to Week 52 with a fixed factor of treatment, fixed stratification factors of MS severity, age and gender, and a covariate of the baseline value for the score on the corresponding outcome measure. This model allows us to test the significance of the effects of the treatment at Week 52. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately.
Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54	Baseline to Week 52	Bayesian analysis is a statistical method that uses probability distributions to make statistical inferences about parameters using prior information. In this outcome measure, Bayesian analysis was used to analyze change in the physical health composite score in treatment versus placebo. In this study, Bayesian analysis was used to estimate the posterior distribution and to estimate the probability of the true treatment difference of change from baseline to Week 52. A linear model for each visit was constructed to model within-subject observation covariance structures by multivariate normal (MVN) distribution in the Markov chain Monte Carlo (MCMC) procedure. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately.
Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline - Multiple Sclerosis Quality of Life (MSQOL)-54	Baseline to Week 52	Bayesian analysis is a statistical method that uses probability distributions to make statistical inferences about parameters using prior information. In this outcome measure, Bayesian analysis was used to analyze change in the mental health composite score in treatment versus placebo. In this study, Bayesian analysis was used to estimate the posterior distribution and to estimate the probability of the true treatment difference of change from baseline to Week 52. A linear model for each visit was constructed to model within-subject observation covariance structures by multivariate normal (MVN) distribution in the Markov chain Monte Carlo (MCMC) procedure. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately.

Secondary

Measure	Time frame	Description
Change From Baseline Physical Examination Results - Lymph Node	Baseline to Week 52	Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Change From Baseline Physical Examination Results - Musculoskeletal	Baseline to Week 52	Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Change From Baseline Physical Examination Results - Neurological	Baseline to Week 52	Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Change From Baseline Physical Examination Results - Respiratory	Baseline to Week 52	Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Change From Baseline Physical Examination Results - Skin	Baseline to Week 52	Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Laboratory Values - CBC (x10^3 Cells/uL)	Baseline to Week 52	Unit (x10\^3 cells/uL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
Laboratory Values - CBC (% of WBC)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CBC laboratory values with unit of % of white blood cell count.
Laboratory Values - CBC (% of Total Blood Cell Count)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CBC laboratory values with unit of % of total blood cell count.
Laboratory Values - CBC (g/dL)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CBC laboratory values with unit of g/dL
Laboratory Values - CBC (pg)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CBC laboratory values with unit of pg
Laboratory Values - CBC (fL)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CBC laboratory values with unit of fL.
Laboratory Values - CBC (x10^6 Cells/uL)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CBC laboratory values with unit of x10\^6 cells/uL.
Laboratory Values - CBC (RDW)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CBC laboratory values with unit of % (RDW - Red Cell Distribution Width)
Laboratory Values - CMP (g/dL)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CMP laboratory values with unit of g/dL.
Laboratory Values - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CMP laboratory values with units of Ratio: Albumin(g/dL) to Calc. Globulin(g/dL)
Laboratory Values - CMP (U/L)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CMP laboratory values with units of U/L.
Laboratory Values - CMP (mg/dL)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CMP laboratory values with units of mg/dL.
Analysis of Covariance (ANCOVA) Model - Total Expanded Disability Status Scale (EDSS) Scores Through Week 52 - Change From Baseline - Efficacy Analysis Set	Baseline to Week 52	The EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. This scale ranges from 0 to 10 in 0.5-unit increments and a higher score represents increased disability. Scoring is based on an examination by a neurologist.
Laboratory Values - CMP (mL/Min/1.73m^2)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CMP laboratory values with units of mL/min/1.73m\^2.
Laboratory Values - CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CMP laboratory values with units of Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL).
Laboratory Values - Coagulation Panel (Seconds)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in Coagulation Panel values with units of seconds.
Laboratory Values - CMP (mEq/L)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CMP laboratory values with units of mEq/L.
Analysis of Covariance (ANCOVA) Model - Change From Baseline Barthel Index Scores Through Week 52 - Efficacy Analysis Set	Baseline to Week 52	The Barthel index is an ordinal scale that evaluates functional independence in the domains of personal care and mobility. A total of ten variables describing activities of daily living and mobility are considered, with a higher number reflecting better capacity to operate independently. The Barthel Index assesses the level of help needed by a person on a set of ten activities of daily living (ADL) related to mobility and self-care. Score ranges from 0 points to 20 points, with lower scores indicating increased disability.
ANCOVA Model - Change From Baseline 9-Hole Peg Test Scores - Dominant Hand Avg Time Through Week 52	Baseline to Week 52	The 9-HPT is a short, standardized upper extremity exam. It measures the time taken to complete the test activity, recorded in seconds. The higher the score the worse the disability.
Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in Coagulation laboratory values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds).
Analysis of Covariance (ANCOVA) Model - Change From Baseline 9-Hole Peg Test Scores - Non-Dominant Hand Avg Time Through Week 52	Baseline to Week 52	The 9-HPT is a short, standardized upper extremity exam. It measures the time taken to complete the test activity, recorded in seconds. The higher the score the worse the disability.
Analysis of Covariance (ANCOVA) Model - Change in Patient Health Questionnaire (PHQ-9) Test Scores	Baseline to Week 52	The PHQ-9 is the most used depression and suicidal thoughts screening test used to monitor the severity of depression and response to treatment. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Baseline Vitals Values - Height	Baseline	Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Change From Baseline Vitals Values - Weight	Baseline to Week 52	Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Change From Baseline Vitals Values - Body Mass Index	Baseline to Week 52	Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Change From Baseline Vitals Values - Respiratory Rate	Baseline to Week 52	Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Change From Baseline Vitals Values - Temperature	Baseline to Week 52	Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Change From Baseline Vitals Values - Systolic Blood Pressure	Baseline to Week 52	Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Change From Baseline Vitals Values - Diastolic Blood Pressure	Baseline to Week 52	Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Change From Baseline Vitals Values - Pulse Rate	Baseline to Week 52	Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Change From Baseline Vitals Values - Oxygen Saturation	Baseline to Week 52	Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Change From Baseline Physical Examination Results - Abdomen	Baseline to Week 52	Change From Baseline Physical Examination Results by Treatment Week - Descriptive Statistics - Safety Analysis Set
Change From Baseline Physical Examination Results - Cardiovascular	Baseline to Week 52	Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Change From Baseline Physical Examination Results - HEENT	Baseline to Week 52	Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set

Countries

United States

Participant flow

Participants by arm

Arm	Count
Treatment Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify. Placebo: Placebo will be administered intravenously to study participants who qualify.	12
Placebo Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify. Placebo: Placebo will be administered intravenously to study participants who qualify.	12
Total	24

Baseline characteristics

Characteristic	Treatment	Placebo	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	2 Participants	3 Participants
Age, Categorical Between 18 and 65 years	11 Participants	10 Participants	21 Participants
Age, Continuous	51.0 years STANDARD_DEVIATION 10.57	49.1 years STANDARD_DEVIATION 12.17	50.0 years STANDARD_DEVIATION 11.19
Age, Customized	51.0 years STANDARD_DEVIATION 10.57	49.1 years STANDARD_DEVIATION 12.17	50.0 years STANDARD_DEVIATION 11.19
Baseline BMI	24.72 kg/m^2 STANDARD_DEVIATION 5.52	27.17 kg/m^2 STANDARD_DEVIATION 5.723	25.94 kg/m^2 STANDARD_DEVIATION 5.639
Baseline Weight	68.61 kilograms STANDARD_DEVIATION 17.493	76.55 kilograms STANDARD_DEVIATION 16.619	72.58 kilograms STANDARD_DEVIATION 17.172
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	2 Participants	5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants	10 Participants	19 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Black or African American	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	11 Participants	11 Participants	22 Participants
Sex: Female, Male Female	9 Participants	9 Participants	18 Participants
Sex: Female, Male Male	3 Participants	3 Participants	6 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 12	0 / 12
other Total, other adverse events	10 / 12	11 / 12
serious Total, serious adverse events	1 / 12	1 / 12

Outcome results

Primary

Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54 Composite Score

Analysis of covariance (ANCOVA) is a statistical model that combines linear regression and ANOVA to analyze the results of different treatments. In this outcome measure, ANCOVA was used to analyze change in the mental health composite score in treatment versus placebo. The ANCOVA model was used to compare HB-adMSC patients with placebo patients on Change from Baseline to Week 52 with a fixed factor of treatment, fixed stratification factors of MS severity, age and gender, and a covariate of the baseline value for the score on the corresponding outcome measure. This model allows us to test the significance of the effects of the treatment at Week 52. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately.

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Value (MEAN)	Dispersion
Treatment	Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54 Composite Score	13.362 score on a scale (100 points total)	Standard Error 3.961
Placebo	Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54 Composite Score	-2.402 score on a scale (100 points total)	Standard Error 4.161

p-value: 0.016695% CI: [3.307, 28.221]ANCOVA

Primary

Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54

Analysis of covariance (ANCOVA) is a statistical model that combines linear regression and ANOVA to analyze the results of different treatments. In this outcome measure, ANCOVA was used to analyze change in the physical health composite score in treatment versus placebo. The ANCOVA model was used to compare HB-adMSC patients with placebo patients on Change from Baseline to Week 52 with a fixed factor of treatment, fixed stratification factors of MS severity, age and gender, and a covariate of the baseline value for the score on the corresponding outcome measure. This model allows us to test the significance of the effects of the treatment at Week 52. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately.

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Value (MEAN)	Dispersion
Treatment	Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54	19.872 score on a scale (100 points total)	Standard Error 2.979
Placebo	Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54	-2.248 score on a scale (100 points total)	Standard Error 3.145

p-value: 0.000295% CI: [12.282, 31.959]ANCOVA

Primary

Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline - Multiple Sclerosis Quality of Life (MSQOL)-54

Bayesian analysis is a statistical method that uses probability distributions to make statistical inferences about parameters using prior information. In this outcome measure, Bayesian analysis was used to analyze change in the mental health composite score in treatment versus placebo. In this study, Bayesian analysis was used to estimate the posterior distribution and to estimate the probability of the true treatment difference of change from baseline to Week 52. A linear model for each visit was constructed to model within-subject observation covariance structures by multivariate normal (MVN) distribution in the Markov chain Monte Carlo (MCMC) procedure. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately.

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Value (MEAN)	Dispersion
Treatment	Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline - Multiple Sclerosis Quality of Life (MSQOL)-54	12.414 score on a scale (100 points total)	Standard Deviation 7.457
Placebo	Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline - Multiple Sclerosis Quality of Life (MSQOL)-54	-3.333 score on a scale (100 points total)	Standard Deviation 7.544

p-value: 0.829295% CI: [3.329, 28.177]ANCOVA

Primary

Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54

Bayesian analysis is a statistical method that uses probability distributions to make statistical inferences about parameters using prior information. In this outcome measure, Bayesian analysis was used to analyze change in the physical health composite score in treatment versus placebo. In this study, Bayesian analysis was used to estimate the posterior distribution and to estimate the probability of the true treatment difference of change from baseline to Week 52. A linear model for each visit was constructed to model within-subject observation covariance structures by multivariate normal (MVN) distribution in the Markov chain Monte Carlo (MCMC) procedure. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately.

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Value (MEAN)	Dispersion
Treatment	Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54	18.373 score on a scale (100 points total)	Standard Deviation 5.426
Placebo	Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54	-3.764 score on a scale (100 points total)	Standard Deviation 5.308

p-value: 0.990595% CI: [12.361, 32.006]ANCOVA

Primary

Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Cognitive Function subscale. The score ranges from 0 to 100 percent, and is 15% of the total Mental Health Composite Score.

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	10.45 score on a scale (100 points total)	Standard Deviation 23.29
Treatment	Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	3.00 score on a scale (100 points total)	Standard Deviation 20.84
Treatment	Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	5.91 score on a scale (100 points total)	Standard Deviation 10.91
Treatment	Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	9.55 score on a scale (100 points total)	Standard Deviation 18.09
Treatment	Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	59.55 score on a scale (100 points total)	Standard Deviation 39.27
Placebo	Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	-2.50 score on a scale (100 points total)	Standard Deviation 10.07
Placebo	Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	64.50 score on a scale (100 points total)	Standard Deviation 36.32
Placebo	Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	6.50 score on a scale (100 points total)	Standard Deviation 16.67
Placebo	Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	5.50 score on a scale (100 points total)	Standard Deviation 14.8
Placebo	Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	4.50 score on a scale (100 points total)	Standard Deviation 17.55

Primary

Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Emotional Wellbeing sub-scale. The score ranges from 0 to 100 percent, and is 29% of the total Mental Health Composite Score.

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	6.91 score on a scale (100 points total)	Standard Deviation 14.32
Treatment	Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	4.80 score on a scale (100 points total)	Standard Deviation 21.81
Treatment	Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	6.55 score on a scale (100 points total)	Standard Deviation 10.47
Treatment	Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	12.36 score on a scale (100 points total)	Standard Deviation 17.66
Treatment	Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	71.27 score on a scale (100 points total)	Standard Deviation 21.45
Placebo	Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	-1.20 score on a scale (100 points total)	Standard Deviation 11.63
Placebo	Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	68.40 score on a scale (100 points total)	Standard Deviation 17.23
Placebo	Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	3.60 score on a scale (100 points total)	Standard Deviation 11.54
Placebo	Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	3.20 score on a scale (100 points total)	Standard Deviation 13.31
Placebo	Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	2.40 score on a scale (100 points total)	Standard Deviation 12.82

Primary

Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Energy/Fatigue sub-scale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score.

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	6.18 score on a scale (100 points total)	Standard Deviation 13.67
Treatment	Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	2.00 score on a scale (100 points total)	Standard Deviation 21.44
Treatment	Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	4.36 score on a scale (100 points total)	Standard Deviation 17.75
Treatment	Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	15.27 score on a scale (100 points total)	Standard Deviation 20.62
Treatment	Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	48.00 score on a scale (100 points total)	Standard Deviation 15.59
Placebo	Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	1.60 score on a scale (100 points total)	Standard Deviation 9.47
Placebo	Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	32.00 score on a scale (100 points total)	Standard Deviation 21.08
Placebo	Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	13.60 score on a scale (100 points total)	Standard Deviation 14.14
Placebo	Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	10.40 score on a scale (100 points total)	Standard Deviation 14.01
Placebo	Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	2.40 score on a scale (100 points total)	Standard Deviation 17.4

Primary

Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Health Distress sub-scale. The score ranges from 0 to 100 percent, and is 14% of the total Mental Health Composite Score and 11% of the total Physical Health Composite Score.

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	19.55 score on a scale (100 points total)	Standard Deviation 25.44
Treatment	Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	5.50 score on a scale (100 points total)	Standard Deviation 40.03
Treatment	Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	13.18 score on a scale (100 points total)	Standard Deviation 25.33
Treatment	Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	25.00 score on a scale (100 points total)	Standard Deviation 28.55
Treatment	Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	54.09 score on a scale (100 points total)	Standard Deviation 24.58
Placebo	Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	-2.00 score on a scale (100 points total)	Standard Deviation 13.58
Placebo	Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	36.00 score on a scale (100 points total)	Standard Deviation 28.07
Placebo	Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	16.50 score on a scale (100 points total)	Standard Deviation 22.12
Placebo	Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	4.50 score on a scale (100 points total)	Standard Deviation 19.36
Placebo	Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	2.50 score on a scale (100 points total)	Standard Deviation 19.18

Primary

Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Health Perception sub-scale. The score ranges from 0 to 100 percent, and is 17% of the total Physical Health Composite Score.

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	9.09 score on a scale (100 points total)	Standard Deviation 18.68
Treatment	Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	10.00 score on a scale (100 points total)	Standard Deviation 15.09
Treatment	Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	0.00 score on a scale (100 points total)	Standard Deviation 17.03
Treatment	Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	12.27 score on a scale (100 points total)	Standard Deviation 19.41
Treatment	Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	59.55 score on a scale (100 points total)	Standard Deviation 18.09
Placebo	Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	-2.00 score on a scale (100 points total)	Standard Deviation 12.06
Placebo	Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	42.00 score on a scale (100 points total)	Standard Deviation 21.76
Placebo	Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	5.00 score on a scale (100 points total)	Standard Deviation 9.43
Placebo	Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	3.50 score on a scale (100 points total)	Standard Deviation 15.82
Placebo	Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	-1.50 score on a scale (100 points total)	Standard Deviation 12.48

Primary

Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. The developers used the SF-36 as a base and added 18 questions to address MS-specific problems, including fatigue and cognitive function. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life).

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	11.04 score on a scale (100 points total)	Standard Deviation 10.96
Treatment	Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	5.48 score on a scale (100 points total)	Standard Deviation 17.96
Treatment	Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	8.81 score on a scale (100 points total)	Standard Deviation 11.2
Treatment	Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	13.54 score on a scale (100 points total)	Standard Deviation 15.65
Treatment	Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	65.37 score on a scale (100 points total)	Standard Deviation 24.83
Placebo	Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	-2.59 score on a scale (100 points total)	Standard Deviation 22.21
Placebo	Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	60.88 score on a scale (100 points total)	Standard Deviation 20.58
Placebo	Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	6.39 score on a scale (100 points total)	Standard Deviation 21.55
Placebo	Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	3.22 score on a scale (100 points total)	Standard Deviation 13.29
Placebo	Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	-0.35 score on a scale (100 points total)	Standard Deviation 22.4

Primary

Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Overall Quality of Life sub-scale. The score ranges from 0 to 100 percent, and is 18% of the total Mental Health Composite Score.

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	6.05 score on a scale (100 points total)	Standard Deviation 13.93
Treatment	Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	-1.83 score on a scale (100 points total)	Standard Deviation 14.54
Treatment	Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	3.04 score on a scale (100 points total)	Standard Deviation 14.2
Treatment	Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	3.64 score on a scale (100 points total)	Standard Deviation 10.14
Treatment	Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	71.82 score on a scale (100 points total)	Standard Deviation 15.92
Placebo	Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	4.50 score on a scale (100 points total)	Standard Deviation 9.85
Placebo	Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	48.50 score on a scale (100 points total)	Standard Deviation 12.62
Placebo	Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	7.00 score on a scale (100 points total)	Standard Deviation 12.55
Placebo	Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	4.67 score on a scale (100 points total)	Standard Deviation 12.15
Placebo	Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	1.84 score on a scale (100 points total)	Standard Deviation 12.52

Primary

Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Pain subscale. The score ranges from 0 to 100 percent, and is 11% of the total Physical Health Composite Score.

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	7.12 score on a scale (100 points total)	Standard Deviation 15.19
Treatment	Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	-1.50 score on a scale (100 points total)	Standard Deviation 32.12
Treatment	Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	4.55 score on a scale (100 points total)	Standard Deviation 26.28
Treatment	Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	13.49 score on a scale (100 points total)	Standard Deviation 18.17
Treatment	Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	71.82 score on a scale (100 points total)	Standard Deviation 14.38
Placebo	Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	1.33 score on a scale (100 points total)	Standard Deviation 17.65
Placebo	Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	59.83 score on a scale (100 points total)	Standard Deviation 27.66
Placebo	Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	7.17 score on a scale (100 points total)	Standard Deviation 17.02
Placebo	Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	4.34 score on a scale (100 points total)	Standard Deviation 16.8
Placebo	Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	0.00 score on a scale (100 points total)	Standard Deviation 14.66

Primary

Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Physical Function sub-scale. The score ranges from 0 to 100 percent, and is 17% of the total Physical Health Composite Score.

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	1.36 score on a scale (100 points total)	Standard Deviation 24.2
Treatment	Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	7.50 score on a scale (100 points total)	Standard Deviation 13.99
Treatment	Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	12.27 score on a scale (100 points total)	Standard Deviation 10.09
Treatment	Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	7.73 score on a scale (100 points total)	Standard Deviation 15.06
Treatment	Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	36.36 score on a scale (100 points total)	Standard Deviation 25.21
Placebo	Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	7.00 score on a scale (100 points total)	Standard Deviation 25.63
Placebo	Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	43.00 score on a scale (100 points total)	Standard Deviation 17.19
Placebo	Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	-1.50 score on a scale (100 points total)	Standard Deviation 15.28
Placebo	Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	-6.00 score on a scale (100 points total)	Standard Deviation 19.26
Placebo	Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	-0.50 score on a scale (100 points total)	Standard Deviation 19.78

Primary

Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument	Infusion 3 (Week 8)	8.21 score on a scale (100 points total)	Standard Deviation 13.08
Treatment	Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument	Follow-Up (Week 42)	4.19 score on a scale (100 points total)	Standard Deviation 18.03
Treatment	Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument	Infusion 5 (Week 24)	6.68 score on a scale (100 points total)	Standard Deviation 7.33
Treatment	Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument	End of Study (Week 52)	15.98 score on a scale (100 points total)	Standard Deviation 12.08
Treatment	Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument	Infusion 1/Baseline (Week 0)	53.85 score on a scale (100 points total)	Standard Deviation 9.61
Placebo	Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument	End of Study (Week 52)	2.03 score on a scale (100 points total)	Standard Deviation 10.62
Placebo	Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument	Infusion 1/Baseline (Week 0)	44.07 score on a scale (100 points total)	Standard Deviation 10.95
Placebo	Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument	Infusion 3 (Week 8)	7.03 score on a scale (100 points total)	Standard Deviation 10.76
Placebo	Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument	Infusion 5 (Week 24)	3.43 score on a scale (100 points total)	Standard Deviation 11
Placebo	Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument	Follow-Up (Week 42)	0.06 score on a scale (100 points total)	Standard Deviation 11.13

Primary

Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Role Limitation/Emotional sub-scale. The score ranges from 0 to 100 percent, and is 24% of the total Mental Health Composite Score.

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	63.64 score on a scale (100 points total)	Standard Deviation 43.35
Treatment	Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	15.15 score on a scale (100 points total)	Standard Deviation 27.34
Treatment	Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	15.15 score on a scale (100 points total)	Standard Deviation 27.34
Treatment	Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	13.33 score on a scale (100 points total)	Standard Deviation 28.11
Treatment	Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	18.18 score on a scale (100 points total)	Standard Deviation 31.14
Placebo	Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	-10.00 score on a scale (100 points total)	Standard Deviation 80.2
Placebo	Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	-10.00 score on a scale (100 points total)	Standard Deviation 66.76
Placebo	Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	3.33 score on a scale (100 points total)	Standard Deviation 65.64
Placebo	Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	73.33 score on a scale (100 points total)	Standard Deviation 43.89
Placebo	Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	0.00 score on a scale (100 points total)	Standard Deviation 41.57

Primary

Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Role Limitations - Physical sub-scale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score.

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	11.36 score on a scale (100 points total)	Standard Deviation 42.37
Treatment	Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	-2.50 score on a scale (100 points total)	Standard Deviation 49.23
Treatment	Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	6.82 score on a scale (100 points total)	Standard Deviation 38.88
Treatment	Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	34.09 score on a scale (100 points total)	Standard Deviation 45.1
Treatment	Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	38.64 score on a scale (100 points total)	Standard Deviation 40.87
Placebo	Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	10.00 score on a scale (100 points total)	Standard Deviation 50.28
Placebo	Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	20.00 score on a scale (100 points total)	Standard Deviation 32.91
Placebo	Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	22.50 score on a scale (100 points total)	Standard Deviation 38.1
Placebo	Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	17.50 score on a scale (100 points total)	Standard Deviation 35.45
Placebo	Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	5.00 score on a scale (100 points total)	Standard Deviation 15.81

Primary

Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Sexual Function subscale. The score ranges from 0 to 100 percent, and is 8% of the total Physical Health Composite Score.

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	8.33 score on a scale (100 points total)	Standard Deviation 25.27
Treatment	Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	6.66 score on a scale (100 points total)	Standard Deviation 33.52
Treatment	Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	8.34 score on a scale (100 points total)	Standard Deviation 26.09
Treatment	Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	9.85 score on a scale (100 points total)	Standard Deviation 19.65
Treatment	Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	65.15 score on a scale (100 points total)	Standard Deviation 30.47
Placebo	Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	-4.16 score on a scale (100 points total)	Standard Deviation 15.84
Placebo	Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	71.67 score on a scale (100 points total)	Standard Deviation 24.6
Placebo	Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	-2.50 score on a scale (100 points total)	Standard Deviation 20.44
Placebo	Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	-3.33 score on a scale (100 points total)	Standard Deviation 20.87
Placebo	Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	-3.33 score on a scale (100 points total)	Standard Deviation 14.28

Primary

Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Social Function subscale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score.

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend their follow-up visit (Week 42) and therefore was unable to complete the MSQOL-54 for that visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	6.06 score on a scale (100 points total)	Standard Deviation 25.02
Treatment	Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	2.50 score on a scale (100 points total)	Standard Deviation 23.26
Treatment	Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	5.30 score on a scale (100 points total)	Standard Deviation 13.58
Treatment	Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	13.64 score on a scale (100 points total)	Standard Deviation 25.35
Treatment	Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	67.42 score on a scale (100 points total)	Standard Deviation 23.7
Placebo	Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	End of Study (Week 52)	1.67 score on a scale (100 points total)	Standard Deviation 15.11
Placebo	Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 1/Baseline (Week 0)	59.17 score on a scale (100 points total)	Standard Deviation 14.93
Placebo	Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 3 (Week 8)	-2.50 score on a scale (100 points total)	Standard Deviation 11.15
Placebo	Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Infusion 5 (Week 24)	-1.67 score on a scale (100 points total)	Standard Deviation 15.11
Placebo	Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.	Follow-Up (Week 42)	-4.16 score on a scale (100 points total)	Standard Deviation 27

Secondary

Analysis of Covariance (ANCOVA) Model - Change From Baseline 9-Hole Peg Test Scores - Non-Dominant Hand Avg Time Through Week 52

The 9-HPT is a short, standardized upper extremity exam. It measures the time taken to complete the test activity, recorded in seconds. The higher the score the worse the disability.

Time frame: Baseline to Week 52

Arm	Measure	Value (MEAN)	Dispersion
Treatment	Analysis of Covariance (ANCOVA) Model - Change From Baseline 9-Hole Peg Test Scores - Non-Dominant Hand Avg Time Through Week 52	-3.771 seconds	Standard Error 1.069
Placebo	Analysis of Covariance (ANCOVA) Model - Change From Baseline 9-Hole Peg Test Scores - Non-Dominant Hand Avg Time Through Week 52	-4.747 seconds	Standard Error 1.127

p-value: 0.558895% CI: [-2.504, 4.457]ANCOVA

Secondary

Analysis of Covariance (ANCOVA) Model - Change From Baseline Barthel Index Scores Through Week 52 - Efficacy Analysis Set

The Barthel index is an ordinal scale that evaluates functional independence in the domains of personal care and mobility. A total of ten variables describing activities of daily living and mobility are considered, with a higher number reflecting better capacity to operate independently. The Barthel Index assesses the level of help needed by a person on a set of ten activities of daily living (ADL) related to mobility and self-care. Score ranges from 0 points to 20 points, with lower scores indicating increased disability.

Time frame: Baseline to Week 52

Arm	Measure	Value (MEAN)	Dispersion
Treatment	Analysis of Covariance (ANCOVA) Model - Change From Baseline Barthel Index Scores Through Week 52 - Efficacy Analysis Set	2.359 score on a scale (20 points total)	Standard Error 1.867
Placebo	Analysis of Covariance (ANCOVA) Model - Change From Baseline Barthel Index Scores Through Week 52 - Efficacy Analysis Set	-3.094 score on a scale (20 points total)	Standard Error 1.962

p-value: 0.066695% CI: [-0.424, 11.33]ANCOVA

Secondary

Analysis of Covariance (ANCOVA) Model - Change in Patient Health Questionnaire (PHQ-9) Test Scores

The PHQ-9 is the most used depression and suicidal thoughts screening test used to monitor the severity of depression and response to treatment. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.

Time frame: Baseline to Week 52

Arm	Measure	Value (MEAN)	Dispersion
Treatment	Analysis of Covariance (ANCOVA) Model - Change in Patient Health Questionnaire (PHQ-9) Test Scores	-4.330 score on a scale (27 points total)	Standard Error 0.693
Placebo	Analysis of Covariance (ANCOVA) Model - Change in Patient Health Questionnaire (PHQ-9) Test Scores	0.263 score on a scale (27 points total)	Standard Error 0.728

p-value: 0.000495% CI: [-6.773, -2.413]ANCOVA

Secondary

Analysis of Covariance (ANCOVA) Model - Total Expanded Disability Status Scale (EDSS) Scores Through Week 52 - Change From Baseline - Efficacy Analysis Set

The EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. This scale ranges from 0 to 10 in 0.5-unit increments and a higher score represents increased disability. Scoring is based on an examination by a neurologist.

Time frame: Baseline to Week 52

Arm	Measure	Value (MEAN)	Dispersion
Treatment	Analysis of Covariance (ANCOVA) Model - Total Expanded Disability Status Scale (EDSS) Scores Through Week 52 - Change From Baseline - Efficacy Analysis Set	-1.502 score on a scale (10 points total)	Standard Error 0.424
Placebo	Analysis of Covariance (ANCOVA) Model - Total Expanded Disability Status Scale (EDSS) Scores Through Week 52 - Change From Baseline - Efficacy Analysis Set	0.052 score on a scale (10 points total)	Standard Error 0.446

p-value: 0.027895% CI: [-2.914, -0.195]ANCOVA

Secondary

ANCOVA Model - Change From Baseline 9-Hole Peg Test Scores - Dominant Hand Avg Time Through Week 52

The 9-HPT is a short, standardized upper extremity exam. It measures the time taken to complete the test activity, recorded in seconds. The higher the score the worse the disability.

Time frame: Baseline to Week 52

Arm	Measure	Value (MEAN)	Dispersion
Treatment	ANCOVA Model - Change From Baseline 9-Hole Peg Test Scores - Dominant Hand Avg Time Through Week 52	0.472 seconds	Standard Error 3.725
Placebo	ANCOVA Model - Change From Baseline 9-Hole Peg Test Scores - Dominant Hand Avg Time Through Week 52	-9.639 seconds	Standard Error 3.915

p-value: 0.086395% CI: [-1.629, 21.853]ANCOVA

Secondary

Baseline Vitals Values - Height

Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Treatment	Baseline Vitals Values - Height	166.17 cm	Standard Error 3.151
Placebo	Baseline Vitals Values - Height	167.86 cm	Standard Error 2.626

Secondary

Change From Baseline Physical Examination Results - Abdomen

Change From Baseline Physical Examination Results by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline to Week 52

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 3 - Week 8	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 1 (Baseline)	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 1 (Baseline)	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 2 - Week 4	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 2 - Week 4	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 2 - Week 4	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 1 (Baseline)	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 3 - Week 8	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 3 - Week 8	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 4 - Week 16	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 4 - Week 16	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 4 - Week 16	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 5 - Week 24	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 5 - Week 24	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 5 - Week 24	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 6 - Week 32	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 6 - Week 32	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Infusion 6 - Week 32	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Follow-Up - Week 42	Normal	11 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Follow-Up - Week 42	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	Follow-Up - Week 42	Not Examined (No longer in Study)	1 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	End of Study - Week 52	Normal	11 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	End of Study - Week 52	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Abdomen	End of Study - Week 52	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	End of Study - Week 52	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 1 (Baseline)	Normal	12 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 5 - Week 24	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 1 (Baseline)	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Follow-Up - Week 42	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 1 (Baseline)	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 5 - Week 24	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 2 - Week 4	Normal	12 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	End of Study - Week 52	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 2 - Week 4	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 5 - Week 24	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 2 - Week 4	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Follow-Up - Week 42	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 3 - Week 8	Normal	11 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 6 - Week 32	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 3 - Week 8	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	End of Study - Week 52	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 3 - Week 8	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 6 - Week 32	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 4 - Week 16	Normal	11 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Follow-Up - Week 42	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 4 - Week 16	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 6 - Week 32	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Abdomen	Infusion 4 - Week 16	Not Examined (No longer in Study)	1 Participants

Secondary

Change From Baseline Physical Examination Results - Cardiovascular

Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline to Week 52

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 3 - Week 8	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 1 (Baseline)	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 1 (Baseline)	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 2 - Week 4	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 2 - Week 4	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 2 - Week 4	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 1 (Baseline)	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 3 - Week 8	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 3 - Week 8	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 4 - Week 16	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 4 - Week 16	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 4 - Week 16	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 5 - Week 24	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 5 - Week 24	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 5 - Week 24	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 6 - Week 32	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 6 - Week 32	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 6 - Week 32	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Follow-Up - Week 42	Normal	11 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Follow-Up - Week 42	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	Follow-Up - Week 42	Not Examined (No longer in Study)	1 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	End of Study - Week 52	Normal	11 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	End of Study - Week 52	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Cardiovascular	End of Study - Week 52	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	End of Study - Week 52	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 1 (Baseline)	Normal	12 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 5 - Week 24	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 1 (Baseline)	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Follow-Up - Week 42	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 1 (Baseline)	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 5 - Week 24	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 2 - Week 4	Normal	12 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	End of Study - Week 52	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 2 - Week 4	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 5 - Week 24	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 2 - Week 4	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Follow-Up - Week 42	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 3 - Week 8	Normal	11 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 6 - Week 32	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 3 - Week 8	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	End of Study - Week 52	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 3 - Week 8	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 6 - Week 32	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 4 - Week 16	Normal	11 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Follow-Up - Week 42	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 4 - Week 16	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 6 - Week 32	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Cardiovascular	Infusion 4 - Week 16	Not Examined (No longer in Study)	1 Participants

Secondary

Change From Baseline Physical Examination Results - HEENT

Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline to Week 52

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 1 (Baseline)	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 5 - Week 24	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 3 - Week 8	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 5 - Week 24	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 2 - Week 4	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 5 - Week 24	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 3 - Week 8	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 6 - Week 32	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 1 (Baseline)	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 6 - Week 32	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 3 - Week 8	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 6 - Week 32	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 2 - Week 4	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Follow-Up - Week 42	Normal	11 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 4 - Week 16	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Follow-Up - Week 42	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 1 (Baseline)	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Follow-Up - Week 42	Not Examined (No longer in Study)	1 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 4 - Week 16	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	End of Study - Week 52	Normal	11 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 2 - Week 4	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	End of Study - Week 52	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	Infusion 4 - Week 16	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - HEENT	End of Study - Week 52	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 5 - Week 24	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 1 (Baseline)	Normal	12 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 1 (Baseline)	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 1 (Baseline)	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 2 - Week 4	Normal	12 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 2 - Week 4	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 2 - Week 4	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 3 - Week 8	Normal	11 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 3 - Week 8	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 3 - Week 8	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 4 - Week 16	Normal	11 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 4 - Week 16	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 4 - Week 16	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 5 - Week 24	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 5 - Week 24	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	End of Study - Week 52	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 6 - Week 32	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 6 - Week 32	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Infusion 6 - Week 32	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Follow-Up - Week 42	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Follow-Up - Week 42	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	Follow-Up - Week 42	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	End of Study - Week 52	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - HEENT	End of Study - Week 52	Abnormal	0 Participants

Secondary

Change From Baseline Physical Examination Results - Lymph Node

Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline to Week 52

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 3 - Week 8	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 1 (Baseline)	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 1 (Baseline)	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 2 - Week 4	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 2 - Week 4	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 2 - Week 4	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 1 (Baseline)	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 3 - Week 8	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 3 - Week 8	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 4 - Week 16	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 4 - Week 16	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 4 - Week 16	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 5 - Week 24	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 5 - Week 24	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 5 - Week 24	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 6 - Week 32	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 6 - Week 32	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Infusion 6 - Week 32	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Follow-Up - Week 42	Normal	11 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Follow-Up - Week 42	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	Follow-Up - Week 42	Not Examined (No longer in Study)	1 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	End of Study - Week 52	Normal	11 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	End of Study - Week 52	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Lymph Node	End of Study - Week 52	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	End of Study - Week 52	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 1 (Baseline)	Normal	12 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 5 - Week 24	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 1 (Baseline)	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Follow-Up - Week 42	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 1 (Baseline)	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 5 - Week 24	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 2 - Week 4	Normal	12 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	End of Study - Week 52	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 2 - Week 4	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 5 - Week 24	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 2 - Week 4	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Follow-Up - Week 42	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 3 - Week 8	Normal	11 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 6 - Week 32	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 3 - Week 8	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	End of Study - Week 52	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 3 - Week 8	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 6 - Week 32	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 4 - Week 16	Normal	11 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Follow-Up - Week 42	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 4 - Week 16	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 6 - Week 32	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Lymph Node	Infusion 4 - Week 16	Not Examined (No longer in Study)	1 Participants

Secondary

Change From Baseline Physical Examination Results - Musculoskeletal

Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline to Week 52

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 2 - Week 4	Abnormal	5 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 6 - Week 32	Normal	4 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 6 - Week 32	Abnormal	8 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 1 (Baseline)	Abnormal	6 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 1 (Baseline)	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 2 - Week 4	Normal	7 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 1 (Baseline)	Normal	6 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 2 - Week 4	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 3 - Week 8	Normal	5 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 3 - Week 8	Abnormal	7 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 3 - Week 8	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 4 - Week 16	Normal	5 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 4 - Week 16	Abnormal	7 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 4 - Week 16	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 5 - Week 24	Normal	4 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 5 - Week 24	Abnormal	8 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 5 - Week 24	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 6 - Week 32	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Follow-Up - Week 42	Normal	2 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Follow-Up - Week 42	Abnormal	9 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	Follow-Up - Week 42	Not Examined (No longer in Study)	1 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	End of Study - Week 52	Normal	3 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	End of Study - Week 52	Abnormal	8 Participants
Treatment	Change From Baseline Physical Examination Results - Musculoskeletal	End of Study - Week 52	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	End of Study - Week 52	Abnormal	6 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 4 - Week 16	Abnormal	7 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 6 - Week 32	Normal	4 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Follow-Up - Week 42	Normal	4 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 6 - Week 32	Abnormal	6 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 1 (Baseline)	Normal	3 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 4 - Week 16	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 1 (Baseline)	Abnormal	9 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	End of Study - Week 52	Normal	4 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 1 (Baseline)	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 5 - Week 24	Normal	4 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 2 - Week 4	Normal	4 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Follow-Up - Week 42	Abnormal	6 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 2 - Week 4	Abnormal	8 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 5 - Week 24	Abnormal	6 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 2 - Week 4	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	End of Study - Week 52	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 3 - Week 8	Normal	3 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 5 - Week 24	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 3 - Week 8	Abnormal	8 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Follow-Up - Week 42	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 3 - Week 8	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 6 - Week 32	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Musculoskeletal	Infusion 4 - Week 16	Normal	4 Participants

Secondary

Change From Baseline Physical Examination Results - Neurological

Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline to Week 52

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 5 - Week 24	Normal	1 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 1 (Baseline)	Abnormal	10 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 5 - Week 24	Abnormal	11 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 3 - Week 8	Normal	1 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 5 - Week 24	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 2 - Week 4	Normal	3 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 6 - Week 32	Normal	2 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 3 - Week 8	Abnormal	11 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 6 - Week 32	Abnormal	10 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 3 - Week 8	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 6 - Week 32	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 1 (Baseline)	Normal	2 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Follow-Up - Week 42	Normal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 4 - Week 16	Normal	1 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Follow-Up - Week 42	Abnormal	11 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 2 - Week 4	Abnormal	9 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Follow-Up - Week 42	Not Examined (No longer in Study)	1 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 4 - Week 16	Abnormal	11 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	End of Study - Week 52	Normal	2 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 1 (Baseline)	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	End of Study - Week 52	Abnormal	9 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 4 - Week 16	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	End of Study - Week 52	Not Examined (No longer in Study)	1 Participants
Treatment	Change From Baseline Physical Examination Results - Neurological	Infusion 2 - Week 4	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	End of Study - Week 52	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 1 (Baseline)	Normal	1 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 1 (Baseline)	Abnormal	11 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 1 (Baseline)	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 2 - Week 4	Normal	1 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 2 - Week 4	Abnormal	11 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 2 - Week 4	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 3 - Week 8	Normal	1 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 3 - Week 8	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 4 - Week 16	Normal	1 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 4 - Week 16	Abnormal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 4 - Week 16	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 5 - Week 24	Normal	1 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 5 - Week 24	Abnormal	9 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 5 - Week 24	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 6 - Week 32	Normal	2 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 6 - Week 32	Abnormal	8 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 6 - Week 32	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Follow-Up - Week 42	Normal	1 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Follow-Up - Week 42	Abnormal	9 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Follow-Up - Week 42	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	End of Study - Week 52	Normal	2 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	End of Study - Week 52	Abnormal	8 Participants
Placebo	Change From Baseline Physical Examination Results - Neurological	Infusion 3 - Week 8	Abnormal	10 Participants

Secondary

Change From Baseline Physical Examination Results - Respiratory

Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline to Week 52

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 1 (Baseline)	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 5 - Week 24	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 3 - Week 8	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 5 - Week 24	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 5 - Week 24	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 2 - Week 4	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 6 - Week 32	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 3 - Week 8	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 6 - Week 32	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 1 (Baseline)	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 6 - Week 32	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 3 - Week 8	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Follow-Up - Week 42	Normal	11 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 2 - Week 4	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Follow-Up - Week 42	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 4 - Week 16	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Follow-Up - Week 42	Not Examined (No longer in Study)	1 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 1 (Baseline)	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	End of Study - Week 52	Normal	11 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 4 - Week 16	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	End of Study - Week 52	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 2 - Week 4	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	End of Study - Week 52	Not Examined (No longer in Study)	1 Participants
Treatment	Change From Baseline Physical Examination Results - Respiratory	Infusion 4 - Week 16	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	End of Study - Week 52	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 1 (Baseline)	Normal	12 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 1 (Baseline)	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 1 (Baseline)	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 2 - Week 4	Normal	12 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 2 - Week 4	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 2 - Week 4	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 3 - Week 8	Normal	11 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 3 - Week 8	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 3 - Week 8	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 4 - Week 16	Normal	11 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 4 - Week 16	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 4 - Week 16	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 5 - Week 24	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 5 - Week 24	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 6 - Week 32	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 6 - Week 32	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 6 - Week 32	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Follow-Up - Week 42	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Follow-Up - Week 42	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Follow-Up - Week 42	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	End of Study - Week 52	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	End of Study - Week 52	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Respiratory	Infusion 5 - Week 24	Abnormal	0 Participants

Secondary

Change From Baseline Physical Examination Results - Skin

Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline to Week 52

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 2 - Week 4	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 1 (Baseline)	Normal	11 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 1 (Baseline)	Abnormal	1 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 1 (Baseline)	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 2 - Week 4	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 2 - Week 4	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 3 - Week 8	Normal	11 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 3 - Week 8	Abnormal	1 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 3 - Week 8	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 4 - Week 16	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 4 - Week 16	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 4 - Week 16	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 5 - Week 24	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 5 - Week 24	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 5 - Week 24	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 6 - Week 32	Normal	12 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 6 - Week 32	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Infusion 6 - Week 32	Not Examined (No longer in Study)	0 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Follow-Up - Week 42	Normal	11 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Follow-Up - Week 42	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	Follow-Up - Week 42	Not Examined (No longer in Study)	1 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	End of Study - Week 52	Normal	11 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	End of Study - Week 52	Abnormal	0 Participants
Treatment	Change From Baseline Physical Examination Results - Skin	End of Study - Week 52	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 6 - Week 32	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	End of Study - Week 52	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 4 - Week 16	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 1 (Baseline)	Normal	12 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	End of Study - Week 52	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 1 (Baseline)	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 5 - Week 24	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 1 (Baseline)	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 6 - Week 32	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 2 - Week 4	Normal	12 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 5 - Week 24	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 2 - Week 4	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Follow-Up - Week 42	Abnormal	1 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 2 - Week 4	Not Examined (No longer in Study)	0 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Follow-Up - Week 42	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 3 - Week 8	Normal	11 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 5 - Week 24	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 3 - Week 8	Abnormal	0 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Follow-Up - Week 42	Normal	9 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 3 - Week 8	Not Examined (No longer in Study)	1 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 6 - Week 32	Normal	10 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 4 - Week 16	Normal	11 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	End of Study - Week 52	Not Examined (No longer in Study)	2 Participants
Placebo	Change From Baseline Physical Examination Results - Skin	Infusion 4 - Week 16	Abnormal	0 Participants

Secondary

Change From Baseline Vitals Values - Body Mass Index

Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline to Week 52

Population: One patient from the treatment group was unable to attend starting at their follow-up visit (Week 42), and two patients from the Placebo group stopped attending visits starting at their Infusion 5 visit (Week 24) .

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline Vitals Values - Body Mass Index	Infusion 1 (Baseline)	24.72 kg/m^2	Standard Error 1.593
Treatment	Change From Baseline Vitals Values - Body Mass Index	Infusion 2 - Week 4	0.05 kg/m^2	Standard Error 0.112
Treatment	Change From Baseline Vitals Values - Body Mass Index	Infusion 3 - Week 8	-0.00 kg/m^2	Standard Error 0.142
Treatment	Change From Baseline Vitals Values - Body Mass Index	Infusion 4 - Week 16	0.46 kg/m^2	Standard Error 0.399
Treatment	Change From Baseline Vitals Values - Body Mass Index	Infusion 5 - Week 24	0.28 kg/m^2	Standard Error 0.417
Treatment	Change From Baseline Vitals Values - Body Mass Index	Infusion 6 - Week 32	0.47 kg/m^2	Standard Error 0.436
Treatment	Change From Baseline Vitals Values - Body Mass Index	Follow-Up - Week 42	0.61 kg/m^2	Standard Error 1.014
Treatment	Change From Baseline Vitals Values - Body Mass Index	End of Study - Week 52	0.37 kg/m^2	Standard Error 0.591
Placebo	Change From Baseline Vitals Values - Body Mass Index	End of Study - Week 52	-0.02 kg/m^2	Standard Error 0.505
Placebo	Change From Baseline Vitals Values - Body Mass Index	Infusion 1 (Baseline)	27.17 kg/m^2	Standard Error 1.652
Placebo	Change From Baseline Vitals Values - Body Mass Index	Infusion 5 - Week 24	-0.19 kg/m^2	Standard Error 0.332
Placebo	Change From Baseline Vitals Values - Body Mass Index	Infusion 2 - Week 4	0.07 kg/m^2	Standard Error 0.146
Placebo	Change From Baseline Vitals Values - Body Mass Index	Follow-Up - Week 42	-0.05 kg/m^2	Standard Error 0.476
Placebo	Change From Baseline Vitals Values - Body Mass Index	Infusion 3 - Week 8	-0.04 kg/m^2	Standard Error 0.164
Placebo	Change From Baseline Vitals Values - Body Mass Index	Infusion 6 - Week 32	-0.11 kg/m^2	Standard Error 0.399
Placebo	Change From Baseline Vitals Values - Body Mass Index	Infusion 4 - Week 16	-0.05 kg/m^2	Standard Error 0.263

Secondary

Change From Baseline Vitals Values - Diastolic Blood Pressure

Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline to Week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline Vitals Values - Diastolic Blood Pressure	Infusion 1 (Baseline)	76.3 mmHg	Standard Error 1.9
Treatment	Change From Baseline Vitals Values - Diastolic Blood Pressure	Infusion 2 - Week 4	2.5 mmHg	Standard Error 2
Treatment	Change From Baseline Vitals Values - Diastolic Blood Pressure	Infusion 3 - Week 8	-1.3 mmHg	Standard Error 1.97
Treatment	Change From Baseline Vitals Values - Diastolic Blood Pressure	Infusion 4 - Week 16	0.9 mmHg	Standard Error 2.66
Treatment	Change From Baseline Vitals Values - Diastolic Blood Pressure	Infusion 5 - Week 24	-3.2 mmHg	Standard Error 2.17
Treatment	Change From Baseline Vitals Values - Diastolic Blood Pressure	Infusion 6 - Week 32	4.0 mmHg	Standard Error 1.85
Treatment	Change From Baseline Vitals Values - Diastolic Blood Pressure	Follow-Up - Week 42	-1.6 mmHg	Standard Error 2.76
Treatment	Change From Baseline Vitals Values - Diastolic Blood Pressure	End of Study - Week 52	-1.1 mmHg	Standard Error 2.27
Placebo	Change From Baseline Vitals Values - Diastolic Blood Pressure	End of Study - Week 52	3.3 mmHg	Standard Error 2.12
Placebo	Change From Baseline Vitals Values - Diastolic Blood Pressure	Infusion 1 (Baseline)	78.9 mmHg	Standard Error 1.53
Placebo	Change From Baseline Vitals Values - Diastolic Blood Pressure	Infusion 5 - Week 24	1.4 mmHg	Standard Error 1.97
Placebo	Change From Baseline Vitals Values - Diastolic Blood Pressure	Infusion 2 - Week 4	1.1 mmHg	Standard Error 1.91
Placebo	Change From Baseline Vitals Values - Diastolic Blood Pressure	Follow-Up - Week 42	3.6 mmHg	Standard Error 3.11
Placebo	Change From Baseline Vitals Values - Diastolic Blood Pressure	Infusion 3 - Week 8	0.0 mmHg	Standard Error 2.23
Placebo	Change From Baseline Vitals Values - Diastolic Blood Pressure	Infusion 6 - Week 32	2.6 mmHg	Standard Error 2.93
Placebo	Change From Baseline Vitals Values - Diastolic Blood Pressure	Infusion 4 - Week 16	2.4 mmHg	Standard Error 2.21

Secondary

Change From Baseline Vitals Values - Oxygen Saturation

Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline to Week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline Vitals Values - Oxygen Saturation	Infusion 1 (Baseline)	98.4 percent of oxygen	Standard Error 0.23
Treatment	Change From Baseline Vitals Values - Oxygen Saturation	Infusion 2 - Week 4	-0.7 percent of oxygen	Standard Error 0.4
Treatment	Change From Baseline Vitals Values - Oxygen Saturation	Infusion 3 - Week 8	-0.4 percent of oxygen	Standard Error 0.38
Treatment	Change From Baseline Vitals Values - Oxygen Saturation	Infusion 4 - Week 16	-0.4 percent of oxygen	Standard Error 0.34
Treatment	Change From Baseline Vitals Values - Oxygen Saturation	Infusion 5 - Week 24	0.0 percent of oxygen	Standard Error 0.3
Treatment	Change From Baseline Vitals Values - Oxygen Saturation	Infusion 6 - Week 32	-0.9 percent of oxygen	Standard Error 0.54
Treatment	Change From Baseline Vitals Values - Oxygen Saturation	Follow-Up - Week 42	-0.4 percent of oxygen	Standard Error 0.28
Treatment	Change From Baseline Vitals Values - Oxygen Saturation	End of Study - Week 52	-0.5 percent of oxygen	Standard Error 0.45
Placebo	Change From Baseline Vitals Values - Oxygen Saturation	End of Study - Week 52	0.4 percent of oxygen	Standard Error 0.54
Placebo	Change From Baseline Vitals Values - Oxygen Saturation	Infusion 1 (Baseline)	98.0 percent of oxygen	Standard Error 0.35
Placebo	Change From Baseline Vitals Values - Oxygen Saturation	Infusion 5 - Week 24	-0.4 percent of oxygen	Standard Error 0.31
Placebo	Change From Baseline Vitals Values - Oxygen Saturation	Infusion 2 - Week 4	0.6 percent of oxygen	Standard Error 0.38
Placebo	Change From Baseline Vitals Values - Oxygen Saturation	Follow-Up - Week 42	-0.5 percent of oxygen	Standard Error 0.64
Placebo	Change From Baseline Vitals Values - Oxygen Saturation	Infusion 3 - Week 8	0.5 percent of oxygen	Standard Error 0.45
Placebo	Change From Baseline Vitals Values - Oxygen Saturation	Infusion 6 - Week 32	0.3 percent of oxygen	Standard Error 0.47
Placebo	Change From Baseline Vitals Values - Oxygen Saturation	Infusion 4 - Week 16	0.3 percent of oxygen	Standard Error 0.47

Secondary

Change From Baseline Vitals Values - Pulse Rate

Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline to Week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline Vitals Values - Pulse Rate	Infusion 1 (Baseline)	71.8 beats per minute	Standard Error 3.16
Treatment	Change From Baseline Vitals Values - Pulse Rate	Infusion 2 - Week 4	0.4 beats per minute	Standard Error 2.6
Treatment	Change From Baseline Vitals Values - Pulse Rate	Infusion 3 - Week 8	3.3 beats per minute	Standard Error 3.4
Treatment	Change From Baseline Vitals Values - Pulse Rate	Infusion 4 - Week 16	0.3 beats per minute	Standard Error 3.7
Treatment	Change From Baseline Vitals Values - Pulse Rate	Infusion 5 - Week 24	-2.6 beats per minute	Standard Error 2.71
Treatment	Change From Baseline Vitals Values - Pulse Rate	Infusion 6 - Week 32	1.9 beats per minute	Standard Error 4.3
Treatment	Change From Baseline Vitals Values - Pulse Rate	Follow-Up - Week 42	1.2 beats per minute	Standard Error 3.3
Treatment	Change From Baseline Vitals Values - Pulse Rate	End of Study - Week 52	-4.1 beats per minute	Standard Error 2.48
Placebo	Change From Baseline Vitals Values - Pulse Rate	End of Study - Week 52	-1.2 beats per minute	Standard Error 3.21
Placebo	Change From Baseline Vitals Values - Pulse Rate	Infusion 1 (Baseline)	76.2 beats per minute	Standard Error 1.66
Placebo	Change From Baseline Vitals Values - Pulse Rate	Infusion 5 - Week 24	-1.1 beats per minute	Standard Error 2.22
Placebo	Change From Baseline Vitals Values - Pulse Rate	Infusion 2 - Week 4	-0.9 beats per minute	Standard Error 2
Placebo	Change From Baseline Vitals Values - Pulse Rate	Follow-Up - Week 42	-4.0 beats per minute	Standard Error 2.56
Placebo	Change From Baseline Vitals Values - Pulse Rate	Infusion 3 - Week 8	2.4 beats per minute	Standard Error 2.57
Placebo	Change From Baseline Vitals Values - Pulse Rate	Infusion 6 - Week 32	-2.1 beats per minute	Standard Error 2.25
Placebo	Change From Baseline Vitals Values - Pulse Rate	Infusion 4 - Week 16	2.0 beats per minute	Standard Error 2.38

Secondary

Change From Baseline Vitals Values - Respiratory Rate

Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline to Week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline Vitals Values - Respiratory Rate	Infusion 1 (Baseline)	16.7 Breaths/min	Standard Error 0.28
Treatment	Change From Baseline Vitals Values - Respiratory Rate	Infusion 2 - Week 4	0.0 Breaths/min	Standard Error 0.35
Treatment	Change From Baseline Vitals Values - Respiratory Rate	Infusion 3 - Week 8	0.0 Breaths/min	Standard Error 0.35
Treatment	Change From Baseline Vitals Values - Respiratory Rate	Infusion 4 - Week 16	0.0 Breaths/min	Standard Error 0
Treatment	Change From Baseline Vitals Values - Respiratory Rate	Infusion 5 - Week 24	-0.2 Breaths/min	Standard Error 0.17
Treatment	Change From Baseline Vitals Values - Respiratory Rate	Infusion 6 - Week 32	0.2 Breaths/min	Standard Error 0.17
Treatment	Change From Baseline Vitals Values - Respiratory Rate	Follow-Up - Week 42	0.4 Breaths/min	Standard Error 0.24
Treatment	Change From Baseline Vitals Values - Respiratory Rate	End of Study - Week 52	0.2 Breaths/min	Standard Error 0.33
Placebo	Change From Baseline Vitals Values - Respiratory Rate	End of Study - Week 52	0.6 Breaths/min	Standard Error 0.31
Placebo	Change From Baseline Vitals Values - Respiratory Rate	Infusion 1 (Baseline)	16.3 Breaths/min	Standard Error 0.22
Placebo	Change From Baseline Vitals Values - Respiratory Rate	Infusion 5 - Week 24	0.6 Breaths/min	Standard Error 0.31
Placebo	Change From Baseline Vitals Values - Respiratory Rate	Infusion 2 - Week 4	0.2 Breaths/min	Standard Error 0.17
Placebo	Change From Baseline Vitals Values - Respiratory Rate	Follow-Up - Week 42	0.6 Breaths/min	Standard Error 0.31
Placebo	Change From Baseline Vitals Values - Respiratory Rate	Infusion 3 - Week 8	0.4 Breaths/min	Standard Error 0.24
Placebo	Change From Baseline Vitals Values - Respiratory Rate	Infusion 6 - Week 32	0.2 Breaths/min	Standard Error 0.2
Placebo	Change From Baseline Vitals Values - Respiratory Rate	Infusion 4 - Week 16	0.5 Breaths/min	Standard Error 0.28

Secondary

Change From Baseline Vitals Values - Systolic Blood Pressure

Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline to Week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline Vitals Values - Systolic Blood Pressure	Infusion 1 (Baseline)	119.2 mmHg	Standard Error 2.9
Treatment	Change From Baseline Vitals Values - Systolic Blood Pressure	Infusion 2 - Week 4	6.3 mmHg	Standard Error 3.1
Treatment	Change From Baseline Vitals Values - Systolic Blood Pressure	Infusion 3 - Week 8	-5.0 mmHg	Standard Error 2.11
Treatment	Change From Baseline Vitals Values - Systolic Blood Pressure	Infusion 4 - Week 16	1.5 mmHg	Standard Error 3.27
Treatment	Change From Baseline Vitals Values - Systolic Blood Pressure	Infusion 5 - Week 24	-3.5 mmHg	Standard Error 3.18
Treatment	Change From Baseline Vitals Values - Systolic Blood Pressure	Infusion 6 - Week 32	4.3 mmHg	Standard Error 3.87
Treatment	Change From Baseline Vitals Values - Systolic Blood Pressure	Follow-Up - Week 42	-4.0 mmHg	Standard Error 3.83
Treatment	Change From Baseline Vitals Values - Systolic Blood Pressure	End of Study - Week 52	1.4 mmHg	Standard Error 4.43
Placebo	Change From Baseline Vitals Values - Systolic Blood Pressure	End of Study - Week 52	0.7 mmHg	Standard Error 4.26
Placebo	Change From Baseline Vitals Values - Systolic Blood Pressure	Infusion 1 (Baseline)	122.2 mmHg	Standard Error 3.72
Placebo	Change From Baseline Vitals Values - Systolic Blood Pressure	Infusion 5 - Week 24	-0.6 mmHg	Standard Error 2.77
Placebo	Change From Baseline Vitals Values - Systolic Blood Pressure	Infusion 2 - Week 4	0.8 mmHg	Standard Error 2.74
Placebo	Change From Baseline Vitals Values - Systolic Blood Pressure	Follow-Up - Week 42	-1.1 mmHg	Standard Error 2.52
Placebo	Change From Baseline Vitals Values - Systolic Blood Pressure	Infusion 3 - Week 8	-2.8 mmHg	Standard Error 3.62
Placebo	Change From Baseline Vitals Values - Systolic Blood Pressure	Infusion 6 - Week 32	1.5 mmHg	Standard Error 3.37
Placebo	Change From Baseline Vitals Values - Systolic Blood Pressure	Infusion 4 - Week 16	5.4 mmHg	Standard Error 3.25

Secondary

Change From Baseline Vitals Values - Temperature

Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline to Week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline Vitals Values - Temperature	Infusion 1 (Baseline)	36.66 degrees Celsius	Standard Error 0.073
Treatment	Change From Baseline Vitals Values - Temperature	Infusion 2 - Week 4	-0.01 degrees Celsius	Standard Error 0.083
Treatment	Change From Baseline Vitals Values - Temperature	Infusion 3 - Week 8	0.03 degrees Celsius	Standard Error 0.095
Treatment	Change From Baseline Vitals Values - Temperature	Infusion 4 - Week 16	-0.03 degrees Celsius	Standard Error 0.074
Treatment	Change From Baseline Vitals Values - Temperature	Infusion 5 - Week 24	0.04 degrees Celsius	Standard Error 0.084
Treatment	Change From Baseline Vitals Values - Temperature	Infusion 6 - Week 32	-0.08 degrees Celsius	Standard Error 0.102
Treatment	Change From Baseline Vitals Values - Temperature	Follow-Up - Week 42	-0.10 degrees Celsius	Standard Error 0.077
Treatment	Change From Baseline Vitals Values - Temperature	End of Study - Week 52	-0.02 degrees Celsius	Standard Error 0.088
Placebo	Change From Baseline Vitals Values - Temperature	End of Study - Week 52	-0.11 degrees Celsius	Standard Error 0.132
Placebo	Change From Baseline Vitals Values - Temperature	Infusion 1 (Baseline)	36.84 degrees Celsius	Standard Error 0.08
Placebo	Change From Baseline Vitals Values - Temperature	Infusion 5 - Week 24	-0.17 degrees Celsius	Standard Error 0.115
Placebo	Change From Baseline Vitals Values - Temperature	Infusion 2 - Week 4	-0.23 degrees Celsius	Standard Error 0.07
Placebo	Change From Baseline Vitals Values - Temperature	Follow-Up - Week 42	-0.15 degrees Celsius	Standard Error 0.092
Placebo	Change From Baseline Vitals Values - Temperature	Infusion 3 - Week 8	-0.21 degrees Celsius	Standard Error 0.108
Placebo	Change From Baseline Vitals Values - Temperature	Infusion 6 - Week 32	-0.18 degrees Celsius	Standard Error 0.101
Placebo	Change From Baseline Vitals Values - Temperature	Infusion 4 - Week 16	-0.06 degrees Celsius	Standard Error 0.095

Secondary

Change From Baseline Vitals Values - Weight

Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline to Week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline Vitals Values - Weight	Infusion 1 (Baseline)	68.61 kg	Standard Error 5.05
Treatment	Change From Baseline Vitals Values - Weight	Infusion 2 - Week 4	0.15 kg	Standard Error 0.309
Treatment	Change From Baseline Vitals Values - Weight	Infusion 3- Week 8	-0.04 kg	Standard Error 0.385
Treatment	Change From Baseline Vitals Values - Weight	Infusion 4- Week 16	1.02 kg	Standard Error 0.972
Treatment	Change From Baseline Vitals Values - Weight	Infusion 5- Week 24	0.56 kg	Standard Error 1.043
Treatment	Change From Baseline Vitals Values - Weight	Infusion 6- Week 32	1.05 kg	Standard Error 1.105
Treatment	Change From Baseline Vitals Values - Weight	Follow-Up- Week 42	1.19 kg	Standard Error 2.665
Treatment	Change From Baseline Vitals Values - Weight	End of Study- Week 52	0.82 kg	Standard Error 1.519
Placebo	Change From Baseline Vitals Values - Weight	End of Study- Week 52	0.03 kg	Standard Error 1.332
Placebo	Change From Baseline Vitals Values - Weight	Infusion 1 (Baseline)	76.55 kg	Standard Error 4.797
Placebo	Change From Baseline Vitals Values - Weight	Infusion 5- Week 24	-0.56 kg	Standard Error 0.923
Placebo	Change From Baseline Vitals Values - Weight	Infusion 2 - Week 4	0.18 kg	Standard Error 0.406
Placebo	Change From Baseline Vitals Values - Weight	Follow-Up- Week 42	-0.14 kg	Standard Error 1.35
Placebo	Change From Baseline Vitals Values - Weight	Infusion 3- Week 8	-0.05 kg	Standard Error 0.441
Placebo	Change From Baseline Vitals Values - Weight	Infusion 6- Week 32	-0.31 kg	Standard Error 1.149
Placebo	Change From Baseline Vitals Values - Weight	Infusion 4- Week 16	-0.18 kg	Standard Error 0.727

Secondary

Laboratory Values - CBC (fL)

Changes from baseline in CBC laboratory values with unit of fL.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Population: One patient from the treatment group was unable to attend their end of study visit (Week 52), and two patients from the Placebo group stopped attending visits from before their Infusion 5 visit (Week 24) .

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Laboratory Values - CBC (fL)	MCV - Baseline	91.36 fL	Standard Error 1.332
Treatment	Laboratory Values - CBC (fL)	MCV - Week 24	-0.60 fL	Standard Error 0.937
Treatment	Laboratory Values - CBC (fL)	MCV - Week 52	0.15 fL	Standard Error 0.9
Placebo	Laboratory Values - CBC (fL)	MCV - Baseline	90.59 fL	Standard Error 1.163
Placebo	Laboratory Values - CBC (fL)	MCV - Week 24	0.65 fL	Standard Error 0.447
Placebo	Laboratory Values - CBC (fL)	MCV - Week 52	1.32 fL	Standard Error 0.857

Secondary

Laboratory Values - CBC (g/dL)

Changes from baseline in CBC laboratory values with unit of g/dL

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Laboratory Values - CBC (g/dL)	Hemoglobin - Baseline	13.60 g/dL	Standard Error 0.301
Treatment	Laboratory Values - CBC (g/dL)	Hemoglobin - Week 24	-0.18 g/dL	Standard Error 0.281
Treatment	Laboratory Values - CBC (g/dL)	Hemoglobin- Week 52	0.21 g/dL	Standard Error 0.168
Treatment	Laboratory Values - CBC (g/dL)	MCHC - Baseline	34.13 g/dL	Standard Error 0.233
Treatment	Laboratory Values - CBC (g/dL)	MCHC - Week 24	-0.01 g/dL	Standard Error 0.34
Treatment	Laboratory Values - CBC (g/dL)	MCHC- Week 52	-0.31 g/dL	Standard Error 0.236
Placebo	Laboratory Values - CBC (g/dL)	MCHC - Week 24	0.31 g/dL	Standard Error 0.312
Placebo	Laboratory Values - CBC (g/dL)	Hemoglobin - Baseline	13.68 g/dL	Standard Error 0.41
Placebo	Laboratory Values - CBC (g/dL)	MCHC - Baseline	33.53 g/dL	Standard Error 0.233
Placebo	Laboratory Values - CBC (g/dL)	Hemoglobin - Week 24	0.61 g/dL	Standard Error 0.498
Placebo	Laboratory Values - CBC (g/dL)	MCHC- Week 52	-0.06 g/dL	Standard Error 0.352
Placebo	Laboratory Values - CBC (g/dL)	Hemoglobin- Week 52	0.81 g/dL	Standard Error 0.401

Secondary

Laboratory Values - CBC (% of Total Blood Cell Count)

Changes from baseline in CBC laboratory values with unit of % of total blood cell count.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Laboratory Values - CBC (% of Total Blood Cell Count)	Hematocrit - Baseline	39.80 % of total blood cell count	Standard Error 0.736
Treatment	Laboratory Values - CBC (% of Total Blood Cell Count)	Hematocrit - Week 24	-0.48 % of total blood cell count	Standard Error 1.064
Treatment	Laboratory Values - CBC (% of Total Blood Cell Count)	Hematocrit- Week 52	1.02 % of total blood cell count	Standard Error 0.562
Placebo	Laboratory Values - CBC (% of Total Blood Cell Count)	Hematocrit - Baseline	40.77 % of total blood cell count	Standard Error 1.111
Placebo	Laboratory Values - CBC (% of Total Blood Cell Count)	Hematocrit - Week 24	1.43 % of total blood cell count	Standard Error 1.392
Placebo	Laboratory Values - CBC (% of Total Blood Cell Count)	Hematocrit- Week 52	2.51 % of total blood cell count	Standard Error 1.116

Secondary

Laboratory Values - CBC (% of WBC)

Changes from baseline in CBC laboratory values with unit of % of white blood cell count.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Laboratory Values - CBC (% of WBC)	Eosinophils - Week 24	0.18 % of white blood cell count	Standard Error 0.656
Treatment	Laboratory Values - CBC (% of WBC)	Lymphocytes - Week 52	-3.46 % of white blood cell count	Standard Error 2.907
Treatment	Laboratory Values - CBC (% of WBC)	Basophils - Week 24	0.22 % of white blood cell count	Standard Error 0.292
Treatment	Laboratory Values - CBC (% of WBC)	Monocytes - Baseline	8.59 % of white blood cell count	Standard Error 1.046
Treatment	Laboratory Values - CBC (% of WBC)	Eosinophils - Week 52	-0.01 % of white blood cell count	Standard Error 0.591
Treatment	Laboratory Values - CBC (% of WBC)	Monocytes - Week 24	-0.15 % of white blood cell count	Standard Error 1.124
Treatment	Laboratory Values - CBC (% of WBC)	Eosinophils - Baseline	1.86 % of white blood cell count	Standard Error 0.552
Treatment	Laboratory Values - CBC (% of WBC)	Monocytes - Week 52	1.83 % of white blood cell count	Standard Error 1.166
Treatment	Laboratory Values - CBC (% of WBC)	Lymphocytes - Baseline	27.98 % of white blood cell count	Standard Error 3.068
Treatment	Laboratory Values - CBC (% of WBC)	Neutrophils - Baseline	61.17 % of white blood cell count	Standard Error 2.777
Treatment	Laboratory Values - CBC (% of WBC)	Basophils - Week 52	0.03 % of white blood cell count	Standard Error 0.259
Treatment	Laboratory Values - CBC (% of WBC)	Neutrophils - Week 24	-2.06 % of white blood cell count	Standard Error 3.201
Treatment	Laboratory Values - CBC (% of WBC)	Lymphocytes - Week 24	1.58 % of white blood cell count	Standard Error 2.945
Treatment	Laboratory Values - CBC (% of WBC)	Neutrophils - Week 52	1.38 % of white blood cell count	Standard Error 3.861
Treatment	Laboratory Values - CBC (% of WBC)	Basophils - Baseline	0.40 % of white blood cell count	Standard Error 0.161
Placebo	Laboratory Values - CBC (% of WBC)	Neutrophils - Week 52	-2.21 % of white blood cell count	Standard Error 5.063
Placebo	Laboratory Values - CBC (% of WBC)	Basophils - Baseline	0.74 % of white blood cell count	Standard Error 0.192
Placebo	Laboratory Values - CBC (% of WBC)	Basophils - Week 24	0.09 % of white blood cell count	Standard Error 0.308
Placebo	Laboratory Values - CBC (% of WBC)	Basophils - Week 52	-0.13 % of white blood cell count	Standard Error 0.256
Placebo	Laboratory Values - CBC (% of WBC)	Eosinophils - Baseline	2.02 % of white blood cell count	Standard Error 0.409
Placebo	Laboratory Values - CBC (% of WBC)	Eosinophils - Week 24	1.06 % of white blood cell count	Standard Error 0.861
Placebo	Laboratory Values - CBC (% of WBC)	Eosinophils - Week 52	0.42 % of white blood cell count	Standard Error 0.373
Placebo	Laboratory Values - CBC (% of WBC)	Lymphocytes - Baseline	24.41 % of white blood cell count	Standard Error 2.049
Placebo	Laboratory Values - CBC (% of WBC)	Lymphocytes - Week 24	1.21 % of white blood cell count	Standard Error 3.152
Placebo	Laboratory Values - CBC (% of WBC)	Lymphocytes - Week 52	1.77 % of white blood cell count	Standard Error 4.329
Placebo	Laboratory Values - CBC (% of WBC)	Monocytes - Baseline	9.10 % of white blood cell count	Standard Error 1.215
Placebo	Laboratory Values - CBC (% of WBC)	Monocytes - Week 24	-0.76 % of white blood cell count	Standard Error 1.735
Placebo	Laboratory Values - CBC (% of WBC)	Monocytes - Week 52	-0.02 % of white blood cell count	Standard Error 1.564
Placebo	Laboratory Values - CBC (% of WBC)	Neutrophils - Baseline	63.73 % of white blood cell count	Standard Error 2.516
Placebo	Laboratory Values - CBC (% of WBC)	Neutrophils - Week 24	-1.68 % of white blood cell count	Standard Error 4.138

Secondary

Laboratory Values - CBC (pg)

Changes from baseline in CBC laboratory values with unit of pg

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Laboratory Values - CBC (pg)	MCH - Baseline	31.20 pg	Standard Error 0.542
Treatment	Laboratory Values - CBC (pg)	MCH - Week 24	-0.23 pg	Standard Error 0.371
Treatment	Laboratory Values - CBC (pg)	MCH- Week 52	-0.25 pg	Standard Error 0.276
Placebo	Laboratory Values - CBC (pg)	MCH - Baseline	30.38 pg	Standard Error 0.471
Placebo	Laboratory Values - CBC (pg)	MCH - Week 24	0.50 pg	Standard Error 0.286
Placebo	Laboratory Values - CBC (pg)	MCH- Week 52	0.44 pg	Standard Error 0.465

Secondary

Laboratory Values - CBC (RDW)

Changes from baseline in CBC laboratory values with unit of % (RDW - Red Cell Distribution Width)

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Laboratory Values - CBC (RDW)	RDW - Baseline	12.51 percentage	Standard Error 0.337
Treatment	Laboratory Values - CBC (RDW)	RDW - Week 24	0.21 percentage	Standard Error 0.155
Treatment	Laboratory Values - CBC (RDW)	RDW - Week 52	0.07 percentage	Standard Error 0.141
Placebo	Laboratory Values - CBC (RDW)	RDW - Baseline	12.82 percentage	Standard Error 0.162
Placebo	Laboratory Values - CBC (RDW)	RDW - Week 24	0.57 percentage	Standard Error 0.585
Placebo	Laboratory Values - CBC (RDW)	RDW - Week 52	0.35 percentage	Standard Error 0.582

Secondary

Laboratory Values - CBC (x10^3 Cells/uL)

Unit (x10\^3 cells/uL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set

Time frame: Baseline to Week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Monocytes - Week 24	-0.030 (x10^3 cells/uL)	Standard Error 0.0479
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Eosinophils - Week 52	0.027 (x10^3 cells/uL)	Standard Error 0.0302
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Monocytes - Week 52	0.069 (x10^3 cells/uL)	Standard Error 0.0543
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Basophils - Week 24	0.008 (x10^3 cells/uL)	Standard Error 0.0063
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Neutrophils - Baseline	3.348 (x10^3 cells/uL)	Standard Error 0.407
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Lymphocytes - Baseline	1.345 (x10^3 cells/uL)	Standard Error 0.0956
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Neutrophils - Week 24	0.470 (x10^3 cells/uL)	Standard Error 0.4303
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Eosinophils - Baseline	0.107 (x10^3 cells/uL)	Standard Error 0.0267
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Neutrophils - Week 52	0.681 (x10^3 cells/uL)	Standard Error 0.5759
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Lymphocytes - Week 24	0.098 (x10^3 cells/uL)	Standard Error 0.1275
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Platelet Count - Baseline	260.6 (x10^3 cells/uL)	Standard Error 20.61
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Basophils - Baseline	0.027 (x10^3 cells/uL)	Standard Error 0.0048
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Platelet Count - Week 24	1.1 (x10^3 cells/uL)	Standard Error 8.64
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Lymphocytes - Week 52	0.155 (x10^3 cells/uL)	Standard Error 0.1179
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Platelet Count - Week 52	19.9 (x10^3 cells/uL)	Standard Error 8.45
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Eosinophils - Week 24	-0.001 (x10^3 cells/uL)	Standard Error 0.0172
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	WBC - Baseline	5.35 (x10^3 cells/uL)	Standard Error 0.447
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Monocytes - Baseline	0.501 (x10^3 cells/uL)	Standard Error 0.0536
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	WBC - Week 24	0.54 (x10^3 cells/uL)	Standard Error 0.45
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	WBC - Week 52	0.95 (x10^3 cells/uL)	Standard Error 0.577
Treatment	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Basophils - Week 52	0.008 (x10^3 cells/uL)	Standard Error 0.0064
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	WBC - Week 52	0.30 (x10^3 cells/uL)	Standard Error 0.537
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Basophils - Baseline	0.030 (x10^3 cells/uL)	Standard Error 0.0051
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Basophils - Week 24	0.003 (x10^3 cells/uL)	Standard Error 0.005
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Basophils - Week 52	-0.001 (x10^3 cells/uL)	Standard Error 0.0053
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Eosinophils - Baseline	0.113 (x10^3 cells/uL)	Standard Error 0.0221
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Eosinophils - Week 24	0.018 (x10^3 cells/uL)	Standard Error 0.0156
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Eosinophils - Week 52	0.012 (x10^3 cells/uL)	Standard Error 0.015
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Lymphocytes - Baseline	1.220 (x10^3 cells/uL)	Standard Error 0.137
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Lymphocytes - Week 24	0.061 (x10^3 cells/uL)	Standard Error 0.0631
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Lymphocytes - Week 52	0.072 (x10^3 cells/uL)	Standard Error 0.0797
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Monocytes - Baseline	0.494 (x10^3 cells/uL)	Standard Error 0.0549
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Monocytes - Week 24	-0.008 (x10^3 cells/uL)	Standard Error 0.0296
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Monocytes - Week 52	0.009 (x10^3 cells/uL)	Standard Error 0.0307
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Neutrophils - Baseline	3.872 (x10^3 cells/uL)	Standard Error 0.4055
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Neutrophils - Week 24	-0.066 (x10^3 cells/uL)	Standard Error 0.5305
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Absolute Neutrophils - Week 52	0.201 (x10^3 cells/uL)	Standard Error 0.5813
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Platelet Count - Baseline	227.1 (x10^3 cells/uL)	Standard Error 20.28
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Platelet Count - Week 24	11.1 (x10^3 cells/uL)	Standard Error 11.83
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	Platelet Count - Week 52	9.5 (x10^3 cells/uL)	Standard Error 7.81
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	WBC - Baseline	5.75 (x10^3 cells/uL)	Standard Error 0.504
Placebo	Laboratory Values - CBC (x10^3 Cells/uL)	WBC - Week 24	0.01 (x10^3 cells/uL)	Standard Error 0.512

Secondary

Laboratory Values - CBC (x10^6 Cells/uL)

Changes from baseline in CBC laboratory values with unit of x10\^6 cells/uL.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Laboratory Values - CBC (x10^6 Cells/uL)	RBC - Baseline	4.362 x10^6 cells/uL	Standard Error 0.0772
Treatment	Laboratory Values - CBC (x10^6 Cells/uL)	RBC - Week 24	-0.027 x10^6 cells/uL	Standard Error 0.113
Treatment	Laboratory Values - CBC (x10^6 Cells/uL)	RBC - Week 52	0.100 x10^6 cells/uL	Standard Error 0.0645
Placebo	Laboratory Values - CBC (x10^6 Cells/uL)	RBC - Baseline	4.507 x10^6 cells/uL	Standard Error 0.1293
Placebo	Laboratory Values - CBC (x10^6 Cells/uL)	RBC - Week 24	0.134 x10^6 cells/uL	Standard Error 0.1769
Placebo	Laboratory Values - CBC (x10^6 Cells/uL)	RBC - Week 52	0.222 x10^6 cells/uL	Standard Error 0.1571

Secondary

Laboratory Values - CMP (g/dL)

Changes from baseline in CMP laboratory values with unit of g/dL.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Laboratory Values - CMP (g/dL)	Albumin - Week 24	-0.03 g/dL	Standard Error 0.093
Treatment	Laboratory Values - CMP (g/dL)	Calc Globulin - Week 52	-0.14 g/dL	Standard Error 0.059
Treatment	Laboratory Values - CMP (g/dL)	Calc Globulin - Baseline	2.53 g/dL	Standard Error 0.1
Treatment	Laboratory Values - CMP (g/dL)	Protein - Baseline	7.23 g/dL	Standard Error 0.12
Treatment	Laboratory Values - CMP (g/dL)	Albumin - Week 52	0.00 g/dL	Standard Error 0.086
Treatment	Laboratory Values - CMP (g/dL)	Protein - Week 24	-0.17 g/dL	Standard Error 0.14
Treatment	Laboratory Values - CMP (g/dL)	Calc Globulin - Week 24	-0.14 g/dL	Standard Error 0.075
Treatment	Laboratory Values - CMP (g/dL)	Protein - Week 52	-0.14 g/dL	Standard Error 0.106
Treatment	Laboratory Values - CMP (g/dL)	Albumin - Baseline	4.70 g/dL	Standard Error 0.089
Placebo	Laboratory Values - CMP (g/dL)	Protein - Week 52	-0.08 g/dL	Standard Error 0.085
Placebo	Laboratory Values - CMP (g/dL)	Albumin - Baseline	4.64 g/dL	Standard Error 0.071
Placebo	Laboratory Values - CMP (g/dL)	Albumin - Week 24	-0.03 g/dL	Standard Error 0.122
Placebo	Laboratory Values - CMP (g/dL)	Albumin - Week 52	-0.03 g/dL	Standard Error 0.091
Placebo	Laboratory Values - CMP (g/dL)	Calc Globulin - Baseline	2.10 g/dL	Standard Error 0.072
Placebo	Laboratory Values - CMP (g/dL)	Calc Globulin - Week 24	-0.06 g/dL	Standard Error 0.072
Placebo	Laboratory Values - CMP (g/dL)	Calc Globulin - Week 52	-0.05 g/dL	Standard Error 0.064
Placebo	Laboratory Values - CMP (g/dL)	Protein - Baseline	6.74 g/dL	Standard Error 0.1
Placebo	Laboratory Values - CMP (g/dL)	Protein - Week 24	-0.09 g/dL	Standard Error 0.146

Secondary

Laboratory Values - CMP (mEq/L)

Changes from baseline in CMP laboratory values with units of mEq/L.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Laboratory Values - CMP (mEq/L)	Chloride - Baseline	103.5 mEq/L	Standard Error 0.97
Treatment	Laboratory Values - CMP (mEq/L)	Chloride - Week 24	-0.3 mEq/L	Standard Error 0.71
Treatment	Laboratory Values - CMP (mEq/L)	Chloride - Week 52	0.2 mEq/L	Standard Error 0.64
Treatment	Laboratory Values - CMP (mEq/L)	Carbon Dioxide - Baseline	25.2 mEq/L	Standard Error 0.76
Treatment	Laboratory Values - CMP (mEq/L)	Carbon Dioxide - Week 24	0.1 mEq/L	Standard Error 0.58
Treatment	Laboratory Values - CMP (mEq/L)	Carbon Dioxide - Week 52	0.5 mEq/L	Standard Error 0.39
Treatment	Laboratory Values - CMP (mEq/L)	Potassium - Baseline	4.47 mEq/L	Standard Error 0.128
Treatment	Laboratory Values - CMP (mEq/L)	Potassium - Week 24	-0.22 mEq/L	Standard Error 0.135
Treatment	Laboratory Values - CMP (mEq/L)	Potassium - Week 52	-0.11 mEq/L	Standard Error 0.164
Treatment	Laboratory Values - CMP (mEq/L)	Sodium - Baseline	142.0 mEq/L	Standard Error 0.76
Treatment	Laboratory Values - CMP (mEq/L)	Sodium - Week 24	-0.9 mEq/L	Standard Error 0.85
Treatment	Laboratory Values - CMP (mEq/L)	Sodium - Week 52	-0.4 mEq/L	Standard Error 0.51
Placebo	Laboratory Values - CMP (mEq/L)	Sodium - Week 24	1.0 mEq/L	Standard Error 0.47
Placebo	Laboratory Values - CMP (mEq/L)	Chloride - Baseline	103.7 mEq/L	Standard Error 0.81
Placebo	Laboratory Values - CMP (mEq/L)	Potassium - Baseline	4.31 mEq/L	Standard Error 0.061
Placebo	Laboratory Values - CMP (mEq/L)	Chloride - Week 24	1.4 mEq/L	Standard Error 0.83
Placebo	Laboratory Values - CMP (mEq/L)	Sodium - Baseline	140.5 mEq/L	Standard Error 0.53
Placebo	Laboratory Values - CMP (mEq/L)	Chloride - Week 52	0.8 mEq/L	Standard Error 1.1
Placebo	Laboratory Values - CMP (mEq/L)	Potassium - Week 24	-0.13 mEq/L	Standard Error 0.06
Placebo	Laboratory Values - CMP (mEq/L)	Carbon Dioxide - Baseline	24.7 mEq/L	Standard Error 0.63
Placebo	Laboratory Values - CMP (mEq/L)	Sodium - Week 52	0.7 mEq/L	Standard Error 0.82
Placebo	Laboratory Values - CMP (mEq/L)	Carbon Dioxide - Week 24	0.1 mEq/L	Standard Error 0.72
Placebo	Laboratory Values - CMP (mEq/L)	Potassium - Week 52	-0.11 mEq/L	Standard Error 0.077
Placebo	Laboratory Values - CMP (mEq/L)	Carbon Dioxide - Week 52	0.1 mEq/L	Standard Error 0.86

Secondary

Laboratory Values - CMP (mg/dL)

Changes from baseline in CMP laboratory values with units of mg/dL.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Laboratory Values - CMP (mg/dL)	Glucose - Week 52	2.5 mg/dL	Standard Error 1.83
Treatment	Laboratory Values - CMP (mg/dL)	Bilirubin - Baseline	0.41 mg/dL	Standard Error 0.045
Treatment	Laboratory Values - CMP (mg/dL)	Bilirubin - Week 24	0.01 mg/dL	Standard Error 0.06
Treatment	Laboratory Values - CMP (mg/dL)	Bilirubin - Week 52	-0.02 mg/dL	Standard Error 0.038
Treatment	Laboratory Values - CMP (mg/dL)	Calcium - Baseline	9.78 mg/dL	Standard Error 0.099
Treatment	Laboratory Values - CMP (mg/dL)	Calcium - Week 24	-0.20 mg/dL	Standard Error 0.145
Treatment	Laboratory Values - CMP (mg/dL)	Calcium - Week 52	-0.11 mg/dL	Standard Error 0.11
Treatment	Laboratory Values - CMP (mg/dL)	Creatinine - Baseline	0.756 mg/dL	Standard Error 0.0453
Treatment	Laboratory Values - CMP (mg/dL)	Creatinine - Week 24	0.008 mg/dL	Standard Error 0.0288
Treatment	Laboratory Values - CMP (mg/dL)	Creatinine - Week 52	-0.001 mg/dL	Standard Error 0.0262
Treatment	Laboratory Values - CMP (mg/dL)	BUN - Baseline	14.3 mg/dL	Standard Error 1.31
Treatment	Laboratory Values - CMP (mg/dL)	BUN - Week 24	-0.5 mg/dL	Standard Error 1.05
Treatment	Laboratory Values - CMP (mg/dL)	BUN - Week 52	1.5 mg/dL	Standard Error 0.86
Treatment	Laboratory Values - CMP (mg/dL)	Glucose - Baseline	95.3 mg/dL	Standard Error 3.58
Treatment	Laboratory Values - CMP (mg/dL)	Glucose - Week 24	-1.9 mg/dL	Standard Error 3.45
Placebo	Laboratory Values - CMP (mg/dL)	Glucose - Week 52	-1.6 mg/dL	Standard Error 3.81
Placebo	Laboratory Values - CMP (mg/dL)	Creatinine - Week 24	-0.000 mg/dL	Standard Error 0.0278
Placebo	Laboratory Values - CMP (mg/dL)	Bilirubin - Baseline	0.44 mg/dL	Standard Error 0.051
Placebo	Laboratory Values - CMP (mg/dL)	BUN - Week 52	-0.1 mg/dL	Standard Error 1.09
Placebo	Laboratory Values - CMP (mg/dL)	Bilirubin - Week 24	0.15 mg/dL	Standard Error 0.062
Placebo	Laboratory Values - CMP (mg/dL)	Creatinine - Week 52	0.024 mg/dL	Standard Error 0.0348
Placebo	Laboratory Values - CMP (mg/dL)	Bilirubin - Week 52	0.09 mg/dL	Standard Error 0.062
Placebo	Laboratory Values - CMP (mg/dL)	Glucose - Week 24	-3.6 mg/dL	Standard Error 3.77
Placebo	Laboratory Values - CMP (mg/dL)	Calcium - Baseline	9.51 mg/dL	Standard Error 0.108
Placebo	Laboratory Values - CMP (mg/dL)	BUN - Baseline	13.4 mg/dL	Standard Error 1.2
Placebo	Laboratory Values - CMP (mg/dL)	Calcium - Week 24	-0.15 mg/dL	Standard Error 0.134
Placebo	Laboratory Values - CMP (mg/dL)	Glucose - Baseline	94.1 mg/dL	Standard Error 2.04
Placebo	Laboratory Values - CMP (mg/dL)	Calcium - Week 52	-0.03 mg/dL	Standard Error 0.128
Placebo	Laboratory Values - CMP (mg/dL)	BUN - Week 24	0.6 mg/dL	Standard Error 1.25
Placebo	Laboratory Values - CMP (mg/dL)	Creatinine - Baseline	0.827 mg/dL	Standard Error 0.0472

Secondary

Laboratory Values - CMP (mL/Min/1.73m^2)

Changes from baseline in CMP laboratory values with units of mL/min/1.73m\^2.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Laboratory Values - CMP (mL/Min/1.73m^2)	Glomerular Filtration Rate (eGFR) - Week 52	-0.8 mL/min/1.73m^2	Standard Error 1.75
Treatment	Laboratory Values - CMP (mL/Min/1.73m^2)	Glomerular Filtration Rate (eGFR) - Baseline	99.5 mL/min/1.73m^2	Standard Error 2.41
Treatment	Laboratory Values - CMP (mL/Min/1.73m^2)	Glomerular Filtration Rate (eGFR) - Week 24	-1.7 mL/min/1.73m^2	Standard Error 2.28
Placebo	Laboratory Values - CMP (mL/Min/1.73m^2)	Glomerular Filtration Rate (eGFR) - Week 24	0.2 mL/min/1.73m^2	Standard Error 3.18
Placebo	Laboratory Values - CMP (mL/Min/1.73m^2)	Glomerular Filtration Rate (eGFR) - Baseline	94.4 mL/min/1.73m^2	Standard Error 5.65
Placebo	Laboratory Values - CMP (mL/Min/1.73m^2)	Glomerular Filtration Rate (eGFR) - Week 52	-2.7 mL/min/1.73m^2	Standard Error 3.99

Secondary

Laboratory Values - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))

Changes from baseline in CMP laboratory values with units of Ratio: Albumin(g/dL) to Calc. Globulin(g/dL)

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Laboratory Values - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))	Calc A/G - Baseline	1.89 Ratio: Albumin(g/dL) to Globulin(g/dL	Standard Error 0.086
Treatment	Laboratory Values - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))	Calc A/G - Week 24	0.10 Ratio: Albumin(g/dL) to Globulin(g/dL	Standard Error 0.066
Treatment	Laboratory Values - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))	Calc A/G - Week 52	0.11 Ratio: Albumin(g/dL) to Globulin(g/dL	Standard Error 0.076
Placebo	Laboratory Values - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))	Calc A/G - Baseline	2.23 Ratio: Albumin(g/dL) to Globulin(g/dL	Standard Error 0.086
Placebo	Laboratory Values - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))	Calc A/G - Week 24	0.08 Ratio: Albumin(g/dL) to Globulin(g/dL	Standard Error 0.1
Placebo	Laboratory Values - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))	Calc A/G - Week 52	0.04 Ratio: Albumin(g/dL) to Globulin(g/dL	Standard Error 0.09

Secondary

Laboratory Values - CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))

Changes from baseline in CMP laboratory values with units of Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL).

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Laboratory Values - CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))	Calc BUN/Creat - Baseline	19.7 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)	Standard Error 2.44
Treatment	Laboratory Values - CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))	Calc BUN/Creat - Week 24	-0.6 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)	Standard Error 1.43
Treatment	Laboratory Values - CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))	Calc BUN/Creat - Week 52	2.5 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)	Standard Error 1.15
Placebo	Laboratory Values - CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))	Calc BUN/Creat - Baseline	16.3 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)	Standard Error 1
Placebo	Laboratory Values - CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))	Calc BUN/Creat - Week 24	0.4 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)	Standard Error 1.61
Placebo	Laboratory Values - CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))	Calc BUN/Creat - Week 52	-0.6 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)	Standard Error 1.59

Secondary

Laboratory Values - CMP (U/L)

Changes from baseline in CMP laboratory values with units of U/L.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Laboratory Values - CMP (U/L)	Alkaline Phosphatase - Week 24	-2.6 U/L	Standard Error 4.67
Treatment	Laboratory Values - CMP (U/L)	ALT - Week 52	1.9 U/L	Standard Error 4.03
Treatment	Laboratory Values - CMP (U/L)	ALT - Baseline	23.9 U/L	Standard Error 2.66
Treatment	Laboratory Values - CMP (U/L)	AST - Baseline	25.7 U/L	Standard Error 2.56
Treatment	Laboratory Values - CMP (U/L)	Alkaline Phosphatase - Week 52	5.5 U/L	Standard Error 4.75
Treatment	Laboratory Values - CMP (U/L)	AST - Week 24	-3.1 U/L	Standard Error 2.07
Treatment	Laboratory Values - CMP (U/L)	ALT - Week 24	-1.4 U/L	Standard Error 1.94
Treatment	Laboratory Values - CMP (U/L)	AST - Week 52	-2.8 U/L	Standard Error 2.91
Treatment	Laboratory Values - CMP (U/L)	Alkaline Phosphatase - Baseline	77.5 U/L	Standard Error 9.35
Placebo	Laboratory Values - CMP (U/L)	AST - Week 52	-0.8 U/L	Standard Error 1.1
Placebo	Laboratory Values - CMP (U/L)	Alkaline Phosphatase - Baseline	69.0 U/L	Standard Error 4.11
Placebo	Laboratory Values - CMP (U/L)	Alkaline Phosphatase - Week 24	-0.3 U/L	Standard Error 2.48
Placebo	Laboratory Values - CMP (U/L)	Alkaline Phosphatase - Week 52	1.0 U/L	Standard Error 1.93
Placebo	Laboratory Values - CMP (U/L)	ALT - Baseline	17.7 U/L	Standard Error 1.05
Placebo	Laboratory Values - CMP (U/L)	ALT - Week 24	2.9 U/L	Standard Error 1.97
Placebo	Laboratory Values - CMP (U/L)	ALT - Week 52	-0.1 U/L	Standard Error 1.51
Placebo	Laboratory Values - CMP (U/L)	AST - Baseline	18.3 U/L	Standard Error 1.5
Placebo	Laboratory Values - CMP (U/L)	AST - Week 24	2.1 U/L	Standard Error 1.92

Secondary

Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))

Changes from baseline in Coagulation laboratory values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds).

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))	INR - Baseline	0.94 Ratio: PT (seconds) / MNPT (seconds)	Standard Error 0.019
Treatment	Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))	INR - Week 24	0.11 Ratio: PT (seconds) / MNPT (seconds)	Standard Error 0.092
Treatment	Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))	INR - Week 52	0.14 Ratio: PT (seconds) / MNPT (seconds)	Standard Error 0.119
Placebo	Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))	INR - Baseline	0.96 Ratio: PT (seconds) / MNPT (seconds)	Standard Error 0.015
Placebo	Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))	INR - Week 24	0.04 Ratio: PT (seconds) / MNPT (seconds)	Standard Error 0.016
Placebo	Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))	INR - Week 52	0.02 Ratio: PT (seconds) / MNPT (seconds)	Standard Error 0.013

Secondary

Laboratory Values - Coagulation Panel (Seconds)

Changes from baseline in Coagulation Panel values with units of seconds.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Laboratory Values - Coagulation Panel (Seconds)	Prothrombin Time (PT) - Week 24	1.00 Seconds	Standard Error 0.833
Treatment	Laboratory Values - Coagulation Panel (Seconds)	PTT - Baseline	29.78 Seconds	Standard Error 1.056
Treatment	Laboratory Values - Coagulation Panel (Seconds)	Prothrombin Time (PT) - Baseline	12.95 Seconds	Standard Error 0.183
Treatment	Laboratory Values - Coagulation Panel (Seconds)	PTT - Week 24	0.73 Seconds	Standard Error 0.936
Treatment	Laboratory Values - Coagulation Panel (Seconds)	Prothrombin Time (PT) - Week 52	1.28 Seconds	Standard Error 1.064
Treatment	Laboratory Values - Coagulation Panel (Seconds)	PTT - Week 52	2.63 Seconds	Standard Error 1.712
Placebo	Laboratory Values - Coagulation Panel (Seconds)	Prothrombin Time (PT) - Week 52	0.12 Seconds	Standard Error 0.049
Placebo	Laboratory Values - Coagulation Panel (Seconds)	Prothrombin Time (PT) - Baseline	13.23 Seconds	Standard Error 0.152
Placebo	Laboratory Values - Coagulation Panel (Seconds)	Prothrombin Time (PT) - Week 24	0.08 Seconds	Standard Error 0.096
Placebo	Laboratory Values - Coagulation Panel (Seconds)	PTT - Week 52	-1.22 Seconds	Standard Error 0.707
Placebo	Laboratory Values - Coagulation Panel (Seconds)	PTT - Baseline	30.06 Seconds	Standard Error 0.618
Placebo	Laboratory Values - Coagulation Panel (Seconds)	PTT - Week 24	-0.88 Seconds	Standard Error 0.528

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

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Study design

Masking description

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54 Composite Score

Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54

Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline - Multiple Sclerosis Quality of Life (MSQOL)-54

Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54

Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument

Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Analysis of Covariance (ANCOVA) Model - Change From Baseline 9-Hole Peg Test Scores - Non-Dominant Hand Avg Time Through Week 52

Analysis of Covariance (ANCOVA) Model - Change From Baseline Barthel Index Scores Through Week 52 - Efficacy Analysis Set

Analysis of Covariance (ANCOVA) Model - Change in Patient Health Questionnaire (PHQ-9) Test Scores

Analysis of Covariance (ANCOVA) Model - Total Expanded Disability Status Scale (EDSS) Scores Through Week 52 - Change From Baseline - Efficacy Analysis Set

ANCOVA Model - Change From Baseline 9-Hole Peg Test Scores - Dominant Hand Avg Time Through Week 52

Baseline Vitals Values - Height

Change From Baseline Physical Examination Results - Abdomen

Change From Baseline Physical Examination Results - Cardiovascular

Change From Baseline Physical Examination Results - HEENT

Change From Baseline Physical Examination Results - Lymph Node

Change From Baseline Physical Examination Results - Musculoskeletal

Change From Baseline Physical Examination Results - Neurological

Change From Baseline Physical Examination Results - Respiratory

Change From Baseline Physical Examination Results - Skin

Change From Baseline Vitals Values - Body Mass Index

Change From Baseline Vitals Values - Diastolic Blood Pressure

Change From Baseline Vitals Values - Oxygen Saturation

Change From Baseline Vitals Values - Pulse Rate

Change From Baseline Vitals Values - Respiratory Rate

Change From Baseline Vitals Values - Systolic Blood Pressure

Change From Baseline Vitals Values - Temperature

Change From Baseline Vitals Values - Weight

Laboratory Values - CBC (fL)

Laboratory Values - CBC (g/dL)

Laboratory Values - CBC (% of Total Blood Cell Count)

Laboratory Values - CBC (% of WBC)

Laboratory Values - CBC (pg)

Laboratory Values - CBC (RDW)

Laboratory Values - CBC (x10^3 Cells/uL)

Laboratory Values - CBC (x10^6 Cells/uL)

Laboratory Values - CMP (g/dL)

Laboratory Values - CMP (mEq/L)

Laboratory Values - CMP (mg/dL)

Laboratory Values - CMP (mL/Min/1.73m^2)

Laboratory Values - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))

Laboratory Values - CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))

Laboratory Values - CMP (U/L)

Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))

Laboratory Values - Coagulation Panel (Seconds)