Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) to provide immune support against COVID-19. The study purpose is to evaluate the safety and efficacy of five IV infusions of HB-adMSCs in subjects with no signs of COVID-19.
This is a Phase II, Randomized, Placebo-Controlled, Double-Blinded, Clinical Trial to Assess Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease. 100 patients will be enrolled. Eligible participants are at high or very high exposure risk of contracting COVID-19. The primary endpoint of this study is to provide immune support against COVID-19, measured by the percentage of subjects that develop symptoms of COVID-19. In addition, participants will be monitored for overall clinical status by standard clinical laboratories and inflammatory markers. Participants will complete Short Form Health Survey (SF-36) and depression module (PHQ-9) questionnaires.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogeneic HB-adMSCs 200MM | Experimental | Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14. |
|
| Allogeneic HB-adMSCs 100MM | Experimental | Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14. |
|
| Allogeneic HB-adMSCs 50MM | Experimental | Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14. |
|
| Placebo | Placebo Comparator | Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Infusions will occur at weeks 0, 2, 6, 10, and 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB-adMSCs | Biological | Hope Biosciences allogeneic adipose-derived mesenchymal stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Were Hospitalized Due to COVID-19 Symptoms | Number of subjects that were hospitalized due to COVID-19 symptoms during the conduct of this study. | Week 0 through Week 26 (End of Study) |
| Number of Participants That Had Symptoms Associated With COVID-19 | Number of subjects who experience symptoms defined to be associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough, etc. | Week 0 through Week 26 (End of Study) |
| Measure | Description | Time Frame |
|---|---|---|
| Leukocyte Differential Count | Change from baseline in Leukocyte Differential Count | Week 0 to Week 26 (End of Study) |
| C Reactive Protein | Change from baseline in C Reactive Protein |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thanh Cheng, MD | Hope Biosciences Stem Cell Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Biosciences Stem Cell Research Foundation | Sugar Land | Texas | 77478 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 84 subjects were assessed for screening, out of which only 53 were enrolled and 31 were screen failed.
Selection of subjects was based on the inclusion and exclusion criteria and only those subjects who met all of the inclusion criteria and none of the exclusion criteria, were eligible to participate in the trial. The first participant was enrolled on 05/14/2020 and the last participant was enrolled on 11/04/2020.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Allogeneic HB-adMSCs 200MM | Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose. HB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells |
| FG001 | Allogeneic HB-adMSCs 100MM | Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells |
| FG002 | Allogeneic HB-adMSCs 50MM | Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose. HB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells |
| FG003 | Placebo | Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Placebos: Saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Allogeneic HB-adMSCs 200MM | Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14. HB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells |
| BG001 | Allogeneic HB-adMSCs 100MM |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants That Were Hospitalized Due to COVID-19 Symptoms | Number of subjects that were hospitalized due to COVID-19 symptoms during the conduct of this study. | A total of 37 subjects completed all 5 infusions. | Posted | Count of Participants | Participants | Week 0 through Week 26 (End of Study) |
|
Week 0 through Week 26 (End of Study)
Out of 53 total subjects, 37 subjects had reported at least one adverse event (AE). A total of 139 AEs were recorded during the entire course of study, out of which 135 were mild in severity, 4 were moderate and none was severe. There were no serious adverse events (SAEs) reported during the study period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Allogeneic HB-adMSCs 200MM | Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose. HB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle fatigue | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ridhima Vij, PhD | Hope Biosciences Stem Cell Research Foundation | 346-900-0340 | 102 | ridhima@hopebio.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 29, 2021 | Sep 9, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 14, 2021 | Sep 12, 2022 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebos | Other | Saline |
|
| Week 0 through Week 26 (End of Study) |
| Tumor Necrosis Factor - Alpha | Change from baseline in TNF alpha | Week 0 through Week 26 (End of Study) |
| Interleukin 6 | Change from baseline in IL-6 | Week 0 through Week 26 (End of Study) |
| Interleukin 10 | Change from baseline in IL-10 | Week 0 through Week 26 (End of Study) |
| Short Form-36 (SF-36) | The Short Form-36 Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores (including Energy/Fatigue scores, Social Functioning, role limitations due to Physical Health, General Health, Physical Functioning, Pain, Emotional Well-Being, and Emotional Problems) which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. | Week 0 to Week 26 (End of Study) |
| Patient Health Questionnaire (PHQ-9) Scores | The study used PHQ-9 as a depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day) to monitor the severity of depression. | Week 0 to Week 26 (End of Study) |
Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14. HB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells |
| BG002 | Allogeneic HB-adMSCs 50MM | Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14. HB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells |
| BG003 | Placebo | Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Infusions will occur at weeks 0, 2, 6, 10, and 14. Placebos: Saline |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | Allogeneic HB-adMSCs 50MM | Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose. HB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells |
| OG003 | Placebo | Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Placebos: Saline |
|
|
| Primary | Number of Participants That Had Symptoms Associated With COVID-19 | Number of subjects who experience symptoms defined to be associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough, etc. | A total of 37 subjects who completed all 5 infusions. | Posted | Count of Participants | Participants | Week 0 through Week 26 (End of Study) |
|
|
|
| Secondary | Leukocyte Differential Count | Change from baseline in Leukocyte Differential Count | Number of subjects contributing to analysis. | Posted | Least Squares Mean | Standard Error | Leukocytes (x10^9/L) | Week 0 to Week 26 (End of Study) |
|
|
|
|
| Secondary | C Reactive Protein | Change from baseline in C Reactive Protein | Number of subjects contributing to analysis. | Posted | Least Squares Mean | Standard Error | mg/L | Week 0 through Week 26 (End of Study) |
|
|
|
|
| Secondary | Tumor Necrosis Factor - Alpha | Change from baseline in TNF alpha | Number of subjects contributing to analysis. | Posted | Least Squares Mean | Standard Error | ng/L | Week 0 through Week 26 (End of Study) |
|
|
|
|
| Secondary | Interleukin 6 | Change from baseline in IL-6 | Number of subjects contributing to analysis. | Posted | Least Squares Mean | Standard Error | ng/L | Week 0 through Week 26 (End of Study) |
|
|
|
|
| Secondary | Interleukin 10 | Change from baseline in IL-10 | Number of subjects contributing to analysis. | Posted | Least Squares Mean | Standard Error | ng/L | Week 0 through Week 26 (End of Study) |
|
|
|
|
| Secondary | Short Form-36 (SF-36) | The Short Form-36 Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores (including Energy/Fatigue scores, Social Functioning, role limitations due to Physical Health, General Health, Physical Functioning, Pain, Emotional Well-Being, and Emotional Problems) which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. | Number of subjects contributing to analysis. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Week 0 to Week 26 (End of Study) |
|
|
|
|
| Secondary | Patient Health Questionnaire (PHQ-9) Scores | The study used PHQ-9 as a depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day) to monitor the severity of depression. | Number of subjects contributing to analysis. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Week 0 to Week 26 (End of Study) |
|
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 15 |
| 19 |
| EG001 | Allogeneic HB-adMSCs 100MM | Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells | 0 | 9 | 0 | 9 | 5 | 9 |
| EG002 | Allogeneic HB-adMSCs 50MM | Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose. HB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells | 0 | 12 | 0 | 12 | 7 | 12 |
| EG003 | Placebo | Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Placebos: Saline | 0 | 13 | 0 | 13 | 10 | 13 |
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle rigidity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Anosmia | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Ageusia | Nervous system disorders | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Influenza like illness | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Salivary hyper-secretion | Gastrointestinal disorders | Non-systematic Assessment |
|
| Corona virus Infection | Infections and infestations | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | Non-systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Appendicectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Rotator cuff repair | Surgical and medical procedures | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Number of Subjects with No Incidence of COVID-19 Symptoms |
|
| Change from baseline |
|
| Mean Difference (Net) |
| -0.434 |
| Standard Error of the Mean |
| 0.638 |
| 2-Sided |
| 95 |
| Superiority |
| ANCOVA | 0.8903 | Mean Difference (Net) | 0.077 | Standard Error of the Mean | 0.555 | 2-Sided | 95 | Superiority |
| Change from baseline |
|
| Mean Difference (Net) |
| -0.913 |
| Standard Error of the Mean |
| 1.342 |
| 2-Sided |
| 95 |
| Superiority |
| ANCOVA | 0.9948 | Mean Difference (Net) | 0.008 | Standard Error of the Mean | 1.193 | 2-Sided | 95 | Superiority |
| Change from baseline |
|
| Mean Difference (Net) |
| -0.045 |
| Standard Error of the Mean |
| 0.198 |
| 2-Sided |
| 95 |
| Superiority |
| ANCOVA | 0.3097 | Median Difference (Net) | 0.178 | Standard Error of the Mean | 0.171 | 2-Sided | 95 | Superiority |
| Change from baseline |
|
| Mean Difference (Net) |
| 0.000 |
| Standard Error of the Mean |
| 0.087 |
| 2-Sided |
| 95 |
| Superiority |
| ANCOVA | 0.1713 | Mean Difference (Net) | 0.112 | Standard Error of the Mean | 0.079 | 2-Sided | 95 | Superiority |
| Change from baseline |
|
| Mean Difference (Net) |
| -0.008 |
| Standard Error of the Mean |
| 0.115 |
| 2-Sided |
| 95 |
| Superiority |
| ANCOVA | 0.9362 | Mean Difference (Net) | -0.008 | Standard Error of the Mean | 0.103 | 2-Sided | 95 | Superiority |
| Average Energy/Fatigue - Change from baseline |
|
| Average Social Functioning |
|
| Average Social Functioning - Change from baseline |
|
| Avg. Role Limitations Due to Physical Health |
|
| Avg. Role Limitations Due to Physical Health - Change from baseline |
|
| Average General Health |
|
| Average General Health - Change from baseline |
|
| Average Physical Functioning |
|
| Average Physical Functioning - Change from baseline |
|
| Average Pain |
|
| Average Pain - Change from baseline |
|
| Average Emotional Well Being |
|
| Average Emotional Well Being - Change from baseline |
|
| Avg. Role Limitations Due to Emotional Problems |
|
| Avg. Role Limitations Due to Emotional Problems - Change from baseline |
|
| ANCOVA |
| 0.3627 |
| Mean Difference (Net) |
| 8.780 |
| Standard Error of the Mean |
| 9.483 |
| 2-Sided |
| 95 |
| Superiority |
| Average Energy/Fatigue - Treatment Contrast | ANCOVA | 0.4160 | Mean Difference (Net) | 6.282 | Standard Error of the Mean | 7.604 | 2-Sided | 95 | Superiority |
| Average Social Functioning - Treatment Contrast | ANCOVA | 0.8768 | Mean Difference (Net) | 0.520 | Standard Error of the Mean | 3.320 | 2-Sided | 95 | Superiority |
| Average Social Functioning - Treatment Contrast | ANCOVA | 0.0869 | Mean Difference (Net) | -7.719 | Standard Error of the Mean | 4.344 | 2-Sided | 95 | Superiority |
| Average Social Functioning - Treatment Contrast | ANCOVA | 0.6864 | Mean Difference (Net) | 1.434 | Standard Error of the Mean | 3.514 | 2-Sided | 95 | Superiority |
| Avg. Role Limitations Due to Physical Health - Treatment Contrast | ANCOVA | 0.2587 | Mean Difference (Net) | -4.120 | Standard Error of the Mean | 3.571 | 2-Sided | 95 | Superiority |
| Avg. Role Limitations Due to Physical Health - Treatment Contrast | ANCOVA | 0.1250 | Mean Difference (Net) | 8.417 | Standard Error of the Mean | 5.316 | 2-Sided | 95 | Superiority |
| Avg. Role Limitations Due to Physical Health - Treatment Contrast | ANCOVA | 0.9780 | Mean Difference (Net) | -0.104 | Standard Error of the Mean | 3.732 | 2-Sided | 95 | Superiority |
| Average General Health - Treatment Contrast | ANCOVA | 0.8721 | Mean Difference (Net) | 0.963 | Standard Error of the Mean | 5.925 | 2-Sided | 95 | Superiority |
| Average General Health - Treatment Contrast | ANCOVA | 0.6694 | Mean Difference (Net) | 3.340 | Standard Error of the Mean | 7.735 | 2-Sided | 95 | Superiority |
| Average General Health - Treatment Contrast | ANCOVA | 0.3733 | Mean Difference (Net) | 5.498 | Standard Error of the Mean | 6.073 | 2-Sided | 95 | Superiority |
| Average Physical Functioning - Treatment Contrast | ANCOVA | 0.5594 | Mean Difference (Net) | 2.433 | Standard Error of the Mean | 4.116 | 2-Sided | 95 | Superiority |
| Average Physical Functioning - Treatment Contrast | ANCOVA | 0.2127 | Mean Difference (Net) | 6.878 | Standard Error of the Mean | 5.389 | 2-Sided | 95 | Superiority |
| Average Physical Functioning - Treatment Contrast | ANCOVA | 0.4012 | Mean Difference (Net) | 3.670 | Standard Error of the Mean | 4.303 | 2-Sided | 95 | Superiority |
| Average Pain - Treatment Contrast | ANCOVA | 0.0521 | Mean Difference (Net) | 11.678 | Standard Error of the Mean | 5.748 | 2-Sided | 95 | Superiority |
| Average Pain - Treatment Contrast | ANCOVA | 0.4704 | Mean Difference (Net) | 5.635 | Standard Error of the Mean | 7.696 | 2-Sided | 95 | Superiority |
| Average Pain - Treatment Contrast | ANCOVA | 0.0544 | Mean Difference (Net) | 12.101 | Standard Error of the Mean | 6.017 | 2-Sided | 95 | Superiority |
| Average Emotional Well Being - Treatment Contrast | ANCOVA | 0.5535 | Mean Difference (Net) | 2.333 | Standard Error of the Mean | 3.888 | 2-Sided | 95 | Superiority |
| Average Emotional Well Being - Treatment Contrast | ANCOVA | 0.4642 | Mean Difference (Net) | 3.689 | Standard Error of the Mean | 4.969 | 2-Sided | 95 | Superiority |
| Average Emotional Well Being - Treatment Contrast | ANCOVA | 0.5692 | Mean Difference (Net) | 2.268 | Standard Error of the Mean | 3.936 | 2-Sided | 95 | Superiority |
| Avg. Role Limitations Due to Emotional Problems - Treatment Contrast | ANCOVA | 0.4642 | Median Difference (Net) | 2.667 | Standard Error of the Mean | 3.592 | 2-Sided | 95 | Superiority |
| Avg. Role Limitations Due to Emotional Problems - Treatment Contrast | ANCOVA | 1.0000 | Mean Difference (Net) | 0.000 | Standard Error of the Mean | 4.444 | 2-Sided | 95 | Superiority |
| Avg. Role Limitations Due to Emotional Problems - Treatment Contrast | ANCOVA | 1.0000 | Mean Difference (Net) | 0.000 | Standard Error of the Mean | 3.526 | 2-Sided | 95 | Superiority |
| Change from baseline |
|
| Mean Difference (Net) |
| -0.605 |
| Standard Error of the Mean |
| 0.940 |
| 2-Sided |
| 95 |
| Superiority |
| ANCOVA | 0.5467 | Mean Difference (Net) | -0.403 | Standard Error of the Mean | 0.659 | 2-Sided | 95 | Superiority |