Trial Outcomes & Findings for A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs Against COVID-19. (NCT NCT04348435)

NCT ID: NCT04348435

Last Updated: 2025-09-26

Results Overview

Number of subjects that were hospitalized due to COVID-19 symptoms during the conduct of this study.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 53 participants
• Primary outcome timeframe: Week 0 through Week 26 (End of Study)
• Results posted on: 2025-09-26

Participant Flow

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.

A total of 84 subjects were assessed for screening, out of which only 53 were enrolled and 31 were screen failed.

Participant milestones

Measure	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	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	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	Placebo Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Placebos: Saline
Overall Study STARTED	19	9	12	13
Overall Study COMPLETED	11	5	9	10
Overall Study NOT COMPLETED	8	4	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs Against COVID-19.

Baseline characteristics by cohort

Measure	Allogeneic HB-adMSCs 200MM n=19 Participants 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	Allogeneic HB-adMSCs 100MM n=9 Participants 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	Allogeneic HB-adMSCs 50MM n=12 Participants 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	Placebo n=13 Participants 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	Total n=53 Participants Total of all reporting groups
Age, Continuous	45.8 years STANDARD_DEVIATION 13.34 • n=5 Participants	47.6 years STANDARD_DEVIATION 9.65 • n=7 Participants	43.9 years STANDARD_DEVIATION 12.38 • n=5 Participants	42.8 years STANDARD_DEVIATION 9.97 • n=4 Participants	44.9 years STANDARD_DEVIATION 11.58 • n=21 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	30 Participants n=21 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	23 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	11 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	9 Participants n=4 Participants	42 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	10 Participants n=4 Participants	38 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	19 participants n=5 Participants	9 participants n=7 Participants	12 participants n=5 Participants	13 participants n=4 Participants	53 participants n=21 Participants
Height	172.05 cm STANDARD_DEVIATION 10.18 • n=5 Participants	167.35 cm STANDARD_DEVIATION 11.60 • n=7 Participants	168.38 cm STANDARD_DEVIATION 8.70 • n=5 Participants	171.54 cm STANDARD_DEVIATION 11.66 • n=4 Participants	170.30 cm STANDARD_DEVIATION 10.39 • n=21 Participants
Body Weight	93.132 kg STANDARD_DEVIATION 29.12 • n=5 Participants	85.982 kg STANDARD_DEVIATION 26.72 • n=7 Participants	78.662 kg STANDARD_DEVIATION 14.69 • n=5 Participants	79.763 kg STANDARD_DEVIATION 23.51 • n=4 Participants	85.362 kg STANDARD_DEVIATION 24.84 • n=21 Participants
BMI	31.14 kg/m^2 STANDARD_DEVIATION 8.426 • n=5 Participants	30.18 kg/m^2 STANDARD_DEVIATION 6.271 • n=7 Participants	27.61 kg/m^2 STANDARD_DEVIATION 3.946 • n=5 Participants	26.83 kg/m^2 STANDARD_DEVIATION 6.606 • n=4 Participants	29.12 kg/m^2 STANDARD_DEVIATION 6.893 • n=21 Participants

PRIMARY outcome

Timeframe: Week 0 through Week 26 (End of Study)

Population: A total of 37 subjects completed all 5 infusions.

Number of subjects that were hospitalized due to COVID-19 symptoms during the conduct of this study.

Outcome measures

Measure	Allogeneic HB-adMSCs 200MM n=13 Participants 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	Allogeneic HB-adMSCs 100MM n=5 Participants 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	Allogeneic HB-adMSCs 50MM n=10 Participants 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	Placebo n=9 Participants Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Placebos: Saline
Number of Participants That Were Hospitalized Due to COVID-19 Symptoms Number of Subjects that were Hospitalized due to COVID-19 Symptoms	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants That Were Hospitalized Due to COVID-19 Symptoms Number of Subjects that were not Hospitalized due to COVID-19 Symptoms	13 Participants	5 Participants	10 Participants	9 Participants

PRIMARY outcome

Timeframe: Week 0 through Week 26 (End of Study)

Population: A total of 37 subjects who completed all 5 infusions.

Number of subjects who experience symptoms defined to be associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough, etc.

Outcome measures

Measure	Allogeneic HB-adMSCs 200MM n=13 Participants 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	Allogeneic HB-adMSCs 100MM n=5 Participants 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	Allogeneic HB-adMSCs 50MM n=10 Participants 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	Placebo n=9 Participants Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Placebos: Saline
Number of Participants That Had Symptoms Associated With COVID-19 Number of Subjects with Incidence of COVID-19 Symptoms	4 Participants	0 Participants	0 Participants	0 Participants
Number of Participants That Had Symptoms Associated With COVID-19 Number of Subjects with No Incidence of COVID-19 Symptoms	9 Participants	5 Participants	10 Participants	9 Participants

SECONDARY outcome

Timeframe: Week 0 to Week 26 (End of Study)

Population: Number of subjects contributing to analysis.

Change from baseline in Leukocyte Differential Count

Outcome measures

Measure	Allogeneic HB-adMSCs 200MM n=11 Participants 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	Allogeneic HB-adMSCs 100MM n=4 Participants 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	Allogeneic HB-adMSCs 50MM n=6 Participants 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	Placebo n=6 Participants Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Placebos: Saline
Leukocyte Differential Count LSMeans	6.204 Leukocytes (x10^9/L) Standard Error 0.296	5.518 Leukocytes (x10^9/L) Standard Error 0.502	6.029 Leukocytes (x10^9/L) Standard Error 0.393	5.951 Leukocytes (x10^9/L) Standard Error 0.392
Leukocyte Differential Count Change from baseline	0.508 Leukocytes (x10^9/L) Standard Error 0.296	-0.179 Leukocytes (x10^9/L) Standard Error 0.502	0.333 Leukocytes (x10^9/L) Standard Error 0.393	0.255 Leukocytes (x10^9/L) Standard Error 0.392

SECONDARY outcome

Timeframe: Week 0 through Week 26 (End of Study)

Population: Number of subjects contributing to analysis.

Change from baseline in C Reactive Protein

Outcome measures

Measure	Allogeneic HB-adMSCs 200MM n=11 Participants 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	Allogeneic HB-adMSCs 100MM n=4 Participants 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	Allogeneic HB-adMSCs 50MM n=6 Participants 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	Placebo n=6 Participants Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Placebos: Saline
C Reactive Protein LSMeans	2.424 mg/L Standard Error 0.632	1.759 mg/L Standard Error 1.047	2.679 mg/L Standard Error 0.846	2.671 mg/L Standard Error 0.843
C Reactive Protein Change from baseline	-0.609 mg/L Standard Error 0.632	-1.275 mg/L Standard Error 1.047	-0.354 mg/L Standard Error 0.846	-0.362 mg/L Standard Error 0.843

SECONDARY outcome

Timeframe: Week 0 through Week 26 (End of Study)

Population: Number of subjects contributing to analysis.

Change from baseline in TNF alpha

Outcome measures

Measure	Allogeneic HB-adMSCs 200MM n=11 Participants 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	Allogeneic HB-adMSCs 100MM n=4 Participants 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	Allogeneic HB-adMSCs 50MM n=6 Participants 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	Placebo n=6 Participants Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Placebos: Saline
Tumor Necrosis Factor - Alpha LSMeans	1.175 ng/L Standard Error 0.091	0.951 ng/L Standard Error 0.150	1.173 ng/L Standard Error 0.123	0.996 ng/L Standard Error 0.124
Tumor Necrosis Factor - Alpha Change from baseline	-0.316 ng/L Standard Error 0.091	-0.540 ng/L Standard Error 0.150	-0.318 ng/L Standard Error 0.123	-0.495 ng/L Standard Error 0.124

SECONDARY outcome

Timeframe: Week 0 through Week 26 (End of Study)

Population: Number of subjects contributing to analysis.

Change from baseline in IL-6

Outcome measures

Measure	Allogeneic HB-adMSCs 200MM n=11 Participants 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	Allogeneic HB-adMSCs 100MM n=4 Participants 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	Allogeneic HB-adMSCs 50MM n=6 Participants 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	Placebo n=6 Participants Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Placebos: Saline
Interleukin 6 LSMeans	1.620 ng/L Standard Error 0.040	1.620 ng/L Standard Error 0.065	1.732 ng/L Standard Error 0.053	1.620 ng/L Standard Error 0.056
Interleukin 6 Change from baseline	-0.019 ng/L Standard Error 0.040	-0.019 ng/L Standard Error 0.065	0.092 ng/L Standard Error 0.053	-0.019 ng/L Standard Error 0.056

SECONDARY outcome

Timeframe: Week 0 through Week 26 (End of Study)

Population: Number of subjects contributing to analysis.

Change from baseline in IL-10

Outcome measures

Measure	Allogeneic HB-adMSCs 200MM n=11 Participants 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	Allogeneic HB-adMSCs 100MM n=4 Participants 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	Allogeneic HB-adMSCs 50MM n=6 Participants 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	Placebo n=6 Participants Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Placebos: Saline
Interleukin 10 LSMeans	0.768 ng/L Standard Error 0.054	0.680 ng/L Standard Error 0.089	0.680 ng/L Standard Error 0.073	0.688 ng/L Standard Error 0.073
Interleukin 10 Change from baseline	0.088 ng/L Standard Error 0.054	0.000 ng/L Standard Error 0.089	0.000 ng/L Standard Error 0.073	0.008 ng/L Standard Error 0.073

SECONDARY outcome

Timeframe: Week 0 to Week 26 (End of Study)

Population: Number of subjects contributing to analysis.

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.

Outcome measures

Measure	Allogeneic HB-adMSCs 200MM n=11 Participants 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	Allogeneic HB-adMSCs 100MM n=4 Participants 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	Allogeneic HB-adMSCs 50MM n=9 Participants 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	Placebo n=8 Participants Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Placebos: Saline
Short Form-36 (SF-36) Average Energy/Fatigue	68.858 Score on a Scale Standard Error 5.139	78.346 Score on a Scale Standard Error 7.672	75.849 Score on a Scale Standard Error 5.125	69.567 Score on a Scale Standard Error 5.826
Short Form-36 (SF-36) Average Energy/Fatigue - Change from baseline	7.140 Score on a Scale Standard Error 5.139	16.628 Score on a Scale Standard Error 7.672	14.130 Score on a Scale Standard Error 5.125	7.848 Score on a Scale Standard Error 5.826
Short Form-36 (SF-36) Average Social Functioning	98.950 Score on a Scale Standard Error 2.190	90.711 Score on a Scale Standard Error 3.556	99.864 Score on a Scale Standard Error 2.503	98.430 Score on a Scale Standard Error 2.484
Short Form-36 (SF-36) Average Social Functioning - Change from baseline	7.153 Score on a Scale Standard Error 2.190	-1.086 Score on a Scale Standard Error 3.556	8.067 Score on a Scale Standard Error 2.503	6.633 Score on a Scale Standard Error 2.484
Short Form-36 (SF-36) Avg. Role Limitations Due to Physical Health	94.711 Score on a Scale Standard Error 2.326	100.00 Score on a Scale Standard Error 4.393	98.727 Score on a Scale Standard Error 2.587	98.831 Score on a Scale Standard Error 2.737
Short Form-36 (SF-36) Avg. Role Limitations Due to Physical Health - Change from baseline	1.742 Score on a Scale Standard Error 2.326	14.280 Score on a Scale Standard Error 4.393	5.758 Score on a Scale Standard Error 2.587	5.862 Score on a Scale Standard Error 2.737
Short Form-36 (SF-36) Average General Health	76.481 Score on a Scale Standard Error 3.818	78.857 Score on a Scale Standard Error 6.274	81.016 Score on a Scale Standard Error 4.196	75.518 Score on a Scale Standard Error 4.454
Short Form-36 (SF-36) Average General Health - Change from baseline	1.481 Score on a Scale Standard Error 3.818	3.857 Score on a Scale Standard Error 6.274	6.016 Score on a Scale Standard Error 4.196	0.518 Score on a Scale Standard Error 4.454
Short Form-36 (SF-36) Average Physical Functioning	92.361 Score on a Scale Standard Error 2.660	96.806 Score on a Scale Standard Error 4.420	93.598 Score on a Scale Standard Error 2.939	89.928 Score on a Scale Standard Error 3.123
Short Form-36 (SF-36) Average Physical Functioning - Change from baseline	1.267 Score on a Scale Standard Error 2.660	5.712 Score on a Scale Standard Error 4.420	2.504 Score on a Scale Standard Error 2.939	-1.166 Score on a Scale Standard Error 3.123
Short Form-36 (SF-36) Average Pain	90.744 Score on a Scale Standard Error 3.746	84.700 Score on a Scale Standard Error 6.291	91.166 Score on a Scale Standard Error 4.124	79.065 Score on a Scale Standard Error 4.377
Short Form-36 (SF-36) Average Pain - Change from baseline	11.212 Score on a Scale Standard Error 3.746	5.169 Score on a Scale Standard Error 6.291	11.635 Score on a Scale Standard Error 4.124	-0.466 Score on a Scale Standard Error 4.377
Short Form-36 (SF-36) Average Emotional Well Being	87.057 Score on a Scale Standard Error 2.566	88.413 Score on a Scale Standard Error 4.096	86.992 Score on a Scale Standard Error 2.739	84.724 Score on a Scale Standard Error 2.863
Short Form-36 (SF-36) Average Emotional Well Being - Change from baseline	4.057 Score on a Scale Standard Error 2.566	5.413 Score on a Scale Standard Error 4.096	3.992 Score on a Scale Standard Error 2.739	1.724 Score on a Scale Standard Error 2.863
Short Form-36 (SF-36) Avg. Role Limitations Due to Emotional Problems	99.667 Score on a Scale Standard Error 2.334	97.000 Score on a Scale Standard Error 3.654	97.000 Score on a Scale Standard Error 2.456	97.000 Score on a Scale Standard Error 2.601
Short Form-36 (SF-36) Avg. Role Limitations Due to Emotional Problems - Change from baseline	3.833 Score on a Scale Standard Error 2.334	1.166 Score on a Scale Standard Error 3.654	1.166 Score on a Scale Standard Error 2.456	1.166 Score on a Scale Standard Error 2.601

SECONDARY outcome

Timeframe: Week 0 to Week 26 (End of Study)

Population: Number of subjects contributing to analysis.

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.

Outcome measures

Measure	Allogeneic HB-adMSCs 200MM n=11 Participants 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	Allogeneic HB-adMSCs 100MM n=3 Participants 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	Allogeneic HB-adMSCs 50MM n=9 Participants 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	Placebo n=8 Participants Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Placebos: Saline
Patient Health Questionnaire (PHQ-9) Scores LSMeans	1.373 Score on a Scale Standard Error 0.489	0.912 Score on a Scale Standard Error 0.763	1.114 Score on a Scale Standard Error 0.456	1.517 Score on a Scale Standard Error 0.538
Patient Health Questionnaire (PHQ-9) Scores Change from baseline	-1.111 Score on a Scale Standard Error 0.489	-1.572 Score on a Scale Standard Error 0.763	-1.370 Score on a Scale Standard Error 0.456	-0.967 Score on a Scale Standard Error 0.538

Adverse Events

Allogeneic HB-adMSCs 200MM

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Allogeneic HB-adMSCs 100MM

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Allogeneic HB-adMSCs 50MM

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Allogeneic HB-adMSCs 200MM n=19 participants at risk 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	Allogeneic HB-adMSCs 100MM n=9 participants at risk 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	Allogeneic HB-adMSCs 50MM n=12 participants at risk 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	Placebo n=13 participants at risk Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Placebos: Saline
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/19 • 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.	11.1% 1/9 • Number of events 1 • 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.	0.00% 0/12 • 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.	15.4% 2/13 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders Back pain	5.3% 1/19 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	7.7% 1/13 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Muscle fatigue	10.5% 2/19 • Number of events 5 • 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.	11.1% 1/9 • Number of events 1 • 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.	16.7% 2/12 • Number of events 2 • 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.	53.8% 7/13 • Number of events 15 • 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.
Musculoskeletal and connective tissue disorders Myalgia	15.8% 3/19 • Number of events 3 • 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.	11.1% 1/9 • Number of events 2 • 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.	8.3% 1/12 • Number of events 3 • 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.	0.00% 0/13 • 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.
Musculoskeletal and connective tissue disorders Joint swelling	5.3% 1/19 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	0.00% 0/13 • 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.
Musculoskeletal and connective tissue disorders Muscle rigidity	5.3% 1/19 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	0.00% 0/13 • 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.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/19 • 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.	11.1% 1/9 • Number of events 1 • 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.	0.00% 0/12 • 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.	0.00% 0/13 • 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.
Nervous system disorders Headache	42.1% 8/19 • Number of events 14 • 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.	22.2% 2/9 • Number of events 3 • 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.	25.0% 3/12 • Number of events 4 • 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.	30.8% 4/13 • Number of events 6 • 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.
Nervous system disorders Anosmia	5.3% 1/19 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	7.7% 1/13 • Number of events 1 • 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.
Nervous system disorders Dizziness	5.3% 1/19 • Number of events 2 • 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.	11.1% 1/9 • Number of events 1 • 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.	0.00% 0/12 • 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.	0.00% 0/13 • 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.
Nervous system disorders Ageusia	5.3% 1/19 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	0.00% 0/13 • 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.
Nervous system disorders Hypoaesthesia	0.00% 0/19 • 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.	0.00% 0/9 • 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.	8.3% 1/12 • Number of events 1 • 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.	0.00% 0/13 • 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.
Nervous system disorders Paresthesia	5.3% 1/19 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	0.00% 0/13 • 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.
Nervous system disorders Somnolence	0.00% 0/19 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	7.7% 1/13 • Number of events 3 • 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.
General disorders Influenza like illness	47.4% 9/19 • Number of events 16 • 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.	22.2% 2/9 • Number of events 4 • 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.	0.00% 0/12 • 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.	38.5% 5/13 • Number of events 10 • 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.
General disorders Fatigue	5.3% 1/19 • Number of events 2 • 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.	11.1% 1/9 • Number of events 1 • 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.	0.00% 0/12 • 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.	0.00% 0/13 • 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.
General disorders Pain	0.00% 0/19 • 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.	0.00% 0/9 • 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.	8.3% 1/12 • Number of events 1 • 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.	0.00% 0/13 • 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.
General disorders Pyrexia	5.3% 1/19 • Number of events 2 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	0.00% 0/13 • 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.
Gastrointestinal disorders Nausea	10.5% 2/19 • Number of events 2 • 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.	11.1% 1/9 • Number of events 1 • 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.	0.00% 0/12 • 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.	7.7% 1/13 • Number of events 1 • 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.
Gastrointestinal disorders Diarrhea	0.00% 0/19 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	7.7% 1/13 • Number of events 1 • 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.
Gastrointestinal disorders Salivary hyper-secretion	0.00% 0/19 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	7.7% 1/13 • Number of events 1 • 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.
Infections and infestations Corona virus Infection	5.3% 1/19 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	7.7% 1/13 • Number of events 1 • 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.
Infections and infestations Cellulitis	0.00% 0/19 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	7.7% 1/13 • Number of events 1 • 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.
Infections and infestations Urinary tract infection	0.00% 0/19 • 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.	0.00% 0/9 • 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.	8.3% 1/12 • Number of events 1 • 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.	0.00% 0/13 • 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.
Ear and labyrinth disorders Vertigo	5.3% 1/19 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	7.7% 1/13 • Number of events 1 • 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.
Eye disorders Visual impairment	10.5% 2/19 • Number of events 4 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	0.00% 0/13 • 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.
Injury, poisoning and procedural complications Back injury	5.3% 1/19 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	0.00% 0/13 • 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.
Injury, poisoning and procedural complications Fracture	0.00% 0/19 • 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.	0.00% 0/9 • 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.	8.3% 1/12 • Number of events 1 • 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.	0.00% 0/13 • 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.
Surgical and medical procedures Appendicectomy	0.00% 0/19 • 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.	0.00% 0/9 • 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.	8.3% 1/12 • Number of events 1 • 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.	0.00% 0/13 • 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.
Surgical and medical procedures Rotator cuff repair	0.00% 0/19 • 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.	0.00% 0/9 • 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.	8.3% 1/12 • Number of events 1 • 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.	0.00% 0/13 • 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.
Blood and lymphatic system disorders Leukocytosis	5.3% 1/19 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	0.00% 0/13 • 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.
Cardiac disorders Atrial fibrillation	5.3% 1/19 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	0.00% 0/13 • 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.
Investigations Blood pressure increased	0.00% 0/19 • 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.	11.1% 1/9 • Number of events 1 • 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.	0.00% 0/12 • 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.	0.00% 0/13 • 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.
Renal and urinary disorders Pollakiuria	0.00% 0/19 • 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.	11.1% 1/9 • Number of events 1 • 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.	0.00% 0/12 • 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.	0.00% 0/13 • 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.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/19 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	7.7% 1/13 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/19 • 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.	0.00% 0/9 • 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.	0.00% 0/12 • 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.	7.7% 1/13 • Number of events 1 • 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.

Additional Information

Ridhima Vij, PhD

Hope Biosciences Stem Cell Research Foundation

Phone: 346-900-0340

Email: ridhima@hopebio.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place