COVID-19 Vaccination
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv), for use as an adjunct to vaccination for COVID-19 in a general population at the time of COVID-19 vaccination.
Detailed description
This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv), for use as an adjunct to vaccination for COVID-19 in a general population at the time of COVID-19 vaccination. Fo and Tv have immunomodulatory properties which may increase antibody titers in response to vaccination more than vaccination alone. However, because they are also immunomodulatory - not purely immune-stimulating - they may have the added benefit of simultaneously decreasing vaccine-related side effects following COVID-19 vaccination. The study aims to establish the safety and feasibility of the use of FoTv vs placebo; evaluate the effect on post-vaccination clinical symptoms and immune response in 45 total subjects.
Interventions
DIETARY_SUPPLEMENTFoTv
Fomitopsis Officinalis and Trametes Versicolor
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Mix model involving two groups and multiple measurements across study time-points
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Scheduled for or planning on scheduling COVID-19 vaccination * Age 18 years and older * Willing to avoid alcohol, cannabis, and dairy products during the study product in-take period. * Capable of documenting vitals, symptoms, and study product intake daily and communicating this information to the study team
Exclusion criteria
* Known liver disease (or diagnosis of cirrhosis) * Known renal disease or acute nephritis. * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| eGFR Normal to Abnormal Transition | 14 days | The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline. |
| AST Normal to Abnormal Transition | 14 days | The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that transitioned to abnormal at Day 14 relative to all participants with normal values at baseline. |
| ALT Normal to Abnormal Transition | 14 days | The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline. |
| ALP Normal to Abnormal Transition | 14 days | The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SARS-CoV-2 Receptor Binding Domain (RBD) | Single-dose vaccine (J&J): days 1, 14, and 28, and 6-months post-vaccination; two-dose vaccine (Pfizer or Moderna): days 1, 14, and 42 (two weeks after second dose), and 6-months post-vaccination; and vaccine booster: days 1, 3, and 14, and 6-months. | higher scores indicate higher levels of RBD levels |
| SARS-CoV-2 Spike Protein (Spike). | Single-dose vaccine (J&J): days 1, 14, and 28, and 6-months post-vaccination; two-dose vaccine (Pfizer or Moderna): days 1, 14, and 42 (two weeks after second dose), and 6-months post-vaccination; and vaccine booster: days 1, 3, and 14, and 6-months. | higher scores indicate higher levels of Spike levels |
| Side-Effect Number | Days, 1, 2, 3, 4, 5 | count of the number of CDC side effects associated with vaccine. higher scores indicate higher number of endorsed side effects. Count of: feeling feverish, low fever in the afternoon, alternating fever and chills, chills, fatigue, muscle aches, nausea, headaches, redness/swelling at injection site, and pain at injection site. The range was from zero to 10. |
| Side-Effect Severity | Days, 1, 2, 3, 4, 5 | Sum of the side effect severities for the CDC side effects associated with vaccine. higher scores indicate higher severity. The side effects included: feeling feverish, low fever in the afternoon, alternating fever and chills, chills, fatigue, muscle aches, nausea, headaches, redness/swelling at injection site, and pain at injection site. The scale for each side effect ranged from zero to 4. The total possible scale was zero to 40. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mushrooms Drug: FoTv The dosage of FoTv is 8 capsules three times a day for 4 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary. Should swallowing capsules be an issue, they can be opened and dispensed into water or juice for easy ingestion.
FoTv: Fomitopsis Officinalis and Trametes Versicolor | 52 |
| Placebo Placebo: organic brown rice The dosage of Placebo is 8 capsules three times a day for 4 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary. Should swallowing capsules be an issue, they can be opened and dispensed into water or juice for easy ingestion.
FoTv: Fomitopsis Officinalis and Trametes Versicolor | 38 |
| Total | 90 |
Baseline characteristics
| Characteristic | Total | Placebo | Mushrooms |
|---|---|---|---|
| Adjusted glomerular filtration rate (Adj. eGFR) Normal | 73 Participants | 35 Participants | 38 Participants |
| Age, Continuous | 39.03 years STANDARD_DEVIATION 15.6 | 33.5 years STANDARD_DEVIATION 13.9 | 43.1 years STANDARD_DEVIATION 15.6 |
| Alanine Transaminase (ALT) Normal | 77 Participants | 34 Participants | 43 Participants |
| Alkaline Phosphatase (ALP) Normal | 88 Participants | 36 Participants | 52 Participants |
| Aspartate Aminotransferase (AST) Normal | 88 participants | 38 participants | 50 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 8 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 67 Participants | 26 Participants | 41 Participants |
| Region of Enrollment United States | 90 participants | 38 participants | 52 participants |
| Sex: Female, Male Female | 52 Participants | 21 Participants | 31 Participants |
| Sex: Female, Male Male | 38 Participants | 17 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 38 |
| other Total, other adverse events | 8 / 52 | 4 / 38 |
| serious Total, serious adverse events | 0 / 52 | 0 / 38 |
Outcome results
Primary
ALP Normal to Abnormal Transition
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Time frame: 14 days
Population: Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded, therefore the number of participants in this analysis is different from the total number of participants in the Mushrooms or Placebo groups described in the study arms/groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mushrooms | ALP Normal to Abnormal Transition | 1.9 % of participants who transitioned |
| Placebo | ALP Normal to Abnormal Transition | 0 % of participants who transitioned |
p-value: 1Chi-squared, Corrected
Primary
ALT Normal to Abnormal Transition
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Time frame: 14 days
Population: Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mushrooms | ALT Normal to Abnormal Transition | 4.7 % of participants who transitioned |
| Placebo | ALT Normal to Abnormal Transition | 5.9 % of participants who transitioned |
p-value: 1Chi-squared, Corrected
Primary
AST Normal to Abnormal Transition
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that transitioned to abnormal at Day 14 relative to all participants with normal values at baseline.
Time frame: 14 days
Population: Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded, therefore the number of participants in this analysis is different from the total number of participants in the Mushrooms or Placebo groups described in the study arms/groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mushrooms | AST Normal to Abnormal Transition | 2.0 % of participants who transitioned |
| Placebo | AST Normal to Abnormal Transition | 2.6 % of participants who transitioned |
p-value: 1Chi-squared, Corrected
Primary
eGFR Normal to Abnormal Transition
The Normal to Abnormal percentage reflects the percentage of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Time frame: 14 days
Population: Number of participants who were normal at baseline. Participants who were abnormal at baseline were excluded, therefore the number of participants in this analysis is different from the total number of participants in the Mushrooms or Placebo groups described in the study arms/groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mushrooms | eGFR Normal to Abnormal Transition | 10.5 % of participants who transitioned |
| Placebo | eGFR Normal to Abnormal Transition | 2.9 % of participants who transitioned |
p-value: 0.359Chi-squared, Corrected
Secondary
SARS-CoV-2 Receptor Binding Domain (RBD)
higher scores indicate higher levels of RBD levels
Time frame: Single-dose vaccine (J&J): days 1, 14, and 28, and 6-months post-vaccination; two-dose vaccine (Pfizer or Moderna): days 1, 14, and 42 (two weeks after second dose), and 6-months post-vaccination; and vaccine booster: days 1, 3, and 14, and 6-months.
Population: Five participants (3 in the Active group and 2 in the Placebo group) had 1 or more antibody test results that were considered outliers, and these participants were excluded from further antibody and side-effect analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | SARS-CoV-2 Receptor Binding Domain (RBD) | 6month | 3209.48933 binding antibody units/mL | Standard Deviation 3720.168648 |
| Mushrooms | SARS-CoV-2 Receptor Binding Domain (RBD) | Day1 | 355.02881 binding antibody units/mL | Standard Deviation 358.066647 |
| Mushrooms | SARS-CoV-2 Receptor Binding Domain (RBD) | Day3 | 541.90950 binding antibody units/mL | Standard Deviation 456.766094 |
| Mushrooms | SARS-CoV-2 Receptor Binding Domain (RBD) | Day14 | 10116.05971 binding antibody units/mL | Standard Deviation 6190.370668 |
| Mushrooms | SARS-CoV-2 Receptor Binding Domain (RBD) | Day28 | 9674.97316 binding antibody units/mL | Standard Deviation 5860.432037 |
| Placebo | SARS-CoV-2 Receptor Binding Domain (RBD) | 6month | 6178.44885 binding antibody units/mL | Standard Deviation 8273.702523 |
| Placebo | SARS-CoV-2 Receptor Binding Domain (RBD) | Day14 | 700.61000 binding antibody units/mL | Standard Deviation 2530.473761 |
| Placebo | SARS-CoV-2 Receptor Binding Domain (RBD) | Day28 | 3953.50332 binding antibody units/mL | Standard Deviation 3460.118026 |
| Placebo | SARS-CoV-2 Receptor Binding Domain (RBD) | Day1 | 1.29801 binding antibody units/mL | Standard Deviation 1.93767 |
| Placebo-Exposed | SARS-CoV-2 Receptor Binding Domain (RBD) | Day1 | 206.22357 binding antibody units/mL | Standard Deviation 188.893233 |
| Placebo-Exposed | SARS-CoV-2 Receptor Binding Domain (RBD) | Day14 | 10052.95574 binding antibody units/mL | Standard Deviation 4834.742085 |
| Placebo-Exposed | SARS-CoV-2 Receptor Binding Domain (RBD) | Day3 | 289.80001 binding antibody units/mL | Standard Deviation 217.354133 |
| Placebo-Exposed | SARS-CoV-2 Receptor Binding Domain (RBD) | Day28 | 10469.33030 binding antibody units/mL | Standard Deviation 3844.263396 |
| Placebo-Exposed | SARS-CoV-2 Receptor Binding Domain (RBD) | 6month | 3398.50612 binding antibody units/mL | Standard Deviation 4093.456937 |
| Placebo-Unexposed | SARS-CoV-2 Receptor Binding Domain (RBD) | 6month | 3359.28725 binding antibody units/mL | Standard Deviation 5108.022295 |
| Placebo-Unexposed | SARS-CoV-2 Receptor Binding Domain (RBD) | Day1 | 1.35671 binding antibody units/mL | Standard Deviation 2.474966 |
| Placebo-Unexposed | SARS-CoV-2 Receptor Binding Domain (RBD) | Day14 | 168.23960 binding antibody units/mL | Standard Deviation 161.993614 |
| Placebo-Unexposed | SARS-CoV-2 Receptor Binding Domain (RBD) | Day28 | 5129.00732 binding antibody units/mL | Standard Deviation 5704.361365 |
Comparison: The LME analysis compared antibodies between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across four time points (days 3, 14, 28, and 6 months). At baseline, participants with detectable anti-CoV-2 antibodies were deemed previously exposed and those with no or very low anti-CoV-2 Abs previously unexposed. Accordingly, all longitudinal analyses excluded baseline antibody data.p-value: 0.002Mixed Models Analysis
Secondary
SARS-CoV-2 Spike Protein (Spike).
higher scores indicate higher levels of Spike levels
Time frame: Single-dose vaccine (J&J): days 1, 14, and 28, and 6-months post-vaccination; two-dose vaccine (Pfizer or Moderna): days 1, 14, and 42 (two weeks after second dose), and 6-months post-vaccination; and vaccine booster: days 1, 3, and 14, and 6-months.
Population: Five participants (3 in the Active group and 2 in the Placebo group) had 1 or more antibody test results that were considered outliers, and these participants were excluded from further antibody and side-effect analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | SARS-CoV-2 Spike Protein (Spike). | Day28 | 3981.34227 binding antibody units/mL | Standard Deviation 1366.702076 |
| Mushrooms | SARS-CoV-2 Spike Protein (Spike). | Day14 | 4488.11297 binding antibody units/mL | Standard Deviation 1542.14135 |
| Mushrooms | SARS-CoV-2 Spike Protein (Spike). | 6month | 1544.40689 binding antibody units/mL | Standard Deviation 1341.873844 |
| Mushrooms | SARS-CoV-2 Spike Protein (Spike). | Day1 | 247.56807 binding antibody units/mL | Standard Deviation 258.452559 |
| Mushrooms | SARS-CoV-2 Spike Protein (Spike). | Day3 | 380.70020 binding antibody units/mL | Standard Deviation 307.487759 |
| Placebo | SARS-CoV-2 Spike Protein (Spike). | Day1 | 0.47756 binding antibody units/mL | Standard Deviation 0.400992 |
| Placebo | SARS-CoV-2 Spike Protein (Spike). | 6month | 2107.24372 binding antibody units/mL | Standard Deviation 2696.389743 |
| Placebo | SARS-CoV-2 Spike Protein (Spike). | Day14 | 392.53283 binding antibody units/mL | Standard Deviation 1047.729456 |
| Placebo | SARS-CoV-2 Spike Protein (Spike). | Day28 | 1958.70983 binding antibody units/mL | Standard Deviation 1542.192284 |
| Placebo-Exposed | SARS-CoV-2 Spike Protein (Spike). | Day1 | 149.40025 binding antibody units/mL | Standard Deviation 119.995872 |
| Placebo-Exposed | SARS-CoV-2 Spike Protein (Spike). | Day3 | 205.36409 binding antibody units/mL | Standard Deviation 143.3426 |
| Placebo-Exposed | SARS-CoV-2 Spike Protein (Spike). | 6month | 1546.52328 binding antibody units/mL | Standard Deviation 1347.920386 |
| Placebo-Exposed | SARS-CoV-2 Spike Protein (Spike). | Day28 | 4719.52003 binding antibody units/mL | Standard Deviation 1192.604423 |
| Placebo-Exposed | SARS-CoV-2 Spike Protein (Spike). | Day14 | 4877.87445 binding antibody units/mL | Standard Deviation 1549.01448 |
| Placebo-Unexposed | SARS-CoV-2 Spike Protein (Spike). | 6month | 1400.07776 binding antibody units/mL | Standard Deviation 1673.265928 |
| Placebo-Unexposed | SARS-CoV-2 Spike Protein (Spike). | Day1 | 0.78453 binding antibody units/mL | Standard Deviation 1.023236 |
| Placebo-Unexposed | SARS-CoV-2 Spike Protein (Spike). | Day14 | 224.88593 binding antibody units/mL | Standard Deviation 242.109014 |
| Placebo-Unexposed | SARS-CoV-2 Spike Protein (Spike). | Day28 | 2383.29307 binding antibody units/mL | Standard Deviation 2275.359574 |
Comparison: LME analysis compared antibodies between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across four time points (days 3, 14, 28, and 6 months). At baseline, participants with detectable anti-CoV-2 antibodies were deemed previously exposed and those with no or very low anti-CoV-2 Abs previously unexposed. Accordingly, all longitudinal analyses excluded baseline antibody data.p-value: 0.002Mixed Models Analysis
Secondary
Side-Effect Number
count of the number of CDC side effects associated with vaccine. higher scores indicate higher number of endorsed side effects. Count of: feeling feverish, low fever in the afternoon, alternating fever and chills, chills, fatigue, muscle aches, nausea, headaches, redness/swelling at injection site, and pain at injection site. The range was from zero to 10.
Time frame: Days, 1, 2, 3, 4, 5
Population: Five participants (3 in the Active group and 2 in the Placebo group) had 1 or more antibody test results that were considered outliers, and these participants were excluded from further antibody and side-effect analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | Side-Effect Number | Day4 | 1.5000 units on a scale | Standard Deviation 2.17747 |
| Mushrooms | Side-Effect Number | Day2 | 2.9333 units on a scale | Standard Deviation 2.36254 |
| Mushrooms | Side-Effect Number | Day5 | 1.0333 units on a scale | Standard Deviation 1.62912 |
| Mushrooms | Side-Effect Number | Day3 | 3.2000 units on a scale | Standard Deviation 2.70886 |
| Mushrooms | Side-Effect Number | Day1 | 0.6333 units on a scale | Standard Deviation 1.73172 |
| Placebo | Side-Effect Number | Day3 | 2.0526 units on a scale | Standard Deviation 2.14667 |
| Placebo | Side-Effect Number | Day4 | 1.0526 units on a scale | Standard Deviation 1.71509 |
| Placebo | Side-Effect Number | Day5 | 0.0526 units on a scale | Standard Deviation 0.22942 |
| Placebo | Side-Effect Number | Day2 | 1.4737 units on a scale | Standard Deviation 1.4737 |
| Placebo | Side-Effect Number | Day1 | 0.2632 units on a scale | Standard Deviation 0.56195 |
| Placebo-Exposed | Side-Effect Number | Day3 | 3.3200 units on a scale | Standard Deviation 2.62552 |
| Placebo-Exposed | Side-Effect Number | Day1 | 0.5200 units on a scale | Standard Deviation 0.77028 |
| Placebo-Exposed | Side-Effect Number | Day2 | 3.2000 units on a scale | Standard Deviation 2.92973 |
| Placebo-Exposed | Side-Effect Number | Day4 | 2.2000 units on a scale | Standard Deviation 2.5658 |
| Placebo-Exposed | Side-Effect Number | Day5 | 0.9200 units on a scale | Standard Deviation 1.55242 |
| Placebo-Unexposed | Side-Effect Number | Day4 | 1.9091 units on a scale | Standard Deviation 1.70027 |
| Placebo-Unexposed | Side-Effect Number | Day2 | 1.2727 units on a scale | Standard Deviation 2.68667 |
| Placebo-Unexposed | Side-Effect Number | Day1 | 0.4545 units on a scale | Standard Deviation 0.52223 |
| Placebo-Unexposed | Side-Effect Number | Day3 | 4.5455 units on a scale | Standard Deviation 3.20511 |
| Placebo-Unexposed | Side-Effect Number | Day5 | 0.6364 units on a scale | Standard Deviation 0.6742 |
Comparison: LME analysis compared symptoms between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across 5 time points (days 1-5)p-value: 0.06Mixed Models Analysis
Secondary
Side-Effect Severity
Sum of the side effect severities for the CDC side effects associated with vaccine. higher scores indicate higher severity. The side effects included: feeling feverish, low fever in the afternoon, alternating fever and chills, chills, fatigue, muscle aches, nausea, headaches, redness/swelling at injection site, and pain at injection site. The scale for each side effect ranged from zero to 4. The total possible scale was zero to 40.
Time frame: Days, 1, 2, 3, 4, 5
Population: Five participants (3 in the Active group and 2 in the Placebo group) had 1 or more antibody test results that were considered outliers, and these participants were excluded from further antibody and side-effect analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mushrooms | Side-Effect Severity | Day4 | 1.5667 units on a scale | Standard Deviation 3.16972 |
| Mushrooms | Side-Effect Severity | Day3 | 4.6667 units on a scale | Standard Deviation 5.93257 |
| Mushrooms | Side-Effect Severity | Day1 | 1.0333 units on a scale | Standard Deviation 3.068 |
| Mushrooms | Side-Effect Severity | Day5 | 0.9333 units on a scale | Standard Deviation 1.70057 |
| Mushrooms | Side-Effect Severity | Day2 | 3.7600 units on a scale | Standard Deviation 3.53883 |
| Placebo | Side-Effect Severity | Day2 | 2.4000 units on a scale | Standard Deviation 5.34255 |
| Placebo | Side-Effect Severity | Day4 | 0.7895 units on a scale | Standard Deviation 1.43678 |
| Placebo | Side-Effect Severity | Day3 | 2.0000 units on a scale | Standard Deviation 4.01386 |
| Placebo | Side-Effect Severity | Day5 | 0.0526 units on a scale | Standard Deviation 0.22942 |
| Placebo | Side-Effect Severity | Day1 | 0.2632 units on a scale | Standard Deviation 0.56195 |
| Placebo-Exposed | Side-Effect Severity | Day5 | 1.2400 units on a scale | Standard Deviation 2.61852 |
| Placebo-Exposed | Side-Effect Severity | Day1 | 0.6800 units on a scale | Standard Deviation 1.14455 |
| Placebo-Exposed | Side-Effect Severity | Day2 | 7.0000 units on a scale | Standard Deviation 7.0852 |
| Placebo-Exposed | Side-Effect Severity | Day3 | 5.6400 units on a scale | Standard Deviation 5.38424 |
| Placebo-Exposed | Side-Effect Severity | Day4 | 3.5600 units on a scale | Standard Deviation 5.49303 |
| Placebo-Unexposed | Side-Effect Severity | Day2 | 4.0000 units on a scale | Standard Deviation 7.12741 |
| Placebo-Unexposed | Side-Effect Severity | Day1 | 0.4545 units on a scale | Standard Deviation 0.52223 |
| Placebo-Unexposed | Side-Effect Severity | Day5 | 0.9091 units on a scale | Standard Deviation 1.22103 |
| Placebo-Unexposed | Side-Effect Severity | Day4 | 2.5455 units on a scale | Standard Deviation 2.84125 |
| Placebo-Unexposed | Side-Effect Severity | Day3 | 8.3636 units on a scale | Standard Deviation 8.88001 |
p-value: 0.326Mixed Models Analysis