Myalgia, Neuralgia
Conditions
Keywords
Copper, nicotinic acid, energy, strength, fatigue, nerve pain, muscle pain, neuralgia, myalgia
Brief summary
Male and female participants were selected based on chronic neuromuscular pain. Patients were instructed to take two doses of the placebo or cuprous nicotinic acid chelate Cunermusmir twice a day for 28 days. Hypothesis: Cunermuspir would improve quality of life as determined by several questionnaires.
Detailed description
A total of 72 subjects were consented and screened, with 56 subjects (28 males and 28 female) being eligible to participate in the study. Fifty-six subjects with muscle/nerve pain were randomized at a ratio of 1:1 to one of two treatment groups. To evaluate primary and secondary objectives, study assessments were conducted at Baseline, and Day 28 ± 2. The Individualized Neuromuscular Quality of Life Questionnaire (INQoL), Symptom Impact Questionnaire (SQIR), Mini-Mental State Examination (MMSE) were completed by participants to assess physical function, pain, fatigue/energy and cognitive function.
Interventions
DRUGCunermuspir
Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide
OTHERPlacebo
same non-medical ingredients and encapsulation as Intervention 1
Sponsors
Mitosynergy LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The investigational product bottles were labeled according to the requirements of ICH--GCP guidelines and applicable local regulatory guidelines. Investigational products were coded by the unblinded personnel at KGK Synergize who were not involved in the collecting or analyzing of study data. Each package contained a similar label differing only in randomization number.
Intervention model description
randomized, double--blind, placebo controlled, parallel study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female age 18-75 * If female, subject is not of child bearing potential. Defined as females who have * had a hysterectomy or oophorectomy. * bilateral tubal ligation or are post-menopausal (natural or surgically with \> 1 year since last menstruation). * Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo--Provera, Lunelle), or hormone implant (Norplant System), Intrauterine devices, Vasectomy of partner, Total Abstinence * Subject has unresolved persistent muscle or nerve pain (muscle or nerve pain population) * Subjects using other therapies for nerve/muscle pain (e.g., exercise, TENS, acupuncture, exercise, psychotherapy, massage, physiotherapy, etc), must be used at a stable schedule for 1 month prior to the trial and subject agrees to continue these therapies at the same schedule during the trial avoiding changes in frequency or intensity and to record therapies in the study diary * Agrees to comply with study procedures * Has given voluntary, written, informed consent to participate in * the study
Exclusion criteria
* Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial * Planned surgery during the course of the trial * Use of prescription drugs for fibromyalgia or nerve pain (e.g.Lyrica, Cymbalta and Savella and others). * Use of prescription medications for depression, anxiety or other mental disorders * Requires the use of prescription drugs to control pain (other than provided rescue medication) * Use of oral or topical prescription or over the counter medications or natural health products for pain relief 3 days prior to randomization and during the trial (other than provided rescue medication) * Use of natural health products including vitamins and minerals within 3 days prior to randomization and during the trial * Use of blood thinning medications (e.g. warfarin) * Chronic lyme disease or chronic parasitic infections * Uncontrolled hypertension defined as untreated systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg * Subjects with diabetes * History of bleeding disorders, or significant blood loss in the past 3 months * Alcohol use \>2 standard alcoholic drinks per day and/or alcohol or drug abuse within the past year * Allergy or sensitivity to study supplement ingredients or acetaminophen * Participation in a clinical research trial within 30 days prior to randomization * Individuals who are cognitively impaired and/or who are unable to give informed consent * Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuromuscular Symptoms | baseline and 28 days after enrollment | Quality of life was assessed by using the Individualized Neuromuscular Quality of Life Questionnaire (INQoL) Answers to symptom questions are scored from 0 to 6 or 7 with 0 being none at all and and 6 to 7 being an extreme amount There are three questions regarding pain. The pain score is (a+b+c)/19 x100. The higher the score, the greater the symptom impact. |
| Platelet ATP | baseline and 28 days after enrollment | Platelet ATP levels were measured as previously published in the literature. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | baseline and 28 days after enrollment | heart rate is measured in beats per minute |
| Diastolic Blood Pressure | baseline and 28 days after enrollment | The diastolic blood pressure was measured in mm Hg |
| Systolic Blood Pressure | baseline and 28 days after enrollment. | Systolic blood pressure was measured in mm Hg |
| Hemoglobin | baseline and 28 days after enrollment. | changes measured in g/L blood |
| Hematocrit | baseline and 28 days after enrollment | changes in the fraction of whole blood occupied by red blood cells measured as L/L |
| WBC | baseline and 28 days after enrollment | changes in white blood cells (WBC) measured in units of 10\^9 per liter blood |
| RBC | baseline and 28 days after enrollment | changes in red blood cells (RBC) measured in units of 10\^12 per liter blood |
| MCV | baseline and 28 days after enrollment | changes in mean corpuscular volume (MCV) measured in units of fL |
| MCH | baseline and 28 days after enrollment | changes in mean corpuscular hemoglobin, measured in units of pg, the average amount of hemoglobin in a single RBC |
| MCHC | baseline and 28 days after enrollment | mean corpuscular hemoglobin concentration is the concentration of hemoglobin in a single RBC measured in units of g/L |
| RDW | baseline and 28 days after enrollment | changes in the RBC distribution width (RDW) are reported in units of percentage (%) |
| Platelets | baseline and 28 days after enrollment | changes in the platelet counts are reported in units of 10\^9 per liter blood |
| Neutrophils | baseline and 28 days after enrollment | changes in neutrophils are reported in units of 10\^9 per liter blood |
| Lymphocyte | baseline and 28 days after enrollment | changes in lymphocytes are reported in units of 10\^9 per liter blood |
| Monocyte | baseline and 28 days after enrollment | changes in monocytes are reported in units of 10\^9 per liter blood |
| Household Chores and Neuro Muscular Sumptoms | baseline and 28 days after enrollment | Physical function in performing household chores was assessed using the Revised Symptom Impact Questionnaire (SQIR) For each household chore participants are asked to check 1 of 11 boxes between no difficulty and extremely difficult No difficulty is scored as 0 and extreme difficulty with the task is scored as 10. The higher the score, the more difficulty experienced performing the chore. Friend & Bennett Arthritis Res & Therapy 2011. Household chores are just one module with 9 questions for a maximum of 90 points. These scores are summed and divided by 3. Module 2 relates to the emotional impact with only two questions for a total of 20 points. Module 3 relates to physical symptoms with a total of ten questions worth a maximum of 100 points. This score is divided by 2. The three modules are summed for a total impact score of 100 points. A score of 0 indicates absolutely no impact and a score of 100 the greatest possible impact. |
| Basophil | baseline and 28 days after enrollment | changes in basophils are reported in units of 10\^9 cells per liter blood |
| NLR | baseline and 28 days after enrollment | Changes in the neutrophil to lymphocyte ratio (NLR) are reported as a dimensionless fraction of 1 |
| Glucose | baseline and 28 days after enrollment | changes in blood glucose are reported in units of mmol per liter |
| Urea | baseline and 28 days after enrollment | changes in renal function as measured by blood urea are reported in units of mmol per liter |
| Creatinine | baseline and 28 days after enrollment | changes in creatinine are reported in units of micromol per liter |
| eGFR | baseline and 28 days after enrollment | changes in the estimated glomerular filtration rate (eGFR) are reported in units of mL/min/1.73m\^2 |
| Sodium | baseline and 28 days after enrollment | changes in plasma sodium are reported in units of mmol per liter, reference range is 133-146 mEq/L, same as mM/L bloodbook.com |
| Potassium | baseline and 28 days after enrollment | changes in plasma potassium are reported in units of mmol per liter, reference value 3.5-5.4 mmol per liter, bloodbook.com |
| Chloride | baseline and 28 days after enrollment | changes in plasma chloride are reported in uits of mmol per liter The reference range is 98-106 mmol per liter, bloodbook.com |
| Bilirubin | baseline and 28 days after enrollment | changes in total bilirubin are reported in units of micro moles per liter. Direct: up to 0.4 mg/dL, Total: up to 1.0 mg/dL bloodbook.com, Converts to 6.84-17.1 micro moles per liter. https://unitslab.com/node/37 |
| ALT | baseline and 28 days after enrollment | changes in the liver enzyme alanine aminotransferase (ALT) in the blood are reported as units per liter Reference range 1 - 21 units/L bloodbook.com |
| AST | baseline and 28 days after enrollment | changes in the liver enzyme aspartate aminotransferase (AST) in the blood are reported as units per liter Reference range 7 - 27 units/L bloodbook.com |
| GGT | baseline and 28 days after enrollment | changes in the liver enzyme gamma-glutamyl transferase in the blood are reported as units per liter |
| Copper | baseline and 28 days after enrollment | changes in copper concentration in the blood are reported in units of micro moles per liter |
| Eosinophil | baseline and 28 days after enrollment | changes in eosinophils are reported in units of 10\^9 cells per liter blood |
| Cognition | baseline and 28 days after enrollment | Cognition is the mental process of knowing, including aspects such as awareness, perception, reasoning, and judgment. The mini-mental state exam (MMSE) puts a number to cognition. Any score of 24 or more out of a total 30 points is considered normal cognition. A test taker may be asked to orientate in space and time by recalling aspects of the physical location as well as month, day, year, and perhaps season. Simple mathematical calculations like counting backwards from 100 by seven may also be included. A complex command such as redrawing geometric figures scores six points in this exam. Since none of the participates were cognitively impaired, the investigators decided to make obtaining a perfect score on this exam an outcome measure. |
Countries
Canada
Participant flow
Recruitment details
A total of 56 met the enrollment requirements. Of these only 49 completed the study
Participants by arm
| Arm | Count |
|---|---|
| Cunermuspir Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.
Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:
Organic evaporated cane juice powder, hypromellose, titanium dioxide | 28 |
| Placebo Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm
Placebo: same non-medical ingredients and encapsulation as Intervention 1 | 28 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | failure to complete questionnaire | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Cunermuspir | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 27 Participants | 55 Participants |
| Age, Continuous | 48.2 years STANDARD_DEVIATION 10.4 | 45.4 years STANDARD_DEVIATION 13.6 | 46.8 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment Canada | 28 participants | 28 participants | 56 participants |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 28 Participants |
| Sex: Female, Male Male | 13 Participants | 15 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 6 / 26 | 7 / 27 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Neuromuscular Symptoms
Quality of life was assessed by using the Individualized Neuromuscular Quality of Life Questionnaire (INQoL) Answers to symptom questions are scored from 0 to 6 or 7 with 0 being none at all and and 6 to 7 being an extreme amount There are three questions regarding pain. The pain score is (a+b+c)/19 x100. The higher the score, the greater the symptom impact.
Time frame: baseline and 28 days after enrollment
Population: Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Neuromuscular Symptoms | baseline | 36.5 score on a scale | Standard Error 16.4 |
| Cunermuspir | Neuromuscular Symptoms | Day 28 | 28.5 score on a scale | Standard Error 18.6 |
| Placebo | Neuromuscular Symptoms | baseline | 43.5 score on a scale | Standard Error 21.1 |
| Placebo | Neuromuscular Symptoms | Day 28 | 32.7 score on a scale | Standard Error 23 |
p-value: <0.01t-test, 2 sided
Comparison: test of the hypothesis that the score on day 28 is different than the baseline scorep-value: 0.01t-test, 2 sided
Primary
Platelet ATP
Platelet ATP levels were measured as previously published in the literature.
Time frame: baseline and 28 days after enrollment
Population: ATP isolated from platelets. Some samples were not used for analysis due to contamination with red blood cells.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Platelet ATP | baseline | 43.6 nmol / E9 Platelets | Standard Deviation 16.4 |
| Cunermuspir | Platelet ATP | day 28 | 59.2 nmol / E9 Platelets | Standard Deviation 20.1 |
| Placebo | Platelet ATP | baseline | 42 nmol / E9 Platelets | Standard Deviation 13.1 |
| Placebo | Platelet ATP | day 28 | 51.2 nmol / E9 Platelets | Standard Deviation 15 |
Comparison: Day 28. Between group comparison was made using ANCOVA accounting for baseline values, no significance at p\<0.05. Within group comparisons were made using the paired Student's t test.p-value: 0.15t-test, 2 sided
Secondary
ALT
changes in the liver enzyme alanine aminotransferase (ALT) in the blood are reported as units per liter Reference range 1 - 21 units/L bloodbook.com
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | ALT | baseline | 27.6 U/L | Standard Error 12.8 |
| Cunermuspir | ALT | day 28 | 28.2 U/L | Standard Error 15.5 |
| Placebo | ALT | baseline | 28.5 U/L | Standard Error 16.3 |
| Placebo | ALT | day 28 | 28.4 U/L | Standard Error 15.4 |
p-value: 0.95Wilcoxon (Mann-Whitney)
Comparison: comparison between baseline and day 28 values in Cunermuspir groupp-value: 0.4Wilcoxon (Mann-Whitney)
Comparison: comparison between baseline and day 28 values for the Placebo Armp-value: 0.8Wilcoxon (Mann-Whitney)
Secondary
AST
changes in the liver enzyme aspartate aminotransferase (AST) in the blood are reported as units per liter Reference range 7 - 27 units/L bloodbook.com
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | AST | baseline | 23.0 U/L | Standard Error 4.9 |
| Cunermuspir | AST | day 28 | 24.2 U/L | Standard Error 6.2 |
| Placebo | AST | baseline | 23.1 U/L | Standard Error 6.3 |
| Placebo | AST | day 28 | 25.8 U/L | Standard Error 9.5 |
Comparison: comparison of AST enzyme activity in blood on day 28 between Cunermuspir and Placebop-value: 0.62Wilcoxon (Mann-Whitney)
Comparison: baseline to day 28 comparisonp-value: 0.24Wilcoxon (Mann-Whitney)
Comparison: baseline to day 28 comparison of AST activity in Placebo groupp-value: 0.11Wilcoxon (Mann-Whitney)
Secondary
Basophil
changes in basophils are reported in units of 10\^9 cells per liter blood
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Basophil | baseline | 0.0107 10^9 cells/L | Standard Error 0.0315 |
| Cunermuspir | Basophil | day 28 | 0.0077 10^9 cells/L | Standard Error 0.0272 |
| Placebo | Basophil | baseline | 0.0071 10^9 cells/L | Standard Error 0.0262 |
| Placebo | Basophil | day 28 | 0.0074 10^9 cells/L | Standard Error 0.0267 |
Comparison: The day 28 basophil counts on day 28 were compared between the two arms of this study.p-value: 0.98Wilcoxon (Mann-Whitney)
Secondary
Bilirubin
changes in total bilirubin are reported in units of micro moles per liter. Direct: up to 0.4 mg/dL, Total: up to 1.0 mg/dL bloodbook.com, Converts to 6.84-17.1 micro moles per liter. https://unitslab.com/node/37
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Bilirubin | baseline | 11.0 micromol/L | Standard Error 5.9 |
| Cunermuspir | Bilirubin | day 28 | 11.2 micromol/L | Standard Error 5.9 |
| Placebo | Bilirubin | baseline | 9.3 micromol/L | Standard Error 3.5 |
| Placebo | Bilirubin | day 28 | 9.9 micromol/L | Standard Error 4.3 |
Comparison: Bilirubin concentrations between Placebo and Cunermuspir compared at day 28p-value: 0.36Wilcoxon (Mann-Whitney)
Comparison: comparison of bilirubin concentrations between baseline and day 28 in the Cunermuspir Armp-value: 0.72Wilcoxon (Mann-Whitney)
Comparison: bilirubin concentrations compared between baseline and Day 28 in the Placebo Armp-value: 0.35Wilcoxon (Mann-Whitney)
Secondary
Chloride
changes in plasma chloride are reported in uits of mmol per liter The reference range is 98-106 mmol per liter, bloodbook.com
Time frame: baseline and 28 days after enrollment
Population: Enrollment pre-screening values are taken as the baseline. The study sponsor was of the opinion that these participants started the study dehydrated. Of the original 56 three were lost to followup or withdrew.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Chloride | baseline | 106.14 mmol/L | Standard Error 2.12 |
| Cunermuspir | Chloride | day 28 | 105.08 mmol/L | Standard Error 2.23 |
| Placebo | Chloride | baseline | 106.43 mmol/L | Standard Error 2.27 |
| Placebo | Chloride | day 28 | 105.15 mmol/L | Standard Error 1.99 |
p-value: 0.87ANCOVA
Comparison: comparison between baseline and day 28 chloride concentrations in the Cunermuspir groupp-value: 0.003t-test, 2 sided
Comparison: comparison of blood chloride concentrations between baseline and day 28 in Placebo Arm participantsp-value: 0.003t-test, 2 sided
Secondary
Cognition
Cognition is the mental process of knowing, including aspects such as awareness, perception, reasoning, and judgment. The mini-mental state exam (MMSE) puts a number to cognition. Any score of 24 or more out of a total 30 points is considered normal cognition. A test taker may be asked to orientate in space and time by recalling aspects of the physical location as well as month, day, year, and perhaps season. Simple mathematical calculations like counting backwards from 100 by seven may also be included. A complex command such as redrawing geometric figures scores six points in this exam. Since none of the participates were cognitively impaired, the investigators decided to make obtaining a perfect score on this exam an outcome measure.
Time frame: baseline and 28 days after enrollment
Population: Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cunermuspir | Cognition | baseline | 18 participants with perfect score |
| Cunermuspir | Cognition | day 28 | 22 participants with perfect score |
| Placebo | Cognition | baseline | 16 participants with perfect score |
| Placebo | Cognition | day 28 | 18 participants with perfect score |
Comparison: base line between group comparisonsp-value: 0.54Fisher Exact
p-value: 0.14Fisher Exact
Secondary
Copper
changes in copper concentration in the blood are reported in units of micro moles per liter
Time frame: baseline and 28 days after enrollment
Population: Of the 56 enrolled in the study three were lost to followup or dropped out.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Copper | baseline | 16.18 U/L | Standard Error 2.42 |
| Cunermuspir | Copper | day 28 | 16.6 U/L | Standard Error 2.8 |
| Placebo | Copper | baseline | 17.62 U/L | Standard Error 2.51 |
| Placebo | Copper | day 28 | 17.57 U/L | Standard Error 2.89 |
Comparison: Between group comparisons were made using ANCOVAp-value: 0.03ANCOVA
Comparison: comparison of baseline with day 28p-value: 0.1t-test, 2 sided
Comparison: comparison between baseline and day 28 serum copper concentrations in the Placebo Armp-value: 0.89t-test, 2 sided
Secondary
Creatinine
changes in creatinine are reported in units of micromol per liter
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Creatinine | baseline | 72.2 micromol/L | Standard Error 11.6 |
| Cunermuspir | Creatinine | day 28 | 72.3 micromol/L | Standard Error 13.7 |
| Placebo | Creatinine | baseline | 72.9 micromol/L | Standard Error 16 |
| Placebo | Creatinine | day 28 | 73.7 micromol/L | Standard Error 15 |
p-value: 0.38ANCOVA
Secondary
Diastolic Blood Pressure
The diastolic blood pressure was measured in mm Hg
Time frame: baseline and 28 days after enrollment
Population: For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Diastolic Blood Pressure | baseline | 70.5 mm Hg | Standard Error 6.4 |
| Cunermuspir | Diastolic Blood Pressure | day 28 | 69.3 mm Hg | Standard Error 7.3 |
| Placebo | Diastolic Blood Pressure | baseline | 75.0 mm Hg | Standard Error 9.4 |
| Placebo | Diastolic Blood Pressure | day 28 | 74.6 mm Hg | Standard Error 7.3 |
Comparison: The original report from KGK Synergize/Science did not specify if the results are ANCOVA or a between group comparison at 2ay 28p-value: <0.01ANCOVA
Secondary
eGFR
changes in the estimated glomerular filtration rate (eGFR) are reported in units of mL/min/1.73m\^2
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | eGFR | baseline | 90.4 mL/min/1.73 m^2 | Standard Error 17.3 |
| Cunermuspir | eGFR | day 28 | 91.2 mL/min/1.73 m^2 | Standard Error 18.3 |
| Placebo | eGFR | baseline | 88.8 mL/min/1.73 m^2 | Standard Error 16.2 |
| Placebo | eGFR | day 28 | 85.9 mL/min/1.73 m^2 | Standard Error 15.7 |
p-value: 0.01ANCOVA
Secondary
Eosinophil
changes in eosinophils are reported in units of 10\^9 cells per liter blood
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Eosinophil | baseline | 0.154 10^9 cells/L | Standard Error 0.074 |
| Cunermuspir | Eosinophil | day 28 | 0.181 10^9 cells/L | Standard Error 0.11 |
| Placebo | Eosinophil | baseline | 0.143 10^9 cells/L | Standard Error 0.063 |
| Placebo | Eosinophil | day 28 | 0.130 10^9 cells/L | Standard Error 0.072 |
Comparison: comparison of eosinophil counts at day 28p-value: 0.11Wilcoxon (Mann-Whitney)
Secondary
GGT
changes in the liver enzyme gamma-glutamyl transferase in the blood are reported as units per liter
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | GGT | baseline | 20.9 U/L | Standard Error 13.6 |
| Cunermuspir | GGT | day 28 | 24.0 U/L | Standard Error 18.1 |
| Placebo | GGT | baseline | 28.6 U/L | Standard Error 36.6 |
| Placebo | GGT | day 28 | 25.6 U/L | Standard Error 23 |
Comparison: comparison between placebo and Cunermuspir at day 28p-value: 0.11Wilcoxon (Mann-Whitney)
Comparison: Comparison of GGT activities in participants' blood at baseline and on day 28p-value: 0.01Wilcoxon Signed Rank
Comparison: Comparison of GGT activity in blood between Placebo Arm participants at baseline and on day 28p-value: 0.97Wilcoxon Signed-Rank
Secondary
Glucose
changes in blood glucose are reported in units of mmol per liter
Time frame: baseline and 28 days after enrollment
Population: In this population the initial screening was considered the baseline for all blood chemistry parameters. Three of the the participants were lost to followup or withdrew from the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Glucose | baseline | 5.12 mmol/L | Standard Error 0.55 |
| Cunermuspir | Glucose | day 28 | 5.25 mmol/L | Standard Error 0.44 |
| Placebo | Glucose | baseline | 5.30 mmol/L | Standard Error 0.42 |
| Placebo | Glucose | day 28 | 5.24 mmol/L | Standard Error 0.48 |
Comparison: Comparison of blood glucose in the Cunermuspir arm between enrollment baseline and day 28.p-value: 0.06t-test, 2 sided
Comparison: Comparison of enrollment baseline blood glucose and day 28 in the placebo armp-value: 0.04t-test, 2 sided
p-value: 0.92ANCOVA
Secondary
Heart Rate
heart rate is measured in beats per minute
Time frame: baseline and 28 days after enrollment
Population: For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Heart Rate | baseline | 70.3 beats per minute | Standard Error 10.8 |
| Cunermuspir | Heart Rate | day 28 | 68.3 beats per minute | Standard Error 9.7 |
| Placebo | Heart Rate | baseline | 68.2 beats per minute | Standard Error 8.1 |
| Placebo | Heart Rate | day 28 | 69.7 beats per minute | Standard Error 9.4 |
p-value: 0.54ANCOVA
Secondary
Hematocrit
changes in the fraction of whole blood occupied by red blood cells measured as L/L
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Hematocrit | baseline | 0.411 L/L | Standard Error 0.034 |
| Cunermuspir | Hematocrit | day 28 | 0.416 L/L | Standard Error 0.038 |
| Placebo | Hematocrit | baseline | 0.416 L/L | Standard Error 0.032 |
| Placebo | Hematocrit | day 28 | 0.415 L/L | Standard Error 0.031 |
p-value: 0.84ANCOVA
Secondary
Hemoglobin
changes measured in g/L blood
Time frame: baseline and 28 days after enrollment.
Population: For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Hemoglobin | baseline | 140.3 g/L | Standard Error 12.9 |
| Cunermuspir | Hemoglobin | day 28 | 142.2 g/L | Standard Error 14.3 |
| Placebo | Hemoglobin | baseline | 141.3 g/L | Standard Error 12.4 |
| Placebo | Hemoglobin | day 28 | 141.0 g/L | Standard Error 12 |
p-value: 0.48ANCOVA
Secondary
Household Chores and Neuro Muscular Sumptoms
Physical function in performing household chores was assessed using the Revised Symptom Impact Questionnaire (SQIR) For each household chore participants are asked to check 1 of 11 boxes between no difficulty and extremely difficult No difficulty is scored as 0 and extreme difficulty with the task is scored as 10. The higher the score, the more difficulty experienced performing the chore. Friend & Bennett Arthritis Res & Therapy 2011. Household chores are just one module with 9 questions for a maximum of 90 points. These scores are summed and divided by 3. Module 2 relates to the emotional impact with only two questions for a total of 20 points. Module 3 relates to physical symptoms with a total of ten questions worth a maximum of 100 points. This score is divided by 2. The three modules are summed for a total impact score of 100 points. A score of 0 indicates absolutely no impact and a score of 100 the greatest possible impact.
Time frame: baseline and 28 days after enrollment
Population: Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Household Chores and Neuro Muscular Sumptoms | baseline | 27.6 units on a scale | Standard Error 16.8 |
| Cunermuspir | Household Chores and Neuro Muscular Sumptoms | day 28 | 16.7 units on a scale | Standard Error 10.9 |
| Placebo | Household Chores and Neuro Muscular Sumptoms | baseline | 34.9 units on a scale | Standard Error 16.9 |
| Placebo | Household Chores and Neuro Muscular Sumptoms | day 28 | 29.3 units on a scale | Standard Error 28.7 |
p-value: <0.01ANCOVA
Comparison: comparison made between placebo and Cunermuspir at baselinep-value: 0.03Wilcoxon (Mann-Whitney)
Comparison: comparison made at day 28p-value: 0.01Wilcoxon (Mann-Whitney)
Comparison: comparison between baseline and day 28p-value: 0.07t-test, 2 sided
Secondary
Lymphocyte
changes in lymphocytes are reported in units of 10\^9 per liter blood
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Lymphocyte | baseline | 2.01 10^9 cells/L | Standard Error 0.64 |
| Cunermuspir | Lymphocyte | day 28 | 2.04 10^9 cells/L | Standard Error 0.72 |
| Placebo | Lymphocyte | baseline | 1.83 10^9 cells/L | Standard Error 0.51 |
| Placebo | Lymphocyte | day 28 | 1.74 10^9 cells/L | Standard Error 0.51 |
p-value: <0.01ANCOVA
Secondary
MCH
changes in mean corpuscular hemoglobin, measured in units of pg, the average amount of hemoglobin in a single RBC
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | MCH | baseline | 29.5 pg per cell | Standard Error 1.64 |
| Cunermuspir | MCH | day 28 | 29.48 pg per cell | Standard Error 1.69 |
| Placebo | MCH | baseline | 29.81 pg per cell | Standard Error 1.36 |
| Placebo | MCH | day 28 | 29.86 pg per cell | Standard Error 1.29 |
p-value: <0.01ANCOVA
Secondary
MCHC
mean corpuscular hemoglobin concentration is the concentration of hemoglobin in a single RBC measured in units of g/L
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | MCHC | baseline | 342.4 g/L | Standard Error 8.2 |
| Cunermuspir | MCHC | day 28 | 341.2 g/L | Standard Error 6.4 |
| Placebo | MCHC | baseline | 339.9 g/L | Standard Error 7.8 |
| Placebo | MCHC | day 28 | 340.5 g/L | Standard Error 5.7 |
p-value: 0.48ANCOVA
Secondary
MCV
changes in mean corpuscular volume (MCV) measured in units of fL
Time frame: baseline and 28 days after enrollment
Population: Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | MCV | baseline | 86.2 fempto liter per cell | Standard Error 3.9 |
| Cunermuspir | MCV | day 28 | 86.4 fempto liter per cell | Standard Error 4.3 |
| Placebo | MCV | baseline | 87.7 fempto liter per cell | Standard Error 3.1 |
| Placebo | MCV | day 28 | 87.7 fempto liter per cell | Standard Error 3.1 |
p-value: <0.01ANCOVA
Secondary
Monocyte
changes in monocytes are reported in units of 10\^9 per liter blood
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Monocyte | baseline | 0.450 10^9 cells/L | Standard Error 0.137 |
| Cunermuspir | Monocyte | day 28 | 0.473 10^9 cells/L | Standard Error 0.176 |
| Placebo | Monocyte | baseline | 0.475 10^9 cells/L | Standard Error 0.14 |
| Placebo | Monocyte | day 28 | 0.500 10^9 cells/L | Standard Error 0.124 |
Comparison: comparison of baseline valuesp-value: 0.47Wilcoxon (Mann-Whitney)
Comparison: comparison performed on data from day 28p-value: 0.24Wilcoxon (Mann-Whitney)
Secondary
Neutrophils
changes in neutrophils are reported in units of 10\^9 per liter blood
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Neutrophils | baseline | 3.28 10^9 cells/L | Standard Error 1.06 |
| Cunermuspir | Neutrophils | day 28 | 3.15 10^9 cells/L | Standard Error 1.19 |
| Placebo | Neutrophils | baseline | 3.35 10^9 cells/L | Standard Error 1.13 |
| Placebo | Neutrophils | day 28 | 3.60 10^9 cells/L | Standard Error 1.13 |
p-value: 0.03ANCOVA
Comparison: comparison of neutrophils from baseline to day 28p-value: 0.05t-test, 2 sided
Secondary
NLR
Changes in the neutrophil to lymphocyte ratio (NLR) are reported as a dimensionless fraction of 1
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | NLR | baseline | 1.77 dimensionaless units | Standard Error 0.15 |
| Cunermuspir | NLR | day 28 | 1.67 dimensionaless units | Standard Error 0.14 |
| Placebo | NLR | baseline | 1.90 dimensionaless units | Standard Error 0.13 |
| Placebo | NLR | day 28 | 2.24 dimensionaless units | Standard Error 0.19 |
Comparison: All other statistical analyses were performed by KGK Synergize. This site was used to determine that the NLR were normally distributed https://www.gigacalculator.com/calculators/normality-test-calculator.php~Because these data fulfilled the assumptions of ANOVA, the data were analyzed using this site:~http://vassarstats.net/anova2u.htmlp-value: 0.025ANOVA
Secondary
Platelets
changes in the platelet counts are reported in units of 10\^9 per liter blood
Time frame: baseline and 28 days after enrollment
Population: By day 28 three participants were lost to followup: two in the Cunermuspir group and one in the placebo group. There were issues in handling of one platelet sample in the Cunermuspir group. This brings the number in the Cunermuspir group down to 25 on day 28. For technical reasons, platelet data are missing for subject 021. All other blood cell data are present in this report of data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Platelets | baseline | 250 10^9 platelets/L | Standard Error 62 |
| Cunermuspir | Platelets | day 28 | 255 10^9 platelets/L | Standard Error 65 |
| Placebo | Platelets | baseline | 266 10^9 platelets/L | Standard Error 71 |
| Placebo | Platelets | day 28 | 269 10^9 platelets/L | Standard Error 69 |
p-value: 0.02ANCOVA
Secondary
Potassium
changes in plasma potassium are reported in units of mmol per liter, reference value 3.5-5.4 mmol per liter, bloodbook.com
Time frame: baseline and 28 days after enrollment
Population: The study sponsor is of the opinion that these participants were dehydrated when they started the study. They were instructed to drink more water. Three of the 56 that started the study were lost to followup or withdrew.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Potassium | baseline | 4.86 mmol/L | Standard Error 0.45 |
| Cunermuspir | Potassium | day 28 | 4.44 mmol/L | Standard Error 0.43 |
| Placebo | Potassium | baseline | 4.84 mmol/L | Standard Error 0.45 |
| Placebo | Potassium | day 28 | 4.39 mmol/L | Standard Error 0.39 |
p-value: 0.58ANCOVA
Comparison: comparison of blood potassium concentration upon enrollment and day 28 in the Cunermuspir participantsp-value: <0.001t-test, 2 sided
Comparison: comparison of blood potassium concentrations from enrollment to day 28 in participants in the Placebo arm.p-value: <0.001t-test, 2 sided
Secondary
RBC
changes in red blood cells (RBC) measured in units of 10\^12 per liter blood
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | RBC | baseline | 4.76 10^12 cells/L | Standard Error 0.38 |
| Cunermuspir | RBC | day 28 | 4.82 10^12 cells/L | Standard Error 0.41 |
| Placebo | RBC | baseline | 4.74 10^12 cells/L | Standard Error 0.38 |
| Placebo | RBC | day 28 | 4.73 10^12 cells/L | Standard Error 0.38 |
p-value: 0.05ANCOVA
Secondary
RDW
changes in the RBC distribution width (RDW) are reported in units of percentage (%)
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | RDW | baseline | 13.78 red cell distribution width % | Standard Error 0.7 |
| Cunermuspir | RDW | day 28 | 13.77 red cell distribution width % | Standard Error 0.63 |
| Placebo | RDW | baseline | 13.80 red cell distribution width % | Standard Error 0.5 |
| Placebo | RDW | day 28 | 13.93 red cell distribution width % | Standard Error 0.58 |
p-value: 0.06ANCOVA
Secondary
Sodium
changes in plasma sodium are reported in units of mmol per liter, reference range is 133-146 mEq/L, same as mM/L bloodbook.com
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Sodium | baseline | 143.39 mmol/L | Standard Error 2.25 |
| Cunermuspir | Sodium | day 28 | 142.62 mmol/L | Standard Error 2.47 |
| Placebo | Sodium | baseline | 143.14 mmol/L | Standard Error 2.16 |
| Placebo | Sodium | day 28 | 141.89 mmol/L | Standard Error 2.12 |
p-value: 0.23ANCOVA
p-value: 0.18t-test, 2 sided
Comparison: Blood sodium concentration between baseline and day 28 in the Placebo group.p-value: 0.01t-test, 2 sided
Secondary
Systolic Blood Pressure
Systolic blood pressure was measured in mm Hg
Time frame: baseline and 28 days after enrollment.
Population: For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Systolic Blood Pressure | baseline | 111.7 mm Hg | Standard Error 10.6 |
| Cunermuspir | Systolic Blood Pressure | day 28 | 109.5 mm Hg | Standard Error 15.8 |
| Placebo | Systolic Blood Pressure | baseline | 114.6 mm Hg | Standard Error 13.1 |
| Placebo | Systolic Blood Pressure | day 28 | 112.3 mm Hg | Standard Error 11.2 |
p-value: 0.31ANCOVA
Secondary
Urea
changes in renal function as measured by blood urea are reported in units of mmol per liter
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | Urea | baseline | 5.16 mmol/L | Standard Error 1.13 |
| Cunermuspir | Urea | day 28 | 5.05 mmol/L | Standard Error 1.57 |
| Placebo | Urea | baseline | 5.33 mmol/L | Standard Error 1.25 |
| Placebo | Urea | day 28 | 5.26 mmol/L | Standard Error 1.08 |
p-value: 0.51ANCOVA
Secondary
WBC
changes in white blood cells (WBC) measured in units of 10\^9 per liter blood
Time frame: baseline and 28 days after enrollment
Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cunermuspir | WBC | day 28 | 5.88 10^9 cells/L | Standard Error 1.81 |
| Cunermuspir | WBC | baseline | 5.93 10^9 cells/L | Standard Error 1.57 |
| Placebo | WBC | day 28 | 6.00 10^9 cells/L | Standard Error 1.34 |
| Placebo | WBC | baseline | 5.82 10^9 cells/L | Standard Error 1.5 |
p-value: 0.63ANCOVA