Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI)

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01956279
• Collaborator: (none)
• Enrollment: 170
• Location: 1
• Arms: 2
• Actual Duration (Months): 60.3
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

This study will investigate the use of adjunctive pregnenolone for the following:

1. fatigue that has limited usual activity,

2. musculoskeletal pain involving 2 or more regions of the body and,

3. cognitive symptoms (memory, concentration, or attentional difficulties by self-report) in Veterans deployed to the Gulf War theatre of operations between 1990 and 1991.

Condition or Disease	Intervention/Treatment	Phase
Fatigue; Musculoskeletal Pain; Cognitive Decline	Drug: Pregnenolone; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 170 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI)
• Actual Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Oct 10, 2018
• Actual Study Completion Date: Oct 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pregnenolone (Arm 1) Pregnenolone	Drug: Pregnenolone; Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days
Placebo Comparator: Placebo (Arm 2) Placebo	Drug: Placebo; Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days

Outcome Measures

Primary Outcome Measures

1. Physical Component of the SF-36 [Baseline to week 4, and Baseline to week 8]

   These data report changes in the mean scores in physical health symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The SF-36 is a health survey with an 8-scale profile embedded in 36 questions that measures physical and mental components of health. Each item is scored on a 0 to 100 range, with the lowest and highest possible scores set at 0 and 100, respectively. All of these items are scored such that a high score defines a more favorable health state, and the Physical Component Score is an average of 4 of the 8 domains of the SF-36. Thus, positive changes in scores represent an improvement relative to baseline.

Secondary Outcome Measures

1. Brief Pain Inventory (BPI) [Baseline to week 4, and Baseline to week 8]

   These data report changes in the mean scores in pain symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The Brief Pain Inventory is a 14-item self-report measure designed to assess the severity, frequency and daily pattern of pain, as well as its perceived interference with quality of life. Severity is measured on a 0-10 scale with 10 being the greatest pain. Interference score is measured by a mean score of 7 items (0-10 scale) with 10 being the greatest interference. Thus, negative changes in scores represent an improvement relative to baseline.

2. Tower of London Test of the Brief Assessment of Cognition in Affective Disorders (BAC-A) [Baseline to week 4, and Baseline to week 8]

   These data report changes in the mean scores in cognitive symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The Tower of London test assesses executive functioning on a scale of 0-20. (Note, if a perfect score of 20 occurs then there is the opportunity of 2 additional points, increasing the score to 22.) The higher the number, the higher the degree of executive functioning. Thus, positive changes in scores represent an improvement relative to baseline.

3. Multidimensional Fatigue Inventory (MFI) [Baseline to week 4, and Baseline to week 8]

   These data report changes in the mean scores in fatigue symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The MFI is a 20-item self-report measure designed to assess the principal manifestations of fatigue. Items are rated on a 1-5 scale indicating how true each statement was for the respondent during the last week, with some questions scored in an inverse fashion in the final calculation of the score. The 20 items are then summed, with higher scores representing greater fatigue. Thus, negative changes in scores represent an improvement relative to baseline.

4. Global Severity Index of the Symptom Checklist-90-Revised (SCL-90R) [Baseline to week 4, and Baseline to week 8]

   These data report changes in the mean scores in psychiatric symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The SCL-90R is used as a screening measure of general psychiatric symptomatology. It includes dimensions measuring somatization, obsessive-compulsive, depression, anxiety, phobic anxiety, hostility, interpersonal sensitivity, paranoid ideation, and psychoticism. Global Severity Index (GSI) of the SCL-90R is designed to measure overall psychological distress. Higher scores reflect greater distress. This is a 90 item measure with each rated on a scale of 0-4, with 4 being the highest level of psychological distress for each item. Thus, negative changes in scores represent an improvement relative to baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Veterans deployed to the Gulf War theatre of operations between 1990 and 1991.

• Veterans who report at least 2 of the following 3 symptoms that began in 1990 or thereafter, that lasted for more than 6 months, and that are present at the time of screening: 1) fatigue that limited usual activity, 2) musculoskeletal pain involving 2 or more regions of the body, 3) cognitive symptoms (memory, concentration, or attentional difficulties by self-report)

• Stable on medication regimen (no change in last 4 weeks) and no anticipated change in medication during study.

• Able to provide informed consent for study participation.

Exclusion Criteria:

• Subjects with a history of clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorders (e.g. unstable angina, seizures, cerebrovascular accident, decompensated congestive heart failure, central nervous system (CNS) infection, cancer [other than non-melanoma skin cancer], or history of HIV seropositivity), which would pose a risk to the patient if s/he were to participate in the study or that might confound the results of the study.

• Concurrent enrollment in another clinical trial.

• Pregnant women or women of child-bearing potential who are not surgically-sterile or not using appropriate methods of birth control.

• Use of oral contraceptives or other hormonal supplementation such as estrogen [although early studies suggested no effects on menstrual cycle, alterations in downstream metabolites or pregnenolone (such as estradiol) could theoretically impact the efficacy or oral contraceptives and/or estrogen replacement]. Similarly, it is theoretically possible that pregnenolone could be metabolized to other steroids such a DHEA, potentially resulting in hair, skin, or other steroid-related changes. Since the investigators' have determined in their prior study that pregnenolone administration does not result in downstream elevations in DHEA, DHEAS, estradiol, or testosterone, these possibilities may be unlikely.

• Women who are breast-feeding.

• Use of narcotic interventions.

• Known allergy to study medication.

• History of moderate or severe TBI (with loss of consciousness greater than 30 minutes)

• A clearly defined disease entity that accounts for the Veteran's symptoms.

• Current DSM-IV/DSM-IVTR/DSM-V diagnosis of bipolar I disorder, schizophrenia or other psychotic disorder, or dementia.

• Subjects with a DSM-IV/DSM-IVTR/DSM-V diagnosis of alcohol or substance dependence (other than nicotine or caffeine) within the last month.

• Subjects with a current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern.

• If in the judgment of the PI it is not in the subject's best interest to participate.

• Final eligibility decisions will be determined by the PI.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Durham VA Medical Center, Durham, NC	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Christine E. Marx, MD MA, Durham VA Medical Center, Durham, NC

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 20, 2015

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01956279
• Other Study ID Numbers: SPLD-013-12S
• First Posted: Oct 8, 2013
• Last Update Posted: May 1, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: Pregnenolone; Gulf War Veteran; Fatigue; Musculoskeletal Pain; Cognitive Decline; Placebo Control
• Additional relevant MeSH terms: Musculoskeletal Pain; Fatigue; Cognitive Dysfunction

Study Results

Participant Flow

Pre-assignment Detail	170 participants enrolled; 142 participants were randomized after a 2-week placebo lead-in phase. The remaining 28 randomized participants were withdrawn prior to week 4 post-randomization for various reasons - including medication changes during the study (exclusionary) and participants unavailable for continued contact.

Arm/Group Title	Pregnenolone (Arm 1)	Placebo (Arm 2)
Arm/Group Description	Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days	Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
Period Title: Overall Study
STARTED	82	88
COMPLETED	68	74
NOT COMPLETED	14	14

Baseline Characteristics

Arm/Group Title	Pregnenolone (Arm 1)	Placebo (Arm 2)	Total
Arm/Group Description	Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days	Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days	Total of all reporting groups
Overall Participants	82	88	170
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	81 98.8%	88 100%	169 99.4%
>=65 years	1 1.2%	0 0%	1 0.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.7 (5.6)	51.4 (4.8)	52.0 (5.2)
Sex: Female, Male (Count of Participants)
Female	10 12.2%	10 11.4%	20 11.8%
Male	72 87.8%	78 88.6%	150 88.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 7.3%	1 1.1%	7 4.1%
Not Hispanic or Latino	76 92.7%	87 98.9%	163 95.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	2 2.3%	2 1.2%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	40 48.8%	56 63.6%	96 56.5%
White	42 51.2%	30 34.1%	72 42.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	82 100%	88 100%	170 100%

Outcome Measures

1. Primary Outcome

Title	Physical Component of the SF-36
Description	These data report changes in the mean scores in physical health symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The SF-36 is a health survey with an 8-scale profile embedded in 36 questions that measures physical and mental components of health. Each item is scored on a 0 to 100 range, with the lowest and highest possible scores set at 0 and 100, respectively. All of these items are scored such that a high score defines a more favorable health state, and the Physical Component Score is an average of 4 of the 8 domains of the SF-36. Thus, positive changes in scores represent an improvement relative to baseline.
Time Frame	Baseline to week 4, and Baseline to week 8

Outcome Measure Data

Analysis Population Description

Change in the Physical Component Score of the SF-36. Some subjects did not reach week 8 of the study, and not all subjects completed all information at all visits.

Arm/Group Title	Pregnenolone (Arm 1)	Placebo (Arm 2)
Arm/Group Description	Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days	Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
Measure Participants	66	74
Baseline to week 4	2.04 (1.50)	2.55 (1.55)
Baseline to week 8	1.23 (1.68)	4.45 (1.75)

2. Secondary Outcome

Title	Brief Pain Inventory (BPI)
Description	These data report changes in the mean scores in pain symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The Brief Pain Inventory is a 14-item self-report measure designed to assess the severity, frequency and daily pattern of pain, as well as its perceived interference with quality of life. Severity is measured on a 0-10 scale with 10 being the greatest pain. Interference score is measured by a mean score of 7 items (0-10 scale) with 10 being the greatest interference. Thus, negative changes in scores represent an improvement relative to baseline.
Time Frame	Baseline to week 4, and Baseline to week 8

Outcome Measure Data

Analysis Population Description

Change in the average pain rating over the last 24 hours, and the magnitude of interference resulting from that pain. Some subjects did not reach week 8 of the study, and not all subjects completed all information at all visits.

Arm/Group Title	Pregnenolone (Arm 1)	Placebo (Arm 2)
Arm/Group Description	Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days	Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
Measure Participants	68	74
Pain rating, Baseline to week 4	-0.44 (0.14)	-0.30 (0.15)
Pain rating, Baseline to week 8	-0.09 (0.21)	-0.11 (0.22)
Interference, Baseline to week 4	-0.03 (0.22)	0.00 (0.21)
Interference, Baseline to week 8	-0.19 (0.25)	-0.26 (0.29)

3. Secondary Outcome

Title	Tower of London Test of the Brief Assessment of Cognition in Affective Disorders (BAC-A)
Description	These data report changes in the mean scores in cognitive symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The Tower of London test assesses executive functioning on a scale of 0-20. (Note, if a perfect score of 20 occurs then there is the opportunity of 2 additional points, increasing the score to 22.) The higher the number, the higher the degree of executive functioning. Thus, positive changes in scores represent an improvement relative to baseline.
Time Frame	Baseline to week 4, and Baseline to week 8

Outcome Measure Data

Analysis Population Description

Change in the Tower of London Score of the BAC-A. Some subjects did not reach week 8 of the study.

Arm/Group Title	Pregnenolone (Arm 1)	Placebo (Arm 2)
Arm/Group Description	Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days	Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
Measure Participants	68	74
Baseline to week 4	1.15 (0.37)	1.31 (0.39)
Baseline to week 8	0.98 (0.37)	1.71 (0.41)

4. Secondary Outcome

Title	Multidimensional Fatigue Inventory (MFI)
Description	These data report changes in the mean scores in fatigue symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The MFI is a 20-item self-report measure designed to assess the principal manifestations of fatigue. Items are rated on a 1-5 scale indicating how true each statement was for the respondent during the last week, with some questions scored in an inverse fashion in the final calculation of the score. The 20 items are then summed, with higher scores representing greater fatigue. Thus, negative changes in scores represent an improvement relative to baseline.
Time Frame	Baseline to week 4, and Baseline to week 8

Outcome Measure Data

Analysis Population Description

Total score of the MFI-20. Some subjects did not reach week 8 of the study, and not all subjects completed all information at all visits.

Arm/Group Title	Pregnenolone (Arm 1)	Placebo (Arm 2)
Arm/Group Description	Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days	Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
Measure Participants	68	74
Baseline to week 4	-0.76 (1.24)	-0.27 (1.04)
Baseline to week 8	-3.63 (1.45)	-3.22 (1.18)

5. Secondary Outcome

Title	Global Severity Index of the Symptom Checklist-90-Revised (SCL-90R)
Description	These data report changes in the mean scores in psychiatric symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The SCL-90R is used as a screening measure of general psychiatric symptomatology. It includes dimensions measuring somatization, obsessive-compulsive, depression, anxiety, phobic anxiety, hostility, interpersonal sensitivity, paranoid ideation, and psychoticism. Global Severity Index (GSI) of the SCL-90R is designed to measure overall psychological distress. Higher scores reflect greater distress. This is a 90 item measure with each rated on a scale of 0-4, with 4 being the highest level of psychological distress for each item. Thus, negative changes in scores represent an improvement relative to baseline.
Time Frame	Baseline to week 4, and Baseline to week 8

Outcome Measure Data

Analysis Population Description

Average Global Severity Index score of the SCL-90. Some subjects did not reach week 8 of the study, and not all subjects completed all information at all visits.

Arm/Group Title	Pregnenolone (Arm 1)	Placebo (Arm 2)
Arm/Group Description	Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days	Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
Measure Participants	68	74
Baseline to week 4	-0.12 (0.04)	-0.09 (0.04)
Baseline to week 8	-0.16 (0.05)	-0.15 (0.05)

Adverse Events

Time Frame	Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse Event Reporting Description	Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
Arm/Group Title	Pregnenolone (Arm 1)		Placebo (Arm 2)
Arm/Group Description	Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days		Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
All Cause Mortality
	Pregnenolone (Arm 1)		Placebo (Arm 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/82 (1.2%)		0/88 (0%)
Serious Adverse Events
	Pregnenolone (Arm 1)		Placebo (Arm 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/82 (1.2%)		0/88 (0%)
General disorders
Participant death by homicide	1/82 (1.2%)		0/88 (0%)
Other (Not Including Serious) Adverse Events
	Pregnenolone (Arm 1)		Placebo (Arm 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	69/82 (84.1%)		73/88 (83%)
Blood and lymphatic system disorders
Cold Extremities	4/82 (4.9%)		12/88 (13.6%)
Cardiac disorders
Palpitations	5/82 (6.1%)		8/88 (9.1%)
Tachycardia	3/82 (3.7%)		1/88 (1.1%)
Hypertension	2/82 (2.4%)		0/88 (0%)
Ear and labyrinth disorders
Tinnitus	11/82 (13.4%)		15/88 (17%)
Eye disorders
Blurred Vision	10/82 (12.2%)		19/88 (21.6%)
Gastrointestinal disorders
Diarrhea	24/82 (29.3%)		26/88 (29.5%)
Constipation	12/82 (14.6%)		17/88 (19.3%)
Nausea	15/82 (18.3%)		20/88 (22.7%)
Vomiting	5/82 (6.1%)		6/88 (6.8%)
Change in Stool Color	0/82 (0%)		1/88 (1.1%)
Flatulence	1/82 (1.2%)		0/88 (0%)
General disorders
Restlessness	12/82 (14.6%)		14/88 (15.9%)
Nasal Congestion	20/82 (24.4%)		33/88 (37.5%)
Peripheral Edema	7/82 (8.5%)		8/88 (9.1%)
Malaise	6/82 (7.3%)		2/88 (2.3%)
Occurrence of Blank Stare	1/82 (1.2%)		0/88 (0%)
Fever	4/82 (4.9%)		5/88 (5.7%)
Irritability	8/82 (9.8%)		14/88 (15.9%)
Musculoskeletal and connective tissue disorders
Cramps	18/82 (22%)		21/88 (23.9%)
Joint Pain/Stiffness	9/82 (11%)		6/88 (6.8%)
Muscle Pain/Stiffness	9/82 (11%)		11/88 (12.5%)
Akathisia	2/82 (2.4%)		5/88 (5.7%)
Increased Motor Activity	2/82 (2.4%)		0/88 (0%)
Muscle Twitching	2/82 (2.4%)		1/88 (1.1%)
Muscle Rigidity	1/82 (1.2%)		0/88 (0%)
Muscle Cramps	1/82 (1.2%)		1/88 (1.1%)
Leg Shaking	1/82 (1.2%)		0/88 (0%)
Decreased Motor Activity	3/82 (3.7%)		2/88 (2.3%)
Pain / Stiffness	2/82 (2.4%)		7/88 (8%)
Myoclonus	7/82 (8.5%)		1/88 (1.1%)
Rigidity	2/82 (2.4%)		4/88 (4.5%)
Nervous system disorders
Drowsiness	16/82 (19.5%)		21/88 (23.9%)
Hypersomnia	1/82 (1.2%)		1/88 (1.1%)
Insomnia	16/82 (19.5%)		14/88 (15.9%)
Decreased Appetite	9/82 (11%)		14/88 (15.9%)
Increased Appetite	8/82 (9.8%)		12/88 (13.6%)
Dry Mouth	15/82 (18.3%)		22/88 (25%)
Headache	28/82 (34.1%)		25/88 (28.4%)
Migraine Headache	0/82 (0%)		1/88 (1.1%)
Tremor	3/82 (3.7%)		2/88 (2.3%)
Increased Salivation	5/82 (6.1%)		5/88 (5.7%)
Dizziness	17/82 (20.7%)		17/88 (19.3%)
Sweating	13/82 (15.9%)		13/88 (14.8%)
Decreased Interest in Sex	3/82 (3.7%)		7/88 (8%)
Impaired Sexual Performance	2/82 (2.4%)		9/88 (10.2%)
Vertigo	5/82 (6.1%)		4/88 (4.5%)
Excitement / Agitation	6/82 (7.3%)		4/88 (4.5%)
Confusion	2/82 (2.4%)		3/88 (3.4%)
Paresthesia	15/82 (18.3%)		10/88 (11.4%)
Disorientation	4/82 (4.9%)		3/88 (3.4%)
Forgetfulness	0/82 (0%)		1/88 (1.1%)
Renal and urinary disorders
Nocturnal/Enuresis	0/82 (0%)		1/88 (1.1%)
Urinary Retention	3/82 (3.7%)		2/88 (2.3%)
Reproductive system and breast disorders
Menstrual Disturbance	3/82 (3.7%)		4/88 (4.5%)
Skin and subcutaneous tissue disorders
Dermatological	17/82 (20.7%)		19/88 (21.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.