Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation

• Sponsor: Becton, Dickinson and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03224299
• Collaborator: (none)
• Enrollment: 131
• Locations: 2
• Arms: 4
• Actual Duration (Months): 3.4
• Patients Per Site: 65.5
• Patients Per Site Per Month: 19.2

Study Details

Study Description

Brief Summary

Objective of this study is to compare the antimicrobial properties of an investigational agent to an active control and a negative control when applied to specific body locations. Testing will be performed according to the procedures outlined in the Food and Drug Administration Tentative Final Monograph (TFM) for Effectiveness Testing of a Patient Preoperative Skin Preparation

Condition or Disease	Intervention/Treatment	Phase
Preoperative Skin Preparation	Drug: OCT - clear; Drug: OCT- tinted; Other: ChloraPrep; Other: Saline	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 131 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation
• Actual Study Start Date: Jun 21, 2017
• Actual Primary Completion Date: Aug 24, 2017
• Actual Study Completion Date: Oct 3, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Investigational Product #1 (IP1) octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear	Drug: OCT - clear; Investigational Product #1: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear
Experimental: Investigational Product #2 (IP2) octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted	Drug: OCT- tinted; Investigational product #2: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted
Active Comparator: Active Control ChloraPrep® - Hi-Lite Orange® applicator	Other: ChloraPrep; Active Control: ChloraPrep® - Hi-Lite Orange® applicator
Placebo Comparator: Negative Control sterile 0.9% saline applied with single use applicator	Other: Saline; Negative Control: sterile 0.9% saline applied with single use applicator

Outcome Measures

Primary Outcome Measures

1. Antimicrobial Activity of the Investigational Products Compared to Control. [10 minutes]

Secondary Outcome Measures

1. Responder Rate at 6 Hours Post-application [6 hours]

   Number of participants with bacterial reduction greater than or equal to baseline (0)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects may be of either sex, at least 18 years of age and of any race.

• Subjects must be in good general health.

• Subjects must read and sign an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and the List of Restricted Products prior to participating in the study.

• Female subjects must complete a urine pregnancy test and have negative results documented before proceeding to treatment with test materials.

• All subjects must meet Screening Day microbial baseline requirements established by the sponsor.

Exclusion Criteria:

• Known allergies or sensitivities to sunscreens, deodorants, laundry detergents, fragrances, vinyl, latex (rubber), alcohols, soaps, metals, inks, dyes, tape adhesives, or to common antibacterial agents found in soaps, lotions, ointments, or particularly the active ingredients of the study product drug solutions.

• Exposure of test sites to strong detergents, solvents, or other irritants within the 14-day product-restriction period or during the test period.

• Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 14-day product-restriction period or during the test period.

• Wear fabric softener-, bug repellent-, or UV-treated clothing during the 14-day product-restriction period or during the test period.

• Use of systemic or topical antibiotic medications, steroid medications (other than for hormonal contraception or post-menopausal reasons), or any other product known to affect the normal microbial flora of the skin during the 14-day product-restriction period or during the test period.

• A medical diagnosis of a physical condition, such as a current or recent severe illness, mitral valve prolapse with a heart murmur, congenital heart disease, hepatitis B, hepatitis C, an organ transplant, ports, or an immunocompromised condition such as AIDS (or HIV positive), lupus, medicated diabetes (Type 1 or 2), ulcerative colitis, Crohn's disease, asthma requiring daily medication, fibromyalgia or multiple sclerosis (medicated).

• Any tattoos or scars within 2 inches of the test sites; skin blemishes or warts may be permissible with the specific approval of the Principal Investigator or consulting physician.

• Dermatoses, cuts, lesions, active skin rashes, scabs, breaks in the skin or other skin disorders within 6 inches, on, or around the test sites.

• A currently active skin disease or inflammatory skin condition (for example, contact dermatitis, psoriasis, eczema) anywhere on the body that, in the opinion of the Principal Investigator, would compromise subject safety or study integrity.

• Subjects who receive an irritation score of 1 (any redness, swelling, rash, or dryness present in any treatment area) for any individual skin condition prior to the Screening Day baseline or Treatment Day baseline sample collection.

• Participation in another clinical study in the past 30 days or current participation in another clinical study at time of signing informed consent.

• Showering, bathing, or swimming within the 72 hour period prior to sampling for baseline screening, the test day, or throughout the test period.

• Pregnancy, plans to become pregnant or impregnate a sexual partner within the pre-test and test periods of the study, or nursing a child. All female subjects will be required to complete a urine pregnancy test on the day of test material application, prior to treatment. Both gender of subjects must be willing to use an acceptable method of contraception to prevent pregnancy for at least 14 days immediately preceding Treatment Day and throughout the duration of the study.

• Any medical condition or use of any medications that, in the opinion of the Principal Investigator or Consulting Physician, would preclude participation.

• Unwillingness to fulfill the performance requirements of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BioScience Laboratories	Bozeman	Montana	United States	59718
2	BioScience Laboratories	Butte	Montana	United States	59701

Sponsors and Collaborators

• Becton, Dickinson and Company

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Apr 19, 2017
• Statistical Analysis Plan - Aug 2, 2017

More Information

Publications

None provided.

• Responsible Party: Becton, Dickinson and Company
• ClinicalTrials.gov Identifier: NCT03224299
• Other Study ID Numbers: MPS-16IPVFT05
• First Posted: Jul 21, 2017
• Last Update Posted: Apr 23, 2021
• Last Verified: Mar 1, 2021

• 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

Study Results

Participant Flow

Pre-assignment Detail	Number of participants enrolled is 131. Each participant has up to 4 sites on their body treated with assigned products. Participants are treated bilaterally on the abdomen and/or groin based on passing screening criteria.

Arm/Group Title	Number of Participants	Number of Sites
Arm/Group Description	Participants were treated with 2 of 4 study products (IP#1 [OCT/IPA-clear], IP#2 [OCT/IPA-tinted], AC [ChloraPrep Hi-Lite Orange], or NC [0.9% saline]), 1 on the left side of the body (abdomen and inguen received the same product) and 1 on the right (abdomen and inguen received the same product). Therefore, treatment groups are not discrete categories and cannot be described by treatment group.	Test sites on body
Period Title: Overall Study
STARTED	131	424
Treated With IP#1	65	101
Treated With IP#2	66	107
Treated With AC	66	110
Treated With NC	65	106
COMPLETED	131	424
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Treated Subjects
Arm/Group Description	All treated subjects
Overall Participants	131
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47 (17)
Sex: Female, Male (Count of Participants)
Female	50 38.2%
Male	81 61.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 3.8%
Not Hispanic or Latino	119 90.8%
Unknown or Not Reported	7 5.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 2.3%
Asian	1 0.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	119 90.8%
More than one race	0 0%
Unknown or Not Reported	8 6.1%
Region of Enrollment (participants) [Number]
United States	131 100%

Outcome Measures

1. Primary Outcome

Title	Antimicrobial Activity of the Investigational Products Compared to Control.
Time Frame	10 minutes

Outcome Measure Data

Analysis Population Description

Analysis only includes participants with required treatment day baseline bacterial counts at each anatomical site at baseline and non-missing data at 30 seconds and 10 minutes.

Arm/Group Title	Investigational Product #1	Investigational Product #2	Active Control	Negative Control
Arm/Group Description	Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear	Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted	ChloraPrep® - Hi-Lite Orange® applicator	Sterile 0.9% saline applied with single use applicator
Measure Participants	65	66	66	65
Abdomen Baseline	3.85 (0.51)	3.91 (0.52)	3.87 (0.55)	3.84 (0.55)
Abdomen 30 seconds	0.98 (1.31)	1.05 (1.23)	1.34 (1.24)	3.42 (0.72)
Abdomen 10 minutes	1.20 (1.30)	0.91 (1.15)	1.08 (1.10)	3.12 (0.87)
Groin Baseline Groin Baseline	6.03 (0.52)	6.05 (0.59)	6.03 (0.53)	5.93 (0.50)
Groin 30 seconds	2.91 (1.26)	3.03 (1.16)	3.05 (1.19)	5.11 (0.41)
Groin 10 minutes	2.37 (1.34)	2.66 (1.37)	2.66 (1.42)	4.91 (0.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Investigational Product #1, Active Control
	Comments	Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Non-Inferiority
	Comments	Investigational product cannot be more than 0.05 log10 CFU/cm^2 less than the active control
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95%; -0.44 to 0.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Investigational Product #1, Negative Control
	Comments	Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.93
	Confidence Interval	(2-Sided) 95%; 1.36 to 2.49
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Investigational Product #2, Active Control
	Comments	Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Non-Inferiority
	Comments	Investigational product cannot be more than 0.05 log10 CFU/cm^2 less than the active control
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95%; -0.73 to 0.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Investigational Product #2, Negative Control
	Comments	Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.23
	Confidence Interval	(2-Sided) 95%; 1.69 to 2.78
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Investigational Product #1, Active Control
	Comments	Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Non-Inferiority
	Comments	Investigational product cannot be more than 0.05 log10 CFU/cm^2 less than the active control
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.30
	Confidence Interval	(2-Sided) 95%; -0.90 to 0.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Investigational Product #1, Negative Control
	Comments	Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.60
	Confidence Interval	(2-Sided) 95%; 1.98 to 3.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Investigational Product #2, Active Control
	Comments	Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Non-Inferiority
	Comments	Investigational product cannot be more than 0.05 log10 CFU/cm^2 less than the active control
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 95%; -0.61 to 0.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Investigational Product #2, Negative Control
	Comments	Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.33
	Confidence Interval	(2-Sided) 95%; 1.72 to 2.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Investigational Product #1, Active Control
	Comments	Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Non-Inferiority
	Comments	Investigational product cannot be more than 0.05 log10 CFU/cm^2 less than the active control
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.35
	Confidence Interval	(2-Sided) 95%; -0.91 to 0.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Investigational Product #1, Negative Control
	Comments	Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.45
	Confidence Interval	(2-Sided) 95%; 1.88 to 3.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Investigational Product #2, Active Control
	Comments	Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Non-Inferiority
	Comments	Investigational product cannot be more than 0.05 log10 CFU/cm^2 less than the active control
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.31
	Confidence Interval	(2-Sided) 95%; -0.85 to 0.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Investigational Product #2, Negative Control
	Comments	Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.41
	Confidence Interval	(2-Sided) 95%; 1.87 to 2.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Investigational Product #1, Active Control
	Comments	Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Non-Inferiority
	Comments	Investigational product cannot be more than 0.05 log10 CFU/cm^2 less than the active control
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.14
	Confidence Interval	(2-Sided) 95%; -0.67 to 0.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Investigational Product #1, Negative Control
	Comments	Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.25
	Confidence Interval	(2-Sided) 95%; 1.70 to 2.80
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Investigational Product #2, Active Control
	Comments	Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Non-Inferiority
	Comments	Investigational product cannot be more than 0.05 log10 CFU/cm^2 less than the active control
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.04
	Confidence Interval	(2-Sided) 95%; -0.56 to 0.48
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Investigational Product #2, Negative Control
	Comments	Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.15
	Confidence Interval	(2-Sided) 95%; 1.62 to 2.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Responder Rate at 6 Hours Post-application
Description	Number of participants with bacterial reduction greater than or equal to baseline (0)
Time Frame	6 hours

Outcome Measure Data

Analysis Population Description

Analysis only includes participants with required treatment day baseline bacterial counts at each anatomical site at baseline and non-missing data at 6 hours

Arm/Group Title	IP#1	IP#2	Active Control	Negative Control
Arm/Group Description	Investigational Product #1 (IP1) Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear	Investigational Product #2 (IP2) Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted	Active Control (AC) - ChloraPrep® - Hi-Lite Orange® applicator	Negative Control (NC) - Sterile 0.9% saline applied with single use applicator
Measure Participants	65	66	66	65
Abdomen	37 28.2%	43 NaN	47 NaN	42 NaN
Inguen	42 32.1%	48 NaN	44 NaN	40 NaN

Adverse Events

Time Frame	6 hours
Arm/Group Title	IP#1		IP#2		Active Control		Negative Control
Arm/Group Description	Investigational Product #1 (IP1) Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear		Investigational Product #2 (IP2) Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted		Active Control (AC) - ChloraPrep® - Hi-Lite Orange® applicator		Negative Control (NC) - Sterile 0.9% saline applied with single use applicator
All Cause Mortality
	IP#1		IP#2		Active Control		Negative Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/66 (0%)		0/66 (0%)		0/65 (0%)
Serious Adverse Events
	IP#1		IP#2		Active Control		Negative Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/66 (0%)		0/66 (0%)		0/65 (0%)
Other (Not Including Serious) Adverse Events
	IP#1		IP#2		Active Control		Negative Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/66 (0%)		0/66 (0%)		0/65 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.