An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00465088
• Collaborator: (none)
• Enrollment: 199
• Locations: 46
• Arms: 2
• Patients Per Site: 4.3

Study Details

Study Description

Brief Summary

To demonstrate that niacin ER and simvastatin (NS) tablets, when compared to atorvastatin (Lipitor®; Pfizer, Inc.), has superior high-density lipoprotein cholesterol (HDL-C) elevating effects at Week 12 in subjects with type II hyperlipidemia or mixed dyslipidemia who are currently off lipid-modifying therapy. This was a prospective, randomized, open-label, blinded endpoint (PROBE) study.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemia; Mixed Dyslipidemia	Drug: Niacin ER/Simvastatin Tablets; Drug: atorvastatin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 199 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: SUPREME: A 12-Week, Open-Label, Multicenter Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Niacin ER/Simvastatin Tablets; Up to 2000 mg/40 mg at bedtime; Other Names: ABT-919/483 Niacin ER/Simvastatin Simcor
Experimental: 2	Drug: atorvastatin; 40 mg at bedtime

Outcome Measures

Primary Outcome Measures

1. Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12 [From baseline to Week 12]

   (Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C

Secondary Outcome Measures

1. Percent Change in HDL-C From Baseline to Week 8 [From baseline to Week 8]

   (Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C

2. Percent Change in Non-HDL-C From Baseline to Week 8 [From baseline to Week 8]

   (Week 8 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C

3. Percent Change in Non-HDL-C From Baseline to Week 12 [From baseline to Week 12]

   (Week 12 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C

4. Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12 [From baseline to Week 12]

   (Week 12 LDL-C minus baseline LDL-C) x 100/baseline LDL-C

5. Percent Change in Triglycerides From Baseline to Week 12 [From baseline to Week 12]

   (Week 12 triglycerides minus baseline triglycerides) x 100/baseline triglycerides

6. Percent Change in LDL-C:HDL-C Ratio [From baseline to Week 12]

   (Week 12 LDL-C:HDL-C ratio minus baseline LDL-C:HDL-C ratio) x 100/baseline LDL-C:HDL-C ratio

7. Percent Change in Total Cholesterol From Baseline to Week 12 [From baseline to Week 12]

   (Week 12 total cholesterol minus baseline total cholesterol) x 100/baseline total cholesterol

8. Percent Change in Total Cholesterol:HDL-C Ratio [From baseline to Week 12]

   (Week 12 total cholesterol:HDL-C ratio minus baseline total cholesterol:HDL-C ratio) x 100/baseline total cholesterol:HDL-C ratio

9. Percent Change in Lipoprotein A From Baseline to Week 12 [From baseline to Week 12]

   (Week 12 lipoprotein A minus baseline lipoprotein A) x 100/baseline lipoprotein A

10. Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12 [12 weeks]

11. Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12 [12 weeks]

    For high-risk patients (coronary heart disease or equivalent), LDL-C < 100 mg/dL and non-HDL-C < 130 mg/dL; for moderate risk patients (having 2 risk factors), LDL-C < 130 mg/dL and non-HDL-C < 160 mg/dL; for low-risk patients (having 0 or 1 risk factor): LDL-C < 160 mg/dL and non-HDL-C < 190 mg/dL.

12. Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12 [12 weeks]

13. Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12 [12 weeks]

    NCEP ATP III goals for LDL-C are as follows: For high-risk patients, LDL-C < 100 mg/dL; for moderate risk patients, LDL-C < 130 mg/dL; for low-risk patients: LDL-C < 160 mg/dL. High-risk means coronary heart disease or risk equivalents; moderate risk means having at least 2 risk factors; low-risk means having no or 1 risk factor.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must meet all of the following laboratory criteria:

• HDL-C <40 mg/dL for men and <50 mg/dL for women.

• LDL-C ≥130 mg/dL but <250 mg/dL.

• TG <350 mg/dL.

• Creatine phosphokinase (CPK) < 3 x upper limit of normal (ULN).

• Alanine aminotransferase (ALT); serum glutamic pyruvic transaminase [SGPT] and aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase [SGOT] < 1.3 x ULN.

• Subjects must also be reasonably compliant with the Therapeutic Lifestyle Changes (TLC) diet during the 4 to 5 week Screening Period prior to randomization (and be willing to comply for the duration of the study).

Exclusion Criteria:

• Subjects who have a history of any important medical conditions or abnormalities (as specified in the protocol) that would preclude study inclusion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Anaheim	California	United States	92801
2		Huntington Park	California	United States	90255
3		Long Beach	California	United States	90822
4		Sacramento	California	United States	95825
5		Walnut Creek	California	United States	94598
6		Brooksville	Florida	United States	34613
7		Daytona Beach	Florida	United States	32117
8		Gainesville	Florida	United States	32605
9		Largo	Florida	United States	33770
10		Merritt Island	Florida	United States	32953
11		Miami	Florida	United States	33126
12		Pembroke Pines	Florida	United States	33026
13		Calhoun	Georgia	United States	30701
14		Decatur	Georgia	United States	30034
15		Dunwoody	Georgia	United States	30338
16		Boise	Idaho	United States	83704
17		Chicago	Illinois	United States	60607
18		Arkansas City	Kansas	United States	67005
19		Newton	Kansas	United States	67114
20		Shawnee Mission	Kansas	United States	66216
21		Topeka	Kansas	United States	55508
22		Wichita	Kansas	United States	67203
23		Auburn	Maine	United States	04210
24		Baltimore	Maryland	United States	21204
25		Missoula	Montana	United States	59808
26		Charlotte	North Carolina	United States	28204
27		High Point	North Carolina	United States	27262
28		Canfield	Ohio	United States	44406
29		Cincinnati	Ohio	United States	45242
30		Dayton	Ohio	United States	45458
31		Protland	Oregon	United States	97239
32		Chicora	Pennsylvania	United States	16025
33		Duncansville	Pennsylvania	United States	16635
34		Harleysville	Pennsylvania	United States	19438
35		Pittsburgh	Pennsylvania	United States	15206
36		Austin	Texas	United States	78752
37		Carrollton	Texas	United States	75006
38		Dallas	Texas	United States	75251
39		Houston	Texas	United States	77074
40		San Antonio	Texas	United States	78224
41		Magna	Utah	United States	84044
42		Salt Lake City	Utah	United States	84107
43		Richmond	Virginia	United States	23249
44		Gig Harbor	Washington	United States	98335
45		Menomonee Falls	Wisconsin	United States	53051
46		Milwaukee	Wisconsin	United States	53209

Sponsors and Collaborators

• Abbott

Investigators

• Study Director: Roopal Thakkar, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00465088
• Other Study ID Numbers: 019-05-06-CR; M10-013
• First Posted: Apr 24, 2007
• Last Update Posted: Jun 13, 2011
• Last Verified: Jun 1, 2011

• Additional relevant MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Niacin; Niacinamide; Nicotinic Acids; Atorvastatin; Simvastatin

Study Results

Participant Flow

Pre-assignment Detail	Of the 199 subjects randomized, 6 did not receive study drug: 2 withdrew consent, 1 had a protocol violation, and 3 had randomization errors. 193 subjects were treated.

Arm/Group Title	Niacin Extended-release Plus Simvastatin	Atorvastatin
Arm/Group Description	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	40 mg atorvastatin once daily at bedtime
Period Title: Overall Study
STARTED	114	79
COMPLETED	82	70
NOT COMPLETED	32	9

Baseline Characteristics

Arm/Group Title	Niacin Extended-release Plus Simvastatin	Atorvastatin	Total
Arm/Group Description	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	40 mg atorvastatin once daily at bedtime	Total of all reporting groups
Overall Participants	114	79	193
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	93 81.6%	73 92.4%	166 86%
>=65 years	21 18.4%	6 7.6%	27 14%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.1 (12.06)	51.5 (11.12)	53.6 (11.80)
Sex: Female, Male (Count of Participants)
Female	71 62.3%	38 48.1%	109 56.5%
Male	43 37.7%	41 51.9%	84 43.5%
Region of Enrollment (participants) [Number]
United States	114 100%	79 100%	193 100%

Outcome Measures

1. Primary Outcome

Title	Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12
Description	(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C
Time Frame	From baseline to Week 12

Outcome Measure Data

Analysis Population Description

All treated subjects whose Week 12 value was obtained within the Week 12 visit window

Arm/Group Title	Niacin Extended-release Plus Simvastatin	Atorvastatin
Arm/Group Description	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	40 mg atorvastatin once daily at bedtime
Measure Participants	82	70
Least Squares Mean (95% Confidence Interval) [percent change]	30.1	9.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Niacin Extended-release Plus Simvastatin, Atorvastatin
	Comments	An n = 81 for niacin extended-release with simvastatin and n = 54 for atorvastatin would provide > 99% power to detect a 13% increase in HDL-C with niacin extended-release with simvastatin relative to atorvastatin, assuming an SD of 16%
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	alpha = 0.05
	Method	Mixed Models Analysis
	Comments

2. Secondary Outcome

Title	Percent Change in HDL-C From Baseline to Week 8
Description	(Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C
Time Frame	From baseline to Week 8

Outcome Measure Data

Analysis Population Description

All treated subjects whose Week 8 value was obtained within the Week 8 visit window

Arm/Group Title	Niacin Extended-release Plus Simvastatin	Atorvastatin
Arm/Group Description	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	40 mg atorvastatin once daily at bedtime
Measure Participants	85	72
Least Squares Mean (95% Confidence Interval) [percent change]	26.7	1.4

3. Secondary Outcome

Title	Percent Change in Non-HDL-C From Baseline to Week 8
Description	(Week 8 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C
Time Frame	From baseline to Week 8

Outcome Measure Data

Analysis Population Description

All treated subjects whose Week 8 value was obtained within the Week 8 visit window

Arm/Group Title	Niacin Extended-release Plus Simvastatin	Atorvastatin
Arm/Group Description	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	40 mg atorvastatin once daily at bedtime
Measure Participants	85	70
Least Squares Mean (95% Confidence Interval) [percent change]	-45.0	-44.3

4. Secondary Outcome

Title	Percent Change in Non-HDL-C From Baseline to Week 12
Description	(Week 12 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C
Time Frame	From baseline to Week 12

Outcome Measure Data

Analysis Population Description

All treated subjects whose Week 12 value was obtained within the Week 12 visit window

Arm/Group Title	Niacin Extended-release Plus Simvastatin	Atorvastatin
Arm/Group Description	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	40 mg atorvastatin once daily at bedtime
Measure Participants	82	70
Least Squares Mean (95% Confidence Interval) [percent change]	-43.4	-43.3

5. Secondary Outcome

Title	Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12
Description	(Week 12 LDL-C minus baseline LDL-C) x 100/baseline LDL-C
Time Frame	From baseline to Week 12

Outcome Measure Data

Analysis Population Description

All treated subjects whose Week 12 value was obtained within the Week 12 visit window (between 70 days after first dose and not more than 3 days after last dose)

Arm/Group Title	Niacin Extended-release Plus Simvastatin	Atorvastatin
Arm/Group Description	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	40 mg atorvastatin once daily at bedtime
Measure Participants	82	70
Least Squares Mean (95% Confidence Interval) [percent change]	-43.8	-46.0

6. Secondary Outcome

Title	Percent Change in Triglycerides From Baseline to Week 12
Description	(Week 12 triglycerides minus baseline triglycerides) x 100/baseline triglycerides
Time Frame	From baseline to Week 12

Outcome Measure Data

Analysis Population Description

All treated subjects whose Week 12 value was obtained within the Week 12 visit window

Arm/Group Title	Niacin Extended-release Plus Simvastatin	Atorvastatin
Arm/Group Description	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	40 mg atorvastatin once daily at bedtime
Measure Participants	82	70
Median (Inter-Quartile Range) [percent change]	-44.0	-37.0

7. Secondary Outcome

Title	Percent Change in LDL-C:HDL-C Ratio
Description	(Week 12 LDL-C:HDL-C ratio minus baseline LDL-C:HDL-C ratio) x 100/baseline LDL-C:HDL-C ratio
Time Frame	From baseline to Week 12

Outcome Measure Data

Analysis Population Description

All treated subjects whose Week 12 values were obtained within the Week 12 visit window

Arm/Group Title	Niacin Extended-release Plus Simvastatin	Atorvastatin
Arm/Group Description	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	40 mg atorvastatin once daily at bedtime
Measure Participants	82	70
Least Squares Mean (95% Confidence Interval) [percent change]	-54.5	-50.5

8. Secondary Outcome

Title	Percent Change in Total Cholesterol From Baseline to Week 12
Description	(Week 12 total cholesterol minus baseline total cholesterol) x 100/baseline total cholesterol
Time Frame	From baseline to Week 12

Outcome Measure Data

Analysis Population Description

All treated subjects whose Week 12 value was obtained within the Week 12 visit window

Arm/Group Title	Niacin Extended-release Plus Simvastatin	Atorvastatin
Arm/Group Description	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	40 mg atorvastatin once daily at bedtime
Measure Participants	82	70
Least Squares Mean (95% Confidence Interval) [percent change]	-31.3	-35.1

9. Secondary Outcome

Title	Percent Change in Total Cholesterol:HDL-C Ratio
Description	(Week 12 total cholesterol:HDL-C ratio minus baseline total cholesterol:HDL-C ratio) x 100/baseline total cholesterol:HDL-C ratio
Time Frame	From baseline to Week 12

Outcome Measure Data

Analysis Population Description

All treated subjects whose Week 12 values were obtained within the Week 12 visit window

Arm/Group Title	Niacin Extended-release Plus Simvastatin	Atorvastatin
Arm/Group Description	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	40 mg atorvastatin once daily at bedtime
Measure Participants	82	70
Least Squares Mean (95% Confidence Interval) [percent change]	-45.2	-40.3

10. Secondary Outcome

Title	Percent Change in Lipoprotein A From Baseline to Week 12
Description	(Week 12 lipoprotein A minus baseline lipoprotein A) x 100/baseline lipoprotein A
Time Frame	From baseline to Week 12

Outcome Measure Data

Analysis Population Description

All treated subjects whose Week 12 value was obtained within the Week 12 visit window

Arm/Group Title	Niacin Extended-release Plus Simvastatin	Atorvastatin
Arm/Group Description	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	40 mg atorvastatin once daily at bedtime
Measure Participants	82	70
Median (Inter-Quartile Range) [percent change]	-15.8	16.0

11. Secondary Outcome

Title	Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

All treated subjects not meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III goals at baseline with both a baseline and at least 1 postbaseline HDL-C value

Arm/Group Title	Niacin Extended-release Plus Simvastatin	Atorvastatin
Arm/Group Description	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	40 mg atorvastatin once daily at bedtime
Measure Participants	45	47
Number [Percentage of subjects]	78	28

12. Secondary Outcome

Title	Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12
Description	For high-risk patients (coronary heart disease or equivalent), LDL-C < 100 mg/dL and non-HDL-C < 130 mg/dL; for moderate risk patients (having 2 risk factors), LDL-C < 130 mg/dL and non-HDL-C < 160 mg/dL; for low-risk patients (having 0 or 1 risk factor): LDL-C < 160 mg/dL and non-HDL-C < 190 mg/dL.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline LDL-C value

Arm/Group Title	Niacin Extended-release Plus Simvastatin	Atorvastatin
Arm/Group Description	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	40 mg atorvastatin once daily at bedtime
Measure Participants	67	58
Number [Percentage of subjects]	78	84

13. Secondary Outcome

Title	Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline triglyceride value

Arm/Group Title	Niacin Extended-release Plus Simvastatin	Atorvastatin
Arm/Group Description	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	40 mg atorvastatin once daily at bedtime
Measure Participants	52	44
Number [Percentage of subjects]	79	70

14. Secondary Outcome

Title	Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12
Description	NCEP ATP III goals for LDL-C are as follows: For high-risk patients, LDL-C < 100 mg/dL; for moderate risk patients, LDL-C < 130 mg/dL; for low-risk patients: LDL-C < 160 mg/dL. High-risk means coronary heart disease or risk equivalents; moderate risk means having at least 2 risk factors; low-risk means having no or 1 risk factor.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline value for all 3 lipid parameters

Arm/Group Title	Niacin Extended-release Plus Simvastatin	Atorvastatin
Arm/Group Description	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime	40 mg atorvastatin once daily at bedtime
Measure Participants	79	65
Number [Percentage of subjects]	65	34

Adverse Events

Arm/Group Title	Niacin Extended-release Plus Simvastatin		Atorvastatin
Arm/Group Description	Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime		40 mg atorvastatin once daily at bedtime
All Cause Mortality
	Niacin Extended-release Plus Simvastatin		Atorvastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Niacin Extended-release Plus Simvastatin		Atorvastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/ (NaN)		1/ (NaN)
Cardiac disorders
Coronary artery disease	1/114 (0.9%)		0/79 (0%)
General disorders
Chest pain	1/114 (0.9%)		1/79 (1.3%)
Other (Not Including Serious) Adverse Events
	Niacin Extended-release Plus Simvastatin		Atorvastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	89/ (NaN)		27/ (NaN)
Gastrointestinal disorders
Abdominal distension	0/114 (0%)		2/79 (2.5%)
Constipation	5/114 (4.4%)		0/79 (0%)
Diarrhea	9/114 (7.9%)		2/79 (2.5%)
Nausea	9/114 (7.9%)		0/79 (0%)
Vomiting	11/114 (9.6%)		0/79 (0%)
General disorders
Edema peripheral	0/114 (0%)		2/79 (2.5%)
Infections and infestations
Nasopharyngitis	2/114 (1.8%)		2/79 (2.5%)
Tooth infection	3/114 (2.6%)		0/79 (0%)
Injury, poisoning and procedural complications
Joint sprain	0/114 (0%)		2/79 (2.5%)
Investigations
Blood creatinine phosphokinase increased	0/114 (0%)		2/79 (2.5%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/114 (1.8%)		2/79 (2.5%)
Arthritis	0/114 (0%)		2/79 (2.5%)
Muscle spasms	0/114 (0%)		2/79 (2.5%)
Myalgia	4/114 (3.5%)		4/79 (5.1%)
Pain in extremity	3/114 (2.6%)		1/79 (1.3%)
Dizziness	3/114 (2.6%)		2/79 (2.5%)
Nervous system disorders
Headache	9/114 (7.9%)		2/79 (2.5%)
Respiratory, thoracic and mediastinal disorders
Nasal congestion	1/114 (0.9%)		2/79 (2.5%)
Skin and subcutaneous tissue disorders
Pruritus	7/114 (6.1%)		0/79 (0%)
Vascular disorders
Flushing	77/114 (67.5%)		8/79 (10.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Prior to release; Sponsor shall receive up to 180 days for review. Differences shall be resolved in good faith through appropriate scientific debate.