Trial Outcomes & Findings for Study to Evaluate the Effects of BMS-813160 on Protein Loss in the Urine of Subjects With Type 2 Diabetes and Diabetic Kidney Disease (NCT NCT01752985)
NCT ID: NCT01752985
Last Updated: 2019-07-30
Results Overview
The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples. UACR was calculated as the geometric mean of two first-morning void urine UACR measurements with samples collected on two separate occasions within a 4-day period.
TERMINATED
PHASE2
319 participants
Baseline, Weeks 2, 4, 8, 12, and 16 (Follow-up)
2019-07-30
Participant Flow
319 were enrolled, 110 completed screening, rest 209 discontinued: (Main reason:did not meet study criteria). Of 110 screened, 98 entered Placebo Lead-in period of which 89 completed period, rest 9 discontinued (2 due to Admin. reason, 3 no longer met study criteria, 2 AEs and 2 were lost to follow-up.)1 was randomized but declined treatment
Participant milestones
| Measure |
BMS-813160 150 mg QD
Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
|
BMS-813160 300 mg BID
Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2\*150 in AM and 2\*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
|
Placebo
Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.
|
|---|---|---|---|
|
Treatment Period
STARTED
|
29
|
30
|
29
|
|
Treatment Period
COMPLETED
|
25
|
27
|
24
|
|
Treatment Period
NOT COMPLETED
|
4
|
3
|
5
|
|
Follow-up Period
STARTED
|
28
|
27
|
26
|
|
Follow-up Period
COMPLETED
|
28
|
27
|
26
|
|
Follow-up Period
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
BMS-813160 150 mg QD
Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
|
BMS-813160 300 mg BID
Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2\*150 in AM and 2\*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
|
Placebo
Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.
|
|---|---|---|---|
|
Treatment Period
Subject request to discontinue treatment
|
1
|
0
|
1
|
|
Treatment Period
Subject no longer meets study criteria
|
0
|
1
|
1
|
|
Treatment Period
Adverse Event
|
2
|
1
|
2
|
|
Treatment Period
Withdrawal by Subject
|
1
|
1
|
0
|
|
Treatment Period
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Effects of BMS-813160 on Protein Loss in the Urine of Subjects With Type 2 Diabetes and Diabetic Kidney Disease
Baseline characteristics by cohort
| Measure |
BMS-813160 150 mg QD
n=29 Participants
Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
|
BMS-813160 300 mg BID
n=30 Participants
Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2\*150 in AM and 2\*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
|
Placebo
n=29 Participants
Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.9 Years
STANDARD_DEVIATION 9.58 • n=5 Participants
|
60.2 Years
STANDARD_DEVIATION 8.31 • n=7 Participants
|
60.6 Years
STANDARD_DEVIATION 11.52 • n=5 Participants
|
61.5 Years
STANDARD_DEVIATION 9.90 • n=4 Participants
|
|
Age, Customized
<65 years
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Age, Customized
>=65 years
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16 (Follow-up)Population: The analysis was performed in all the participants who received any study drug. Here, 'n' signifies evaluable participants for specified categories in respective treatment arms.
The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples. UACR was calculated as the geometric mean of two first-morning void urine UACR measurements with samples collected on two separate occasions within a 4-day period.
Outcome measures
| Measure |
BMS-813160 150 mg QD
n=29 Participants
Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
|
BMS-813160 300 mg BID
n=30 Participants
Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2\*150 in AM and 2\*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
|
Placebo
n=29 Participants
Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.
|
|---|---|---|---|
|
Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment With BMS-813160
Week 2
|
5.78 Percent Change
Standard Deviation 48.994
|
3.79 Percent Change
Standard Deviation 62.795
|
2.05 Percent Change
Standard Deviation 30.771
|
|
Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment With BMS-813160
Week 4
|
18.43 Percent Change
Standard Deviation 62.661
|
5.81 Percent Change
Standard Deviation 83.274
|
1.46 Percent Change
Standard Deviation 40.051
|
|
Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment With BMS-813160
Week 8
|
19.49 Percent Change
Standard Deviation 65.381
|
9.87 Percent Change
Standard Deviation 56.557
|
5.68 Percent Change
Standard Deviation 43.659
|
|
Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment With BMS-813160
Week 12
|
6.91 Percent Change
Standard Deviation 56.666
|
29.16 Percent Change
Standard Deviation 78.69
|
8.91 Percent Change
Standard Deviation 54.025
|
|
Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment With BMS-813160
Week 16
|
0.97 Percent Change
Standard Deviation 61.72
|
20.63 Percent Change
Standard Deviation 85.578
|
23.77 Percent Change
Standard Deviation 70.411
|
SECONDARY outcome
Timeframe: From the date of subject's written consent until 30 days post discontinuation of dosing, assessed up to 26 monthsPopulation: The analysis was performed in all the participants who received any study drug.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event.
Outcome measures
| Measure |
BMS-813160 150 mg QD
n=29 Participants
Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
|
BMS-813160 300 mg BID
n=30 Participants
Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2\*150 in AM and 2\*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
|
Placebo
n=29 Participants
Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs), Who Died and With Other (Not Including Serious) Adverse Events
SAEs
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Who Died and With Other (Not Including Serious) Adverse Events
Death
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Who Died and With Other (Not Including Serious) Adverse Events
Other (Non-Serious) Adverse Events 5 % cut-off
|
3 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The analysis was performed in all the participants who received any study drug.
12-lead ECGs were performed before and 1 hour after dosing at Weeks 0, 2 and 4. ECGs were recorded after the participant has been supine for at least 5 minutes. The PR interval was defined as the beginning of the P wave to the beginning of the QRS complex, and represents the time taken by electrical impulse to travel from the sinus node through the atrioventricular (AV) node. The QRS complex represented the rapid depolarization of the right and left ventricles. The QT interval was defined as the time from the start of the Q wave to the end of the T wave, and represents the time taken for ventricular depolarization and repolarization. Participants were evaluated for abnormal ECG intervals. Criteria's for abnormality were PR \>200, QRS \>120, QT \>500, QTcF \>450, Change From Baseline \>30 milliseconds (msec).
Outcome measures
| Measure |
BMS-813160 150 mg QD
n=29 Participants
Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
|
BMS-813160 300 mg BID
n=30 Participants
Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2\*150 in AM and 2\*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
|
Placebo
n=29 Participants
Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.
|
|---|---|---|---|
|
Number of Participants With Out-of-Range Electrocardiogram (ECG) Interval
PR >200 msec
|
8 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With Out-of-Range Electrocardiogram (ECG) Interval
QRS >120 msec
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Out-of-Range Electrocardiogram (ECG) Interval
QT >500 msec
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Out-of-Range Electrocardiogram (ECG) Interval
QTcF >450 msec
|
7 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Out-of-Range Electrocardiogram (ECG) Interval
Change from baseline in QT >30 msec
|
8 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Out-of-Range Electrocardiogram (ECG) Interval
Change from baseline in QTcF >30 msec
|
4 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Pre-dose at Week 2, 4, 8, 12 and 0.5, 1, 2, 4, and 6 hours post-dose at Week 12Population: The analysis was planned to be performed in the Pharmacokinetic (PK) analysis set which included all participants who receive a dose of study drug and have adequate PK concentration-time data. Data was not collected for any participants due to termination of the study
Ctrough is the minimum estimated plasma concentration at steady state.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12Population: The analysis was planned to be performed in the Pharmacokinetic (PK) analysis set which included all participants who receive a dose of study drug and have adequate PK concentration-time data. Data was not collected for any participants due to termination of the study
AUC(0-6 h) is the area under the plasma concentration-time curve from pre-dose (0 h) to 6 h post-dose.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12Population: The analysis was planned to be performed in the Pharmacokinetic (PK) analysis set which included all participants who receive a dose of study drug and have adequate PK concentration-time data.Data was not collected for any participants due to termination of the study
CLr was calculated by dividing the total amount excreted in the urine from 0 to 6 hours by the area under the plasma concentration-time curve from time zero extrapolated to infinite time. The renal function was classified based on estimated glomerular filtration rate as normal (\>=90 mL/min/1.73 m\^2), mildly impaired (60-89 mL/min/1.73 m\^2), moderately impaired stage 3A (45-59 mL/min/1.73 m\^2), and moderately impaired stage 3B (30-44 L/min/1.73 m\^2).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: Data was not collected for any participants due to termination of the study
The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples. UACR was calculated as the geometric mean of two first-morning void urine UACR measurements with samples collected on two separate occasions within a 4-day period. The effect of BMS-813160 on urinary albumin excretion as measured by UACR values in participants with diabetic kidney disease after 12 weeks of treatment was assessed. The model included treatment group as a main effect, and the log of baseline UACR values, as well as baseline values of eGFR, blood pressure, blood glucose and lipid levels, as covariates.
Outcome measures
Outcome data not reported
Adverse Events
BMS-813160 150 mg QD
BMS-813160 300 mg BID
Placebo
Serious adverse events
| Measure |
BMS-813160 150 mg QD
n=29 participants at risk
Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
|
BMS-813160 300 mg BID
n=30 participants at risk
Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2\*150 in AM and 2\*150 in PM) for 12 weeks.
|
Placebo
n=29 participants at risk
Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks.
|
|---|---|---|---|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
3.3%
1/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
3.4%
1/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
3.4%
1/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
3.4%
1/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
|
Cardiac disorders
Angina unstable
|
3.4%
1/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
|
Nervous system disorders
Transient ischaemic attack
|
3.4%
1/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
|
General disorders
Death
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
3.3%
1/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.4%
1/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
3.3%
1/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
3.3%
1/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
Other adverse events
| Measure |
BMS-813160 150 mg QD
n=29 participants at risk
Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.
|
BMS-813160 300 mg BID
n=30 participants at risk
Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2\*150 in AM and 2\*150 in PM) for 12 weeks.
|
Placebo
n=29 participants at risk
Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks.
|
|---|---|---|---|
|
General disorders
Oedema peripheral
|
3.4%
1/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
6.7%
2/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
10.3%
3/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
|
General disorders
Fatigue
|
10.3%
3/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
3.3%
1/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
3.4%
1/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
6.9%
2/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
6.7%
2/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
2/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
3.3%
1/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
6.7%
2/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
|
Nervous system disorders
Headache
|
6.9%
2/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
3.3%
1/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
|
Nervous system disorders
Dizziness
|
6.9%
2/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/30 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
0.00%
0/29 • From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER