Trial Outcomes & Findings for Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy (NCT NCT01828593)
NCT ID: NCT01828593
Last Updated: 2017-06-21
Results Overview
Change in number of abnormal or unformed stools by week 4
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
103 participants
Primary outcome timeframe
Baseline and 4 weeks
Results posted on
2017-06-21
Participant Flow
Study consists of 2 phases, the Placebo-controlled (PC) phase and the Placebo-free (PF) extension phase. Participants were randomized in a 1:1:2:2 ratio into 4 groups: Placebo for 4 wk PC phase followed by either 2.5g or 5.0g BID for 20 wk PF phase or SBI 2.5g or 5.0g BID for 4-wk PC phase followed by 2.5g or 5.0g for 20 wk PF phase.
Participant milestones
| Measure |
Placebo
Matching Placebo
Following 4 weeks in placebo-controlled phase were randomized to either SBI 2.5 g or SBI 5.0 g
|
SBI 2.5 g
Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
SBI 5.0g
Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
|---|---|---|---|
|
Placebo-Controlled Phase
STARTED
|
36
|
34
|
33
|
|
Placebo-Controlled Phase
COMPLETED
|
36
|
34
|
32
|
|
Placebo-Controlled Phase
NOT COMPLETED
|
0
|
0
|
1
|
|
Placebo-Free Phase
STARTED
|
0
|
55
|
47
|
|
Placebo-Free Phase
COMPLETED
|
0
|
49
|
41
|
|
Placebo-Free Phase
NOT COMPLETED
|
0
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
Baseline characteristics by cohort
| Measure |
Placebo
n=36 Participants
Matching Placebo
|
SBI 2.5 g
n=34 Participants
Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
SBI 5.0g
n=33 Participants
Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
50.9 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
50.7 years
STANDARD_DEVIATION 8 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Years with HIV
|
16 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
16.9 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
17.9 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
16.9 years
STANDARD_DEVIATION 6.76 • n=4 Participants
|
|
Years with HIV-associated diarrhea
|
4.4 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
6.9 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
6.6 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
5.9 years
STANDARD_DEVIATION 6.54 • n=4 Participants
|
|
Baseline Plasma CD4+ cell count
|
629 cells/microliter
STANDARD_DEVIATION 307 • n=5 Participants
|
746 cells/microliter
STANDARD_DEVIATION 324 • n=7 Participants
|
671 cells/microliter
STANDARD_DEVIATION 319 • n=5 Participants
|
682 cells/microliter
STANDARD_DEVIATION 317 • n=4 Participants
|
|
Plasma viral load
|
24 copies/mL
STANDARD_DEVIATION 11 • n=5 Participants
|
27 copies/mL
STANDARD_DEVIATION 22 • n=7 Participants
|
28 copies/mL
STANDARD_DEVIATION 28 • n=5 Participants
|
26 copies/mL
STANDARD_DEVIATION 21 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksChange in number of abnormal or unformed stools by week 4
Outcome measures
| Measure |
Placebo
n=36 Participants
Matching Placebo
|
SBI 2.5 g
n=34 Participants
Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
SBI 5.0g
n=33 Participants
Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
|---|---|---|---|
|
Frequency of Daily Unformed Bowel Movements
|
-2.46 abnormal or unformed stools
Standard Deviation 2.01
|
-2.16 abnormal or unformed stools
Standard Deviation 2.18
|
-2.20 abnormal or unformed stools
Standard Deviation 1.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 4 weeksLowest baseline CD4+ quartile (less than or equal to 418)
Outcome measures
| Measure |
Placebo
n=10 Participants
Matching Placebo
|
SBI 2.5 g
n=7 Participants
Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
SBI 5.0g
n=8 Participants
Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
|---|---|---|---|
|
Change From Baseline in Peripheral CD4+ T Cell Counts in Lowest Baseline CD4+ Quartile (Less Than or Equal to 418)
|
-19.8 cells/microliter
Standard Deviation 59.22
|
41.86 cells/microliter
Standard Deviation 84.83
|
47.63 cells/microliter
Standard Deviation 42.63
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 4 weeks2nd Baseline CD4+ Quartile (greater than 418 and less than or equal to 630)
Outcome measures
| Measure |
Placebo
n=13 Participants
Matching Placebo
|
SBI 2.5 g
n=6 Participants
Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
SBI 5.0g
n=6 Participants
Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
|---|---|---|---|
|
Change From Baseline in Peripheral CD4+ T Cell Counts in 2nd Baseline CD4+ Quartile (Greater Than 418 and Less Than or Equal to 630
|
31.46 cells/microliter
Standard Deviation 122.70
|
82.67 cells/microliter
Standard Deviation 205.16
|
12.00 cells/microliter
Standard Deviation 119.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 4 weeks3rd Baseline CD4+ Quartile (Greater than 630 and Less than or Equal to 893)
Outcome measures
| Measure |
Placebo
n=1 Participants
Matching Placebo
|
SBI 2.5 g
n=10 Participants
Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
SBI 5.0g
n=13 Participants
Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
|---|---|---|---|
|
Change From Baseline in Peripheral CD4+ T Cell Counts in 3rd Baseline CD4+ Quartile (Greater Than 630 and Less Than or Equal to 890)
|
48.00 cells/microliter
Standard Deviation NA
|
36.70 cells/microliter
Standard Deviation 183.14
|
-29.46 cells/microliter
Standard Deviation 224.83
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 4 weeks4th Baseline CD4+ Quartile (greater than 893)
Outcome measures
| Measure |
Placebo
n=10 Participants
Matching Placebo
|
SBI 2.5 g
n=10 Participants
Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
SBI 5.0g
n=4 Participants
Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
|---|---|---|---|
|
Change From Baseline in Peripheral CD4+ T Cell Counts in 4th Baseline CD4+ Quartile (Greater Than 893)
|
-144.00 cells/microliter
Standard Deviation 155.15
|
-54.20 cells/microliter
Standard Deviation 230.43
|
-365.25 cells/microliter
Standard Deviation 464.04
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24Population: Sub-study
Outcome measures
| Measure |
Placebo
n=8 Participants
Matching Placebo
|
SBI 2.5 g
n=8 Participants
Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
SBI 5.0g
Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
|---|---|---|---|
|
Change From Baseline in Duodenal Gut-associated Lymphoid Tissue (GALT) CD4+ T Cell Densities
|
144.80 cells/mm3
Interval -107.5 to 324.7
|
-67.95 cells/mm3
Interval -339.4 to 187.9
|
—
|
Adverse Events
SBI 2.5 g
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
SBI 5.0g
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SBI 2.5 g
n=55 participants at risk
Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g - Subjects on 2.5 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 2.5 g in the placebo free phase
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
SBI 5.0g
n=47 participants at risk
Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g - Subjects on 5.0 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 5.0 g in the placebo free phase
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
|---|---|---|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/55 • 24 weeks
|
2.1%
1/47 • Number of events 1 • 24 weeks
|
|
Nervous system disorders
Neuropathy Peripheral
|
1.8%
1/55 • Number of events 1 • 24 weeks
|
0.00%
0/47 • 24 weeks
|
|
Injury, poisoning and procedural complications
Subarachnoid Haemorrhage
|
0.00%
0/55 • 24 weeks
|
2.1%
1/47 • Number of events 1 • 24 weeks
|
|
Psychiatric disorders
Alcohol Abuse
|
1.8%
1/55 • Number of events 1 • 24 weeks
|
0.00%
0/47 • 24 weeks
|
Other adverse events
| Measure |
SBI 2.5 g
n=55 participants at risk
Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g - Subjects on 2.5 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 2.5 g in the placebo free phase
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
SBI 5.0g
n=47 participants at risk
Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g - Subjects on 5.0 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 5.0 g in the placebo free phase
Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
|
|---|---|---|
|
Gastrointestinal disorders
Toothache
|
5.5%
3/55 • Number of events 3 • 24 weeks
|
2.1%
1/47 • Number of events 1 • 24 weeks
|
|
General disorders
Nausea
|
3.6%
2/55 • Number of events 2 • 24 weeks
|
2.1%
1/47 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Flatulence
|
3.6%
2/55 • Number of events 2 • 24 weeks
|
0.00%
0/47 • 24 weeks
|
|
Gastrointestinal disorders
Gastritis
|
3.6%
2/55 • Number of events 2 • 24 weeks
|
0.00%
0/47 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.7%
7/55 • Number of events 7 • 24 weeks
|
6.4%
3/47 • Number of events 3 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
5/55 • Number of events 5 • 24 weeks
|
6.4%
3/47 • Number of events 3 • 24 weeks
|
|
Nervous system disorders
Headache
|
3.6%
2/55 • Number of events 2 • 24 weeks
|
4.3%
2/47 • Number of events 2 • 24 weeks
|
|
Nervous system disorders
Dizziness
|
3.6%
2/55 • Number of events 2 • 24 weeks
|
2.1%
1/47 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/55 • 24 weeks
|
4.3%
2/47 • Number of events 2 • 24 weeks
|
|
Psychiatric disorders
Anxiety
|
9.1%
5/55 • Number of events 5 • 24 weeks
|
2.1%
1/47 • Number of events 1 • 24 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/55 • 24 weeks
|
4.3%
2/47 • Number of events 2 • 24 weeks
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/55 • 24 weeks
|
4.3%
2/47 • Number of events 2 • 24 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/55 • 24 weeks
|
4.3%
2/47 • Number of events 2 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no multi-site publication is made within 18 months, Site may publish Site's results, subject to the following. At least 30 days prior to submitting a manuscript the Site shall provide to Entera a copy, and Entera shall have 30 days to review. Site shall remove any Confidential Information, upon Entera's request, prior to submitting the materials, and the Site shall delay publication for an additional period of up to 60 days to allow Entera to protect its interests in any Inventions.
- Publication restrictions are in place
Restriction type: OTHER