Trial Outcomes & Findings for Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants (NCT NCT01892085)
NCT ID: NCT01892085
Last Updated: 2023-08-24
Results Overview
Volume of pumped milk on day 1 postpartum
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
Day 1 postpartum
Results posted on
2023-08-24
Participant Flow
Participant milestones
| Measure |
Early Initiation
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Overall Study
STARTED
|
58
|
62
|
60
|
|
Overall Study
COMPLETED
|
52
|
61
|
55
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
5
|
Reasons for withdrawal
| Measure |
Early Initiation
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Overall Study
Death
|
4
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
Baseline Characteristics
Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Baseline characteristics by cohort
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.4 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
26.1 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
28.2 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
150 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
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 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
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
82 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
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
61 participants
n=7 Participants
|
55 participants
n=5 Participants
|
168 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 postpartumVolume of pumped milk on day 1 postpartum
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Pumped Milk Volume Day 1
|
3 mL
Standard Deviation 3
|
4 mL
Standard Deviation 4
|
5 mL
Standard Deviation 4
|
PRIMARY outcome
Timeframe: Day 2 postpartumVolume of breast milk pumped on day 2 postpartum
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Pumped Milk Volume on Day 2
|
11 mL
Standard Deviation 11
|
13 mL
Standard Deviation 12
|
15 mL
Standard Deviation 12
|
PRIMARY outcome
Timeframe: Day 3 postpartumVolume of milk pumped on day 3 postpartum
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Pumped Milk Volume Day 3
|
31 mL
Standard Deviation 30
|
36 mL
Standard Deviation 31
|
41 mL
Standard Deviation 31
|
PRIMARY outcome
Timeframe: Day 4 postpartumVolume of pumped milk on Day 4 postpartum
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Pumped Milk Volume Day 4
|
73 mL
Standard Deviation 70
|
82 mL
Standard Deviation 70
|
94 mL
Standard Deviation 72
|
PRIMARY outcome
Timeframe: Day 5 postpartumVolume of pumped milk on Day 5 postpartum
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Pumped Milk Volume on Day 5
|
145 mL
Standard Deviation 138
|
157 mL
Standard Deviation 135
|
180 mL
Standard Deviation 138
|
PRIMARY outcome
Timeframe: Day 6 postpartumVolume of pumped milk on Day 6 postpartum
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=60 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Pumped Milk Volume Day 6
|
240 mL
Standard Deviation 230
|
253 mL
Standard Deviation 217
|
293 mL
Standard Deviation 233
|
PRIMARY outcome
Timeframe: Day 7 postpartumVolume of milk pumped on day 7 postpartum
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Pumped Milk Volume on Day 7
|
337 mL
Standard Deviation 322
|
343 mL
Standard Deviation 294
|
400 mL
Standard Deviation 305
|
PRIMARY outcome
Timeframe: Day 14 postpartumVolume of pumped milk on day 14 postpartum
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Pumped Milk Volume at Day 14
|
398 mL
Standard Deviation 380
|
391 mL
Standard Deviation 335
|
461 mL
Standard Deviation 352
|
PRIMARY outcome
Timeframe: Day 21 postpartumVolume of milk pumped on day 21 postpartum
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Pumped Milk Volume Day 21
|
396 mL
Standard Deviation 370
|
377 mL
Standard Deviation 305
|
447 mL
Standard Deviation 341
|
PRIMARY outcome
Timeframe: Day 28 postpartumVolume of milk pumped on day 28 postpartum
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Pumped Milk Volume Day 28
|
332 mL
Standard Deviation 317
|
305 mL
Standard Deviation 262
|
365 mL
Standard Deviation 275
|
PRIMARY outcome
Timeframe: Day 35 postpartumVolume of milk pumped on day 35 postpartum
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Pumped Milk Volume on Day 35
|
234 mL
Standard Deviation 224
|
209 mL
Standard Deviation 179
|
252 mL
Standard Deviation 192
|
PRIMARY outcome
Timeframe: Day 42 postpartumVolume of milk pumped on day 42 postpartum
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Pumped Milk Volume on Day 42
|
139 mL
Standard Deviation 133
|
120 mL
Standard Deviation 103
|
146 mL
Standard Deviation 112
|
SECONDARY outcome
Timeframe: Hours from birth to onset of lactogenesis stage 2Mothers were asked daily concerning a feeling of fullness in their breasts as a measure of onset of lactogenesis stage 2
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Hours From Birth to Onset of Lactogenesis Stage 2
|
140.5 hours from birth
Standard Deviation 144.7
|
94.7 hours from birth
Standard Deviation 65
|
109 hours from birth
Standard Deviation 98.4
|
SECONDARY outcome
Timeframe: birth to approximately 3 monthsDays mothers lactated until infant NICU discharge
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Days Lactated
|
45.3 days
Standard Deviation 31.8
|
48.7 days
Standard Deviation 28.2
|
48.2 days
Standard Deviation 28.3
|
SECONDARY outcome
Timeframe: Day 1 to 7The percentage of feeds consisting of mother's own milk consumed by the participant's infants from day 1-7
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Percentage of Feeds Consisting of Mother's Own Milk Week 1
|
71.7 percent
Standard Deviation 42.1
|
69.2 percent
Standard Deviation 43.4
|
81.9 percent
Standard Deviation 36.3
|
SECONDARY outcome
Timeframe: Day 7-14The percentage of feeds consisting of mother's own milk consumed by the participants infants from day 7-14
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Percentage of Feeds Consisting of Mother's Own Milk Week 2 Consumed by Infants
|
65.7 percent
Standard Deviation 45.1
|
66.7 percent
Standard Deviation 44.1
|
70.2 percent
Standard Deviation 45.6
|
SECONDARY outcome
Timeframe: Day 14-21The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 14-21
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Percentage of Feeds Consisting of Mother's Own Milk Week 3
|
55.7 percent
Standard Deviation 48.5
|
59.6 percent
Standard Deviation 48.7
|
70.2 percent
Standard Deviation 45.1
|
SECONDARY outcome
Timeframe: Day 21-28The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 21-28
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Percentage of Feeds Consisting of Mother's Own Milk Week 4
|
57.5 percent
Standard Deviation 48
|
62.3 percent
Standard Deviation 46.4
|
64.5 percent
Standard Deviation 47.7
|
SECONDARY outcome
Timeframe: Day 28-35The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 28-35
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Percentage of Feeds Consisting of Mother's Own Milk Week 5
|
51.8 percent
Standard Deviation 49
|
54.3 percent
Standard Deviation 48.1
|
65.6 percent
Standard Deviation 46.5
|
SECONDARY outcome
Timeframe: Day 35-42The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 35-42
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Percentage of Feeds Consisting of Mother's Own Milk Week 6
|
51.1 percent
Standard Deviation 48.9
|
53.9 percent
Standard Deviation 49.7
|
56 percent
Standard Deviation 48.6
|
SECONDARY outcome
Timeframe: 24 hour period prior to NICU dischargeThe percentage of feedings consisting of mother's own milk consumed by the participant's infant over the 24 hours period prior to NICU discharge among mothers who continued to lactate
Outcome measures
| Measure |
Early Initiation
n=52 Participants
Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery.
|
Intermediate Expression
n=61 Participants
Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery.
|
Late Initiation
n=55 Participants
Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery.
|
|---|---|---|---|
|
Percentage of Feedings Consisting of Mother's Own Milk at NICU Discharge
|
82 Percent
Standard Deviation 30.8
|
80 Percent
Standard Deviation 31.2
|
90 Percent
Standard Deviation 20
|
Adverse Events
Early Initiation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intermediate Expression
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Late Initiation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place