Trial Outcomes & Findings for Effect of Infant Formula on Energy Balance (NCT NCT01700205)
NCT ID: NCT01700205
Last Updated: 2019-11-22
Results Overview
At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length (WLZ) Zscores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
113 participants
Primary outcome timeframe
0.5 to 12.5 months with followup visit at 18.5 mos
Results posted on
2019-11-22
Participant Flow
From 2012 to 2015, newly parturient women whose decision not to lactate was firmly established were recruited through ads in regional newspapers, websites and hospitals in the greater Philadelphia area.
Participant milestones
| Measure |
Type of Formula: CMF
infant is randomized to feed standard cow milk formula during first year of life
Type of Formula: infant formula
|
Type of Formula: EHF
infant is randomized to feed extensively hydrolyzed infant formula during first year of life
Type of Formula: infant formula
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
54
|
|
Overall Study
COMPLETED
|
44
|
39
|
|
Overall Study
NOT COMPLETED
|
15
|
15
|
Reasons for withdrawal
| Measure |
Type of Formula: CMF
infant is randomized to feed standard cow milk formula during first year of life
Type of Formula: infant formula
|
Type of Formula: EHF
infant is randomized to feed extensively hydrolyzed infant formula during first year of life
Type of Formula: infant formula
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
13
|
|
Overall Study
Protocol Violation
|
2
|
2
|
Baseline Characteristics
Effect of Infant Formula on Energy Balance
Baseline characteristics by cohort
| Measure |
Type of Formula: CMF
n=59 Participants
infant is randomized to feed standard cow milk infant formula \[CMF\] during first year of life
Type of Formula: infant formula
|
Type of Formula: EHF
n=54 Participants
infant is randomized to feed extensively hydrolyzed protein infant formula \[EHF\] first year of life
Type of Formula: infant formula
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
0.4 Months
STANDARD_DEVIATION 0.1 • n=5 Participants
|
0.4 Months
STANDARD_DEVIATION 0.1 • n=7 Participants
|
0.4 Months
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
54 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
TAS2R38 genotype, A49P allele; infants
AA, homozygous recessive
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
TAS2R38 genotype, A49P allele; infants
AP, heterozygous
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
TAS2R38 genotype, A49P allele; infants
PP, homozygous dominant
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0.5 to 12.5 months with followup visit at 18.5 mosPopulation: We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.
At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length (WLZ) Zscores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).
Outcome measures
| Measure |
Type of Formula: CMF
n=59 Participants
Infant is randomized to be fed standard cow milk formula during first year of life
Type of Formula: CMF
|
Type of Formula: EHF
n=54 Participants
Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life
Type of Formula: EHF
|
|---|---|---|
|
Growth, Weight for Length (WLZ) Z Scores
Weight for Length Z, 0.5 mos
|
-0.26 Z score
Standard Error 0.13
|
-0.12 Z score
Standard Error 0.13
|
|
Growth, Weight for Length (WLZ) Z Scores
Weight for Length Z, 18.5 mos
|
0.80 Z score
Standard Error 0.14
|
0.68 Z score
Standard Error 0.15
|
|
Growth, Weight for Length (WLZ) Z Scores
Weight for Length Z, 0.75 mos
|
-0.12 Z score
Standard Error 0.13
|
0.13 Z score
Standard Error 0.13
|
|
Growth, Weight for Length (WLZ) Z Scores
Weight for Length Z, 1.5 mos
|
0.24 Z score
Standard Error 0.13
|
-0.17 Z score
Standard Error 0.13
|
|
Growth, Weight for Length (WLZ) Z Scores
Weight for Length Z, 2.5 mos
|
0.24 Z score
Standard Error 0.13
|
-0.17 Z score
Standard Error 0.13
|
|
Growth, Weight for Length (WLZ) Z Scores
Weight for Length Z, 3.5 mos
|
0.22 Z score
Standard Error 0.13
|
-0.38 Z score
Standard Error 0.14
|
|
Growth, Weight for Length (WLZ) Z Scores
Weight for Length Z, 4.5 mos
|
0.39 Z score
Standard Error 0.13
|
-0.24 Z score
Standard Error 0.14
|
|
Growth, Weight for Length (WLZ) Z Scores
Weight for Length Z, 5.5 mos
|
0.42 Z score
Standard Error 0.14
|
-0.36 Z score
Standard Error 0.14
|
|
Growth, Weight for Length (WLZ) Z Scores
Weight for Length Z, 6.5 mos
|
0.52 Z score
Standard Error 0.14
|
0.18 Z score
Standard Error 0.14
|
|
Growth, Weight for Length (WLZ) Z Scores
Weight for Length Z, 7.5 mos
|
0.59 Z score
Standard Error 0.14
|
0.20 Z score
Standard Error 0.14
|
|
Growth, Weight for Length (WLZ) Z Scores
Weight for Length Z, 8.5 mos
|
0.76 Z score
Standard Error 0.14
|
0.29 Z score
Standard Error 0.14
|
|
Growth, Weight for Length (WLZ) Z Scores
Weight for Length Z, 9.5 mos
|
0.71 Z score
Standard Error 0.14
|
0.40 Z score
Standard Error 0.14
|
|
Growth, Weight for Length (WLZ) Z Scores
Weight for Length Z, 10.5 mos
|
0.76 Z score
Standard Error 0.14
|
0.46 Z score
Standard Error 0.14
|
|
Growth, Weight for Length (WLZ) Z Scores
Weight for Length Z, 11.5 mos
|
0.72 Z score
Standard Error 0.14
|
0.51 Z score
Standard Error 0.14
|
|
Growth, Weight for Length (WLZ) Z Scores
Weight for Length Z, 12.5 mos
|
0.70 Z score
Standard Error 0.14
|
0.52 Z score
Standard Error 0.14
|
PRIMARY outcome
Timeframe: 0.5 to 12.5 months with followup visit at 18.5 mosPopulation: We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.
At each visit, infants were weighed to monitor normal growth. These anthropometric data were converted to Weight for age Z (WAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).
Outcome measures
| Measure |
Type of Formula: CMF
n=59 Participants
Infant is randomized to be fed standard cow milk formula during first year of life
Type of Formula: CMF
|
Type of Formula: EHF
n=54 Participants
Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life
Type of Formula: EHF
|
|---|---|---|
|
Growth, Weight for Age (WAZ) Z Score
Weight for Age Z score, 2.5 mos
|
-0.34 Z score
Standard Error 0.12
|
-0.66 Z score
Standard Error 0.13
|
|
Growth, Weight for Age (WAZ) Z Score
Weight for Age Z score, 4.5 mos
|
0.07 Z score
Standard Error 0.13
|
-0.37 Z score
Standard Error 0.13
|
|
Growth, Weight for Age (WAZ) Z Score
Weight for Age Z score, 7.5 mos
|
0.38 Z score
Standard Error 0.13
|
0.02 Z score
Standard Error 0.13
|
|
Growth, Weight for Age (WAZ) Z Score
Weight for Age Z score, 8.5 mos
|
0.50 Z score
Standard Error 0.13
|
0.08 Z score
Standard Error 0.13
|
|
Growth, Weight for Age (WAZ) Z Score
Weight for Age Z score, 9.5 mos
|
0.51 Z score
Standard Error 0.13
|
0.16 Z score
Standard Error 0.13
|
|
Growth, Weight for Age (WAZ) Z Score
Weight for Age Z score, 12.5 mos
|
0.52 Z score
Standard Error 0.13
|
0.32 Z score
Standard Error 0.13
|
|
Growth, Weight for Age (WAZ) Z Score
Weight for Age Z score, 18.5 mos
|
0.56 Z score
Standard Error 0.14
|
0.40 Z score
Standard Error 0.15
|
|
Growth, Weight for Age (WAZ) Z Score
Weight for Age Z score, 0.5 mos
|
-0.36 Z score
Standard Error 0.12
|
-0.25 Z score
Standard Error 0.13
|
|
Growth, Weight for Age (WAZ) Z Score
Weight for Age Z score, 0.75 mos
|
-0.41 Z score
Standard Error 0.12
|
-0.28 Z score
Standard Error 0.13
|
|
Growth, Weight for Age (WAZ) Z Score
Weight for Age Z score, 1.5 mos
|
-0.38 Z score
Standard Error 0.12
|
-0.61 Z score
Standard Error 0.13
|
|
Growth, Weight for Age (WAZ) Z Score
Weight for Age Z score, 3.5 mos
|
-0.14 Z score
Standard Error 0.12
|
0.64 Z score
Standard Error 0.13
|
|
Growth, Weight for Age (WAZ) Z Score
Weight for Age Z score, 5.5 mos
|
0.18 Z score
Standard Error 0.13
|
-0.20 Z score
Standard Error 0.13
|
|
Growth, Weight for Age (WAZ) Z Score
Weight for Age Z score, 6.5 mos
|
0.29 Z score
Standard Error 0.13
|
-0.03 Z score
Standard Error 0.13
|
|
Growth, Weight for Age (WAZ) Z Score
Weight for Age Z score, 10.5 mos
|
0.54 Z score
Standard Error 0.13
|
0.20 Z score
Standard Error 0.13
|
|
Growth, Weight for Age (WAZ) Z Score
Weight for Age Z score, 11.5 mos
|
0.52 Z score
Standard Error 0.13
|
0.28 Z score
Standard Error 0.13
|
|
Growth, Weight for Age (WAZ) Z Score
Length for Age Z score, 18.5 mos
|
-0.07 Z score
Standard Error 0.14
|
-0.22 Z score
Standard Error 0.16
|
PRIMARY outcome
Timeframe: 0.5 to 12.5 months with followup visit at 18.5 mosPopulation: We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.
At each visit, infants were measured to monitor normal growth. These anthropometric data were converted to Length for age Z (LAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).
Outcome measures
| Measure |
Type of Formula: CMF
n=59 Participants
Infant is randomized to be fed standard cow milk formula during first year of life
Type of Formula: CMF
|
Type of Formula: EHF
n=54 Participants
Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life
Type of Formula: EHF
|
|---|---|---|
|
Growth: Length for Age (LAZ) Z Scores
Length for Age Z score, 0.5 mos
|
-0.49 Z score
Standard Error 0.14
|
-0.46 Z score
Standard Error 0.14
|
|
Growth: Length for Age (LAZ) Z Scores
Length for Age Z score, 4.5 mos
|
-0.26 Z score
Standard Error 0.14
|
-0.21 Z score
Standard Error 0.15
|
|
Growth: Length for Age (LAZ) Z Scores
Length for Age Z score, 6.5 mos
|
-0.05 Z score
Standard Error 0.14
|
-0.17 Z score
Standard Error 0.15
|
|
Growth: Length for Age (LAZ) Z Scores
Length for Age Z score, 11.5 mos
|
0.00 Z score
Standard Error 0.14
|
-0.18 Z score
Standard Error 0.15
|
|
Growth: Length for Age (LAZ) Z Scores
Length for Age Z score, 12.5 mos
|
0.03 Z score
Standard Error 0.14
|
-0.13 Z score
Standard Error 0.15
|
|
Growth: Length for Age (LAZ) Z Scores
Length for Age Z score, 18.5 mos
|
-0.07 Z score
Standard Error 0.14
|
-0.22 Z score
Standard Error 0.16
|
|
Growth: Length for Age (LAZ) Z Scores
Length for Age Z score, 0.75 mos
|
-0.56 Z score
Standard Error 0.14
|
0.59 Z score
Standard Error 0.14
|
|
Growth: Length for Age (LAZ) Z Scores
Length for Age Z score, 1.5 mos
|
-0.55 Z score
Standard Error 0.14
|
-0.48 Z score
Standard Error 0.14
|
|
Growth: Length for Age (LAZ) Z Scores
Length for Age Z score, 2.5 mos
|
-0.57 Z score
Standard Error 0.14
|
-0.62 Z score
Standard Error 0.14
|
|
Growth: Length for Age (LAZ) Z Scores
Length for Age Z score, 3.5mos
|
-0.36 Z score
Standard Error 0.14
|
-0.43 Z score
Standard Error 0.15
|
|
Growth: Length for Age (LAZ) Z Scores
Length for Age Z score, 5.5 mos
|
-0.13 Z score
Standard Error 0.14
|
-0.17 Z score
Standard Error 0.15
|
|
Growth: Length for Age (LAZ) Z Scores
Length for Age Z score, 7.5 mos
|
0.01 Z score
Standard Error 0.14
|
-0.11 Z score
Standard Error 0.15
|
|
Growth: Length for Age (LAZ) Z Scores
Length for Age Z score, 8.5 mos
|
-0.02 Z score
Standard Error 0.14
|
-0.16 Z score
Standard Error 0.15
|
|
Growth: Length for Age (LAZ) Z Scores
Length for Age Z score, 9.5 mos
|
0.01 Z score
Standard Error 0.14
|
-0.19 Z score
Standard Error 0.15
|
|
Growth: Length for Age (LAZ) Z Scores
Length for Age Z score, 10.5 mos
|
0.01 Z score
Standard Error 0.14
|
-0.21 Z score
Standard Error 0.15
|
PRIMARY outcome
Timeframe: 0.75, 3.5, 12.5 mosPopulation: Intent-to-treat analysis (N=113).
Energy intake (kcal/day) of infant formula and other sources was determined by three-day weighed bottle intake and records of the infants' intake of any liquid or food other than formula during the three days
Outcome measures
| Measure |
Type of Formula: CMF
n=59 Participants
Infant is randomized to be fed standard cow milk formula during first year of life
Type of Formula: CMF
|
Type of Formula: EHF
n=54 Participants
Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life
Type of Formula: EHF
|
|---|---|---|
|
Energy Balance: Energy Intake From Infant Formula and Other Sources
Energy Intake from Formula, 12.5 mos
|
425 kcal per day
Standard Error 50
|
284 kcal per day
Standard Error 56
|
|
Energy Balance: Energy Intake From Infant Formula and Other Sources
Energy Intake from Other Sources, 12.5 mos
|
712 kcal per day
Standard Error 51
|
863 kcal per day
Standard Error 57
|
|
Energy Balance: Energy Intake From Infant Formula and Other Sources
Energy Intake from Formula, 0.75 months
|
466 kcal per day
Standard Error 14
|
383 kcal per day
Standard Error 15
|
|
Energy Balance: Energy Intake From Infant Formula and Other Sources
Energy Intake from Other Sources, 0.75 months
|
0 kcal per day
Standard Error 0
|
0 kcal per day
Standard Error 0
|
|
Energy Balance: Energy Intake From Infant Formula and Other Sources
Energy Intake from Formula, 3.5 mos
|
628 kcal per day
Standard Error 21
|
596 kcal per day
Standard Error 21
|
|
Energy Balance: Energy Intake From Infant Formula and Other Sources
Energy Intake from Other Sources, 3.5 mos
|
11 kcal per day
Standard Error 5
|
10 kcal per day
Standard Error 6
|
PRIMARY outcome
Timeframe: 0.75, 3.5, 12.5 mosPopulation: Intent-to-treat analysis (N=113).
Postprandial SEE (kcal/day), a proxy for resting energy expenditure in infant, was measured for a minimum of 30 min by open-circuit, indirect calorimetry using a metabolic cart with canopy hood, in a quiet, thermal-neutral room.
Outcome measures
| Measure |
Type of Formula: CMF
n=59 Participants
Infant is randomized to be fed standard cow milk formula during first year of life
Type of Formula: CMF
|
Type of Formula: EHF
n=54 Participants
Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life
Type of Formula: EHF
|
|---|---|---|
|
Energy Balance: Sleeping Energy Expenditure (SEE)
Sleeping Energy Expenditure (0.75 months)
|
206 kcal per day
Standard Error 6
|
201 kcal per day
Standard Error 6
|
|
Energy Balance: Sleeping Energy Expenditure (SEE)
Sleeping Energy Expenditure, 3.5 months
|
329 kcal per day
Standard Error 8
|
321 kcal per day
Standard Error 8
|
|
Energy Balance: Sleeping Energy Expenditure (SEE)
Sleeping Energy Expenditure, 12.5 months
|
507 kcal per day
Standard Error 11
|
509 kcal per day
Standard Error 11
|
PRIMARY outcome
Timeframe: 0.75, 3.5, 12.5 mosPopulation: Intent-to-treat analysis (N=113).
TEE (kcal/day) was measured over 7 days at each of the three time points (0.75, 3.5 and12.5 mos) using the doubly labeled water method
Outcome measures
| Measure |
Type of Formula: CMF
n=59 Participants
Infant is randomized to be fed standard cow milk formula during first year of life
Type of Formula: CMF
|
Type of Formula: EHF
n=54 Participants
Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life
Type of Formula: EHF
|
|---|---|---|
|
Energy Balance: Total Energy Expenditure (TEE)
Total energy expenditure, 0.75 months
|
283 kcal per day
Standard Error 18
|
243 kcal per day
Standard Error 19
|
|
Energy Balance: Total Energy Expenditure (TEE)
Total energy expenditure, 3.5 months
|
488 kcal per day
Standard Error 24
|
444 kcal per day
Standard Error 26
|
|
Energy Balance: Total Energy Expenditure (TEE)
Total energy expenditure, 12.5 months
|
859 kcal per day
Standard Error 42
|
858 kcal per day
Standard Error 45
|
PRIMARY outcome
Timeframe: 0.75, 3.5, 12.5 mosPopulation: Intent-to-treat analysis (N=113).
Stool EL (kcal/day) was determined from 3-day stool collection by bomb calorimetry at each timepoint
Outcome measures
| Measure |
Type of Formula: CMF
n=59 Participants
Infant is randomized to be fed standard cow milk formula during first year of life
Type of Formula: CMF
|
Type of Formula: EHF
n=54 Participants
Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life
Type of Formula: EHF
|
|---|---|---|
|
Energy Balance: Energy Loss in Stools
Energy Loss in Stools, 3.5 months
|
20.7 kcal per day
Standard Error 1.8
|
17.0 kcal per day
Standard Error 1.9
|
|
Energy Balance: Energy Loss in Stools
Energy Loss in Stools, 0.75 months
|
22.3 kcal per day
Standard Error 3.9
|
34.9 kcal per day
Standard Error 4.1
|
|
Energy Balance: Energy Loss in Stools
Energy Loss in Stools, 12.5 months
|
27.1 kcal per day
Standard Error 3.2
|
33.8 kcal per day
Standard Error 3.4
|
SECONDARY outcome
Timeframe: 0.5 monthsPopulation: Some mothers responded N/A on questions related to restrictive feeding styles and thus score for this subscale could not be computed.
Maternal perception of infant feeding behavior, using standardized questionnaires (Infant feeding style questionnaire; IFSQ); values ranged from 1 to 5; higher scores reflect more of that feeding style. Only baseline data reported herein.
Outcome measures
| Measure |
Type of Formula: CMF
n=59 Participants
Infant is randomized to be fed standard cow milk formula during first year of life
Type of Formula: CMF
|
Type of Formula: EHF
n=54 Participants
Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life
Type of Formula: EHF
|
|---|---|---|
|
Feeding Behaviors, Maternal Perceptions
Laissez-Faire Feeding Style, 0.5 mos
|
3.1 Units on a scale
Standard Error 0.1
|
3.0 Units on a scale
Standard Error 0.1
|
|
Feeding Behaviors, Maternal Perceptions
Restrictive Feeding Style, 0.5 mos
|
2.8 Units on a scale
Standard Error 0.1
|
2.6 Units on a scale
Standard Error 0.2
|
|
Feeding Behaviors, Maternal Perceptions
Responsive Feeding Styly, 0.5 mos
|
4.1 Units on a scale
Standard Error 0.1
|
4.0 Units on a scale
Standard Error 0.1
|
|
Feeding Behaviors, Maternal Perceptions
Pressure to Eat Feeding Style, 0.5 mos
|
2.2 Units on a scale
Standard Error 0.1
|
2.4 Units on a scale
Standard Error 0.1
|
Adverse Events
Type of Formula: CMF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Type of Formula: EHF
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