Trial Outcomes & Findings for Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot) (NCT NCT03568643)

NCT ID: NCT03568643

Last Updated: 2022-09-01

Results Overview

Weight will be measured at all follow-up time points and weight gain will be calculated at 8 weeks

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 301 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2022-09-01

Participant Flow

Participant milestones

Measure	Azithromycin children in this arm will receive one dose of azithromycin Azithromycin: Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.	Amoxicillin Children in this arm will receive a 7 day course of amoxicillin (standard of care) Amoxicillin: Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
Overall Study STARTED	161	140
Overall Study COMPLETED	161	140
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)

Baseline characteristics by cohort

Measure	Azithromycin n=161 Participants children in this arm will receive one dose of azithromycin Azithromycin: Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.	Amoxicillin n=140 Participants Children in this arm will receive a 7 day course of amoxicillin (standard of care) Amoxicillin: Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Total n=301 Participants Total of all reporting groups
Age, Categorical <=18 years	161 Participants n=5 Participants	140 Participants n=7 Participants	301 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	16.9 months STANDARD_DEVIATION 8.4 • n=5 Participants	16.5 months STANDARD_DEVIATION 8.2 • n=7 Participants	16.7 months STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	77 Participants n=7 Participants	169 Participants n=5 Participants
Sex: Female, Male Male	69 Participants n=5 Participants	63 Participants n=7 Participants	132 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	161 Participants n=5 Participants	140 Participants n=7 Participants	301 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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 Burkina Faso	161 participants n=5 Participants	140 participants n=7 Participants	301 participants n=5 Participants
Curently breastfeeding	108 Participants n=5 Participants	104 Participants n=7 Participants	212 Participants n=5 Participants
Exclusively breastfeeding	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Number of children under 5 in the household	2 Children STANDARD_DEVIATION 1.7 • n=5 Participants	1.9 Children STANDARD_DEVIATION 1.5 • n=7 Participants	1.9 Children STANDARD_DEVIATION 1.6 • n=5 Participants
Mother's age	26 years STANDARD_DEVIATION 6.2 • n=5 Participants	26.2 years STANDARD_DEVIATION 6 • n=7 Participants	26.1 years STANDARD_DEVIATION 6.1 • n=5 Participants
Weight	6.8 Kg STANDARD_DEVIATION 1.3 • n=5 Participants	6.6 Kg STANDARD_DEVIATION 1.3 • n=7 Participants	6.7 Kg STANDARD_DEVIATION 1.3 • n=5 Participants
Height	72.2 cm STANDARD_DEVIATION 6.6 • n=5 Participants	71.6 cm STANDARD_DEVIATION 6.6 • n=7 Participants	71.9 cm STANDARD_DEVIATION 6.6 • n=5 Participants
MUAC (Middle Upper Arm Circumference)	11.2 cm STANDARD_DEVIATION 0.4 • n=5 Participants	11.2 cm STANDARD_DEVIATION 0.5 • n=7 Participants	11.2 cm STANDARD_DEVIATION 0.5 • n=5 Participants
HAZ (Height for Age Z-score)	-2.4 Z score STANDARD_DEVIATION 1.5 • n=5 Participants	-2.5 Z score STANDARD_DEVIATION 1.6 • n=7 Participants	-2.4 Z score STANDARD_DEVIATION 1.6 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: All children who were followed up to 8 weeks. This analysis excludes 19 children who were lost to follow-up before 8 weeks.

Weight will be measured at all follow-up time points and weight gain will be calculated at 8 weeks

Outcome measures

Measure	Azithromycin n=150 Participants children in this arm will receive one dose of azithromycin Azithromycin: Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.	Amoxicillin n=132 Participants Children in this arm will receive a 7 day course of amoxicillin (standard of care) Amoxicillin: Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
Weight Gain	1.8 g/kg/day Standard Deviation 2.1	2.0 g/kg/day Standard Deviation 2.2

SECONDARY outcome

Timeframe: 8 weeks

Population: All children who were followed up to 8 weeks. This analysis excludes 19 children who were lost to follow-up before 8 weeks.

Nutritional recovery is defined as, depending on admission criteria: weight-for-height/length is equal to or more than -2 Z-score and the child have had no oedema for at least 2 weeks, or the mid-upper-arm circumference is equal to or more than 125 mm and the child have had no oedema for at least 2 weeks.

Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards:

Stunted is length/height-for-age below the -2 z-score line. Severely stunted is below the -3 z-score line

Outcome measures

Measure	Azithromycin n=150 Participants children in this arm will receive one dose of azithromycin Azithromycin: Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.	Amoxicillin n=132 Participants Children in this arm will receive a 7 day course of amoxicillin (standard of care) Amoxicillin: Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
Nutritional Recovery - Primary Definition	56 Participants	48 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: All children who were followed up to 8 weeks. This analysis excludes 19 children who were lost to follow-up before 8 weeks.

Summarize the cumulative proportion recovered by arm. Children are considered recovered if they had mean upper arm circumference > 12.5 or weight-for-height/length > -2 for 2 consecutive measurements. Additionally, it includes children who had had mean upper arm circumference >12.5 or weight-for-height/length > -2 on their final measurement, regardless of whether they met these criteria on the previous visit.

Outcome measures

Measure	Azithromycin n=150 Participants children in this arm will receive one dose of azithromycin Azithromycin: Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.	Amoxicillin n=132 Participants Children in this arm will receive a 7 day course of amoxicillin (standard of care) Amoxicillin: Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
Nutritional Recovery - Secondary Definition	98 Participants	87 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: All children who were followed up to 8 weeks. This analysis excludes 19 children who were lost to follow-up before 8 weeks.

Rapid diagnostic tests for malaria will be conducted at baseline and week 8 to determine malaria infection status.

Outcome measures

Measure	Azithromycin n=150 Participants children in this arm will receive one dose of azithromycin Azithromycin: Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.	Amoxicillin n=132 Participants Children in this arm will receive a 7 day course of amoxicillin (standard of care) Amoxicillin: Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
Malaria	13 Participants	15 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: All children who were followed up to 8 weeks. This analysis excludes 19 children who were lost to follow-up before 8 weeks.

Vital status will be assessed at all follow-up time points and mortality will be defined as death during the study period.

Outcome measures

Measure	Azithromycin n=150 Participants children in this arm will receive one dose of azithromycin Azithromycin: Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.	Amoxicillin n=132 Participants Children in this arm will receive a 7 day course of amoxicillin (standard of care) Amoxicillin: Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
Mortality	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: All children who were followed up to 8 weeks. This analysis excludes 19 children who were lost to follow-up before 8 weeks.

Height or length will be measured at all follow-up time points and height-for-age z-scores will be calculated.

A z-score of 0 represents the population mean. The z-score will be positive if the data value lies above the mean, and negative if the data value lies below the mean.

Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards:

Stunted is length/height-for-age below the -2 z-score line. Severely stunted is below the -3 z-score line

Outcome measures

Measure	Azithromycin n=150 Participants children in this arm will receive one dose of azithromycin Azithromycin: Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.	Amoxicillin n=132 Participants Children in this arm will receive a 7 day course of amoxicillin (standard of care) Amoxicillin: Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
Length/Height-for-age Z-score (LAZ/HAZ)	-2.3 Z-score Standard Deviation 1.5	-2.37 Z-score Standard Deviation 1.5

SECONDARY outcome

Timeframe: 8 weeks

Population: All children who were followed up to 8 weeks. This analysis excludes 19 children who were lost to follow-up before 8 weeks.

Mid-upper arm circumference will be measured at all follow-up time points

Outcome measures

Measure	Azithromycin n=150 Participants children in this arm will receive one dose of azithromycin Azithromycin: Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.	Amoxicillin n=132 Participants Children in this arm will receive a 7 day course of amoxicillin (standard of care) Amoxicillin: Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
Mid-Upper Arm Circumference (MUAC)	12.4 cm Standard Deviation 0.8	12.3 cm Standard Deviation 0.8

SECONDARY outcome

Timeframe: 8 weeks

Population: All children who were followed up to 8 weeks. This analysis excludes 19 children who were lost to follow-up before 8 weeks.

Weight will be measured at all follow-up time points and weight-for-age z-scores will be calculated.

A z-score of 0 represents the population mean. The z-score will be positive if the data value lies above the mean, and negative if the data value lies below the mean.

Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards:

Underweight is weight-for-age below the -2 z-score line. Severely underweight is below the -3 z-score line.

Outcome measures

Measure	Azithromycin n=150 Participants children in this arm will receive one dose of azithromycin Azithromycin: Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.	Amoxicillin n=132 Participants Children in this arm will receive a 7 day course of amoxicillin (standard of care) Amoxicillin: Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
Weight-for-Age Z-scores (WAZ)	-2.58 Z-score Standard Deviation 1.1	-2.65 Z-score Standard Deviation 1.1

SECONDARY outcome

Timeframe: 8 weeks

Population: All children who were followed up to 8 weeks. This analysis excludes 19 children who were lost to follow-up before 8 weeks.

Weight and height, assessed at all follow-up time points, will be used to calculate weight-for-height z-scores.

A z-score of 0 represents the population mean. The z-score will be positive if the data value lies above the mean, and negative if the data value lies below the mean.

Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards:

Overweight is weight-for-length/height above the 2 z-score line. Severely overweight; weight-for-length/height above the 3 z-score line

Outcome measures

Measure	Azithromycin n=150 Participants children in this arm will receive one dose of azithromycin Azithromycin: Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.	Amoxicillin n=132 Participants Children in this arm will receive a 7 day course of amoxicillin (standard of care) Amoxicillin: Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
Weight-for-Height Z-score (WHZ)	-1.89 Z-score Standard Deviation 1.2	-1.95 Z-score Standard Deviation 1.0

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Population: Children who had a rectal swab collected at baseline and at 8 weeks.

baseline and 8 week intestinal microbiome will be compared between the 2 arms alpha diversity using inverse Simpson's index and Shannon's index, expressed in effective number.

The Shannon Diversity Index is a quantitative measure that reflects how many different bacterial species there are in a sample. The greater the index, the more diverse the gut microbiota. An index of 0 indicates a community that only has one species. A negative change indicates a decrease in diversity and a positive change indicates an increase in diversity.

The Simpson's Diversity Index is a measure of diversity which takes into account the number of species present, as well as the relative abundance of each species. As species richness and evenness increase, so diversity increases. The value ranges between 0 and 1, where 1 represents infinite diversity and 0, no diversity.

Outcome measures

Measure	Azithromycin n=49 Participants children in this arm will receive one dose of azithromycin Azithromycin: Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.	Amoxicillin n=46 Participants Children in this arm will receive a 7 day course of amoxicillin (standard of care) Amoxicillin: Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
Intestinal Microbiome Baseline Shannon's Index	6.6 Index Standard Deviation 4.4	8.3 Index Standard Deviation 5.6
Intestinal Microbiome Week 8 Simpson's Index	4.5 Index Standard Deviation 2.8	5.3 Index Standard Deviation 2.9
Intestinal Microbiome Baseline Simpson's Index	4.0 Index Standard Deviation 2.6	5.1 Index Standard Deviation 3.5
Intestinal Microbiome Week 8 Shannon's Index	7.5 Index Standard Deviation 4.6	9.1 Index Standard Deviation 5.8

Adverse Events

Azithromycin

Serious events: 41 serious events

Other events: 106 other events

Deaths: 2 deaths

Amoxicillin

Serious events: 43 serious events

Other events: 100 other events

Deaths: 1 deaths

Serious adverse events

Measure	Azithromycin n=161 participants at risk children in this arm will receive one dose of azithromycin Azithromycin: Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.	Amoxicillin n=140 participants at risk Children in this arm will receive a 7 day course of amoxicillin (standard of care) Amoxicillin: Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
Surgical and medical procedures Hospitalization	1.2% 2/161 • Number of events 2 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.	2.1% 3/140 • Number of events 4 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.
Surgical and medical procedures Clinic visit	25.5% 41/161 • Number of events 59 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.	30.0% 42/140 • Number of events 58 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.
Cardiac disorders Death	1.2% 2/161 • Number of events 2 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.	0.71% 1/140 • Number of events 1 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.

Other adverse events

Measure	Azithromycin n=161 participants at risk children in this arm will receive one dose of azithromycin Azithromycin: Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.	Amoxicillin n=140 participants at risk Children in this arm will receive a 7 day course of amoxicillin (standard of care) Amoxicillin: Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
Infections and infestations fever	50.9% 82/161 • Number of events 131 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.	57.1% 80/140 • Number of events 134 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.
Gastrointestinal disorders Diarrhea	28.6% 46/161 • Number of events 62 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.	31.4% 44/140 • Number of events 62 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.
Gastrointestinal disorders Vomiting	20.5% 33/161 • Number of events 42 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.	16.4% 23/140 • Number of events 33 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.
Gastrointestinal disorders Abdominal pain	4.3% 7/161 • Number of events 8 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.	4.3% 6/140 • Number of events 7 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.
Skin and subcutaneous tissue disorders skin rash	4.3% 7/161 • Number of events 10 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.	11.4% 16/140 • Number of events 22 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.
Gastrointestinal disorders constipation	4.3% 7/161 • Number of events 8 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.	5.0% 7/140 • Number of events 9 • 8 weeks Cumulative number of adverse event incidences over a period of 8 weeks.

Additional Information

Dr Catherine Oldenburg

UCSF FI Proctor Foundation

Phone: (415) 502-8843

Email: catherine.oldenburg@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place