A Study to Evaluate the Safety and Efficacy of JNJ-645651... | NCT03486392

NCT03486392

ID	Type	Description	Link
64565111OBE2001	Other Identifier	Janssen Research & Development, LLC
2017-003616-39	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Double-Blind: JNJ-64565111 Dose Level 1	Experimental	Participants will receive a JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 26-week treatment phase.	Drug: JNJ-64565111 Dose Level 1
Double-Blind: JNJ-64565111 Dose Level 2	Experimental	Participants will receive a JNJ-64565111 Dose Level 2 SC once-weekly for 26-week treatment phase.	Drug: JNJ-64565111 Dose Level 2
Double-Blind: JNJ-64565111 Dose Level 3	Experimental	Participants will receive a JNJ-64565111 Dose Level 3 SC once-weekly for 26-week treatment phase.	Drug: JNJ-64565111 Dose Level 3
Double-Blind: Placebo	Placebo Comparator	Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 26-week treatment phase.	Drug: Placebo
Open-Label: 3.0 milligram (mg) Liraglutide	Active Comparator	Participant will receive once-daily doses of 0.6, 1.2, 1.8, 2.4, or 3.0 mg. The participants will receive liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1. Participants will be instructed to increase the dose of liraglutide by 0.6 mg dose increment every 7 days, up to the full dosage of 3.0 mg by Week 5. Participants will then continue on the 3.0 mg once-daily dosage until Week 26.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JNJ-64565111 Dose Level 1	Drug	Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.	Double-Blind: JNJ-64565111 Dose Level 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Body Weight at Week 26	Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.	Baseline, Week 26
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A TEAE was defined as an AE with an onset after the initiation study drug and before the last study drug date of the double-blind (26-week) treatment phase for plus 28 days for liraglutide participants, and plus 35 days for JNJ-64565111 and placebo participants.	Up to Week 30

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26	Number of participants with >= 5% body weight loss from baseline to Week 26 were reported.	Week 26
Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Central Phoenix Medical Clinic		Phoenix	Arizona	85020	United States
Diablo Clinical Research, Inc.

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Double Blind: Placebo	Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
FG001	Double Blind: JNJ-64565111 5.0 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 23, 2018	Jan 14, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Double Blind: Placebo	Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
BG001	Double Blind: JNJ-64565111 5.0 mg	Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
BG002	Double Blind: JNJ-64565111 7.4 mg	Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
BG003	Double Blind: JNJ-64565111 10.0 mg	Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
BG004	Open Label: Liraglutide 3.0 mg	Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00046.9± 11.84 BG00147.3± 11.18 BG00246.2± 11.68 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00048 BG00147 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0003 BG0015 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

BELGIUM

Title	Measurements
	BG0007 BG0015 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent Change From Baseline in Body Weight at Week 26

Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.

Modified intent-to-treat (mITT) population included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population. N (number of participants analyzed) = participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Week 26

ID	Title	Description
OG000	Double Blind: Placebo	Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
OG001	Double Blind: JNJ-64565111 5.0 mg	Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
OG002	Double Blind: JNJ-64565111 7.4 mg	Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
OG003	Double Blind: JNJ-64565111 10.0 mg	Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
OG004	Open Label: Liraglutide 3.0 mg	Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.

Units	Counts
Participants	OG00060 OG00158 OG002109 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-1.76± 0.73 OG001-8.51± 0.76 OG002-9.83± 0.56 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Dunnett's method		< 0.001		Difference of least square (LS) Means	-6.75	Standard Error of the Mean	1.056	2-Sided	95	-9.31	-4.19					Superiority
OG000 OG002		Dunnett's method

Primary

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A TEAE was defined as an AE with an onset after the initiation study drug and before the last study drug date of the double-blind (26-week) treatment phase for plus 28 days for liraglutide participants, and plus 35 days for JNJ-64565111 and placebo participants.

Safety analysis set included all randomized participants who had received at least one dose of study drug.

Posted

Count of Participants

Participants

Up to Week 30

ID	Title	Description
OG000	Double Blind: Placebo	Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
OG001	Double Blind: JNJ-64565111 5.0 mg	Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.

Secondary

Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26

Number of participants with >= 5% body weight loss from baseline to Week 26 were reported.

mITT population included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population.

Posted

Count of Participants

Participants

Week 26

ID	Title	Description
OG000	Double Blind: Placebo	Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
OG001	Double Blind: JNJ-64565111 5.0 mg	Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
OG002	Double Blind: JNJ-64565111 7.4 mg	Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.

Secondary

Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26

Number of participants with >= 10 % body weight loss from baseline to Week 26 were reported.

Posted

Count of Participants

Participants

Week 26

ID	Title	Description
OG000	Double Blind: Placebo	Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
OG001	Double Blind: JNJ-64565111 5.0 mg	Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
OG002	Double Blind: JNJ-64565111 7.4 mg	Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.

Secondary

Change From Baseline in Body Weight at Week 26

Change from baseline in body weight at Week 26 was reported.

Posted

Least Squares Mean

Standard Error

Baseline, Week 26

ID	Title	Description
OG000	Double Blind: Placebo	Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
OG001	Double Blind: JNJ-64565111 5.0 mg	Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
OG002	Double Blind: JNJ-64565111 7.4 mg	Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Double Blind: Placebo	Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	0	60	4	60	33	60
EG001	Double Blind: JNJ-64565111 5.0 mg	Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	0	59	3	59	43	59
EG002	Double Blind: JNJ-64565111 7.4 mg	Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	0	118	2	118	106	118
EG003	Double Blind: JNJ-64565111 10.0 mg	Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	0	118	4	118	104	118
EG004	Open Label: Liraglutide 3.0 mg	Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.	1	119	4	119	81	119

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Myocardial Infarction	Cardiac disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected60 at risk EG0010 affected59 at risk EG0020 affected118 at risk EG0030 affected118 at risk EG0041 affected119 at risk
Stress Cardiomyopathy	Cardiac disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected60 at risk EG0010 affected59 at risk EG0021 affected118 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected60 at risk EG0011 affected59 at risk EG0020 affected118 at risk EG003
Pancreatitis Acute	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected60 at risk EG0010 affected59 at risk EG0020 affected118 at risk EG003
Umbilical Hernia	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected60 at risk EG0010 affected59 at risk EG0020 affected118 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected60 at risk EG0010 affected59 at risk EG0021 affected118 at risk EG003
Biliary Colic	Hepatobiliary disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected60 at risk EG0011 affected59 at risk EG0020 affected118 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected60 at risk EG0010 affected59 at risk EG0020 affected118 at risk EG003
Pneumonia	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected60 at risk EG0010 affected59 at risk EG0020 affected118 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected60 at risk EG0010 affected59 at risk EG0020 affected118 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected60 at risk EG0010 affected59 at risk EG0020 affected118 at risk EG003
Obesity	Metabolism and nutrition disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected60 at risk EG0010 affected59 at risk EG0020 affected118 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected60 at risk EG0010 affected59 at risk EG0020 affected118 at risk EG003
Abortion Spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected60 at risk EG0011 affected59 at risk EG0020 affected118 at risk EG003
Major Depression	Psychiatric disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected60 at risk EG0010 affected59 at risk EG0020 affected118 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected60 at risk EG0010 affected59 at risk EG0020 affected118 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Discomfort	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected60 at risk EG0013 affected59 at risk EG0020 affected118 at risk EG0033 affected118 at risk EG0041 affected119 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0002 affected60 at risk EG0014 affected59 at risk EG0026 affected118 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected60 at risk EG0012 affected59 at risk EG0028 affected118 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0002 affected60 at risk EG0012 affected59 at risk EG00210 affected118 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0003 affected60 at risk EG0017 affected59 at risk EG00220 affected118 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0003 affected60 at risk EG0018 affected59 at risk EG00224 affected118 at risk EG003
Dry Mouth	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected60 at risk EG0014 affected59 at risk EG0026 affected118 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0002 affected60 at risk EG0015 affected59 at risk EG00218 affected118 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected60 at risk EG0014 affected59 at risk EG00214 affected118 at risk EG003
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected60 at risk EG0015 affected59 at risk EG00213 affected118 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0004 affected60 at risk EG00130 affected59 at risk EG00280 affected118 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected60 at risk EG00112 affected59 at risk EG00247 affected118 at risk EG003
Fatigue	General disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0002 affected60 at risk EG0017 affected59 at risk EG00215 affected118 at risk EG003
Injection Site Bruising	General disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0004 affected60 at risk EG0012 affected59 at risk EG0021 affected118 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0003 affected60 at risk EG0011 affected59 at risk EG0021 affected118 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0009 affected60 at risk EG0015 affected59 at risk EG00211 affected118 at risk EG003
Pharyngitis	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0003 affected60 at risk EG0010 affected59 at risk EG0022 affected118 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0003 affected60 at risk EG0010 affected59 at risk EG0024 affected118 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0003 affected60 at risk EG0014 affected59 at risk EG00210 affected118 at risk EG003
Hepatic Enzyme Increased	Investigations	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected60 at risk EG0010 affected59 at risk EG0022 affected118 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected60 at risk EG00110 affected59 at risk EG00216 affected118 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected60 at risk EG0014 affected59 at risk EG0023 affected118 at risk EG003
Headache	Nervous system disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0006 affected60 at risk EG0017 affected59 at risk EG00220 affected118 at risk EG003

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000069450	Liraglutide

Ancestor Terms

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

EG0040 affected119 at risk

EG0041 affected119 at risk

EG0040 affected119 at risk

EG0041 affected119 at risk

EG0040 affected119 at risk

EG0041 affected119 at risk

EG0040 affected119 at risk

EG0047 affected119 at risk

EG0043 affected119 at risk

EG0048 affected119 at risk

EG00420 affected119 at risk

EG00427 affected119 at risk

EG0043 affected119 at risk

EG0049 affected119 at risk

EG0045 affected119 at risk

EG0049 affected119 at risk

EG00448 affected119 at risk

EG00420 affected119 at risk

EG0045 affected119 at risk

EG0041 affected119 at risk

EG00410 affected119 at risk

EG0043 affected119 at risk

EG0046 affected119 at risk

EG0045 affected119 at risk

EG0040 affected119 at risk

EG00410 affected119 at risk

EG0040 affected119 at risk

EG0049 affected119 at risk