Bivalent Norovirus Vaccine Study | NCT01168401 | Trialant
NCT01168401
Sponsor
Takeda
Status
Completed
Last Update Posted
Nov 23, 2018Actual
Enrollment
102Actual
Phase
Phase 1
Conditions
Gastroenteritis
Interventions
NoV GI.1/GII.4 Bivalent VLP Vaccine
Saline
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01168401
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
LV03-104
Secondary IDs
ID
Type
Description
Link
U1111-1187-1052
Registry Identifier
WHO
Brief Title
Bivalent Norovirus Vaccine Study
Official Title
Phase 1, Randomized Controlled Dose Escalation, Safety and Immunogenicity Study of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine Adjuvanted With Monophosphoryl Lipid A (MPL) and Aluminum Hydroxide [Al(OH)3] in Adults
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Apr 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 3, 2010Actual
Primary Completion Date
Jan 1, 2013Actual
Completion Date
Jan 9, 2013Actual
First Submitted Date
Jul 21, 2010
First Submission Date that Met QC Criteria
Jul 22, 2010
First Posted Date
Jul 23, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
May 4, 2017
Results First Submitted that Met QC Criteria
Apr 27, 2018
Results First Posted Date
Nov 23, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 27, 2018
Last Update Posted Date
Nov 23, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
TakedaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four dosage levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with MPL and Al(OH)3 compared to controls. Participants will receive two doses, by IM injection, 28 days apart.
The hypotheses for this study are:
The incidence of adverse events after vaccination with IM Norovirus Bivalent VLP Vaccine will be similar to the incidence of adverse events after other IM vaccines including CERVARIX® which contains MPL and Al(OH)3.
Two doses of IM Norovirus Bivalent VLP Vaccine will be more immunogenic than one dose.
The post-vaccination serum antibody responses, the number of antibody secreting cells (ASC), including homing markers, and memory B-cell responses directed against norovirus antigens will be increased after IM Norovirus Bivalent VLP Vaccine compared to controls.
Detailed Description
Not provided
Conditions Module
Conditions
Gastroenteritis
Keywords
Vaccine, norovirus, acute gastroenteritis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
102Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
NoV GI.1/GII.4 Bivalent VLP Vaccine
Experimental
Norovirus Bivalent GI.1 and GII.4 VLP Vaccine, adjuvanted with 50 microgram (mcg) MPL and 500 mcg Al(OH)3, IM, on Days 0 and 28.
Biological: NoV GI.1/GII.4 Bivalent VLP Vaccine
Saline
Placebo Comparator
Biological: Saline
Interventions
Name
Type
Description
Arm Group Labels
Other Names
NoV GI.1/GII.4 Bivalent VLP Vaccine
Biological
2 Doses 28 days apart Cohort A: 18-49 Years
Cohort A1: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (5/5 mcg)
Cohort A2: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (15/15 mcg)
Cohort A3: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg)
Cohort A4: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (150/150 mcg)
Cohort B: 50-64 Years IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg)
Cohort C: 65-85 Years IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg)
Cohort D: 18-49 Years IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1
The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfere with activity); Moderate (repeated use of non-narcotic pain reliever greater than (>) 24 hours [24h] or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mild (2.5-5 centimeter [cm] and did not interfere with activity); Moderate (5.1-10 cm or interfered with activity); and Severe (>10 cm or prevented daily activity).
Day 0 up to Day 7
Number of Participants With Solicited Local AEs Post Dose 2
The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfered with activity); Moderate (repeated use of non-narcotic pain reliever >24h or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mild (2.5-5 cm and did not interfere with activity); Moderate (5.1-10 cm or interfered with activity); and Severe (>10 cm or prevented daily activity).
Day 28 up to Day 35
Number of Participants With Solicited Systemic AEs Post Dose 1
Elevated oral temperature:Mild(38-38.4 Celsius[C]);Moderate(38.5-38.9 C);Severe(39-40 C).Headache:Mild(no interference with activity);Moderate(repeated use of non-narcotic pain reliever>24h/some interference with activity);Severe(significant;any use of narcotic pain reliever/prevented daily activity).Fatigue,Malaise:Mild(no interference with activity);Moderate(some interference with activity);Severe(significant;prevented daily activity).Diarrhea:Mild(2-3loose stools/<400gram[g]/24h);Moderate(4-5stools/400-800g/24h);Severe(>=6watery stools/>800g/24h/required intravenous[IV]hydration).Nausea/Vomiting:Mild(no interference with activity/1-2 episodes/24h);Moderate(some interference with activity/>2 episodes/24h);Severe(prevented daily activity,required IV hydration).Muscle ache,chills,joint ache,abdominal cramp/pain:Mild(no interference with activity);Moderate(some interference with activity,not required medical intervention);Severe(prevented daily activity,required medical intervention).
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
First (I) run: predose 1 and 7, 21, 28 days postdose (PD)1, and 7 and 28 days PD2; second (II) run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants must meet all of the inclusion criteria listed below:
Signed written informed consent.
Age:
Cohort A: 18-49 years, inclusive
Cohort B: 50-64 years, inclusive
Cohort C: 65-85 years, inclusive
Cohort D: 18-49 years, inclusive
Health Status:
Cohort A and D: In good health as determined by a screening evaluation that includes vital signs, medical history, and physical exam within 45 days before administration of IM Norovirus Bivalent VLP Vaccine or control.
Cohorts B and C: In good health as determined by a screening evaluation that includes vital signs, medical history, and physical exam within 45 days before administration of IM Norovirus Bivalent VLP Vaccine or control. Any existing medical diagnoses or conditions must be stable based on medical history and targeted physical examination. A stable medical condition is defined as: (A) Clinically acceptable health outcomes for the specific condition over the prior 6 months and (B) No change in prescription medication(s), dose, or frequency over the prior 3 months. Acceptable changes in medications are: a change of health care provider or insurance company or that is made for financial reasons as long as the medications are in the same class and/or a change due to improvement in a disease outcome.
Expressed interest and availability to fulfill the study requirements.
Female participants must be of non-childbearing potential (surgically sterile or post-menopausal for greater than or equal to [>=] 12 months), or if of childbearing potential (as determined by the investigator) must be practicing abstinence or using an effective licensed method of birth control (example oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream, or foam; intrauterine contraceptive device, or Depo-Provera; skin patch; vaginal ring or cervical cap) for 30 days prior to vaccination and must agree to continue such precautions for at least 60 days after the last vaccination. A woman is eligible if she is monogamous with a male who has had a vasectomy. Male participants must agree not to father a child for at least 60 days after the last vaccination and to practice abstinence or use an effective method of birth control as noted above.
Agrees not to participate in another clinical trial with an investigational product for the entire duration of the study one year after the last study dose that is 393 days.
Agrees to storage of unused clinical specimens for an indefinite period of time for future norovirus research or research on other gastrointestinal pathogens.
Exclusion Criteria:
Participants who meet any of the exclusion criteria at baseline will be excluded from study participation. The exclusion criteria are:
History of any of the following medical illnesses:
Diabetes
Cancer (malignancy other than resolved/excised skin lesion)
Heart disease (hospitalization for a heart attack, arrhythmia, or syncope)
Unconsciousness (other than a single brief "concussion")
Seizures (other than febrile seizures as a child less than [<] 5 years old)
Recurrent infections (more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis)
Any condition associated with immunodeficiency or participants taking immunosuppressant medication
Neuroinflamatory or auto-immune disease
Any current illness requiring daily medication other than the following:
Cohort A and D: Vitamins, birth control, anti-hypertensive medication, antihistamines or anti-depressant medication. The Principal Investigator (PI) should consult with the Central Safety Monitor and/or the sponsor for any clarification of medications allowable.
Cohorts B and C: Vitamins, birth control, anti-hypertensive medication, antihistamines or anti-depressant medication or any current illness requiring daily medication other than as noted above in inclusion criteria 3. The PI should consult with the Central Safety Monitor and/or the sponsor for any clarification of medications allowable.
Allergies or hypersensitivity to any component of the vaccine including MPL and Al(OH)3 adjuvants.
Any clinically significant abnormality detected on physical examination, including:
Murmur (other than a functional murmur)
Focal neurological abnormality
Hepatosplenomegaly
Lymphadenopathy
Jaundice
Hypertension (Blood Pressure [BP] greater than [>] 140/90 millimeter of mercury [mm Hg] on two separate days)
Any lab abnormality (per the site local laboratory), as listed below:
Absolute Neutrophil Count (ANC) outside the normal range (may be repeated if outside this limit)
Total white blood cells (WBC) outside the normal range (may be repeated if outside this limit)
Hemoglobin outside the normal range (may be repeated if outside this limit)
Platelet count outside the normal range (may be repeated if outside this limit)
Blood urea nitrogen (BUN) > upper limit of normal (ULN) (may be repeated if outside this limit)
Creatinine > ULN (may be repeated if outside this limit)
Glucose (fasting or random) outside the normal range (may be repeated if outside this limit)
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) > ULN (may be repeated if outside this limit)
Positive serology for hepatitis C or Human Immunodeficiency Virus (HIV) antibody or hepatitis B surface antigen.
For women of child bearing potential, positive serum pregnancy test within 14 days and urine pregnancy test within 24 hours of administering either dose of IM Norovirus Bivalent VLP Vaccine or control.
Nursing mother.
Temperature >100.4 degree Fahrenheit (F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 3 days of administration of IM Norovirus Bivalent VLP Vaccine or control.
Previous participation in a Norovirus vaccine or challenge study.
Study site personnel or their family members.
Significant history of psychiatric hospitalization, alcohol abuse, or illicit drug use in the prior 5 years.
Completion of an investigational vaccine or drug study within 28 days before administration of IM Norovirus Bivalent VLP Vaccine or control.
Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
Other condition that in the clinical judgment of the investigator would jeopardize the safety or rights of a participant participating in the trial, would render the participant unable to comply with the protocol or would interfere with the evaluation of the vaccine.
Healthy volunteers were enrolled in 1 of the following treatment groups: Bivalent Norovirus GI.1/GII.4 Vaccine (Cohort A: 5/5 microgram [mcg], 15/15 mcg, 50/50 mcg, 150/150 mcg; Cohort B: 50/50 mcg; Cohort C: 50/50 mcg and Cohort D: 50/50 mcg) adjuvanted with 50 mcg monophosphoryl lipid A (MPL) and 500 mcg aluminum hydroxide [Al(OH)3]) or Placebo.
Recruitment Details
Participants took part in the study at 3 investigative sites in the United States from 03 September 2010 to 09 January 2013.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent Virus-Like Particle (VLP) Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
FG001
Cohort A2:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
FG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
FG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9 percent [%] sodium chloride [NaCl] and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
FG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
FG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
FG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
FG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
FG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
FG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00010 subjects
FG00110 subjects
FG00210 subjects
FG0039 subjects
FG0049 subjects
FG0059 subjects
FG00610 subjects
FG00710 subjects
FG0089 subjects
FG0098 subjects
FG0108 subjects
COMPLETED
FG0009 subjects
FG0019 subjects
FG0028 subjects
FG0037 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Modified Intent to Treat (mITT) population included all participants who received at least 1 dose of study product.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
BG001
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Outcome Measures Module
Outcome Measures
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
Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1
The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfere with activity); Moderate (repeated use of non-narcotic pain reliever greater than (>) 24 hours [24h] or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mild (2.5-5 centimeter [cm] and did not interfere with activity); Moderate (5.1-10 cm or interfered with activity); and Severe (>10 cm or prevented daily activity).
mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.
Posted
Number
participants
Day 0 up to Day 7
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Adverse Events Module
Frequency Threshold
5
Time Frame
Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
Description
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
All-Cause Mortality Comment
Not provided
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
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Idiopathic central retinal vein occlusion
Eye disorders
MedDRA (15.0)
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Motion sickness
Ear and labyrinth disorders
MedDRA (15.0)
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Takeda
Medical Director
+1-877-825-3327
trialdisclosures@takeda.com
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D005759
Gastroenteritis
Ancestor Terms
ID
Term
D005767
Gastrointestinal Diseases
D004066
Digestive System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D012965
Sodium Chloride
Ancestor Terms
ID
Term
D002712
Chlorides
D006851
Hydrochloric Acid
D017606
Chlorine Compounds
D007287
Inorganic Chemicals
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
NoV GI.1/GII.4 Bivalent VLP Vaccine
Saline
Biological
Two doses 28 days apart
Saline
Day 0 up to Day 7
Number of Participants With Solicited Systemic AEs Post Dose 2
Elevated oral temperature:Mild(38-38.4 C);Moderate(38.5-38.9 C);Severe(39-40 C).Headache:Mild(no interference with activity);Moderate(repeated use of non-narcotic pain reliever>24h/some interference with activity);Severe(significant;any use of narcotic pain reliever/prevented daily activity).Fatigue,Malaise:Mild(no interference with activity);Moderate(some interference with activity);Severe(significant;prevented daily activity).Diarrhea:Mild(2-3loose stools/<400g/24h);Moderate(4-5stools/400-800g/24h);Severe(>=6watery stools/>800g/24h/required IV hydration).Nausea/Vomiting:Mild(no interference with activity/1-2 episodes/24h);Moderate(some interference with activity/>2 episodes/24h);Severe(prevented daily activity,required IV hydration).Muscle ache,chills,joint ache,abdominal cramp/pain:Mild(no interference with activity);Moderate(some interference with activity,not required medical intervention);Severe(prevented daily activity,required medical intervention).
Day 28 up to Day 35
Number of Participants With Unsolicited AEs Post Dose 1
Baseline up to Day 28 (Pre-dose 2)
Number of Participants With Unsolicited AEs Post Dose 2
Day 28 up to Day 56 (Post dose 2)
Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values
The number of participants with any markedly abnormal standard safety laboratory values (serum chemistry or hematology) collected throughout study.
Baseline up to Day 35
Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI)
Baseline up to 365 Days after post dose 2 (Day 393)
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
I run: predose 1 and 7, 21, 28 days PD1, and 7 and 28 days PD2; II run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgM
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
I run: predose 1 and 7, 21, 28 days PD1, and 7 and 28 days PD2; II run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgM as Compared to Baseline
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgM
Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GMTs were assessed for Anti-norovirus GI.1 and GII.4 VLP by Pan-Ig ELISA. A pan ELISA assay captured IgG, IgA and IgM combined. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
I run: predose 1, 7, 21, 28 days PD1, 7 and 28 days PD2; II run: predose 1, 28, 152 and 365 days PD2 (up to Day 393)
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GMFRs in GMTs of Anti-norovirus GI.1 and GII.4 VLP by Pan-Ig ELISA. A pan ELISA assay captured IgG, IgA and IgM combined. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
St Louis
Missouri
63104
United States
University of Rochester Medical Center
Rochester
New York
14642
United States
Derived
Lindesmith LC, Ferris MT, Mullan CW, Ferreira J, Debbink K, Swanstrom J, Richardson C, Goodwin RR, Baehner F, Mendelman PM, Bargatze RF, Baric RS. Broad blockade antibody responses in human volunteers after immunization with a multivalent norovirus VLP candidate vaccine: immunological analyses from a phase I clinical trial. PLoS Med. 2015 Mar 24;12(3):e1001807. doi: 10.1371/journal.pmed.1001807. eCollection 2015 Mar.
Treanor JJ, Atmar RL, Frey SE, Gormley R, Chen WH, Ferreira J, Goodwin R, Borkowski A, Clemens R, Mendelman PM. A novel intramuscular bivalent norovirus virus-like particle vaccine candidate--reactogenicity, safety, and immunogenicity in a phase 1 trial in healthy adults. J Infect Dis. 2014 Dec 1;210(11):1763-71. doi: 10.1093/infdis/jiu337. Epub 2014 Jun 20.
9 subjects
FG0059 subjects
FG00610 subjects
FG00710 subjects
FG0089 subjects
FG0098 subjects
FG0108 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
1 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
BG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
BG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
BG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
BG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
BG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
BG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
BG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
BG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
BG011
Total
Total of all reporting groups
10
BG00110
BG00210
BG0039
BG0049
BG0059
BG00610
BG00710
BG0089
BG0098
BG0108
BG011102
participants
Title
Denominators
Categories
Greater than or equal to (>=) 18 and <64 years
Title
Measurements
BG00010
BG00110
BG00210
BG0039
BG0049
BG0059
BG00610
BG0070
BG0080
BG0098
BG0108
BG01183
>=65 years
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG0016
BG0027
BG0037
BG0048
BG0055
BG0065
BG0078
BG0085
BG0093
BG0107
BG01168
Male
BG0003
BG0014
BG0023
BG0032
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00010
BG00110
BG00210
BG0039
BG0049
BG0059
BG00610
BG00710
BG0089
BG0098
BG0108
BG011102
Race
Count of Participants
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
BG0070
BG0080
BG0090
BG0100
BG0111
Asian
Title
Measurements
BG0000
BG0010
BG0022
BG003
Black or African American
Title
Measurements
BG0002
BG0012
BG0022
BG003
White
Title
Measurements
BG0008
BG0017
BG0026
BG003
More than one race
Title
Measurements
BG0000
BG0011
BG0020
BG003
Ethnicity
Count of Participants
Participants
Title
Denominators
Categories
Non-Hispanic
Title
Measurements
BG0008
BG00110
BG00210
BG0039
BG0049
BG0059
BG0069
BG00710
BG0089
BG0096
BG0108
BG01197
Hispanic
Title
Measurements
BG0002
BG0010
BG0020
BG003
Saliva Secretor Status
Count of Participants
Participants
Title
Denominators
Categories
Saliva Secretor Status Positive
Title
Measurements
BG0007
BG0018
BG0026
BG0039
BG0048
BG0056
BG0068
BG0078
BG0087
BG0097
BG0105
BG01179
Saliva Secretor Status Negative
Title
Measurements
BG0003
BG0012
BG0024
BG003
Blood Type
Count of Participants
Participants
Title
Denominators
Categories
Blood Type A
Title
Measurements
BG0003
BG0013
BG0025
BG0033
BG0042
BG0052
BG0066
BG0073
BG0082
BG0091
BG0102
BG01132
Blood Type B
Title
Measurements
BG0000
BG0011
BG0020
BG003
Blood Type O
Title
Measurements
BG0006
BG0014
BG0025
BG003
Blood Type AB
Title
Measurements
BG0001
BG0012
BG0020
BG003
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG0039
OG0049
OG0059
OG00610
OG00710
OG0089
OG0098
OG0108
Title
Denominators
Categories
Pain: Mild
Title
Measurements
OG0004
OG0015
OG0026
OG0035
OG0041
OG0055
OG0060
OG0074
OG0080
OG0094
OG0100
Pain: Moderate
Title
Measurements
OG0004
OG0012
OG0022
OG003
Tenderness: Mild
Title
Measurements
OG0004
OG0015
OG0026
OG003
Tenderness: Moderate
Title
Measurements
OG0003
OG0014
OG0022
OG003
Swelling: Mild
Title
Measurements
OG0001
OG0012
OG0022
OG003
Primary
Number of Participants With Solicited Local AEs Post Dose 2
The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfered with activity); Moderate (repeated use of non-narcotic pain reliever >24h or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mild (2.5-5 cm and did not interfere with activity); Moderate (5.1-10 cm or interfered with activity); and Severe (>10 cm or prevented daily activity).
mITT population where Day 28 to 35 assessment were available for this measure. mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.
Posted
Number
participants
Day 28 up to Day 35
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG0009
OG0017
OG00210
OG003
Title
Denominators
Categories
Pain: Mild
Title
Measurements
OG0005
OG0014
OG0024
OG003
Primary
Number of Participants With Solicited Systemic AEs Post Dose 1
Elevated oral temperature:Mild(38-38.4 Celsius[C]);Moderate(38.5-38.9 C);Severe(39-40 C).Headache:Mild(no interference with activity);Moderate(repeated use of non-narcotic pain reliever>24h/some interference with activity);Severe(significant;any use of narcotic pain reliever/prevented daily activity).Fatigue,Malaise:Mild(no interference with activity);Moderate(some interference with activity);Severe(significant;prevented daily activity).Diarrhea:Mild(2-3loose stools/<400gram[g]/24h);Moderate(4-5stools/400-800g/24h);Severe(>=6watery stools/>800g/24h/required intravenous[IV]hydration).Nausea/Vomiting:Mild(no interference with activity/1-2 episodes/24h);Moderate(some interference with activity/>2 episodes/24h);Severe(prevented daily activity,required IV hydration).Muscle ache,chills,joint ache,abdominal cramp/pain:Mild(no interference with activity);Moderate(some interference with activity,not required medical intervention);Severe(prevented daily activity,required medical intervention).
mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.
Posted
Number
participants
Day 0 up to Day 7
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003
Title
Denominators
Categories
Headache: Mild
Title
Measurements
OG0001
OG0013
OG0023
OG003
Primary
Number of Participants With Solicited Systemic AEs Post Dose 2
Elevated oral temperature:Mild(38-38.4 C);Moderate(38.5-38.9 C);Severe(39-40 C).Headache:Mild(no interference with activity);Moderate(repeated use of non-narcotic pain reliever>24h/some interference with activity);Severe(significant;any use of narcotic pain reliever/prevented daily activity).Fatigue,Malaise:Mild(no interference with activity);Moderate(some interference with activity);Severe(significant;prevented daily activity).Diarrhea:Mild(2-3loose stools/<400g/24h);Moderate(4-5stools/400-800g/24h);Severe(>=6watery stools/>800g/24h/required IV hydration).Nausea/Vomiting:Mild(no interference with activity/1-2 episodes/24h);Moderate(some interference with activity/>2 episodes/24h);Severe(prevented daily activity,required IV hydration).Muscle ache,chills,joint ache,abdominal cramp/pain:Mild(no interference with activity);Moderate(some interference with activity,not required medical intervention);Severe(prevented daily activity,required medical intervention).
mITT population where Day 28 to 35 assessment were available for this measure. mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.
Posted
Number
participants
Day 28 up to Day 35
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG0009
OG0017
OG00210
OG003
Title
Denominators
Categories
Headache: Mild
Title
Measurements
OG0001
OG0011
OG0023
OG003
Primary
Number of Participants With Unsolicited AEs Post Dose 1
mITT population included all participants who received at least 1 dose of study product.
Posted
Number
participants
Baseline up to Day 28 (Pre-dose 2)
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0007
OG0014
OG0024
OG003
Primary
Number of Participants With Unsolicited AEs Post Dose 2
mITT population where Day 28 to 56 assessment were available for this measure. mITT population included all participants who received at least 1 dose of study product.
Posted
Number
participants
Day 28 up to Day 56 (Post dose 2)
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG0009
OG0017
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0022
OG003
Primary
Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values
The number of participants with any markedly abnormal standard safety laboratory values (serum chemistry or hematology) collected throughout study.
mITT population included all participants who received at least 1 dose of study product.
Posted
Number
participants
Baseline up to Day 35
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0013
OG0021
OG003
Primary
Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI)
mITT population included all participants who received at least 1 dose of study product.
Posted
Number
participants
Baseline up to 365 Days after post dose 2 (Day 393)
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003
Title
Denominators
Categories
SAE
Title
Measurements
OG0001
OG0010
OG0021
OG003
Secondary
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Per Protocol (PP) population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Posted
Geometric Mean
95% Confidence Interval
titer
First (I) run: predose 1 and 7, 21, 28 days postdose (PD)1, and 7 and 28 days PD2; second (II) run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG0009
OG0018
OG00210
OG003
Title
Denominators
Categories
GI.1: I Run: Pre-Dose 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG003
Secondary
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Posted
Geometric Mean
95% Confidence Interval
titer
I run: predose 1 and 7, 21, 28 days PD1, and 7 and 28 days PD2; II run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG0009
OG0018
OG00210
OG003
Title
Denominators
Categories
GI.1: I Run: Pre-Dose 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG003
Secondary
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgM
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Data was not collected because serum specimens were not tested for specific IgM antibodies to Norovirus GI.1 and GII.4 VLPs as per the change in planned analysis, because this measurement was not informative in a previous study LV01-103 (NCT00973284).
Posted
I run: predose 1 and 7, 21, 28 days PD1, and 7 and 28 days PD2; II run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Posted
Geometric Mean
95% Confidence Interval
fold rise
I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG0009
OG0018
OG00210
OG003
Title
Denominators
Categories
GI.1: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG003
Secondary
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Posted
Geometric Mean
95% Confidence Interval
fold rise
I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG0009
OG0018
OG00210
OG003
Title
Denominators
Categories
GI.1: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG003
Secondary
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgM as Compared to Baseline
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Data was not collected because serum specimens were not tested for specific IgM antibodies to Norovirus GI.1 and GII.4 VLPs as per the change in planned analysis, because this measurement was not informative in a previous study LV01-103 (NCT00973284).
Posted
I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Posted
Number
95% Confidence Interval
percentage of participants
I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG0009
OG0018
OG00210
OG003
Title
Denominators
Categories
GI.1: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG003
Secondary
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Posted
Number
95% Confidence Interval
percentage of participants
I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG0009
OG0018
OG00210
OG003
Title
Denominators
Categories
GI.1: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG003
Secondary
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgM
Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Data was not collected because serum specimens were not tested for specific IgM antibodies to Norovirus GI.1 and GII.4 VLPs as per the change in planned analysis, because this measurement was not informative in a previous study LV01-103 (NCT00973284).
Posted
I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GMTs were assessed for Anti-norovirus GI.1 and GII.4 VLP by Pan-Ig ELISA. A pan ELISA assay captured IgG, IgA and IgM combined. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Posted
Geometric Mean
95% Confidence Interval
titer
I run: predose 1, 7, 21, 28 days PD1, 7 and 28 days PD2; II run: predose 1, 28, 152 and 365 days PD2 (up to Day 393)
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG0009
OG0018
OG00210
OG003
Title
Denominators
Categories
GI.1: I Run: Pre-Dose 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG003
Secondary
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GMFRs in GMTs of Anti-norovirus GI.1 and GII.4 VLP by Pan-Ig ELISA. A pan ELISA assay captured IgG, IgA and IgM combined. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Posted
Geometric Mean
95% Confidence Interval
fold rise
I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG0009
OG0018
OG00210
OG003
Title
Denominators
Categories
GI.1: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG003
Secondary
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Posted
Number
95% Confidence Interval
percentage of participants
I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
ID
Title
Description
OG000
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
OG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
OG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
OG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Units
Counts
Participants
OG0009
OG0018
OG00210
OG003
Title
Denominators
Categories
GI.1: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG003
1
10
8
10
EG001
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
0
10
5
10
EG002
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
0
9
3
9
EG004
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
0
9
3
9
EG005
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
0
9
5
9
EG006
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
1
10
3
10
EG007
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
2
10
4
10
EG008
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
0
9
5
9
EG009
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
0
8
5
8
EG010
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
0
8
5
8
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0061 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Chest pain
Cardiac disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0071 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Gastroparesis
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Fractured right fibula
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Bleeding following urologic surgery
Renal and urinary disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0071 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Constipation
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0071 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Nausea
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0071 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Chills
General disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Injection site haematoma
General disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Injection site pruritus
General disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0031 affected9 at risk
EG0040 affected9 at risk
EG0051 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Cholelithiasis
Hepatobiliary disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0041 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Croup infectious
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Gastroenteritis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0041 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Sinusitis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0051 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0002 affected10 at risk
EG0012 affected10 at risk
EG0023 affected10 at risk
EG0032 affected9 at risk
EG0041 affected9 at risk
EG0052 affected9 at risk
EG0061 affected10 at risk
EG0072 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Alanine aminotransferase increased
Investigations
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Aspartate aminotransferase increased
Investigations
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Blood glucose increased
Investigations
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
White blood cell count increased
Investigations
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0101 affected8 at risk
Dizziness
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Headache
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0041 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0081 affected9 at risk
EG0091 affected8 at risk
EG0100 affected8 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0092 affected8 at risk
EG0100 affected8 at risk
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0041 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (15.0)
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0071 affected10 at risk
EG0081 affected9 at risk
EG0090 affected8 at risk
EG0101 affected8 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0081 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Rash papular
Skin and subcutaneous tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Capillary fragility
Vascular disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Flatulence
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0051 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Nodule
General disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0051 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Urinary tract infection
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0061 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Nerve injury
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0051 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0061 affected10 at risk
EG0070 affected10 at risk
EG0081 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0051 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Flushing
Vascular disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0051 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0071 affected10 at risk
EG0081 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Nail bed infection
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0071 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0071 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0081 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0081 affected9 at risk
EG0090 affected8 at risk
EG0100 affected8 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0091 affected8 at risk
EG0100 affected8 at risk
Eructation
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0091 affected8 at risk
EG0100 affected8 at risk
Vomiting
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0091 affected8 at risk
EG0100 affected8 at risk
Injection site haemorrhage
General disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0101 affected8 at risk
Otitis media
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0091 affected8 at risk
EG0100 affected8 at risk
Rhinitis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0091 affected8 at risk
EG0100 affected8 at risk
Viral upper respiratory tract infection
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0101 affected8 at risk
Joint injury
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0101 affected8 at risk
Eosinophil count increased
Investigations
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0101 affected8 at risk
Haematocrit decreased
Investigations
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0101 affected8 at risk
Haemoglobin decreased
Investigations
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0101 affected8 at risk
Lymphocyte count increased
Investigations
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0101 affected8 at risk
Mean cell haemoglobin decreased
Investigations
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0101 affected8 at risk
Neutrophil count increased
Investigations
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0101 affected8 at risk
Red cell distribution width increased
Investigations
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0101 affected8 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0091 affected8 at risk
EG0100 affected8 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0092 affected8 at risk
EG0100 affected8 at risk
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected9 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected10 at risk
EG0070 affected10 at risk
EG0080 affected9 at risk
EG0090 affected8 at risk
EG0101 affected8 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.
D017670
Sodium Compounds
0
BG0040
BG0050
BG0060
BG00710
BG0089
BG0090
BG0100
BG01119
1
BG0054
BG0065
BG0072
BG0084
BG0095
BG0101
BG01134
2
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0114
1
BG0042
BG0050
BG0060
BG0070
BG0080
BG0095
BG0105
BG01119
6
BG0047
BG0059
BG0069
BG00710
BG0089
BG0093
BG0102
BG01176
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0101
BG0112
0
BG0040
BG0050
BG0061
BG0070
BG0080
BG0092
BG0100
BG0115
0
BG0041
BG0053
BG0062
BG0072
BG0082
BG0091
BG0103
BG01123
1
BG0041
BG0052
BG0060
BG0070
BG0082
BG0092
BG0102
BG01111
5
BG0045
BG0055
BG0063
BG0077
BG0085
BG0095
BG0103
BG01153
0
BG0041
BG0050
BG0061
BG0070
BG0080
BG0090
BG0101
BG0116
2
OG0040
OG0052
OG0060
OG0070
OG0080
OG0090
OG0100
5
OG0041
OG0054
OG0061
OG0076
OG0080
OG0093
OG0102
2
OG0040
OG0052
OG0060
OG0070
OG0080
OG0091
OG0100
1
OG0040
OG0051
OG0061
OG0071
OG0080
OG0093
OG0103
8
OG0048
OG0058
OG00610
OG0079
OG0089
OG0098
OG0107
2
OG0040
OG0053
OG0060
OG0075
OG0080
OG0093
OG0101
Pain: Moderate
Title
Measurements
OG0003
OG0011
OG0020
OG0030
OG0040
OG0052
OG0060
OG0070
OG0080
OG0091
OG0100
Tenderness: Mild
Title
Measurements
OG0007
OG0016
OG0026
OG0033
OG0041
OG0056
OG0061
OG0074
OG0080
OG0095
OG0102
Tenderness: Moderate
Title
Measurements
OG0001
OG0011
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
OG0100
Swelling: Mild
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0040
OG0050
OG0060
OG0070
OG0080
OG0094
OG0105
Swelling: Moderate
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Redness: Mild
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
9
OG0049
OG0059
OG00610
OG00710
OG0089
OG0098
OG0108
2
OG0042
OG0055
OG0060
OG0072
OG0082
OG0090
OG0102
Headache: Moderate
Title
Measurements
OG0003
OG0011
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
Fatigue/ Malaise: Mild
Title
Measurements
OG0001
OG0011
OG0021
OG0031
OG0040
OG0052
OG0061
OG0070
OG0080
OG0090
OG0101
Fatigue/ Malaise: Moderate
Title
Measurements
OG0004
OG0011
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Muscle Aches : Mild
Title
Measurements
OG0004
OG0012
OG0021
OG0033
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Muscle Aches : Moderate
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0100
Joint Aches: Mild
Title
Measurements
OG0001
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Joint Aches: Moderate
Title
Measurements
OG0002
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Nausea: Mild
Title
Measurements
OG0001
OG0011
OG0022
OG0031
OG0041
OG0051
OG0061
OG0070
OG0081
OG0090
OG0100
Nausea: Moderate
Title
Measurements
OG0002
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Abdominal Cramps/Discomfort: Mild
Title
Measurements
OG0002
OG0010
OG0021
OG0032
OG0040
OG0050
OG0060
OG0071
OG0081
OG0091
OG0100
Abdominal Cramps/Discomfort: Moderate
Title
Measurements
OG0002
OG0010
OG0020
OG0030
OG0041
OG0050
OG0061
OG0070
OG0080
OG0090
OG0100
Chills: Mild
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Chills: Moderate
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Vomiting: Moderate
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Diarrhea: Mild
Title
Measurements
OG0002
OG0010
OG0021
OG0031
OG0040
OG0050
OG0060
OG0071
OG0081
OG0091
OG0102
Diarrhea: Moderate
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
OG0100
Diarrhea: Severe
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
8
OG0048
OG0058
OG00610
OG0079
OG0089
OG0098
OG0107
2
OG0041
OG0053
OG0060
OG0071
OG0081
OG0091
OG0101
Headache: Moderate
Title
Measurements
OG0002
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
Headache: Severe
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0100
Fatigue/ Malaise: Mild
Title
Measurements
OG0001
OG0010
OG0023
OG0030
OG0041
OG0052
OG0060
OG0070
OG0080
OG0090
OG0100
Fatigue/ Malaise: Moderate
Title
Measurements
OG0002
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
Muscle Aches: Mild
Title
Measurements
OG0002
OG0011
OG0023
OG0031
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Muscle Aches: Moderate
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0081
OG0090
OG0100
Joint Aches: Mild
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Joint Aches: Moderate
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0081
OG0090
OG0100
Nausea: Mild
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
OG0100
Nausea: Moderate
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Abdominal Cramps/Discomfort: Mild
Title
Measurements
OG0001
OG0011
OG0021
OG0032
OG0040
OG0051
OG0061
OG0070
OG0080
OG0090
OG0100
Chills: Mild
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Chills: Moderate
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Diarrhea: Mild
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
OG0100
Diarrhea: Severe
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
9
OG0049
OG0059
OG00610
OG00710
OG0089
OG0098
OG0108
1
OG0042
OG0054
OG0060
OG0073
OG0083
OG0093
OG0104
8
OG0048
OG0058
OG00610
OG0079
OG0089
OG0098
OG0107
2
OG0042
OG0053
OG0063
OG0072
OG0082
OG0093
OG0101
9
OG0049
OG0059
OG00610
OG00710
OG0089
OG0098
OG0108
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0102
9
OG0049
OG0059
OG00610
OG00710
OG0089
OG0098
OG0108
0
OG0040
OG0050
OG0061
OG0072
OG0080
OG0090
OG0100
New Medical Conditions
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
8
OG0049
OG0058
OG00610
OG0079
OG0089
OG0098
OG0107
8
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0009(3 to 26)
OG0015(3 to 7)
OG0025(3 to 10)
OG0036(3 to 13)
OG00410(3 to 32)
OG0053(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
OG0065(3 to 8)
OG0075(3 to 9)
OG0084(3 to 5)
OG0093(3 to 3)
OG0103(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
GI.1: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0037
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000204(126 to 332)
OG001357(141 to 906)
OG002458(97 to 2154)
OG003
GI.1: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG0069
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000164(87 to 311)
OG001164(71 to 379)
OG002269(90 to 799)
OG003
GI.1: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000143(70 to 293)
OG001106(42 to 267)
OG002183(61 to 544)
OG003
GI.1: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000134(62 to 291)
OG001112(46 to 275)
OG002130(57 to 294)
OG003
GI.1: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000115(55 to 243)
OG00180(28 to 224)
OG00270(24 to 202)
OG003
GI.1: II Run:Pre-Dose 1
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0005(2 to 9)
OG0013(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
OG0023(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
OG003
GI.1: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00032(13 to 81)
OG00115(7 to 33)
OG00211(6 to 21)
OG003
GI.1: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00017(6 to 47)
OG00113(6 to 26)
OG00210(6 to 19)
OG003
GI.1: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG00023(6 to 92)
OG00111(6 to 22)
OG0028(5 to 14)
OG003
GII.4: I Run: Pre-Dose 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00021(7 to 63)
OG00113(5 to 34)
OG0025(2 to 12)
OG003
GII.4: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0037
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000140(92 to 213)
OG001193(87 to 432)
OG00257(24 to 138)
OG003
GII.4: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000120(95 to 151)
OG001113(53 to 239)
OG00227(8 to 93)
OG003
GII.4: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000116(84 to 161)
OG00168(32 to 149)
OG00219(6 to 61)
OG003
GII.4: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000108(73 to 160)
OG00194(44 to 202)
OG00217(6 to 48)
OG003
GII.4: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000108(79 to 149)
OG00176(36 to 174)
OG00219(7 to 54)
OG003
GII.4: II Run:Pre-Dose 1
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0008(4 to 17)
OG0014(2 to 7)
OG0024(2 to 11)
OG003
GII.4: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00039(22 to 71)
OG00132(17 to 60)
OG00217(7 to 42)
OG003
GII.4: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00025(11 to 54)
OG00120(9 to 44)
OG0029(4 to 23)
OG003
GII.4: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG00016(5 to 45)
OG00113(5 to 38)
OG0028(3 to 22)
OG003
8
OG0049
OG0058
OG00610
OG0079
OG0089
OG0098
OG0107
8
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00013(3 to 55)
OG0018(2 to 27)
OG00228(11 to 73)
OG00322(7 to 68)
OG0049(2 to 37)
OG0059(3 to 26)
OG0067(3 to 21)
OG00714(5 to 38)
OG00811(4 to 26)
OG0097(2 to 32)
OG0105(1 to 14)
GI.1: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0037
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000211(98 to 452)
OG001237(120 to 466)
OG0021650(673 to 4047)
OG003
GI.1: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG0069
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000266(130 to 545)
OG001184(93 to 363)
OG0021165(495 to 2741)
OG003
GI.1: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000261(140 to 486)
OG001152(76 to 305)
OG002910(379 to 2185)
OG003
GI.1: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000281(152 to 520)
OG001167(77 to 365)
OG002723(360 to 1452)
OG003
GI.1: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000286(151 to 540)
OG001168(76 to 346)
OG002605(256 to 1432)
OG003
GI.1: II Run:Pre-Dose 1
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0005(2 to 14)
OG0017(3 to 14)
OG0025(3 to 8)
OG003
GI.1: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00083(45 to 156)
OG00194(46 to 192)
OG00289(44 to 181)
OG003
GI.1: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00044(22 to 91)
OG00165(43 to 99)
OG00246(24 to 89)
OG003
GI.1: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG00058(26 to 131)
OG00153(40 to 68)
OG00228(15 to 54)
OG003
GII.4: I Run: Pre-Dose 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00038(10 to 142)
OG00119(6 to 62)
OG0025(2 to 14)
OG003
GII.4: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0037
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00097(56 to 167)
OG001136(66 to 279)
OG00243(30 to 62)
OG003
GII.4: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000142(70 to 286)
OG001128(59 to 279)
OG00235(25 to 50)
OG003
GII.4: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000139(73 to 267)
OG00198(42 to 225)
OG00231(22 to 45)
OG003
GII.4: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000144(72 to 288)
OG001132(71 to 248)
OG00234(28 to 42)
OG003
GII.4: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000174(90 to 336)
OG001125(72 to 218)
OG00234(26 to 46)
OG003
GII.4: II Run:Pre-Dose 1
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00013(5 to 31)
OG00111(4 to 32)
OG0025(2 to 13)
OG003
GII.4: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00065(39 to 106)
OG00174(46 to 120)
OG00257(35 to 91)
OG003
GII.4: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00052(31 to 87)
OG00144(22 to 91)
OG00218(8 to 41)
OG003
GII.4: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG00028(11 to 75)
OG00151(27 to 96)
OG00213(7 to 25)
OG003
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
8
OG0048
OG0058
OG00610
OG0079
OG0089
OG0098
OG0107
7
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00023.1(7.4 to 71.9)
OG00176.1(38.1 to 152)
OG00284.4(20.6 to 345.1)
OG003122.9(30 to 503.7)
OG0040.8(0.3 to 1.8)
OG005115.2(35.5 to 373.7)
OG0061(1 to 1)
OG00739.1(10.3 to 148.2)
OG0081(1 to 1)
OG00912.6(4.2 to 37.6)
OG0101(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
GI.1: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0069
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00018.5(7 to 49)
OG00134.9(16.6 to 73.4)
OG00249.6(18.2 to 134.9)
OG003
GI.1: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00016.2(6.1 to 42.8)
OG00122.6(11.1 to 46)
OG00233.7(11.7 to 46)
OG003
GI.1: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00015.1(6.2 to 37)
OG00122.5(11.8 to 42.9)
OG00223.9(9.6 to 59.7)
OG003
GI.1: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00013(5 to 33.6)
OG00116(7.4 to 34.5)
OG00212.1(4.8 to 30.7)
OG003
GI.1: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0007(3.7 to 13.3)
OG0015(2.3 to 10.7)
OG0023.6(1.9 to 6.8)
OG003
GI.1: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0003.6(1.8 to 7.1)
OG0014.1(2 to 8.3)
OG0023.3(1.8 to 6)
OG003
GI.1: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG0004.1(1.3 to 13.5)
OG0013.7(1.9 to 7.1)
OG0022.6(1.6 to 4.4)
OG003
GII.4: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0006.7(2.2 to 20.7)
OG00115.4(4.7 to 50.8)
OG00210.7(3.5 to 32.9)
OG003
GII.4: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0005.7(2 to 16.5)
OG0019(4.1 to 20)
OG0025(1.3 to 18.9)
OG003
GII.4: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0005.6(2.1 to 14.8)
OG0015.5(2.4 to 12.3)
OG0023.6(1.1 to 12)
OG003
GII.4: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0005.2(2.1 to 12.6)
OG0016.1(2.9 to 12.7)
OG0023.2(1.1 to 9.4)
OG003
GII.4: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0005.2(2.1 to 12.6)
OG0015.2(2.6 to 10.2)
OG0023.4(1.4 to 8.4)
OG003
GII.4: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0004.7(2.9 to 7.7)
OG0017.5(4.6 to 12.2)
OG0023.9(1.6 to 9.1)
OG003
GII.4: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0002.6(1.8 to 3.9)
OG0014.8(2.4 to 9.4)
OG0022(1 to 4)
OG003
GII.4: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG0002(1.2 to 3.2)
OG0013.1(1.3 to 7.3)
OG0021.7(0.9 to 3.5)
OG003
8
OG0048
OG0058
OG00610
OG0079
OG0089
OG0098
OG0107
7
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00016.2(3.8 to 68.7)
OG00129.4(11.2 to 77.2)
OG00259.5(27.2 to 130.2)
OG00354.9(17.6 to 171)
OG0040.7(0.2 to 2)
OG00543(5.9 to 315.7)
OG0060.9(0.6 to 1.4)
OG0076.8(2.3 to 20.8)
OG0080.9(0.8 to 1)
OG00911.2(2.4 to 52.4)
OG0101(0.9 to 1.1)
GI.1: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0069
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00020.5(5.2 to 80.2)
OG00122.8(8.7 to 59.8)
OG00242(22.6 to 78.3)
OG003
GI.1: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00020(4.9 to 81.6)
OG00118.9(6.8 to 52.6)
OG00232.8(18.2 to 59.2)
OG003
GI.1: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00021.6(5.4 to 86.1)
OG00123.8(9 to 63.2)
OG00226.1(15.2 to 44.8)
OG003
GI.1: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00022(5.6 to 86.3)
OG00123.1(8.8 to 60.6)
OG00219.7(11.8 to 32.9)
OG003
GI.1: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00017(4.9 to 59.2)
OG00114.1(7.9 to 25.3)
OG00218.8(9.3 to 37.9)
OG003
GI.1: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0007.9(2.3 to 26.6)
OG0019.8(5.2 to 18.5)
OG0029.6(5.1 to 18)
OG003
GI.1: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG0009.3(1.7 to 49.5)
OG0017.9(4.1 to 14.9)
OG0026.1(3.6 to 10.4)
OG003
GII.4: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0002.6(0.8 to 8.3)
OG0017.1(2.4 to 20.3)
OG0028.3(3.4 to 20.1)
OG003
GII.4: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0003.8(1.1 to 12.8)
OG0016.6(2.5 to 17.6)
OG0026.8(2.8 to 16.1)
OG003
GII.4: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0003.7(1.1 to 12.8)
OG0015.1(1.9 to 13.4)
OG0026(2.6 to 14.3)
OG003
GII.4: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0003.8(1.1 to 13.9)
OG0014.8(1.8 to 12.6)
OG0026.6(2.7 to 16.1)
OG003
GII.4: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0004.6(1.3 to 16.3)
OG0014.6(1.8 to 11.6)
OG0025.8(2.5 to 13.8)
OG003
GII.4: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0005(2.3 to 10.8)
OG0016.8(2.8 to 16.4)
OG00212(5.5 to 26.2)
OG003
GII.4: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0003.1(1.4 to 6.7)
OG0014(1.6 to 10)
OG0023.9(1.5 to 10)
OG003
GII.4: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG0002.7(1 to 7.4)
OG0014.6(2 to 10.6)
OG0022.4(0.8 to 7.5)
OG003
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
8
OG0048
OG0058
OG00610
OG0079
OG0089
OG0098
OG0107
7
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00077.8(40.0 to 97.2)
OG001100.0(63.1 to 100.0)
OG00290.0(55.5 to 99.7)
OG003100.0(59.0 to 100.0)
OG0040.0(0.0 to 36.9)
OG005100.0(63.1 to 100.0)
OG0060.0(0.0 to 30.8)
OG00788.9(51.8 to 99.7)
OG0080.0(0.0 to 33.6)
OG00987.5(47.3 to 99.7)
OG0100.0(0.0 to 41.0)
GI.1: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0069
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00088.9(51.8 to 99.7)
OG001100.0(63.1 to 100.0)
OG002100.0(63.1 to 100.0)
OG003
GI.1: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00077.8(40.0 to 97.2)
OG001100.0(63.1 to 100.0)
OG00290.0(55.5 to 99.7)
OG003
GI.1: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00077.8(40.0 to 97.2)
OG001100.0(59.0 to 100.0)
OG002100.0(69.2 to 100.0)
OG003
GI.1: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00077.8(40.0 to 97.2)
OG001100.0(59.0 to 100.0)
OG00288.9(51.8 to 99.7)
OG003
GI.1: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00066.7(29.9 to 92.5)
OG00171.4(29.0 to 96.3)
OG00255.6(21.2 to 86.3)
OG003
GI.1: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00062.5(24.5 to 91.5)
OG00142.9(9.9 to 81.6)
OG00244.4(13.7 to 78.8)
OG003
GI.1: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG00050.0(11.8 to 88.2)
OG00142.9(9.9 to 81.6)
OG00237.5(8.5 to 75.5)
OG003
GII.4: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00055.6(21.2 to 86.3)
OG00175.0(34.9 to 96.8)
OG00270.0(34.8 to 93.3)
OG003
GII.4: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00055.6(21.2 to 86.3)
OG00175.0(34.9 to 96.8)
OG00250.0(18.7 to 81.3)
OG003
GII.4: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00055.6(21.2 to 86.3)
OG00162.5(24.5 to 91.5)
OG00250.0(18.7 to 81.3)
OG003
GII.4: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00044.4(13.7 to 78.8)
OG00171.4(29.0 to 96.3)
OG00250.0(18.7 to 81.3)
OG003
GII.4: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00044.4(13.7 to 78.8)
OG00157.1(18.4 to 90.1)
OG00244.4(13.7 to 78.8)
OG003
GII.4: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00077.8(40.0 to 97.2)
OG001100.0(59.0 to 100.0)
OG00255.6(21.2 to 86.3)
OG003
GII.4: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00012.5(0.3 to 52.7)
OG00142.9(9.9 to 81.6)
OG00233.3(7.5 to 70.1)
OG003
GII.4: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00142.6(9.9 to 81.6)
OG00237.5(8.5 to 75.5)
OG003
8
OG0048
OG0058
OG00610
OG0079
OG0089
OG0098
OG0107
7
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00066.7(29.9 to 92.5)
OG001100.0(63.1 to 100.0)
OG002100.0(69.2 to 100.0)
OG003100.0(59.0 to 100.0)
OG0040.0(0.0 to 36.9)
OG00587.5(47.3 to 99.7)
OG0060.0(0.0 to 30.8)
OG00755.6(21.2 to 86.3)
OG0080.0(0.0 to 33.6)
OG00975.0(34.9 to 96.8)
OG0100.0(0.0 to 41.0)
GI.1: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0069
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00077.8(40.0 to 97.2)
OG001100.0(63.1 to 100.0)
OG002100.0(69.2 to 100.0)
OG003
GI.1: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00077.8(40.0 to 97.2)
OG00187.5(47.3 to 99.7)
OG002100.0(69.2 to 100.0)
OG003
GI.1: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00077.8(40.0 to 97.2)
OG001100.0(59.0 to 100.0)
OG002100.0(69.2 to 100.0)
OG003
GI.1: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00077.8(40.0 to 97.2)
OG001100.0(59.0 to 100.0)
OG002100.0(66.4 to 100.0)
OG003
GI.1: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00077.8(40.0 to 97.2)
OG001100.0(59.0 to 100.0)
OG00288.9(51.8 to 99.7)
OG003
GI.1: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00050.0(15.7 to 84.3)
OG00185.7(42.1 to 99.6)
OG00288.9(51.8 to 99.7)
OG003
GI.1: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG00050.0(11.8 to 88.2)
OG00185.7(42.1 to 99.6)
OG00275.0(34.9 to 96.8)
OG003
GII.4: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00022.2(2.8 to 60.0)
OG00162.5(24.5 to 91.5)
OG00280.0(44.4 to 97.5)
OG003
GII.4: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00033.3(7.5 to 70.1)
OG00162.5(24.5 to 91.5)
OG00270.0(34.8 to 93.3)
OG003
GII.4: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00033.3(7.5 to 70.1)
OG00162.5(24.5 to 91.5)
OG00270.0(34.8 to 93.3)
OG003
GII.4: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00044.4(13.7 to 78.8)
OG00157.1(18.4 to 90.1)
OG00270.0(34.8 to 93.3)
OG003
GII.4: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00033.3(7.5 to 70.1)
OG00157.1(18.4 to 90.1)
OG00266.7(29.9 to 92.5)
OG003
GII.4: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00055.6(21.2 to 86.3)
OG00171.4(29.0 to 96.3)
OG00277.8(40.0 to 97.2)
OG003
GII.4: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00050.0(15.7 to 84.3)
OG00142.9(9.9 to 81.6)
OG00266.7(29.9 to 92.5)
OG003
GII.4: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG00033.3(4.3 to 77.7)
OG00157.1(18.4 to 90.1)
OG00250.0(15.7 to 584.3)
OG003
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
8
OG0049
OG0058
OG00610
OG0079
OG0089
OG0098
OG0107
8
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0003763(894 to 15838)
OG0012348(599 to 9198)
OG0022560(950 to 6901)
OG0032153(447 to 10366)
OG0041396(162 to 12052)
OG0051810(486 to 6737)
OG0062744(806 to 9337)
OG0076451(2020 to 20603)
OG0082763(668 to 21197)
OG0091280(320 to 5115)
OG010861(147 to 5054)
GI.1: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0037
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000163840(77123 to 348063)
OG001231705(135499 to 396217)
OG002351199(159240 to 774559)
OG003
GI.1: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000260080(122425 to 552516)
OG001194840(92705 to 409496)
OG002285262(127800 to 636731)
OG003
GI.1: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000222952(109569 to 453664)
OG001126338(59394 to 268734)
OG002216188(102476 to 456081)
OG003
GI.1: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000176957(85545 to 366049)
OG001163840(86301 to 311047)
OG002266159(143088 to 495085)
OG003
GI.1: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000206425(102014 to 417702)
OG001148394(83353 to 264185)
OG002176957(81595 to 383771)
OG003
GI.1: II Run:Pre-Dose 1
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0004389(978 to 19405)
OG0013121(657 to 14817)
OG0023484(870 to 13946)
OG003
GI.1: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000260080(112007 to 603906)
OG001243465(117694 to 503640)
OG002222952(91740 to 541832)
OG003
GI.1: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00097420(41130 to 230749)
OG001121733(53847 to 275205)
OG00295562(43402 to 210408)
OG003
GI.1: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG000145965(62364 to 341636)
OG00167202(25756 to 175341)
OG00263169(21663 to 184198)
OG003
GII.4: I Run: Pre-Dose 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00011945(3089 to 46196)
OG0013948(1103 to 14126)
OG0021470(287 to 7526)
OG003
GII.4: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0037
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00055738(32476 to 95661)
OG00153119(23492 to 120106)
OG00271316(35649 to 142667)
OG003
GII.4: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00070225(39229 to 125714)
OG00144667(20355 to 98017)
OG00250428(24962 to 101872)
OG003
GII.4: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00070225(33407 to 147623)
OG00140960(19180 to 87472)
OG00238217(17951 to 81361)
OG003
GII.4: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00075848(40737 to 141221)
OG00160866(36756 to 100792)
OG00243900(24247 to 79483)
OG003
GII.4: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00075848(34973 to 164493)
OG00160866(36756 to 100792)
OG00247781(25186 to 90647)
OG003
GII.4: II Run:Pre-Dose 1
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00013934(3481 to 55783)
OG00110240(2841 to 36907)
OG0024389(1026 to 18781)
OG003
GII.4: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00088478(44992 to 173997)
OG00190447(38184 to 214241)
OG002103213(65064 to 163729)
OG003
GII.4: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00081920(34112 to 196732)
OG00149931(24467 to 101894)
OG00227869(15260 to 50896)
OG003
GII.4: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG00045976(13134 to 160938)
OG00149931(19137 to 130278)
OG00220480(11977 to 35021)
OG003
8
OG0048
OG0058
OG00610
OG0079
OG0089
OG0098
OG0107
7
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00043.5(9.9 to 192.4)
OG00198.7(21.7 to 449.2)
OG002137.2(50.3 to 374.4)
OG003128(61.1 to 268.3)
OG0041(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
OG00583(9.7 to 708.7)
OG0060.8(0.6 to 1)
OG00723.5(5.5 to 101.4)
OG0081(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
OG00998.7(28.7 to 339.9)
OG0101(0.7 to 1.4)
GI.1: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00069.1(15.9 to 300.6)
OG00183(17.7 to 389.8)
OG002111.4(51.7 to 240.2)
OG003
GI.1: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00059.3(12.4 to 283)
OG00153.8(11.5 to 251.3)
OG00284.4(49.6 to 143.9)
OG003
GI.1: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00047(8.9 to 248.9)
OG00178(15.1 to 403.5)
OG002104(58.5 to 184.8)
OG003
GI.1: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00054.9(10.2 to 294.4)
OG00170.7(16.5 to 302.4)
OG00264(37.6 to 109)
OG003
GI.1: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00059.3(13 to 270.2)
OG00178(16.4 to 370.4)
OG00264(31.6 to 129.5)
OG003
GI.1: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00017.4(4.3 to 70.8)
OG00139(7.9 to 193.4)
OG00227.4(11.9 to 63.1)
OG003
GI.1: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG00025.4(2.1 to 311.2)
OG00121.5(4.7 to 98.4)
OG00219(8.5 to 42.5)
OG003
GII.4: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0004.7(1.5 to 14.3)
OG00113.5(3 to 60.9)
OG00248.5(7.9 to 297.4)
OG003
GII.4: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0005.9(1.5 to 23.5)
OG00111.3(3.6 to 36.1)
OG00234.3(7.3 to 160.1)
OG003
GII.4: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0005.9(1.5 to 22.3)
OG00110.4(3.6 to 30.3)
OG00226(5.1 to 131.4)
OG003
GII.4: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0006.3(2 to 20.3)
OG00110.8(2.9 to 40.6)
OG00229.9(6.1 to 146.9)
OG003
GII.4: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0006.3(1.7 to 24.1)
OG00110.8(3.4 to 34.4)
OG00221.8(6.6 to 71.9)
OG003
GII.4: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0006.3(1.6 to 24.7)
OG0018.8(2.5 to 30.9)
OG00223.5(6.5 to 84.6)
OG003
GII.4: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG0003.7(1.5 to 9)
OG0014.9(1.4 to 17.3)
OG0026.3(1.9 to 21.5)
OG003
GII.4: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG0004(0.7 to 23.8)
OG0014.9(1.2 to 19.2)
OG0023.4(0.8 to 13.3)
OG003
8
OG0048
OG0058
OG00610
OG0079
OG0089
OG0098
OG0107
7
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00088.9(51.8 to 99.7)
OG001100.0(63.1 to 100.0)
OG002100.0(69.2 to 100.0)
OG003100.0(59.0 to 100.0)
OG0040.0(0.0 to 36.9)
OG00587.5(47.3 to 99.7)
OG0060.0(0.0 to 30.8)
OG00788.9(51.8 to 99.7)
OG0080.0(0.0 to 33.6)
OG009100.0(63.1 to 100.0)
OG0100.0(0.0 to 41.0)
GI.1: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000100.0(66.4 to 100.0)
OG001100.0(63.1 to 100.0)
OG002100.0(69.2 to 100.0)
OG003
GI.1: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000100.0(66.4 to 100.0)
OG001100.0(63.1 to 100.0)
OG002100.0(69.2 to 100.0)
OG003
GI.1: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000100.0(66.4 to 100.0)
OG001100.0(59.0 to 100.0)
OG002100.0(69.2 to 100.0)
OG003
GI.1: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000100.0(66.4 to 100.0)
OG001100.0(59.0 to 100.0)
OG002100.0(66.4 to 100.0)
OG003
GI.1: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG000100.0(66.4 to 100.0)
OG001100.0(59.0 to 100.0)
OG002100.0(66.4 to 100.0)
OG003
GI.1: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00087.5(47.3 to 99.7)
OG001100.0(59.0 to 100.0)
OG002100.0(66.4 to 100.0)
OG003
GI.1: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG00066.7(22.3 to 95.7)
OG001100.0(59.0 to 100.0)
OG002100.0(63.1 to 100.0)
OG003
GII.4: I Run:7 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00066.7(29.9 to 92.5)
OG00175.0(34.9 to 96.8)
OG00280.0(44.4 to 97.5)
OG003
GII.4: I Run:21 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00055.6(21.2 to 86.3)
OG00187.5(47.3 to 99.7)
OG00280.0(44.4 to 97.5)
OG003
GII.4: I Run:28 Days PD1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00055.6(21.2 to 86.3)
OG00187.5(47.3 to 99.7)
OG00280.0(44.4 to 97.5)
OG003
GII.4: I Run:7 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00066.7(29.9 to 92.5)
OG00171.4(29.0 to 96.3)
OG00280.0(44.4 to 97.5)
OG003
GII.4: I Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00055.6(21.2 to 86.3)
OG00185.7(42.1 to 96.6)
OG00288.9(51.8 to 99.7)
OG003
GII.4: II Run:28 Days PD2
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00066.7(29.9 to 92.5)
OG00171.4(29.0 to 96.3)
OG00288.9(51.8 to 99.7)
OG003
GII.4: II Run:152 Days PD2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0098
ParticipantsOG0107
Title
Measurements
OG00050.0(15.7 to 84.3)
OG00157.1(18.4 to 90.1)
OG00266.7(29.9 to 92.5)
OG003
GII.4: II Run:365 Days PD2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0089
ParticipantsOG0097
ParticipantsOG0107
Title
Measurements
OG00033.3(4.3 to 77.7)
OG00157.1(18.4 to 90.1)
OG00262.5(24.5 to 91.5)
OG003
675
(136 to 3334)
OG0047(2 to 20)
OG005357(110 to 1158)
OG0065(3 to 8)
OG007208(48 to 903)
OG0084(3 to 5)
OG00940(13 to 120)
OG0103(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
307
(84 to 1115)
OG0049(3 to 26)
OG005252(151 to 421)
OG0065(3 to 9)
OG007114(31 to 423)
OG0084(3 to 5)
OG00931(10 to 96)
OG0103(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
149
(43 to 517)
OG0049(3 to 23)
OG005178(95 to 335)
OG0065(3 to 8)
OG007104(29 to 375)
OG0084(3 to 5)
OG00921(7 to 60)
OG0103(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
131
(45 to 376)
OG00411(3 to 34)
OG005140(73 to 270)
OG0065(3 to 8)
OG007105(33 to 329)
OG0084(3 to 5)
OG00919(7 to 55)
OG0103(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
78
(20 to 310)
OG00410(3 to 29)
OG00597(48 to 198)
OG0065(3 to 8)
OG00776(23 to 251)
OG0084(3 to 5)
OG00917(7 to 42)
OG0103(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
3
(3 to 4)
OG0046(2 to 18)
OG0053(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
OG0066(3 to 12)
OG0076(3 to 13)
OG0085(3 to 9)
OG0094(2 to 6)
OG0103(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
16
(6 to 43)
OG0046(2 to 18)
OG005120(62 to 231)
OG0066(3 to 11)
OG007154(68 to 348)
OG0085(3 to 8)
OG00935(13 to 99)
OG0103(3 to 5)
16
(6 to 43)
OG0046(2 to 18)
OG00557(36 to 92)
OG0066(3 to 12)
OG00778(42 to 143)
OG0086(4 to 10)
OG00924(10 to 58)
OG0103(3 to 4)
14
(4 to 44)
OG0045(2 to 13)
OG00538(22 to 65)
OG0066(3 to 12)
OG00753(29 to 99)
OG0087(4 to 13)
OG00916(7 to 39)
OG0103(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
9
(4 to 20)
OG00423(7 to 70)
OG0059(3 to 29)
OG0065(3 to 7)
OG0079(4 to 23)
OG0086(3 to 12)
OG0095(2 to 9)
OG0106(3 to 12)
52
(35 to 78)
OG00418(6 to 53)
OG00592(26 to 322)
OG0065(3 to 8)
OG00741(26 to 65)
OG0087(3 to 14)
OG00996(22 to 421)
OG0106(3 to 13)
25
(14 to 42)
OG00416(6 to 45)
OG00563(21 to 186)
OG0065(3 to 9)
OG00725(9 to 70)
OG0087(3 to 16)
OG00955(18 to 170)
OG0106(3 to 13)
19
(10 to 34)
OG00419(7 to 48)
OG00542(11 to 159)
OG0065(3 to 7)
OG00722(9 to 55)
OG0086(3 to 12)
OG00939(15 to 100)
OG0106(3 to 12)
22
(10 to 50)
OG00429(12 to 72)
OG00544(12 to 159)
OG0065(3 to 8)
OG00722(9 to 55)
OG0087(3 to 14)
OG00936(15 to 89)
OG0106(3 to 11)
19
(9 to 39)
OG00430(12 to 76)
OG00534(10 to 117)
OG0065(3 to 7)
OG00721(9 to 53)
OG0086(3 to 14)
OG00931(13 to 73)
OG0106(3 to 13)
8
(4 to 17)
OG0045(2 to 10)
OG0059(3 to 28)
OG0065(3 to 8)
OG00718(5 to 66)
OG0088(4 to 17)
OG0095(2 to 12)
OG0107(3 to 16)
19
(12 to 31)
OG0047(3 to 20)
OG00538(11 to 125)
OG0065(3 to 9)
OG00744(13 to 144)
OG0088(4 to 19)
OG00942(20 to 89)
OG0107(3 to 16)
14
(7 to 28)
OG0046(3 to 15)
OG00527(9 to 83)
OG0066(3 to 11)
OG00729(10 to 85)
OG0089(4 to 19)
OG00925(10 to 65)
OG0106(3 to 13)
16
(9 to 29)
OG0046(3 to 11)
OG00517(5 to 56)
OG0067(3 to 18)
OG00724(9 to 66)
OG00811(4 to 28)
OG00919(7 to 47)
OG0106(3 to 13)
1171
(251 to 5457)
OG0045(1 to 20)
OG005375(97 to 1447)
OG0067(2 to 19)
OG00796(32 to 289)
OG00810(4 to 24)
OG00982(18 to 373)
OG0105(1 to 16)
1235
(534 to 2858)
OG0047(2 to 26)
OG005457(159 to 1312)
OG0065(1 to 18)
OG00797(30 to 309)
OG00813(5 to 30)
OG009107(24 to 468)
OG0105(1 to 14)
878
(409 to 1882)
OG0047(2 to 26)
OG005429(178 to 1036)
OG0066(2 to 18)
OG007110(41 to 300)
OG00810(4 to 23)
OG00993(22 to 395)
OG0105(2 to 16)
957
(554 to 1651)
OG00410(2 to 49)
OG005513(249 to 1060)
OG0067(3 to 21)
OG007157(66 to 373)
OG00810(4 to 24)
OG009108(25 to 474)
OG0105(2 to 14)
737
(399 to 1361)
OG00411(2 to 50)
OG005518(278 to 966)
OG0066(2 to 19)
OG007177(78 to 399)
OG00810(4 to 26)
OG009127(27 to 586)
OG0105(2 to 16)
5
(2 to 10)
OG0047(2 to 27)
OG0058(4 to 19)
OG0067(3 to 14)
OG0079(3 to 30)
OG0088(4 to 18)
OG0093(1 to 6)
OG0103(1 to 5)
113
(78 to 164)
OG00410(3 to 36)
OG005270(178 to 411)
OG0066(2 to 14)
OG007103(53 to 200)
OG0088(4 to 17)
OG00980(56 to 116)
OG0103(1 to 6)
73
(45 to 118)
OG0048(2 to 28)
OG005135(90 to 202)
OG0067(3 to 16)
OG00782(47 to 143)
OG0088(4 to 17)
OG00935(27 to 44)
OG0103(1 to 5)
46
(23 to 92)
OG0046(2 to 19)
OG00575(55 to 103)
OG0066(2 to 16)
OG00757(33 to 99)
OG00810(4 to 28)
OG00921(13 to 34)
OG0103(1 to 6)
17
(7 to 41)
OG00419(5 to 69)
OG0058(2 to 29)
OG0065(2 to 15)
OG00710(4 to 28)
OG0086(2 to 20)
OG00911(5 to 22)
OG01013(4 to 45)
40
(27 to 60)
OG00414(4 to 53)
OG00554(14 to 206)
OG0065(2 to 15)
OG00723(14 to 37)
OG0089(3 to 24)
OG009178(100 to 317)
OG01016(6 to 46)
39
(27 to 55)
OG00413(4 to 45)
OG00593(33 to 262)
OG0065(2 to 15)
OG00729(17 to 49)
OG0089(3 to 28)
OG009180(126 to 259)
OG01017(6 to 48)
37
(28 to 49)
OG00416(6 to 46)
OG00586(31 to 237)
OG0065(2 to 13)
OG00730(20 to 45)
OG0087(2 to 20)
OG009148(105 to 208)
OG01016(6 to 45)
42
(34 to 51)
OG00425(9 to 69)
OG00599(42 to 233)
OG0065(2 to 14)
OG00734(25 to 45)
OG0088(3 to 24)
OG009144(106 to 196)
OG01015(5 to 46)
41
(32 to 51)
OG00427(10 to 75)
OG005102(43 to 242)
OG0066(2 to 15)
OG00736(28 to 47)
OG0087(3 to 21)
OG009140(97 to 202)
OG01017(6 to 49)
10
(3 to 33)
OG0045(2 to 14)
OG0056(2 to 18)
OG0064(2 to 9)
OG0079(2 to 42)
OG0087(2 to 20)
OG0093(1 to 7)
OG0106(2 to 14)
37
(18 to 73)
OG0048(2 to 34)
OG005104(65 to 166)
OG0065(2 to 12)
OG00752(22 to 120)
OG0087(2 to 18)
OG00937(25 to 56)
OG0106(2 to 15)
18
(9 to 36)
OG0047(2 to 23)
OG00577(30 to 194)
OG0065(2 to 11)
OG00733(14 to 75)
OG0088(2 to 26)
OG00920(12 to 33)
OG0105(2 to 12)
23
(11 to 51)
OG0046(2 to 16)
OG00544(24 to 81)
OG0066(2 to 16)
OG00722(9 to 54)
OG00813(5 to 34)
OG00916(8 to 34)
OG0105(2 to 12)
52.1
(19.3 to 140.4)
OG0041(0.9 to 1.2)
OG00581.2(48.6 to 135.7)
OG0061(0.9 to 1.1)
OG00724.2(6.9 to 85.7)
OG0081(0.9 to 1)
OG0099.7(3.1 to 30.2)
OG0101(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
25.4
(10.5 to 61.3)
OG0041(0.8 to 1.2)
OG00557.5(30.6 to 108)
OG0061(0.9 to 1.1)
OG00719.6(6.4 to 60.5)
OG0081(0.9 to 1)
OG0096.6(2.4 to 18.8)
OG0101(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
22.2
(10.8 to 45.4)
OG0041.1(0.7 to 1.6)
OG00545.2(23.4 to 87.2)
OG0061(1 to 1.1)
OG00719.7(7.3 to 53.2)
OG0081(0.9 to 1)
OG0096(2.1 to 17.3)
OG0101(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
13.2
(5 to 34.7)
OG0041(0.7 to 1.3)
OG00531.3(15.4 to 63.7)
OG0061.1(0.9 to 1.3)
OG00714.2(5.1 to 39.8)
OG0081(1 to 1.1)
OG0095.3(2.1 to 13.1)
OG0101(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
4.7
(1.9 to 11.7)
OG0041(1 to 1)
OG00538.6(19.9 to 74.6)
OG0061(0.9 to 1.1)
OG00725.5(9.1 to 71.4)
OG0081(1 to 1)
OG0099.6(3.7 to 24.9)
OG0101.1(0.9 to 1.5)
4.6
(1.7 to 12)
OG0041(1 to 1)
OG00518.5(11.5 to 29.8)
OG0061.1(0.9 to 1.3)
OG00712.9(5.5 to 30)
OG0081.1(0.9 to 1.3)
OG0096.6(2.9 to 15.1)
OG0101.1(0.9 to 1.4)
4.5
(1.4 to 14.1)
OG0041(0.9 to 1)
OG00512.2(7.1 to 20.9)
OG0061(0.9 to 1.2)
OG0078.8(3.9 to 20.2)
OG0081.3(0.9 to 1.9)
OG0095.2(2.1 to 12.7)
OG0101(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
5
(2.2 to 11)
OG0041(0.9 to 1.1)
OG0059.7(3 to 30.6)
OG0061(1 to 1.1)
OG0074.4(2.1 to 9.6)
OG0081.2(0.9 to 1.4)
OG00919.9(5.9 to 67.6)
OG0101(1 to 1.1)
2.7
(1.3 to 5.5)
OG0040.9(0.7 to 1)
OG0056.6(3 to 14.4)
OG0061.1(0.9 to 1.2)
OG0073.5(1.2 to 9.7)
OG0081.1(0.8 to 1.6)
OG00911.4(3.9 to 33.3)
OG0101(1 to 1.1)
2
(1 to 4.3)
OG0041(0.6 to 1.9)
OG0054.5(1.9 to 10.7)
OG0061(0.9 to 1.1)
OG0072.4(0.9 to 6.4)
OG0081(0.8 to 1.2)
OG0098.1(3.2 to 20.4)
OG0101(0.9 to 1.1)
2.5
(1 to 5.9)
OG0041.3(0.4 to 3.6)
OG0054.6(2.1 to 10.3)
OG0061.1(1 to 1.1)
OG0072.4(0.9 to 6.3)
OG0081.1(0.9 to 1.5)
OG0097.5(3 to 18.6)
OG0101(0.8 to 1.1)
2
(1 to 4.4)
OG0041.3(0.5 to 3.3)
OG0053.5(1.7 to 7.4)
OG0061(1 to 1.1)
OG0072.3(1 to 5.7)
OG0081.1(0.9 to 1.4)
OG0096.4(2.6 to 15.6)
OG0101.1(1 to 1.2)
2.5
(1 to 5.9)
OG0041.5(0.6 to 3.6)
OG0054(1.9 to 8.3)
OG0061.1(0.9 to 1.4)
OG0072.4(0.8 to 7.2)
OG0081(0.9 to 1.2)
OG0098.1(3.2 to 20.4)
OG0101(0.9 to 1)
1.9
(0.8 to 4.5)
OG0041.3(0.7 to 2.4)
OG0052.8(1.5 to 5.2)
OG0061.2(0.9 to 1.6)
OG0071.6(0.5 to 4.8)
OG0081.1(0.9 to 1.4)
OG0094.8(1.8 to 12.7)
OG0100.8(0.6 to 1.2)
1.8
(0.8 to 4.2)
OG0041.3(0.8 to 2.1)
OG0051.8(0.9 to 3.6)
OG0061.5(0.9 to 2.6)
OG0071.3(0.4 to 4.1)
OG0081.4(0.8 to 2.3)
OG0094.4(1.6 to 12)
OG0100.8(0.6 to 1.1)
55.2
(25.7 to 118.7)
OG0041(0.8 to 1.2)
OG00552.5(10.2 to 270.8)
OG0060.8(0.5 to 1.2)
OG0077.5(2.4 to 23.1)
OG0080.9(0.8 to 1.1)
OG00914.4(2.9 to 71.8)
OG0101(0.9 to 1.1)
39.2
(17.6 to 87.6)
OG0041(0.8 to 1.2)
OG00549.3(11.2 to 217.8)
OG0060.8(0.5 to 1.3)
OG0077.9(3.1 to 20.4)
OG0080.9(0.8 to 1)
OG00912.7(2.7 to 59.3)
OG0101.1(0.9 to 1.2)
42.8
(17.4 to 104.8)
OG0041.2(0.7 to 2.1)
OG00559(14.4 to 241)
OG0061(0.6 to 1.7)
OG00711.3(4.3 to 29.8)
OG0080.9(0.8 to 1)
OG00914.7(3.1 to 70.3)
OG0101(0.8 to 1.2)
32.9
(14.6 to 74.5)
OG0041.2(0.8 to 1.9)
OG00559.5(16.9 to 209.6)
OG0060.9(0.5 to 1.5)
OG00712.6(4.9 to 32.8)
OG0080.9(0.9 to 1)
OG00917.2(3.6 to 82.7)
OG0101.1(0.9 to 1.2)
23.9
(14.4 to 39.7)
OG0041.4(0.8 to 2.5)
OG00532(14.5 to 70.5)
OG0060.8(0.6 to 1.3)
OG00710.9(3.8 to 31)
OG0081(0.8 to 1.2)
OG00926.6(11.2 to 63)
OG0101.1(0.9 to 1.3)
15.5
(7.1 to 33.9)
OG0041.1(0.7 to 1.9)
OG00515.9(6.5 to 38.9)
OG0061(0.7 to 1.4)
OG0078.7(3.3 to 22.7)
OG0081(0.7 to 1.3)
OG00911.5(5.1 to 26)
OG0100.9(0.6 to 1.3)
11.7
(5 to 27.4)
OG0041.1(0.6 to 2.1)
OG0058.9(4.1 to 19.3)
OG0060.9(0.5 to 1.6)
OG0076(2.4 to 15)
OG0081.3(0.7 to 2.5)
OG0098.2(3.6 to 18.6)
OG0101(0.9 to 1.2)
2.4
(1.1 to 5.1)
OG0041(0.9 to 1.1)
OG0056.8(2.2 to 21.1)
OG0061(1 to 1.1)
OG0072.3(1.2 to 4.4)
OG0081.4(0.9 to 2)
OG00916.1(5.7 to 45.4)
OG0101.3(1 to 1.6)
2.3
(1.2 to 4.2)
OG0040.9(0.8 to 1)
OG00511.7(4.7 to 29.2)
OG0061(0.9 to 1.1)
OG0073.3(1.4 to 8)
OG0081.3(0.9 to 1.8)
OG00916.4(7 to 38.3)
OG0101.4(1 to 1.8)
2.2
(1.1 to 4.4)
OG0041.1(0.6 to 2.2)
OG00510.8(4.2 to 27.9)
OG0060.9(0.9 to 1)
OG0073(1.4 to 6.4)
OG0081(0.9 to 1.2)
OG00913.4(5.7 to 31.6)
OG0101.3(1 to 1.6)
2.5
(1.1 to 5.5)
OG0041.4(0.5 to 4.1)
OG00512.3(4.6 to 32.6)
OG0061(0.9 to 1.1)
OG0073.4(1.4 to 7.9)
OG0081.2(1 to 1.6)
OG00913.1(6.1 to 27.8)
OG0101.2(0.9 to 1.5)
2.4
(1.2 to 5)
OG0041.5(0.5 to 4.5)
OG00512.8(4.6 to 35.5)
OG0061.1(0.9 to 1.3)
OG0073.7(1.6 to 8.5)
OG0081.1(0.9 to 1.4)
OG00912.7(6.3 to 25.5)
OG0101.3(1 to 1.8)
3.5
(1.1 to 11.5)
OG0041.6(0.5 to 4.5)
OG00518.1(4.4 to 74.6)
OG0061.3(1 to 1.6)
OG0075.7(1.7 to 19.6)
OG0081(0.7 to 1.5)
OG00912.2(5.7 to 26.3)
OG0101(0.9 to 1.2)
1.7
(0.7 to 4.2)
OG0041.4(0.8 to 2.6)
OG00513.4(3.4 to 51.9)
OG0061.2(0.8 to 1.8)
OG0073.6(0.9 to 14.9)
OG0081.2(0.6 to 2.3)
OG0096.5(3.4 to 12.2)
OG0100.9(0.6 to 1.2)
1.9
(0.6 to 5.9)
OG0041.3(0.7 to 2.5)
OG0057.7(2.5 to 23.7)
OG0061.4(0.8 to 2.5)
OG0072.5(0.6 to 9.9)
OG0081.9(0.9 to 4.3)
OG0096(3.2 to 11.2)
OG0100.9(0.7 to 1.1)
100.0
(69.2 to 100.0)
OG0040.0(0.0 to 36.9)
OG005100.0(63.1 to 100.0)
OG0060.0(0.0 to 33.6)
OG00787.5(47.3 to 99.7)
OG0080.0(0.0 to 36.9)
OG00975.0(34.9 to 96.8)
OG0100.0(0.0 to 41.0)
87.5
(47.3 to 99.7)
OG0040.0(0.0 to 36.9)
OG005100.0(63.1 to 100.0)
OG0060.0(0.0 to 30.8)
OG00777.8(40.0 to 97.2)
OG0080.0(0.0 to 33.6)
OG00962.5(24.5 to 91.5)
OG0100.0(0.0 to 41.0)
100.0
(63.1 to 100.0)
OG0040.0(0.0 to 36.9)
OG005100.0(63.1 to 100.0)
OG0060.0(0.0 to 30.8)
OG00788.9(51.8 to 99.7)
OG0080.0(0.0 to 33.6)
OG00962.5(24.5 to 91.5)
OG0100.0(0.0 to 41.0)
87.5
(47.3 to 99.7)
OG0040.0(0.0 to 36.9)
OG005100.0(63.1 to 100.0)
OG0060.0(0.0 to 30.8)
OG00788.9(51.8 to 99.7)
OG0080.0(0.0 to 33.6)
OG00962.5(24.5 to 91.5)
OG0100.0(0.0 to 41.0)
62.5
(24.5 to 91.5)
OG0040.0(0.0 to 41.0)
OG005100.0(63.1 to 100.0)
OG0060.0(0.0 to 30.8)
OG007100.0(66.4 to 100.0)
OG0080.0(0.0 to 33.6)
OG00987.5(47.3 to 99.7)
OG0100.0(0.0 to 41.0)
50.0
(15.7 to 84.3)
OG0040.0(0.0 to 41.0)
OG005100.0(63.1 to 100.0)
OG0060.0(0.0 to 30.8)
OG00766.7(29.9 to 92.5)
OG0080.0(0.0 to 33.6)
OG00975.0(34.9 to 96.8)
OG0100.0(0.0 to 41.0)
57.1
(18.4 to 90.1)
OG0040.0(0.0 to 41.0)
OG005100.0(63.1 to 100.0)
OG0060.0(0.0 to 30.8)
OG00766.7(29.9 to 92.5)
OG0080.0(0.0 to 33.6)
OG00971.4(29.0 to 96.3)
OG0100.0(0.0 to 41.0)
42.9
(9.9 to 81.6)
OG0040.0(0.0 to 36.9)
OG00562.5(24.5 to 91.5)
OG0060.0(0.0 to 30.8)
OG00755.6(21.2 to 86.3)
OG0080.0(0.0 to 33.6)
OG00987.5(47.3 to 99.7)
OG0100.0(0.0 to 41.0)
25.0
(3.2 to 65.1)
OG0040.0(0.0 to 36.9)
OG00575.0(34.9 to 96.8)
OG0060.0(0.0 to 30.8)
OG00725.0(3.2 to 65.1)
OG0080.0(0.0 to 36.9)
OG00975.0(34.9 to 96.8)
OG0100.0(0.0 to 41.0)
12.5
(0.3 to 52.7)
OG00412.5(0.3 to 52.7)
OG00550.0(15.7 to 84.3)
OG0060.0(0.0 to 30.8)
OG00722.2(2.8 to 60.0)
OG0080.0(0.0 to 33.6)
OG00975.0(34.9 to 96.8)
OG0100.0(0.0 to 41.0)
25.0
(3.2 to 65.1)
OG00412.5(0.3 to 52.7)
OG00562.5(24.5 to 91.5)
OG0060.0(0.0 to 30.8)
OG00733.3(7.5 to 70.1)
OG0080.0(0.0 to 33.6)
OG00962.5(24.5 to 91.5)
OG0100.0(0.0 to 41.0)
25.0
(3.2 to 65.1)
OG00412.5(0.3 to 52.7)
OG00550.0(15.7 to 84.3)
OG0060.0(0.0 to 30.8)
OG00722.2(2.8 to 60.0)
OG0080.0(0.0 to 33.6)
OG00962.5(24.5 to 91.5)
OG0100.0(0.0 to 41.0)
37.5
(8.5 to 75.5)
OG00414.3(0.4 to 57.9)
OG00550.0(15.7 to 84.3)
OG0060.0(0.0 to 30.8)
OG00733.3(7.5 to 70.1)
OG0080.0(0.0 to 33.6)
OG00962.5(24.5 to 91.5)
OG0100.0(0.0 to 41.0)
25.0
(3.2 to 65.1)
OG00414.3(0.4 to 57.9)
OG00525.0(3.2 to 65.1)
OG0060.0(0.0 to 30.8)
OG00733.3(7.5 to 70.1)
OG0080.0(0.0 to 33.6)
OG00950.0(15.7 to 84.3)
OG0100.0(0.0 to 41.0)
14.3
(0.4 to 57.9)
OG00414.3(0.4 to 57.9)
OG00525.0(3.2 to 65.1)
OG00610.0(0.3 to 44.5)
OG00722.2(2.8 to 60.0)
OG00811.1(0.3 to 48.2)
OG00957.1(18.4 to 90.1)
OG0100.0(0.0 to 41.0)
100.0
(63.1 to 100.0)
OG0040.0(0.0 to 36.9)
OG00587.5(47.3 to 99.7)
OG0060.0(0.0 to 33.6)
OG00750.0(15.7 to 84.3)
OG0080.0(0.0 to 36.9)
OG00975.0(34.9 to 96.8)
OG0100.0(0.0 to 41.0)
100.0
(63.1 to 100.0)
OG0040.0(0.0 to 36.9)
OG00587.5(47.3 to 99.7)
OG0060.0(0.0 to 30.8)
OG00755.6(21.2 to 86.3)
OG0080.0(0.0 to 33.6)
OG00975.0(34.9 to 96.8)
OG0100.0(0.0 to 41.0)
100.0
(63.1 to 100.0)
OG00412.5(0.3 to 52.7)
OG00587.5(47.3 to 99.7)
OG0060.0(0.0 to 30.8)
OG00766.7(29.9 to 92.5)
OG0080.0(0.0 to 33.6)
OG00975.0(34.9 to 96.8)
OG0100.0(0.0 to 41.0)
100.0
(63.1 to 100.0)
OG00412.5(0.3 to 52.7)
OG00587.5(47.3 to 99.7)
OG0060.0(0.0 to 30.8)
OG00777.8(40.0 to 97.2)
OG0080.0(0.0 to 33.6)
OG00975.0(34.9 to 96.8)
OG0100.0(0.0 to 41.0)
100.0
(63.1 to 100.0)
OG00414.3(0.4 to 57.9)
OG005100.0(63.1 to 100.0)
OG0060.0(0.0 to 30.8)
OG00788.9(51.8 to 99.7)
OG0080.0(0.0 to 33.6)
OG009100.0(63.1 to 100.0)
OG0100.0(0.0 to 41.0)
87.5
(47.3 to 99.7)
OG00414.3(0.4 to 57.9)
OG00587.5(47.3 to 99.7)
OG0060.0(0.0 to 30.8)
OG00788.9(51.8 to 99.7)
OG0080.0(0.0 to 33.6)
OG00975.0(34.9 to 96.8)
OG0100.0(0.0 to 41.0)
85.7
(42.1 to 99.6)
OG0040.0(0.0 to 41.0)
OG00587.5(47.3 to 99.7)
OG0060.0(0.0 to 30.8)
OG00766.7(29.9 to 92.5)
OG00811.1(0.3 to 48.2)
OG00971.4(29.0 to 96.3)
OG0100.0(0.0 to 41.0)
28.6
(3.7 to 871.0)
OG0040.0(0.0 to 36.9)
OG00562.5(24.5 to 91.5)
OG0060.0(0.0 to 30.8)
OG00733.3(7.5 to 70.1)
OG0080.0(0.0 to 33.6)
OG00975.0(34.9 to 96.8)
OG0100.0(0.0 to 41.0)
12.5
(0.3 to 52.7)
OG0040.0(0.0 to 36.9)
OG00587.5(47.3 to 99.7)
OG0060.0(0.0 to 30.8)
OG00750.0(15.7 to 84.3)
OG0080.0(0.0 to 36.9)
OG00987.5(47.3 to 99.7)
OG0100.0(0.0 to 41.0)
12.5
(0.3 to 52.7)
OG00412.5(0.3 to 52.7)
OG00575.0(34.9 to 96.8)
OG0060.0(0.0 to 30.8)
OG00744.4(13.7 to 878.8)
OG0080.0(0.0 to 33.6)
OG00987.5(47.3 to 99.7)
OG0100.0(0.0 to 41.0)
25.0
(3.2 to 65.1)
OG00412.5(0.3 to 52.7)
OG00575.0(34.9 to 96.8)
OG0060.0(0.0 to 30.8)
OG00744.4(13.7 to 78.8)
OG0080.0(0.0 to 33.6)
OG00987.5(47.3 to 99.7)
OG0100.0(0.0 to 41.0)
12.5
(0.3 to 52.7)
OG00412.5(0.3 to 52.7)
OG00587.5(47.3 to 99.7)
OG0060.0(0.0 to 30.8)
OG00744.4(13.7 to 78.8)
OG0080.0(0.0 to 33.6)
OG009100.0(63.1 to 100.0)
OG0100.0(0.0 to 41.0)
50.0
(15.7 to 84.3)
OG00414.3(0.4 to 57.9)
OG00575.0(34.9 to 96.8)
OG0060.0(0.0 to 30.8)
OG00766.7(29.9 to 92.5)
OG0080.0(0.0 to 33.6)
OG00987.5(47.3 to 99.7)
OG0100.0(0.0 to 41.0)
25.0
(3.5 to 65.1)
OG00414.3(0.4 to 57.9)
OG00562.5(24.5 to 91.5)
OG00610.0(0.3 to 44.5)
OG00766.7(29.9 to 92.5)
OG00811.1(0.3 to 48.2)
OG00975.0(34.9 to 96.8)
OG0100.0(0.0 to 41.0)
28.6
(3.7 to 71.0)
OG00414.3(0.4 to 57.9)
OG00550.0(15.7 to 84.3)
OG00610.0(0.3 to 44.5)
OG00755.6(21.2 to 86.3)
OG00822.2(2.8 to 60.0)
OG00985.7(42.1 to 99.6)
OG0100.0(0.0 to 41.0)
220512
(57489 to 831259)
OG0041185(179 to 7861)
OG005150242(52704 to 428288)
OG0062229(596 to 8327)
OG007151695(57115 to 402894)
OG0083763(668 to 21197)
OG009126338(39749 to 401554)
OG010861(153 to 4860)
212474
(93970 to 480425)
OG0041185(193 to 7282)
OG005212474(114914 to 392862)
OG0062389(658 to 8676)
OG007115852(51050 to 262916)
OG0087241(2719 to 19283)
OG009137772(58166 to 326329)
OG010861(207 to 3587)
194840
(106949 to 354959)
OG0041280(219 to 7493)
OG005212474(106756 to 422883)
OG0062389(658 to 8676)
OG007120401(56380 to 257117)
OG0083763(696 to 20334)
OG009106230(42084 to 268187)
OG010707(122 to 4078)
212474
(124953 to 361298)
OG0041974(396 to 9852)
OG005231705(169986 to 315832)
OG0062229(584 to 8500)
OG007176957(116676 to 268383)
OG0084389(872 to 22081)
OG009126338(68328 to 233597)
OG010861(207 to 3587)
150242
(92634 to 243676)
OG0041974(352 to 11056)
OG005300484(156475 to 577028)
OG0062079(532 to 8134)
OG007176957(128475 to 243735)
OG0085120(1388 to 18883)
OG00989334(61622 to 129510)
OG010861(180 to 4116)
1974
(408 to 9540)
OG0043121(415 to 23466)
OG0052560(803 to 8158)
OG0062941(804 to 10760)
OG0074389(156 to 12222)
OG0082560(567 to 11554)
OG009587(155 to 2219)
OG010390(82 to 1852)
212474
(124953 to 361298)
OG0043446(506 to 23456)
OG005357338(246486 to 518042)
OG0062744(696 to 10819)
OG007140451(98461 to 200348)
OG0082195(392 to 12279)
OG00989334(61622 to 129510)
OG010353(53 to 2369)
126338
(93602 to 170523)
OG0043121(478 to 20386)
OG005150242(103635 to 217810)
OG0062941(756 to 11445)
OG00781920(56204 to 119401)
OG0082370(409 to 13721)
OG00931584(20522 to 48609)
OG010390(75 to 2018)
81920
(48537 to 138264)
OG0042153(409 to 11331)
OG00575121(51817 to 108905)
OG0062941(699 to 12376)
OG00747781(30650 to 74487)
OG0083484(560 to 21684)
OG00918549(10419 to 33023)
OG010353(64 to 1960)
28963
(5792 to 144824)
OG0045583(1425 to 21877)
OG0054695(804 to 27403)
OG0062229(408 to 12181)
OG0079481(1706 to 52683)
OG0088127(1540 to 42902)
OG0096089(2015 to 18402)
OG0109275(2069 to 41572)
593575
(250592 to 1405995)
OG0044740(1381 to 16278)
OG005115852(45745 to 293407)
OG0061940(377 to 9997)
OG00788478(42773 to 183024)
OG0086451(1429 to 29113)
OG009300484(110464 to 817377)
OG0107608(1665 to 34773)
505352
(297190 to 859315)
OG0045120(1603 to 16352)
OG005163840(81963 to 327507)
OG0061810(329 to 9966)
OG007126338(55875 to 285662)
OG0089390(1854 to 47567)
OG009212474(114914 to 392862)
OG0108400(1694 to 41653)
275545
(151249 to 501988)
OG0046451(2151 to 19348)
OG005150242(84602 to 266810)
OG0062079(426 to 10158)
OG007111476(52201 to 238058)
OG0087525(1588 to 35664)
OG009126338(74298 to 214829)
OG0107608(1665 to 34773)
300484
(185267 to 487353)
OG00410240(3502 to 29943)
OG005163840(88181 to 304413)
OG0061810(329 to 9966)
OG007130040(67714 to 249731)
OG0088127(1573 to 41991)
OG009178669(100609 to 317292)
OG01010240(2130 to 49233)
212474
(106756 to 422883)
OG00411167(3442 to 36230)
OG005126338(68328 to 233597)
OG0061810(363 to 9026)
OG007103213(46414 to 229521)
OG0086967(1405 to 34539)
OG009115852(57957 to 231582)
OG01010240(2330 to 45004)
18780
(3498 to 100825)
OG0044200(968 to 18216)
OG0053948(544 to 28648)
OG0062560(606 to 10815)
OG0077525(1257 to 45038)
OG0086967(1540 to 31526)
OG0095120(2022 to 12967)
OG0105653(1106 to 28892)
126338
(63477 to 251448)
OG0048400(1240 to 56896)
OG005150242(78238 to 288514)
OG0062560(727 to 9014)
OG00765020(32132 to 131568)
OG0086967(1577 to 30788)
OG009115852(62354 to 215253)
OG0106241(1439 to 27068)
63169
(34164 to 116798)
OG0046241(1158 to 33639)
OG005150242(48269 to 467639)
OG0062744(740 to 10177)
OG00735113(14643 to 84196)
OG0088778(2002 to 38482)
OG00948710(23176 to 102374)
OG0105653(1321 to 24190)
67202
(25756 to 175341)
OG0043948(957 to 16290)
OG00557926(33875 to 99054)
OG0063378(690 to 16544)
OG00727869(11467 to 67729)
OG00812902(3151 to 52826)
OG00937098(17025 to 80838)
OG0105653(1321 to 24190)
98.7
(41.2 to 236.2)
OG0041.1(0.8 to 1.6)
OG005117.4(23.2 to 594.6)
OG0060.9(0.7 to 1.1)
OG00720.7(4.2 to 103.6)
OG0081(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.
OG009107.6(23.8 to 487)
OG0101(0.6 to 1.7)
90.5
(31 to 264.7)
OG0041.2(0.8 to 1.8)
OG005117.4(19.1 to 722.8)
OG0060.9(0.7 to 1.1)
OG00718.7(5.7 to 61)
OG0081(0.8 to 1.3)
OG00983(18.2 to 377.8)
OG0100.8(0.6 to 1.1)
98.7
(31.1 to 313.7)
OG0041.4(0.6 to 3.2)
OG005128(29 to 565.4)
OG0060.8(0.6 to 1)
OG00727.4(8.9 to 84.3)
OG0081.2(0.9 to 1.5)
OG00998.7(28.7 to 339.9)
OG0101(0.6 to 1.7)
69.8
(20.7 to 235.7)
OG0041.4(0.6 to 3.2)
OG005166(35.3 to 779.6)
OG0060.8(0.5 to 1.1)
OG00727.4(9.9 to 76.4)
OG0081.4(0.7 to 2.5)
OG00969.8(19.9 to 245)
OG0101(0.7 to 1.4)
107.6
(34.1 to 339.4)
OG0041.1(0.6 to 2)
OG005139.6(46.8 to 416.2)
OG0060.9(0.6 to 1.3)
OG00732(12.2 to 83.6)
OG0080.9(0.7 to 1.1)
OG009152.2(41.3 to 561.3)
OG0100.9(0.6 to 1.4)
64
(15 to 273.6)
OG0041(0.7 to 1.4)
OG00558.7(21.6 to 159.6)
OG0061(0.7 to 1.5)
OG00718.7(8.5 to 41.1)
OG0080.9(0.7 to 1.3)
OG00953.8(15.7 to 184)
OG0101(0.7 to 1.4)
58
(16.6 to 202.6)
OG0041(0.6 to 1.7)
OG00529.3(10.8 to 79.8)
OG0061(0.7 to 1.5)
OG00710.9(3.7 to 31.7)
OG0081.4(0.7 to 2.5)
OG00943.1(19.7 to 97.4)
OG0100.9(0.6 to 1.4)
19.5
(1.8 to 213)
OG0041(NA to NA)Confidence interval could not be calculated because there was no variance in the observed data.