Safety, Tolerability and Clinical Effect of Danirixin in... | NCT02469298

NCT02469298

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Brief Summary

Study 201682 is a Phase IIa, randomized, double blind, placebo-controlled four arm outpatient study evaluating the safety, tolerability and clinical effect of danirixin or danirixin + oseltamivir combination in comparison to placebo or oseltamivir twice daily for 5 days in otherwise healthy adults with laboratory confirmed influenza infection. Danirixin is a selective and reversible C-X-C Chemokine Receptor 2 (CXCR2) antagonist that inhibits neutrophil transmigration and activation to areas of inflammation. The study endpoints are intended to test the hypothesis that inhibition of neutrophil activation by approximately 50-60% (as previously measured by cluster of differentiation [CD11b] expression in response to chemokine [C-X-C motif] ligand 1 [CXCL1] stimulation ex vivo in human studies) will not impact safety parameters or worsen clinical manifestations of disease, disease-related events of interest, or viral load, and may possibly improve these parameters when administered within 48 hours of symptom onset. The aim of this exploratory study is to obtain data on the safety, tolerability and clinical effect of GSK1325756 (danirixin [DNX]) alone or in combination with oseltamivir (OSV) in otherwise healthy adults with acute, uncomplicated influenza prior to future evaluation in hospitalized patients with complicated influenza. The primary objective is to assess safety and tolerability of DNX with and without a neuraminidase inhibitor through the evaluation of AEs, SAEs, clinical laboratory tests, vital signs, and electrocardiogram (ECG) parameters. Safety assessments will also include an assessment of disease related events (DREs) of interest and associated antibiotic use. The Influenza Intensity and Impact Questionnaire (FluiiQ™) will be used in the study to document patient reported outcomes (PROs). The screening visit in Australia will be composed of a pre-screen for influenza infection with an influenza rapid antigen test followed by a screen for the remaining eligibility criteria for those subjects with a positive result on the influenza rapid antigen test. FluiiQ is trademark owned by Measured Solutions for Health Private Limited.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Danirixin + Oseltamivir matching placebo	Experimental	Subjects will receive 75 mg oral Danirixin twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days	Drug: GSK1325756 (Danirixin) Drug: Placebo To Match Oseltamivir Phosphate
Danirixin matching placebo + Oseltamivir matching placebo	Placebo Comparator	Subjects will receive Danirixin matching placebo twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days	Drug: Placebo To Match GSK1325756 Drug: Placebo To Match Oseltamivir Phosphate
Danirixin + Oseltamivir	Experimental	Subjects will receive 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days	Drug: GSK1325756 (Danirixin) Drug: Oseltamivir Phosphate
Danirixin matching placebo + Oseltamivir	Active Comparator	Subjects will receive Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days	Drug: Placebo To Match GSK1325756 Drug: Oseltamivir Phosphate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GSK1325756 (Danirixin)	Drug	It will be supplied as capsule shaped white film coated tablet containing 75 mg GSK1325756 for oral use	Danirixin + Oseltamivir Danirixin + Oseltamivir matching placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.	Up to Day 28/withdrawal
Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count	Hematology parameters included Basophils, Eosinophils, Lymphocytes, Monocytes, Total neutrophils (Total ANC), Platelet count and WBC count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.	Baseline (Day 1) and up to Day 28/withdrawal
Change From Baseline in Hematology Parameters- Hemoglobin	Hematology parameters included Hemoglobin. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.	Baseline (Day 1) and up to Day 28/withdrawal
Change From Baseline in Hematology Parameters- Hematocrit	Hematology parameters included Hematocrit. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Secondary Outcomes

Measure	Description	Time Frame
Time to Resolution of Fever Over Time Post Initiation of Treatment	Time to resolution of fever was defined as the time when oral temperature was <= 37.2 degree Celsius (<=99.0 degree Fahrenheit) for at least 24 hours (with one hour window) without having taken any antipyretic medication for at least 4 hours. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature <=37.2 degree Celsius or <=99 degree Fahrenheit for 24 hours.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Between 18 and 64 years of age inclusive, at the time of signing the informed consent;
Onset of influenza-like illness symptoms within 48 hours prior to study enrollment. Onset of symptoms is defined as the time when the subject's temperature was measured as elevated (>=38.0°C [>=100.4°F]) OR the time when the subject first experienced at least one symptom (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, or fatigue);
Subjects have an oral temperature >=38.0°C (>=100.4°F) at screening visit or history of feeling feverish within the 24 hours prior to screening visit;
At least one respiratory symptom (cough, sore throat, nasal congestion) and at least one systemic symptom (headache, body aches and pain, fatigue) due to influenza infection;
A positive influenza rapid antigen test;
Body weight >60 Kilogram (kg) for men and >45 kg for women; and Body Mass Index (BMI) between 19 to 35 kilogram per meters squared (kg/m^2), inclusive;
Male or Female subjects could be eligible if :

Male subjects with female partners of child-bearing potential must comply with the following contraception requirements from the time of first dose of study medication until at least 36 hours (five half-lives) of study medication after the last dose of study medication:

Vasectomy with documentation of azoospermia; Male condom plus partner use of one of the following contraceptive options: Contraceptive subdermal implant; Intrauterine device or intrauterine system; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen; Contraceptive vaginal ring ; Percutaneous contraceptive patches; This is an all-inclusive list of those methods that meet the following GlaxoSmithKline (GSK) definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product methods (e.g., male sterility), the investigator determines what is consistent and correct use. The GSK definition is based on the definition provided by the International Conference on Harmonisation (ICH). The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception;

Female subject: is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies

Non-reproductive potential defined as:

Pre-menopausal females with one of the following: documented Tubal ligation; Documented Hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral oophorectomy; Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study.

Reproductive potential agrees to follow one of the options listed below in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from the time of screening, during dosing, and until at least 36 hrs after the last dose of study medication and completion of the follow-up visit.

GSK List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) meeting GSK criteria of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. This list does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penilevaginal intercourse on a long term and persistent basis.

Contraceptive subdermal implant; Intrauterine device or intrauterine system; Combined estrogen and progestogen oral contraceptive; Injectable progestogen; Contraceptive vaginal ring; Percutaneous contraceptive patches; Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject.

These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.

- Subjects willing and able to give written informed consent to participate in the study and to adhere to the procedures stated in the protocol.

Exclusion Criteria:

- Subject defined as being at high risk of complications from influenza infection according to the World Health Organization (WHO) Guidelines for Pharmacological Management of Pandemic Influenza A (H1N1) and other Influenza Viruses: Pregnant women; Persons of any age with chronic pulmonary disease (e.g. Mild persistent, Moderate or severe asthma, Chronic Obstruction Pulmonary Disease [COPD], cystic fibrosis, bronchiectasis); Persons of any age with chronic cardiac disease (e.g. congestive cardiac failure);

Persons with metabolic disorders (e.g. diabetes); Persons with chronic renal disease, chronic hepatic disease, certain neurological conditions (including neuromuscular, neurocognitive and seizure disorders, but not including autism spectrum disorders); Hemoglobinopathies, or immunosuppression, whether due to primary immunosuppressive conditions, such as Human Immunodeficiency Virus (HIV) infection, or secondary conditions, such as immunosuppressive medication or malignancy;
Subjects in whom treatment with an influenza antiviral is considered essential;
Severity of illness requiring or anticipated to require in-hospital care;
Pulse Oximetry levels <92% (at rest on room air) at screening or requirement for supplemental oxygen;
Any complication of respiratory tract infection, signs of severe or progressive disease, or worsening of any pre-existing medical condition at the time of enrollment, that, in the opinion of the investigator, would place the subject at an unreasonably increased risk of participation in this study;
Suspicion or confirmation of bacterial infection (e.g. otitis media, sinusitis, bronchitis, focal pneumonia) or who are requiring oral or systemic antibiotics within one week before enrollment;
Women who are pregnant as determined by a positive urine human chorionic gonadotrophin (hCG) test prior to dosing or women who are breastfeeding;
Current or chronic documented history of liver disease (including Hepatitis A, B, or C), or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones); In this case "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records). In questionable cases the subject cannot be enrolled;
Corrected QT interval (QTc) >450 millisecond (msec) or QTc >480 msec in subjects with Bundle Branch Block.
Subjects currently using or expected to use: oral or injectable Cytochrome P450 3A4 (CYP3A4) or Breast Cancer Resistance Protein (BCRP) substrates with a narrow therapeutic index, or oral or systemic glucocorticoids during the study period; Antacids can be used but should not be taken for at least 3 hours preceding and 2 hours after administration of study drug; proton pump inhibitors and histamine H2-receptor antagonists are prohibited from the screening visit until 12 hours after completion of the final dose of study treatment.
Subjects who have taken an approved or investigational anti-influenza medication (e.g., oseltamivir, zanamivir, peramivir, laninamivir, amantadine, rimantidine, ribavirin) within the past 4 weeks before enrollment;
Subjects who received the live attenuated influenza virus vaccine within the past 21 days;
Subjects treated with systemic steroids or immunosuppressants within 2 weeks of study start.
History of alcohol/drug abuse within 6 months of the study start;
Consumption of >3 alcoholic units for males and females over the past 24 hours. One unit is equivalent to 8 grams of alcohol: a half-pint (~240 milliliter [mL]) of beer; 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period;
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer);
Exposure to more than four investigational medicinal products within 12 months prior to the first dosing day.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Palmetto Bay	Florida	33157	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31024969	Background	Roberts G, Chen S, Yates P, Madan A, Walker J, Washburn ML, Peat AJ, Soucie G, Kerwin E, Roy-Ghanta S. Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Clinical Effect of Danirixin in Adults With Acute, Uncomplicated Influenza. Open Forum Infect Dis. 2019 Apr 22;6(4):ofz072. doi: 10.1093/ofid/ofz072. eCollection 2019 Apr.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
FG001	Placebo (PBO)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
BG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
BG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
BG003	Oseltamivir (OSV) 75 mg	Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00037.9± 13.40 BG00133.4± 11.56 BG00242.6± 11.53 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0006 BG0011 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

African American/African Heritage

Title	Measurements
	BG0002 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.

Safety population comprised of all randomized participants who received at least one dose of investigational product (IP).

Posted

Count of Participants

Participants

Up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
OG003	Oseltamivir (OSV) 75 mg	Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Units	Counts
Participants	OG00015 OG0017 OG00216 OG003

Title

Denominators

Categories

Title	Measurements
	OG0003 OG0014 OG0027 OG003

Primary

Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count

Hematology parameters included Basophils, Eosinophils, Lymphocytes, Monocytes, Total neutrophils (Total ANC), Platelet count and WBC count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Giga cells per litre (GI/L)

Baseline (Day 1) and up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 Milligram (mg)	Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg

Primary

Change From Baseline in Hematology Parameters- Hemoglobin

Hematology parameters included Hemoglobin. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Grams per Litre (G/L)

Baseline (Day 1) and up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
OG003

Primary

Change From Baseline in Hematology Parameters- Hematocrit

Hematology parameters included Hematocrit. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Fraction

Baseline (Day 1) and up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
OG003

Primary

Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH)

Hematology parameters included Mean corpuscle hemoglobin (MCH). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Picogram (PG)

Baseline (Day 1) and up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
OG003

Primary

Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV)

Hematology parameters included Mean corpuscle volume (MCV). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Femtoliters (FL)

Baseline (Day 1) and up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
OG003

Primary

Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count

Hematology parameters included RBC count and Reticulocytes count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Trillion cells per Liter (TI/L)

Baseline (Day 1) and up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Primary

Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein

Clinical chemistry parameters included Albumin and Total protein. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Grams per Litre (G/L)

Baseline (Day 1) and up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Primary

Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT)

Clinical chemistry parameters included Alkaline phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase and Gamma Glutamyl Transferase. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

International Units per litre (IU/L)

Baseline (Day 1) and up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Primary

Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid

Clinical chemistry parameters included Direct Bilirubin, Total Bilirubin, Creatinine and Uric acid. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Micromole per Liter (UMOL/L)

Baseline (Day 1) and up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 Milligram (mg)	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Primary

Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)

Clinical chemistry parameters included Calcium, CO2 content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/(BUN). Blood samples were collected on Day 1, Day 3, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Millimoles per Liter (MMOL/L)

Baseline (Day 1) and up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Primary

Change From Baseline in Urinalysis Parameters- Urine pH

Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. Urinalysis was done on Day 1, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Points on a scale

Baseline (Day 1), Day 5 and Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Primary

Change From Baseline in Urinalysis Parameters- Urine Specific Gravity

Urinalysis parameter included Urine specific gravity and was measured on Day 1, Day 5 and Day 28. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Ratio

Baseline (Day 1), Day 5 and Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Primary

Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick)

The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine occult blood can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.

Safety population.

Posted

Count of Participants

Participants

Up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
OG003

Primary

Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick)

The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine glucose can be read as negative, Trace, 1+ or 1/4 gram per deciliter (G/dL), 2+ OR 1/2 G/dL, 3+ or 1 G/dL and 4+ indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.

Safety population

Posted

Count of Participants

Participants

Up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
OG003

Primary

Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick)

The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.

Safety population

Posted

Count of Participants

Participants

Up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
OG003

Primary

Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

Vital signs were measured in semi-supine position after 5 minutes rest and included systolic and diastolic blood pressure. Three readings of blood pressure were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Millimeters of Mercury (mmHg)

Baseline (Day 1) and up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg

Primary

Change From Baseline in Vital Signs- Heart Rate (HR)

Vital signs were measured in semi-supine position after 5 minutes rest and included HR. Three readings of pulse rate were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Beats per minute

Baseline (Day 1) and up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Primary

Change From Baseline in Vital Signs- Respiration Rate (RR)

Vital signs were measured in semi-supine position after 5 minutes rest and included RR. RR was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Breaths per minute

Baseline (Day 1) and up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Primary

Change From Baseline in Vital Signs- Temperature

Vital signs were measured in semi-supine position after 5 minutes rest and included temperature. Oral temperature was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Centigrade

Baseline (Day 1) and up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Primary

Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB)

Vital signs were measured in semi-supine position after 5 minutes rest and included POB. POB was obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Percentage (%)

Baseline (Day 1) and up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Primary

Change From Baseline in Electrocardiogram (ECG) Parameters

12-lead ECGs were obtained on Day 1, Day 3 and Day28/withdrawal using an ECG machine that automatically calculates and measures RR, PR, QRS, QT, and Corrected QT Interval using Bazette's formula (QTcB) and Corrected QT Interval using Fridericia forumula (QTcF) intervals. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Millisecond (msec)

Baseline (Day 1) and up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Primary

Number of Participants With Disease Related Events (DREs) of Interest

Disease-related events of interest included Otitis media, Sinusitis, Bronchitis and Pneumonia and were captured separately from AEs and SAEs. DREs of interest were assessed and recorded by the site on all clinical visit days.

Safety population

Posted

Count of Participants

Participants

Up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
OG003	Oseltamivir (OSV) 75 mg

Primary

Number of Participants With DRE of Interest-associated Antibiotic Use

Use of antibiotics for DREs of interest was monitored. Roxithromycin was used for DRE sinusitis by one participant.

Safety population

Posted

Count of Participants

Participants

Up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
OG003	Oseltamivir (OSV) 75 mg	Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Secondary

Time to Resolution of Fever Over Time Post Initiation of Treatment

Time to resolution of fever was defined as the time when oral temperature was <= 37.2 degree Celsius (<=99.0 degree Fahrenheit) for at least 24 hours (with one hour window) without having taken any antipyretic medication for at least 4 hours. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature <=37.2 degree Celsius or <=99 degree Fahrenheit for 24 hours.

Influenza positive population (IPP) comprised of all randomized participants who received at least one dose of IP with proven influenza infection (positive rapid antigen test and positive influenza by quantitative reverse transcription-polymerase chain reaction (qRT-PCR) or culture test at any time point). Participants with fever are analyzed.

Posted

Median

Full Range

Hours

Up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days

Secondary

Number of Afebrile Participants Over Time Post Initiation of Treatment

Afebrile participants were defined as participants with oral temperature <=37.2 degree Celsius, <=99.0 degree Fahrenheit over time post initiation of treatment. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature <=37.2 degree Celsius or <=99 degree Fahrenheit for 24 hours.

IPP population. Only those participants available at the specified time points were analyzed.

Posted

Count of Participants

Participants

Up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg

Secondary

Number of Participants Who Used Relief Medication

Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded.

Safety population.

Posted

Count of Participants

Participants

Up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
OG003	Oseltamivir (OSV) 75 mg	Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Secondary

Number of Hospital Admissions Due to Influenza Infection

Number of participants admitted in hospital due to influenza infection was recorded.

Safety population

Posted

Number

Participants

Up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
OG003	Oseltamivir (OSV) 75 mg	Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Secondary

Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14

Influenza viral load as measured by quantitative reverse transcription - polymerase chain reaction (qRT-PCR) from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

IPP population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Log viral particles/mL

Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Secondary

Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14

Number of participants with no detectable influenza viral ribonucleic acid (RNA) by qRT-PCR from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline.

IPP Population. Only those participants available at the specified time points were analyzed.

Posted

Count of Participants

Participants

Up to Day 14

ID	Title	Description
OG000	Danirixin (DNX) 75 mg	Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Secondary

Total Dose of Relief Medication

Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded. The total dose of these relief medications used by these participants are presented.

Safety population. Only those participants using relief medication were analyzed.

Posted

Median

Full Range

Milligrams

Up to Day 28/withdrawal

ID	Title	Description
OG000	Danirixin (DNX) 75 Milligram (mg)	Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
OG003

Secondary

Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14

Influenza viral load as measured by quantitative virus culture from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.

IPP population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Log median tissue culture infective dose

Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14

ID	Title	Description
OG000	Danirixin (DNX) 75 Milligram (mg)	Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days

Secondary

Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14

Number of participants with no detectable influenza viral RNA by quantitative virus culture from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline.

IPP Population. Only those participants (number with nasopharyngeal samples) available at the specified time points were analyzed.

Posted

Count of Participants

Participants

Up to Day 14

ID	Title	Description
OG000	Danirixin (DNX) 75 Milligram (mg)	Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
OG001	Placebo (PBO)	Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
OG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Danirixin (DNX) 75 Milligram (mg)	Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days	15	1	15	1	15
EG001	Placebo (PBO)	Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days	7	0	7	2	7
EG002	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days	16	0	16	3	16
EG003	Oseltamivir (OSV) 75 mg	Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days	7	0	7	0	7

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Electrocardiogram T wave abnormal	Investigations	MedDRA	Systematic Assessment		EG0001 affected15 at risk EG0010 affected7 at risk EG0020 affected16 at risk EG0030 affected7 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0011 affected7 at risk EG0020 affected16 at risk EG0030 affected7 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected7 at risk EG0021 affected16 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0010 affected7 at risk EG0022 affected16 at risk EG003

ID	Term
D014777	Virus Diseases

ID	Term
C581951	danirixin
D053139	Oseltamivir

Ancestor Terms

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D053138	Cyclohexenes
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons

Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days

Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days

Title	Measurements
	OG000-0.009± 0.0569 OG0010.017± 0.0427 OG002-0.007± 0.0172 OG003-0.002± 0.0110

Title	Measurements
	OG000-0.008± 0.0634 OG0010.013± 0.0356 OG0020.005± 0.0190 OG0030.008± 0.0311

Title	Measurements
	OG000-0.007± 0.0517 OG0010.003± 0.0287 OG0020.030± 0.0520 OG0030.010± 0.0332

Title	Measurements
	OG0000.017± 0.0929 OG0010.026± 0.0477 OG002-0.012± 0.1378 OG003-0.012± 0.0661

Title	Measurements
	OG0000.034± 0.1048 OG0010.035± 0.0846 OG0020.012± 0.1856 OG0030.136± 0.3057

Title	Measurements
	OG0000.074± 0.1248 OG0010.078± 0.1332 OG0020.036± 0.1416 OG003-0.000± 0.0959

Title	Measurements
	OG0000.093± 0.6701 OG0010.778± 0.5904 OG0020.463± 0.5443 OG0030.432± 0.5124

Title	Measurements
	OG0000.557± 0.7137 OG0011.038± 0.7784 OG0020.813± 0.6445 OG0030.576± 0.3765

Title	Measurements
	OG0000.716± 0.7584 OG0011.275± 0.8948 OG0020.918± 0.9233 OG0030.722± 0.5434

Title	Measurements
	OG000-0.117± 0.1524 OG001-0.178± 0.1970 OG002-0.105± 0.1927 OG003-0.070± 0.1562

Title	Measurements
	OG000-0.175± 0.2817 OG001-0.128± 0.1631 OG002-0.090± 0.2479 OG003-0.118± 0.2104

Title	Measurements
	OG000-0.104± 0.2310 OG001-0.097± 0.1425 OG002-0.108± 0.2043 OG0030.024± 0.1730

Title	Measurements
	OG000-0.061± 0.1785 OG001-0.011± 0.2230 OG002-0.016± 0.2232 OG0030.064± 0.1343

Title	Measurements
	OG000-1.614± 2.1846 OG001-2.276± 1.5252 OG002-1.791± 1.9580 OG003-0.416± 1.0604

Title	Measurements
	OG000-1.371± 2.1110 OG001-1.223± 2.2278 OG002-0.677± 1.6269 OG003-0.424± 0.7956

Title	Measurements
	OG0000.463± 2.0336 OG001-0.830± 2.0826 OG002-0.137± 2.4279 OG0031.766± 2.4391

Title	Measurements
	OG000-9.5± 16.13 OG0014.3± 17.68 OG002-6.1± 17.68 OG003-3.0± 16.08

Title	Measurements
	OG00016.4± 22.92 OG0016.7± 21.70 OG00213.7± 31.50 OG00310.4± 17.78

Title	Measurements
	OG00064.3± 45.02 OG00162.1± 58.12 OG00253.3± 61.73 OG00366.2± 22.20

Title	Measurements
	OG000-1.62± 1.949 OG001-1.64± 0.879 OG002-1.49± 1.624 OG003-0.06± 0.691

Title	Measurements
	OG000-0.94± 2.408 OG001-0.39± 1.676 OG002-0.17± 1.618 OG0030.18± 1.221

Title	Measurements
	OG0001.14± 2.676 OG0010.49± 1.842 OG0020.79± 2.309 OG0032.52± 2.797

Title	Measurements
	OG0000.31± 2.310 OG0011.56± 1.992 OG0020.51± 2.250 OG0031.76± 1.696

Title	Measurements
	OG000-1.3± 6.37 OG0010.4± 4.96 OG002-5.9± 10.87 OG003-7.4± 11.28

Title	Measurements
	OG000-5.2± 6.27 OG001-0.6± 4.65 OG002-6.1± 11.65 OG003-7.0± 13.77

Title	Measurements
	OG000-5.9± 9.61 OG001-5.1± 4.49 OG002-10.1± 7.83 OG003-4.4± 12.14

Title	Measurements
	OG000-0.0056± 0.01917 OG001-0.0029± 0.01734 OG002-0.0182± 0.03470 OG003-0.0250± 0.03033

Title	Measurements
	OG000-0.0173± 0.01958 OG001-0.0063± 0.01612 OG002-0.0176± 0.03636 OG003-0.0244± 0.04140

Title	Measurements
	OG000-0.0224± 0.02773 OG001-0.0171± 0.01933 OG002-0.0331± 0.02586 OG003-0.0136± 0.03978

Title	Measurements
	OG000-0.11± 0.407 OG001-0.19± 0.121 OG002-0.14± 0.609 OG0030.02± 0.455

Title	Measurements
	OG000-0.16± 0.363 OG001-0.13± 0.198 OG002-0.24± 0.477 OG0030.08± 0.277

Title	Measurements
	OG0000.12± 0.638 OG001-0.00± 0.231 OG0020.18± 0.479 OG0030.20± 0.381

Title	Measurements
	OG000-0.7± 1.20 OG001-1.3± 1.50 OG002-0.4± 0.85 OG003-0.2± 0.84

Title	Measurements
	OG000-0.6± 1.55 OG001-1.1± 1.07 OG002-0.5± 1.02 OG003-0.4± 1.14

Title	Measurements
	OG000-0.4± 2.06 OG001-0.3± 2.06 OG0020.1± 1.04 OG0030.6± 0.55

Title	Measurements
	OG000-0.01± 0.203 OG0010.06± 0.190 OG002-0.19± 0.390 OG003-0.28± 0.363

Title	Measurements
	OG000-0.13± 0.194 OG0010.01± 0.146 OG002-0.17± 0.389 OG003-0.28± 0.476

Title	Measurements
	OG000-0.22± 0.272 OG001-0.16± 0.113 OG002-0.38± 0.283 OG003-0.20± 0.464

Title	Measurements
	OG000-0.00989± 0.032767 OG001-0.00392± 0.018792 OG002-0.01735± 0.025837 OG003-0.01694± 0.029436

Title	Measurements
	OG000-0.01793± 0.023690 OG001-0.00314± 0.025877 OG002-0.02635± 0.024815 OG003-0.01406± 0.024957

Title	Measurements
	OG000-0.00158± 0.038763 OG001-0.00546± 0.022484 OG002-0.01032± 0.032152 OG0030.01020± 0.006260

Title	Measurements
	OG000-1.8± 1.90 OG001-1.0± 2.08 OG002-2.3± 4.37 OG003-2.6± 1.95

Title	Measurements
	OG000-1.8± 2.75 OG001-0.3± 2.50 OG002-1.7± 4.12 OG003-0.4± 3.36

Title	Measurements
	OG000-1.6± 2.21 OG0010.4± 1.62 OG002-1.5± 2.24 OG0030.2± 3.49

Title	Measurements
	OG000-1.9± 2.84 OG001-2.3± 4.61 OG002-2.8± 4.55 OG003-4.4± 5.32

Title	Measurements
	OG000-1.9± 2.20 OG001-1.3± 3.25 OG002-2.9± 5.54 OG003-4.0± 4.06

Title	Measurements
	OG000-1.3± 2.92 OG0010.4± 2.88 OG002-1.4± 5.77 OG003-2.2± 5.07

Title	Measurements
	OG000-5.4± 10.96 OG001-1.9± 6.12 OG002-4.5± 8.83 OG003-5.8± 5.26

Title	Measurements
	OG000-4.4± 8.30 OG001-0.9± 8.32 OG0022.9± 9.32 OG0030.8± 8.56

Title	Measurements
	OG000-2.8± 9.06 OG0014.9± 7.43 OG002-3.8± 7.94 OG003-1.6± 9.84

Title	Measurements
	OG0007.9± 28.12 OG001-0.1± 4.14 OG0020.1± 5.25 OG003-8.4± 8.38

Title	Measurements
	OG0004.2± 15.27 OG0012.4± 7.18 OG0020.9± 10.70 OG003-11.8± 12.50

Title	Measurements
	OG0002.9± 3.92 OG0019.1± 10.98 OG0022.7± 15.18 OG003-11.0± 20.65

Title	Measurements
	OG0002.5± 5.00 OG0012.4± 9.69 OG002-2.9± 11.84 OG003-12.8± 23.64

Title	Measurements
	OG0006.3± 22.53 OG0012.9± 5.87 OG002-0.9± 4.60 OG003-7.2± 4.49

Title	Measurements
	OG0000.9± 4.10 OG0012.4± 4.76 OG002-2.8± 8.33 OG003-9.4± 5.94

Title	Measurements
	OG000-0.8± 5.48 OG0013.4± 4.54 OG002-3.3± 7.55 OG003-10.4± 8.91

Title	Measurements
	OG000-0.2± 6.75 OG001-1.9± 4.18 OG002-4.9± 7.62 OG003-9.8± 11.48

Title	Measurements
	OG0009.3± 28.87 OG0011.0± 4.08 OG0020.9± 3.45 OG003-2.6± 3.13

Title	Measurements
	OG0007.4± 22.36 OG0015.0± 6.58 OG0020.8± 5.14 OG0030.2± 5.63

Title	Measurements
	OG0003.3± 11.11 OG0017.4± 8.12 OG0021.5± 7.50 OG0030.2± 10.50

Title	Measurements
	OG000-7.6± 17.60 OG001-1.1± 5.79 OG002-3.5± 10.62 OG003-0.6± 15.44

Title	Measurements
	OG000-0.5± 0.83 OG001-0.6± 1.13 OG002-0.5± 0.74 OG0030.2± 0.45

Title	Measurements
	OG0000.1± 0.73 OG001-0.1± 1.46 OG002-0.1± 0.83 OG0030.0± 1.41

Title	Measurements
	OG000-1.0± 2.30 OG001-2.0± 7.46 OG002-1.6± 2.10 OG003-0.8± 1.79

Title	Measurements
	OG000-1.2± 2.73 OG001-2.7± 6.37 OG0020.0± 2.56 OG0031.0± 1.41

Title	Measurements
	OG000-0.9± 1.99 OG001-0.9± 6.72 OG0020.5± 3.09 OG0032.2± 3.49

Title	Measurements
	OG000-1.47± 7.891 OG001-4.39± 6.733 OG002-6.58± 12.081 OG003-8.14± 11.291

Title	Measurements
	OG000-4.38± 6.330 OG001-7.39± 7.240 OG002-10.16± 14.060 OG003-11.12± 9.955

Title	Measurements
	OG000-5.79± 7.262 OG001-10.70± 10.266 OG002-8.87± 13.815 OG003-10.32± 5.273

Title	Measurements
	OG000-15.1± 31.18 OG001-9.9± 42.57 OG002-15.1± 39.17 OG003-45.8± 36.03

Title	Measurements
	OG000-18.0± 27.46 OG001-47.4± 39.09 OG002-16.3± 45.05 OG003-54.8± 33.69

Title	Measurements
	OG00020.8± 48.26 OG001-14.3± 53.04 OG0020.9± 27.41 OG003-13.0± 69.07

Title	Measurements
	OG00030.1± 47.40 OG001-0.4± 48.19 OG00212.5± 45.09 OG00340.6± 63.50

Title	Measurements
	OG000-0.029± 0.0917 OG0010.019± 0.0672 OG002-0.033± 0.1079 OG003-0.052± 0.0642

Title	Measurements
	OG000-0.010± 0.0842 OG0010.053± 0.0720 OG0020.030± 0.0994 OG0030.004± 0.1178

Title	Measurements
	OG000-0.019± 0.1077 OG0010.099± 0.0334 OG0020.031± 0.0842 OG0030.098± 0.1274

Title	Measurements
	OG0000.1± 2.74 OG0010.9± 2.34 OG0020.3± 2.50 OG003-1.8± 2.77

Title	Measurements
	OG0000.4± 2.35 OG0010.9± 1.07 OG002-0.5± 2.45 OG003-1.4± 3.21

Title	Measurements
	OG0000.6± 3.10 OG001-0.1± 1.95 OG0020.4± 2.67 OG003-0.2± 1.10

Title	Measurements
	OG0000.28± 1.084 OG0010.23± 1.680 OG0020.51± 1.385 OG0030.62± 0.782

Title	Measurements
	OG0000.13± 1.084 OG0010.13± 1.529 OG0020.29± 1.904 OG0031.30± 2.374

Title	Measurements
	OG0000.20± 1.301 OG001-0.16± 1.042 OG002-0.13± 1.669 OG0030.48± 0.733

Title	Measurements
	OG0000.27± 1.221 OG0010.71± 2.685 OG0020.43± 1.909 OG0030.22± 0.760

Title	Measurements
	OG000-0.12± 0.351 OG0010.13± 0.411 OG0020.01± 0.237 OG003-0.12± 0.396

Title	Measurements
	OG000-0.07± 0.401 OG0010.16± 0.428 OG0020.11± 0.317 OG0030.08± 0.572

Title	Measurements
	OG0000.08± 0.353 OG0010.21± 0.285 OG0020.15± 0.223 OG0030.02± 0.409

Title	Measurements
	OG000-0.04± 0.455 OG0010.07± 0.419 OG0020.14± 0.422 OG0030.24± 0.635

Title	Measurements
	OG0000.5± 1.77 OG0010.1± 2.41 OG0021.4± 1.64 OG0032.0± 1.87

Title	Measurements
	OG0000.3± 2.82 OG0011.1± 1.86 OG0020.7± 2.63 OG0031.8± 2.39

Title	Measurements
	OG0000.9± 2.64 OG0010.3± 1.70 OG0021.5± 2.33 OG0032.4± 1.67

Title	Measurements
	OG000-0.3± 1.82 OG0010.6± 2.99 OG0020.6± 2.50 OG0031.6± 1.34

Title	Measurements
	OG0000.31± 0.956 OG001-0.31± 0.888 OG0020.29± 1.046 OG003-0.24± 1.328

Title	Measurements
	OG0000.47± 0.830 OG001-0.19± 1.194 OG0020.32± 1.197 OG003-0.88± 1.413

Title	Measurements
	OG0000.90± 1.563 OG0010.17± 1.081 OG0020.82± 1.050 OG0030.32± 1.134

Title	Measurements
	OG0000.60± 1.091 OG0010.96± 2.082 OG0021.19± 0.910 OG0030.66± 1.324

Title	Measurements
	OG0000.27± 0.633 OG0010.14± 0.852 OG0020.07± 0.938 OG0030.70± 0.570

Title	Measurements
	OG000-0.0045± 0.00702 OG0010.0013± 0.00929 OG002-0.0021± 0.00855 OG003-0.0050± 0.00656

Title	Measurements
	OG0000.3± 6.76 OG001-1.1± 8.76 OG002-2.1± 8.53 OG003-5.2± 6.98

Title	Measurements
	OG000-4.4± 7.13 OG001-4.6± 10.36 OG002-2.3± 7.96 OG003-0.8± 5.07

Title	Measurements
	OG000-4.5± 7.43 OG001-0.7± 10.63 OG0020.8± 9.66 OG003-7.8± 4.87

Title	Measurements
	OG000-4.4± 10.37 OG001-0.6± 13.82 OG002-1.1± 8.18 OG003-3.5± 6.57

Title	Measurements
	OG000-5.73± 13.599 OG001-5.29± 8.597 OG002-2.87± 6.802 OG003-5.00± 5.568

Title	Measurements
	OG000-3.00± 11.802 OG001-0.71± 4.923 OG002-1.93± 11.279 OG003-3.00± 8.456

Title	Measurements
	OG000-5.86± 19.907 OG001-9.29± 13.889 OG002-2.60± 13.741 OG0030.60± 10.164

Title	Measurements
	OG000-6.20± 12.260 OG001-4.57± 10.163 OG002-1.20± 12.667 OG003-3.80± 7.259

Title	Measurements
	OG000-3.36± 16.284 OG001-0.43± 7.115 OG002-0.80± 6.982 OG003-2.83± 7.278

Title	Measurements
	OG000-2.60± 7.385 OG001-10.29± 21.109 OG002-9.60± 14.161 OG003-6.80± 12.637

Title	Measurements
	OG000-2.79± 10.297 OG001-12.29± 21.422 OG002-10.87± 14.589 OG003-0.80± 17.541

Title	Measurements
	OG0000.80± 13.165 OG001-13.43± 14.444 OG002-8.73± 14.553 OG003-4.20± 17.584

Title	Measurements
	OG000-6.57± 11.043 OG001-17.14± 19.912 OG002-11.80± 15.799 OG0030.17± 12.952

Title	Measurements
	OG000-0.5± 2.10 OG0010.0± 1.63 OG002-0.7± 2.58 OG0031.2± 1.10

Title	Measurements
	OG000-0.3± 2.46 OG0010.7± 2.21 OG002-0.6± 2.38 OG0030.6± 1.34

Title	Measurements
	OG000-0.7± 2.66 OG0010.6± 2.23 OG002-0.3± 2.77 OG0030.8± 1.10

Title	Measurements
	OG000-0.4± 2.02 OG0010.4± 3.46 OG002-0.3± 2.97 OG0030.8± 2.23

Title	Measurements
	OG000-0.75± 1.278 OG001-1.34± 0.978 OG002-0.76± 0.766 OG003-0.14± 0.422

Title	Measurements
	OG000-0.46± 0.818 OG001-1.50± 1.127 OG002-0.83± 0.786 OG003-0.16± 0.537

Title	Measurements
	OG000-0.73± 1.177 OG001-1.59± 1.051 OG002-0.83± 0.970 OG003-0.28± 0.409

Title	Measurements
	OG000-0.7± 1.35 OG001-0.4± 3.10 OG0020.4± 1.76 OG0031.0± 2.00

Title	Measurements
	OG000-0.8± 1.31 OG0010.4± 1.62 OG002-0.1± 2.09 OG0030.8± 3.70

Title	Measurements
	OG000-0.7± 1.71 OG0010.9± 3.13 OG0020.0± 1.77 OG0030.8± 2.39

Title	Measurements
	OG000-1.1± 1.83 OG0011.1± 1.86 OG0020.2± 1.42 OG0031.5± 2.88

Title	Measurements
	OG0003.1± 25.90 OG00125.0± 19.86 OG00217.7± 28.78 OG00330.7± 38.72

Title	Measurements
	OG0004.5± 21.76 OG00118.8± 13.90 OG0026.5± 12.89 OG00324.6± 13.03

Title	Measurements
	OG00011.0± 14.10 OG00124.8± 11.73 OG00211.0± 18.07 OG0034.3± 5.31

Title	Measurements
	OG0004.1± 25.69 OG00114.3± 11.93 OG0020.3± 12.63 OG00320.9± 8.83

Title	Measurements
	OG0006.6± 15.25 OG00117.0± 22.12 OG0023.5± 14.03 OG0030.1± 7.16

Title	Measurements
	OG0002.4± 6.47 OG001-5.4± 20.25 OG0020.4± 10.53 OG0032.3± 10.52

Title	Measurements
	OG0001.5± 4.45 OG001-5.6± 6.47 OG002-0.5± 6.14 OG0031.9± 8.92

Title	Measurements
	OG000-1.912± 1.2895 OG001-2.812± 1.8841 OG002-2.962± 1.8515 OG003-2.644± 0.5206

Title	Measurements
	OG000-3.764± 1.8831 OG001-4.063± 1.4120 OG002-3.862± 1.3284 OG003-4.250± 1.7995

Title	Measurements
	OG000-4.024± 1.0387 OG001-4.992± 1.1296 OG002-4.518± 1.2408 OG003-4.250± 1.7995

Title	Measurements
	OG0000 OG0010 OG0020 OG0030

Title	Measurements
	OG0000 OG0010 OG0023 OG0031

Title	Measurements
	OG0003 OG0011 OG0026 OG0035

Title	Measurements
	OG0005 OG0014 OG00211 OG0035

Title	Measurements
	OG000150.00(15.0 to 360.0) OG001390.00(120.0 to 2250.0) OG002120.00(30.0 to 2250.0) OG00360.00(15.0 to 300.0)

Title	Measurements
	OG000-2.534± 1.4499 OG001-2.172± 1.9242 OG002-2.467± 1.8842 OG003-3.108± 2.0998

Title	Measurements
	OG000-2.885± 1.1877 OG001-2.843± 2.2061 OG002-2.698± 1.4621 OG003-3.108± 2.0998

Title	Measurements
	OG000-2.564± 1.4694 OG001-2.260± 1.8792 OG002-2.614± 1.5899 OG003-3.108± 2.0998

Title	Measurements
	OG0005 OG0012 OG0026 OG0033

Title	Measurements
	OG0007 OG0013 OG00210 OG0035

Title	Measurements
	OG0008 OG0016 OG00212 OG0035

Title	Measurements
	OG0009 OG0015 OG00212 OG0035