Trial Outcomes & Findings for Safety, Tolerability and Clinical Effect of Danirixin in Adults With Influenza (NCT NCT02469298)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

Up to Day 28/withdrawal

Results posted on

2019-07-23

Participant Flow

A total of 45 healthy adult participants with acute, uncomplicated influenza were enrolled. The study was conducted from 01-June 2015 to 25-April-2016 at 17 centres in 3 countries.

A total of 288 participants were screened for this study. Of these, 243 participants were screen failures and 45 were randomized. The reasons for screen failure included: not meeting inclusion/exclusion criteria (238 participants), lost to follow up (1 participant), investigator discretion (1 participant) and withdrew consent (43 participants).

Participant milestones

Participant milestones
Measure	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	Placebo (PBO) Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	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	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
Overall Study STARTED	15	7	16	7
Overall Study COMPLETED	14	6	14	5
Overall Study NOT COMPLETED	1	1	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Placebo (PBO) Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	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	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
Overall Study Protocol Violation	0	1	1	0
Overall Study Lost to Follow-up	1	0	1	0
Overall Study Physician Decision	0	0	0	1
Overall Study Withdrawal by Subject	0	0	0	1

Baseline Characteristics

Safety, Tolerability and Clinical Effect of Danirixin in Adults With Influenza

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Total n=45 Participants Total of all reporting groups
Age, Continuous	37.9 Years STANDARD_DEVIATION 13.40 • n=5 Participants	33.4 Years STANDARD_DEVIATION 11.56 • n=7 Participants	42.6 Years STANDARD_DEVIATION 11.53 • n=5 Participants	36.3 Years STANDARD_DEVIATION 9.83 • n=4 Participants	38.6 Years STANDARD_DEVIATION 12.04 • n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants	2 Participants n=4 Participants	16 Participants n=21 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	5 Participants n=4 Participants	29 Participants n=21 Participants
Race/Ethnicity, Customized African American/African Heritage	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	11 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants	6 Participants n=4 Participants	35 Participants n=21 Participants
Race/Ethnicity, Customized Mixed Race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to Day 28/withdrawal

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) AE	3 Participants	4 Participants	7 Participants	0 Participants
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) SAE	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

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

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

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.

Outcome measures

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Change From Baseline in Hematology Parameters- Hemoglobin Day 3	0.0 Grams per Litre (G/L) Standard Deviation 6.08	2.2 Grams per Litre (G/L) Standard Deviation 5.78	-4.4 Grams per Litre (G/L) Standard Deviation 6.87	-8.8 Grams per Litre (G/L) Standard Deviation 9.78
Change From Baseline in Hematology Parameters- Hemoglobin Day 5	-1.3 Grams per Litre (G/L) Standard Deviation 6.37	0.4 Grams per Litre (G/L) Standard Deviation 4.96	-5.9 Grams per Litre (G/L) Standard Deviation 10.87	-7.4 Grams per Litre (G/L) Standard Deviation 11.28
Change From Baseline in Hematology Parameters- Hemoglobin Day 8	-5.2 Grams per Litre (G/L) Standard Deviation 6.27	-0.6 Grams per Litre (G/L) Standard Deviation 4.65	-6.1 Grams per Litre (G/L) Standard Deviation 11.65	-7.0 Grams per Litre (G/L) Standard Deviation 13.77
Change From Baseline in Hematology Parameters- Hemoglobin Day 28/withdrawal	-5.9 Grams per Litre (G/L) Standard Deviation 9.61	-5.1 Grams per Litre (G/L) Standard Deviation 4.49	-10.1 Grams per Litre (G/L) Standard Deviation 7.83	-4.4 Grams per Litre (G/L) Standard Deviation 12.14

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Change From Baseline in Hematology Parameters- Hematocrit Day 3	-0.0051 Fraction Standard Deviation 0.01940	0.0050 Fraction Standard Deviation 0.01917	-0.0126 Fraction Standard Deviation 0.02310	-0.0294 Fraction Standard Deviation 0.03218
Change From Baseline in Hematology Parameters- Hematocrit Day 5	-0.0056 Fraction Standard Deviation 0.01917	-0.0029 Fraction Standard Deviation 0.01734	-0.0182 Fraction Standard Deviation 0.03470	-0.0250 Fraction Standard Deviation 0.03033
Change From Baseline in Hematology Parameters- Hematocrit Day 8	-0.0173 Fraction Standard Deviation 0.01958	-0.0063 Fraction Standard Deviation 0.01612	-0.0176 Fraction Standard Deviation 0.03636	-0.0244 Fraction Standard Deviation 0.04140
Change From Baseline in Hematology Parameters- Hematocrit Day 28/withdrawal	-0.0224 Fraction Standard Deviation 0.02773	-0.0171 Fraction Standard Deviation 0.01933	-0.0331 Fraction Standard Deviation 0.02586	-0.0136 Fraction Standard Deviation 0.03978

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) Day 3	0.03 Picogram (PG) Standard Deviation 0.334	-0.23 Picogram (PG) Standard Deviation 0.242	-0.21 Picogram (PG) Standard Deviation 0.218	0.06 Picogram (PG) Standard Deviation 0.329
Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) Day 5	-0.11 Picogram (PG) Standard Deviation 0.407	-0.19 Picogram (PG) Standard Deviation 0.121	-0.14 Picogram (PG) Standard Deviation 0.609	0.02 Picogram (PG) Standard Deviation 0.455
Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) Day 8	-0.16 Picogram (PG) Standard Deviation 0.363	-0.13 Picogram (PG) Standard Deviation 0.198	-0.24 Picogram (PG) Standard Deviation 0.477	0.08 Picogram (PG) Standard Deviation 0.277
Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) Day 28/withdrawal	0.12 Picogram (PG) Standard Deviation 0.638	-0.00 Picogram (PG) Standard Deviation 0.231	0.18 Picogram (PG) Standard Deviation 0.479	0.20 Picogram (PG) Standard Deviation 0.381

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) Day 3	-0.9 Femtoliters (FL) Standard Deviation 1.38	-0.8 Femtoliters (FL) Standard Deviation 1.17	-0.4 Femtoliters (FL) Standard Deviation 1.70	-0.2 Femtoliters (FL) Standard Deviation 0.84
Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) Day 5	-0.7 Femtoliters (FL) Standard Deviation 1.20	-1.3 Femtoliters (FL) Standard Deviation 1.50	-0.4 Femtoliters (FL) Standard Deviation 0.85	-0.2 Femtoliters (FL) Standard Deviation 0.84
Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) Day 8	-0.6 Femtoliters (FL) Standard Deviation 1.55	-1.1 Femtoliters (FL) Standard Deviation 1.07	-0.5 Femtoliters (FL) Standard Deviation 1.02	-0.4 Femtoliters (FL) Standard Deviation 1.14
Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) Day 28/withdrawal	-0.4 Femtoliters (FL) Standard Deviation 2.06	-0.3 Femtoliters (FL) Standard Deviation 2.06	0.1 Femtoliters (FL) Standard Deviation 1.04	0.6 Femtoliters (FL) Standard Deviation 0.55

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count RBC: Day 3	-0.01 Trillion cells per Liter (TI/L) Standard Deviation 0.209	0.13 Trillion cells per Liter (TI/L) Standard Deviation 0.197	-0.11 Trillion cells per Liter (TI/L) Standard Deviation 0.235	-0.32 Trillion cells per Liter (TI/L) Standard Deviation 0.370
Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count RBC: Day 5	-0.01 Trillion cells per Liter (TI/L) Standard Deviation 0.203	0.06 Trillion cells per Liter (TI/L) Standard Deviation 0.190	-0.19 Trillion cells per Liter (TI/L) Standard Deviation 0.390	-0.28 Trillion cells per Liter (TI/L) Standard Deviation 0.363
Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count RBC: Day 8	-0.13 Trillion cells per Liter (TI/L) Standard Deviation 0.194	0.01 Trillion cells per Liter (TI/L) Standard Deviation 0.146	-0.17 Trillion cells per Liter (TI/L) Standard Deviation 0.389	-0.28 Trillion cells per Liter (TI/L) Standard Deviation 0.476
Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count RBC: Day 28/withdrawal	-0.22 Trillion cells per Liter (TI/L) Standard Deviation 0.272	-0.16 Trillion cells per Liter (TI/L) Standard Deviation 0.113	-0.38 Trillion cells per Liter (TI/L) Standard Deviation 0.283	-0.20 Trillion cells per Liter (TI/L) Standard Deviation 0.464
Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count Reticulocytes: Day 3	-0.00989 Trillion cells per Liter (TI/L) Standard Deviation 0.032767	-0.00392 Trillion cells per Liter (TI/L) Standard Deviation 0.018792	-0.01735 Trillion cells per Liter (TI/L) Standard Deviation 0.025837	-0.01694 Trillion cells per Liter (TI/L) Standard Deviation 0.029436
Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count Reticulocytes: Day 5	-0.01793 Trillion cells per Liter (TI/L) Standard Deviation 0.023690	-0.00314 Trillion cells per Liter (TI/L) Standard Deviation 0.025877	-0.02635 Trillion cells per Liter (TI/L) Standard Deviation 0.024815	-0.01406 Trillion cells per Liter (TI/L) Standard Deviation 0.024957
Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count Reticulocytes: Day 8	-0.00158 Trillion cells per Liter (TI/L) Standard Deviation 0.038763	-0.00546 Trillion cells per Liter (TI/L) Standard Deviation 0.022484	-0.01032 Trillion cells per Liter (TI/L) Standard Deviation 0.032152	0.01020 Trillion cells per Liter (TI/L) Standard Deviation 0.006260
Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count Reticulocytes: Day 28/withdrawal	0.00071 Trillion cells per Liter (TI/L) Standard Deviation 0.020099	0.02313 Trillion cells per Liter (TI/L) Standard Deviation 0.018277	-0.00477 Trillion cells per Liter (TI/L) Standard Deviation 0.030198	0.01528 Trillion cells per Liter (TI/L) Standard Deviation 0.018000

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein Albumin: Day 3	-1.9 Grams per Litre (G/L) Standard Deviation 2.12	-1.7 Grams per Litre (G/L) Standard Deviation 2.87	-2.3 Grams per Litre (G/L) Standard Deviation 3.15	-3.0 Grams per Litre (G/L) Standard Deviation 4.42
Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein Albumin: Day 5	-1.8 Grams per Litre (G/L) Standard Deviation 1.90	-1.0 Grams per Litre (G/L) Standard Deviation 2.08	-2.3 Grams per Litre (G/L) Standard Deviation 4.37	-2.6 Grams per Litre (G/L) Standard Deviation 1.95
Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein Albumin: Day 8	-1.8 Grams per Litre (G/L) Standard Deviation 2.75	-0.3 Grams per Litre (G/L) Standard Deviation 2.50	-1.7 Grams per Litre (G/L) Standard Deviation 4.12	-0.4 Grams per Litre (G/L) Standard Deviation 3.36
Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein Albumin: Day 28/withdrawal	-1.6 Grams per Litre (G/L) Standard Deviation 2.21	0.4 Grams per Litre (G/L) Standard Deviation 1.62	-1.5 Grams per Litre (G/L) Standard Deviation 2.24	0.2 Grams per Litre (G/L) Standard Deviation 3.49
Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein Total protein: Day 3	-1.9 Grams per Litre (G/L) Standard Deviation 2.84	-2.3 Grams per Litre (G/L) Standard Deviation 4.61	-2.8 Grams per Litre (G/L) Standard Deviation 4.55	-4.4 Grams per Litre (G/L) Standard Deviation 5.32
Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein Total protein: Day 5	-1.9 Grams per Litre (G/L) Standard Deviation 2.20	-1.3 Grams per Litre (G/L) Standard Deviation 3.25	-2.9 Grams per Litre (G/L) Standard Deviation 5.54	-4.0 Grams per Litre (G/L) Standard Deviation 4.06
Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein Total protein: Day 8	-1.3 Grams per Litre (G/L) Standard Deviation 2.92	0.4 Grams per Litre (G/L) Standard Deviation 2.88	-1.4 Grams per Litre (G/L) Standard Deviation 5.77	-2.2 Grams per Litre (G/L) Standard Deviation 5.07
Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein Total protein: Day 28/withdrawal	-3.7 Grams per Litre (G/L) Standard Deviation 3.41	-1.0 Grams per Litre (G/L) Standard Deviation 2.94	-3.2 Grams per Litre (G/L) Standard Deviation 4.14	-1.0 Grams per Litre (G/L) Standard Deviation 5.24

PRIMARY outcome

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

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

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.

Outcome measures

PRIMARY outcome

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

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

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.

Outcome measures

PRIMARY outcome

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

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

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.

Outcome measures

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Change From Baseline in Urinalysis Parameters- Urine pH Day 5	0.00 Points on a scale Standard Deviation 0.784	0.21 Points on a scale Standard Deviation 0.951	0.20 Points on a scale Standard Deviation 0.592	0.40 Points on a scale Standard Deviation 0.652
Change From Baseline in Urinalysis Parameters- Urine pH Day 28/withdrawal	0.27 Points on a scale Standard Deviation 0.633	0.14 Points on a scale Standard Deviation 0.852	0.07 Points on a scale Standard Deviation 0.938	0.70 Points on a scale Standard Deviation 0.570

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Change From Baseline in Urinalysis Parameters- Urine Specific Gravity Day 5	-0.0001 Ratio Standard Deviation 0.00469	-0.0004 Ratio Standard Deviation 0.00675	-0.0038 Ratio Standard Deviation 0.00731	-0.0076 Ratio Standard Deviation 0.00385
Change From Baseline in Urinalysis Parameters- Urine Specific Gravity Day 28/withdrawal	-0.0045 Ratio Standard Deviation 0.00702	0.0013 Ratio Standard Deviation 0.00929	-0.0021 Ratio Standard Deviation 0.00855	-0.0050 Ratio Standard Deviation 0.00656

PRIMARY outcome

Timeframe: Up to Day 28/withdrawal

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=4 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=2 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=4 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	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
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick) 1+	2 Participants	1 Participants	1 Participants	—
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick) 2+	1 Participants	1 Participants	1 Participants	—
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick) 3+	1 Participants	0 Participants	0 Participants	—
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick) 4+	0 Participants	0 Participants	2 Participants	—

PRIMARY outcome

Timeframe: Up to Day 28/withdrawal

Population: Safety population

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=1 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=1 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=1 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	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
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick) 1+ OR 1/4 G/DL (%)	0 Participants	1 Participants	0 Participants	—
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick) 2+ OR 1/2 G/DL (%)	1 Participants	0 Participants	0 Participants	—
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick) 3+ OR 1 G/DL (%)	0 Participants	0 Participants	1 Participants	—
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick) 4+	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Up to Day 28/withdrawal

Population: Safety population

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=3 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=1 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=3 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=1 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) 1+	3 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) 2+	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) 3+	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) 4+	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) DBP: Day 3	-2.1 Millimeters of Mercury (mmHg) Standard Deviation 8.07	-0.7 Millimeters of Mercury (mmHg) Standard Deviation 7.97	-1.1 Millimeters of Mercury (mmHg) Standard Deviation 9.18	-4.2 Millimeters of Mercury (mmHg) Standard Deviation 3.90
Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) DBP: Day 5	0.3 Millimeters of Mercury (mmHg) Standard Deviation 6.76	-1.1 Millimeters of Mercury (mmHg) Standard Deviation 8.76	-2.1 Millimeters of Mercury (mmHg) Standard Deviation 8.53	-5.2 Millimeters of Mercury (mmHg) Standard Deviation 6.98
Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) DBP: Day 8	-4.4 Millimeters of Mercury (mmHg) Standard Deviation 7.13	-4.6 Millimeters of Mercury (mmHg) Standard Deviation 10.36	-2.3 Millimeters of Mercury (mmHg) Standard Deviation 7.96	-0.8 Millimeters of Mercury (mmHg) Standard Deviation 5.07
Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) DBP: Day 14	-4.5 Millimeters of Mercury (mmHg) Standard Deviation 7.43	-0.7 Millimeters of Mercury (mmHg) Standard Deviation 10.63	0.8 Millimeters of Mercury (mmHg) Standard Deviation 9.66	-7.8 Millimeters of Mercury (mmHg) Standard Deviation 4.87
Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) DBP: Day 28/withdrawal	-4.4 Millimeters of Mercury (mmHg) Standard Deviation 10.37	-0.6 Millimeters of Mercury (mmHg) Standard Deviation 13.82	-1.1 Millimeters of Mercury (mmHg) Standard Deviation 8.18	-3.5 Millimeters of Mercury (mmHg) Standard Deviation 6.57
Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) SBP: Day 3	-5.73 Millimeters of Mercury (mmHg) Standard Deviation 13.599	-5.29 Millimeters of Mercury (mmHg) Standard Deviation 8.597	-2.87 Millimeters of Mercury (mmHg) Standard Deviation 6.802	-5.00 Millimeters of Mercury (mmHg) Standard Deviation 5.568
Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) SBP: Day 5	-3.00 Millimeters of Mercury (mmHg) Standard Deviation 11.802	-0.71 Millimeters of Mercury (mmHg) Standard Deviation 4.923	-1.93 Millimeters of Mercury (mmHg) Standard Deviation 11.279	-3.00 Millimeters of Mercury (mmHg) Standard Deviation 8.456
Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) SBP: Day 8	-5.86 Millimeters of Mercury (mmHg) Standard Deviation 19.907	-9.29 Millimeters of Mercury (mmHg) Standard Deviation 13.889	-2.60 Millimeters of Mercury (mmHg) Standard Deviation 13.741	0.60 Millimeters of Mercury (mmHg) Standard Deviation 10.164
Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) SBP: Day 14	-6.20 Millimeters of Mercury (mmHg) Standard Deviation 12.260	-4.57 Millimeters of Mercury (mmHg) Standard Deviation 10.163	-1.20 Millimeters of Mercury (mmHg) Standard Deviation 12.667	-3.80 Millimeters of Mercury (mmHg) Standard Deviation 7.259
Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) SBP: Day 28/withdrawal	-3.36 Millimeters of Mercury (mmHg) Standard Deviation 16.284	-0.43 Millimeters of Mercury (mmHg) Standard Deviation 7.115	-0.80 Millimeters of Mercury (mmHg) Standard Deviation 6.982	-2.83 Millimeters of Mercury (mmHg) Standard Deviation 7.278

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Change From Baseline in Vital Signs- Heart Rate (HR) Heart rate: Day 3	3.93 Beats per minute Standard Deviation 10.375	-8.00 Beats per minute Standard Deviation 14.855	-8.87 Beats per minute Standard Deviation 11.637	-1.20 Beats per minute Standard Deviation 16.976
Change From Baseline in Vital Signs- Heart Rate (HR) Heart rate: Day 5	-2.60 Beats per minute Standard Deviation 7.385	-10.29 Beats per minute Standard Deviation 21.109	-9.60 Beats per minute Standard Deviation 14.161	-6.80 Beats per minute Standard Deviation 12.637
Change From Baseline in Vital Signs- Heart Rate (HR) Heart rate: Day 8	-2.79 Beats per minute Standard Deviation 10.297	-12.29 Beats per minute Standard Deviation 21.422	-10.87 Beats per minute Standard Deviation 14.589	-0.80 Beats per minute Standard Deviation 17.541
Change From Baseline in Vital Signs- Heart Rate (HR) Heart rate: Day 14	0.80 Beats per minute Standard Deviation 13.165	-13.43 Beats per minute Standard Deviation 14.444	-8.73 Beats per minute Standard Deviation 14.553	-4.20 Beats per minute Standard Deviation 17.584
Change From Baseline in Vital Signs- Heart Rate (HR) Heart rate: Day 28/withdrawal	-6.57 Beats per minute Standard Deviation 11.043	-17.14 Beats per minute Standard Deviation 19.912	-11.80 Beats per minute Standard Deviation 15.799	0.17 Beats per minute Standard Deviation 12.952

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Change From Baseline in Vital Signs- Respiration Rate (RR) RR: Day 3	-0.1 Breaths per minute Standard Deviation 2.03	0.0 Breaths per minute Standard Deviation 2.00	-0.5 Breaths per minute Standard Deviation 2.23	1.4 Breaths per minute Standard Deviation 1.95
Change From Baseline in Vital Signs- Respiration Rate (RR) RR: Day 5	-0.5 Breaths per minute Standard Deviation 2.10	0.0 Breaths per minute Standard Deviation 1.63	-0.7 Breaths per minute Standard Deviation 2.58	1.2 Breaths per minute Standard Deviation 1.10
Change From Baseline in Vital Signs- Respiration Rate (RR) RR: Day 8	-0.3 Breaths per minute Standard Deviation 2.46	0.7 Breaths per minute Standard Deviation 2.21	-0.6 Breaths per minute Standard Deviation 2.38	0.6 Breaths per minute Standard Deviation 1.34
Change From Baseline in Vital Signs- Respiration Rate (RR) RR: Day 14	-0.7 Breaths per minute Standard Deviation 2.66	0.6 Breaths per minute Standard Deviation 2.23	-0.3 Breaths per minute Standard Deviation 2.77	0.8 Breaths per minute Standard Deviation 1.10
Change From Baseline in Vital Signs- Respiration Rate (RR) RR: Day 28/withdrawal	-0.4 Breaths per minute Standard Deviation 2.02	0.4 Breaths per minute Standard Deviation 3.46	-0.3 Breaths per minute Standard Deviation 2.97	0.8 Breaths per minute Standard Deviation 2.23

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Change From Baseline in Vital Signs- Temperature Temperature: Day 3	-0.20 Centigrade Standard Deviation 1.342	-1.11 Centigrade Standard Deviation 0.749	-0.57 Centigrade Standard Deviation 0.884	-0.08 Centigrade Standard Deviation 0.239
Change From Baseline in Vital Signs- Temperature Temperature: Day 5	-0.75 Centigrade Standard Deviation 1.278	-1.34 Centigrade Standard Deviation 0.978	-0.76 Centigrade Standard Deviation 0.766	-0.14 Centigrade Standard Deviation 0.422
Change From Baseline in Vital Signs- Temperature Temperature: Day 8	-0.46 Centigrade Standard Deviation 0.818	-1.50 Centigrade Standard Deviation 1.127	-0.83 Centigrade Standard Deviation 0.786	-0.16 Centigrade Standard Deviation 0.537
Change From Baseline in Vital Signs- Temperature Temperature: Day 14	-0.73 Centigrade Standard Deviation 1.177	-1.59 Centigrade Standard Deviation 1.051	-0.83 Centigrade Standard Deviation 0.970	-0.28 Centigrade Standard Deviation 0.409
Change From Baseline in Vital Signs- Temperature Temperature: Day 28/withdrawal	-0.71 Centigrade Standard Deviation 1.240	-1.39 Centigrade Standard Deviation 0.958	-0.71 Centigrade Standard Deviation 0.905	-0.22 Centigrade Standard Deviation 0.454

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) POB: Day 3	-1.7 Percentage (%) Standard Deviation 3.97	1.1 Percentage (%) Standard Deviation 1.68	0.1 Percentage (%) Standard Deviation 1.60	0.4 Percentage (%) Standard Deviation 2.61
Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) POB: Day 5	-0.7 Percentage (%) Standard Deviation 1.35	-0.4 Percentage (%) Standard Deviation 3.10	0.4 Percentage (%) Standard Deviation 1.76	1.0 Percentage (%) Standard Deviation 2.00
Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) POB: Day 8	-0.8 Percentage (%) Standard Deviation 1.31	0.4 Percentage (%) Standard Deviation 1.62	-0.1 Percentage (%) Standard Deviation 2.09	0.8 Percentage (%) Standard Deviation 3.70
Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) POB: Day 14	-0.7 Percentage (%) Standard Deviation 1.71	0.9 Percentage (%) Standard Deviation 3.13	0.0 Percentage (%) Standard Deviation 1.77	0.8 Percentage (%) Standard Deviation 2.39
Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) POB: Day 28/withdrawal	-1.1 Percentage (%) Standard Deviation 1.83	1.1 Percentage (%) Standard Deviation 1.86	0.2 Percentage (%) Standard Deviation 1.42	1.5 Percentage (%) Standard Deviation 2.88

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Change From Baseline in Electrocardiogram (ECG) Parameters RR Interval: Day 3	-5.8 Millisecond (msec) Standard Deviation 123.37	49.4 Millisecond (msec) Standard Deviation 75.29	83.0 Millisecond (msec) Standard Deviation 144.39	39.2 Millisecond (msec) Standard Deviation 200.77
Change From Baseline in Electrocardiogram (ECG) Parameters RR Interval: Day 28/withdrawal	58.2 Millisecond (msec) Standard Deviation 94.94	76.9 Millisecond (msec) Standard Deviation 151.52	107.4 Millisecond (msec) Standard Deviation 195.56	41.2 Millisecond (msec) Standard Deviation 103.82
Change From Baseline in Electrocardiogram (ECG) Parameters QT Interval: Day 3	3.1 Millisecond (msec) Standard Deviation 25.90	25.0 Millisecond (msec) Standard Deviation 19.86	17.7 Millisecond (msec) Standard Deviation 28.78	30.7 Millisecond (msec) Standard Deviation 38.72
Change From Baseline in Electrocardiogram (ECG) Parameters QT Interval: Day 28/withdrawal	18.9 Millisecond (msec) Standard Deviation 19.35	35.9 Millisecond (msec) Standard Deviation 20.36	25.3 Millisecond (msec) Standard Deviation 39.96	11.1 Millisecond (msec) Standard Deviation 16.79
Change From Baseline in Electrocardiogram (ECG) Parameters QTcF: Day 3	4.5 Millisecond (msec) Standard Deviation 21.76	18.8 Millisecond (msec) Standard Deviation 13.90	6.5 Millisecond (msec) Standard Deviation 12.89	24.6 Millisecond (msec) Standard Deviation 13.03
Change From Baseline in Electrocardiogram (ECG) Parameters QTcF:Day 28/withdrawal	11.0 Millisecond (msec) Standard Deviation 14.10	24.8 Millisecond (msec) Standard Deviation 11.73	11.0 Millisecond (msec) Standard Deviation 18.07	4.3 Millisecond (msec) Standard Deviation 5.31
Change From Baseline in Electrocardiogram (ECG) Parameters QTcB: Day 3	4.1 Millisecond (msec) Standard Deviation 25.69	14.3 Millisecond (msec) Standard Deviation 11.93	0.3 Millisecond (msec) Standard Deviation 12.63	20.9 Millisecond (msec) Standard Deviation 8.83
Change From Baseline in Electrocardiogram (ECG) Parameters QTcB: Day 28/withdrawal	6.6 Millisecond (msec) Standard Deviation 15.25	17.0 Millisecond (msec) Standard Deviation 22.12	3.5 Millisecond (msec) Standard Deviation 14.03	0.1 Millisecond (msec) Standard Deviation 7.16
Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval: Day 3	2.4 Millisecond (msec) Standard Deviation 6.47	-5.4 Millisecond (msec) Standard Deviation 20.25	0.4 Millisecond (msec) Standard Deviation 10.53	2.3 Millisecond (msec) Standard Deviation 10.52
Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval: Day 28/withdrawal	3.1 Millisecond (msec) Standard Deviation 6.33	9.3 Millisecond (msec) Standard Deviation 11.87	3.0 Millisecond (msec) Standard Deviation 13.47	2.5 Millisecond (msec) Standard Deviation 5.27
Change From Baseline in Electrocardiogram (ECG) Parameters QRS Duration: Day 3	1.5 Millisecond (msec) Standard Deviation 4.45	-5.6 Millisecond (msec) Standard Deviation 6.47	-0.5 Millisecond (msec) Standard Deviation 6.14	1.9 Millisecond (msec) Standard Deviation 8.92
Change From Baseline in Electrocardiogram (ECG) Parameters QRS Duration: Day 28/withdrawal	-1.3 Millisecond (msec) Standard Deviation 5.29	-5.7 Millisecond (msec) Standard Deviation 12.47	0.6 Millisecond (msec) Standard Deviation 8.77	0.3 Millisecond (msec) Standard Deviation 4.09

PRIMARY outcome

Timeframe: Up to Day 28/withdrawal

Population: Safety population

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Number of Participants With Disease Related Events (DREs) of Interest	2 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 28/withdrawal

Population: Safety population

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

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Number of Participants With DRE of Interest-associated Antibiotic Use	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 28/withdrawal

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=7 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=6 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=12 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=5 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Time to Resolution of Fever Over Time Post Initiation of Treatment	119.833 Hours Interval 15.167 to Missing Kaplan Meier estimates are due to censoring	98.092 Hours Interval 46.033 to 129.917	54.425 Hours Interval 13.833 to Missing Kaplan Meier estimates are due to censoring	76.167 Hours Interval 18.15 to Missing Kaplan Meier estimates are due to censoring

SECONDARY outcome

Timeframe: Up to Day 28/withdrawal

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=7 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=6 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=12 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=5 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Number of Afebrile Participants Over Time Post Initiation of Treatment At 0 hour	0 Participants	0 Participants	0 Participants	0 Participants
Number of Afebrile Participants Over Time Post Initiation of Treatment At 24 hours	1 Participants	0 Participants	2 Participants	1 Participants
Number of Afebrile Participants Over Time Post Initiation of Treatment At 72 hours	2 Participants	2 Participants	8 Participants	2 Participants
Number of Afebrile Participants Over Time Post Initiation of Treatment At 120 hours	4 Participants	4 Participants	10 Participants	3 Participants
Number of Afebrile Participants Over Time Post Initiation of Treatment At 192 hours	4 Participants	6 Participants	11 Participants	3 Participants
Number of Afebrile Participants Over Time Post Initiation of Treatment At 336 hours	5 Participants	6 Participants	11 Participants	3 Participants
Number of Afebrile Participants Over Time Post Initiation of Treatment At 672 hours	5 Participants	6 Participants	11 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to Day 28/withdrawal

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Number of Participants Who Used Relief Medication Paracetamol use	12 Participants	7 Participants	15 Participants	7 Participants
Number of Participants Who Used Relief Medication Dextromethorphan use	12 Participants	5 Participants	13 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to Day 28/withdrawal

Population: Safety population

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

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Number of Hospital Admissions Due to Influenza Infection	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=9 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=6 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=13 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
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 Day 3	-0.897 Log viral particles/mL Standard Deviation 1.1390	-1.415 Log viral particles/mL Standard Deviation 1.5986	-1.620 Log viral particles/mL Standard Deviation 1.3461	-1.904 Log viral particles/mL Standard Deviation 1.6289
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 Day 5	-1.912 Log viral particles/mL Standard Deviation 1.2895	-2.812 Log viral particles/mL Standard Deviation 1.8841	-2.962 Log viral particles/mL Standard Deviation 1.8515	-2.644 Log viral particles/mL Standard Deviation 0.5206
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 Day 8	-3.764 Log viral particles/mL Standard Deviation 1.8831	-4.063 Log viral particles/mL Standard Deviation 1.4120	-3.862 Log viral particles/mL Standard Deviation 1.3284	-4.250 Log viral particles/mL Standard Deviation 1.7995
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 Day 14	-4.024 Log viral particles/mL Standard Deviation 1.0387	-4.992 Log viral particles/mL Standard Deviation 1.1296	-4.518 Log viral particles/mL Standard Deviation 1.2408	-4.250 Log viral particles/mL Standard Deviation 1.7995

SECONDARY outcome

Timeframe: Up to Day 14

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=9 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=6 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=13 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
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 Day 1	0 Participants	0 Participants	0 Participants	0 Participants
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 Day 3	0 Participants	0 Participants	0 Participants	0 Participants
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 Day 5	0 Participants	0 Participants	3 Participants	1 Participants
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 Day 8	3 Participants	1 Participants	6 Participants	5 Participants
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 Day 14	5 Participants	4 Participants	11 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to Day 28/withdrawal

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Total Dose of Relief Medication Paracetamol total dose	5000.00 Milligrams Interval 1000.0 to 14000.0	9000.00 Milligrams Interval 500.0 to 71000.0	5500.00 Milligrams Interval 500.0 to 20000.0	3000.00 Milligrams Interval 1000.0 to 12000.0
Total Dose of Relief Medication Dextromethorphan total dose	150.00 Milligrams Interval 15.0 to 360.0	390.00 Milligrams Interval 120.0 to 2250.0	120.00 Milligrams Interval 30.0 to 2250.0	60.00 Milligrams Interval 15.0 to 300.0

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=9 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=6 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=13 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
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 Day 3	-1.810 Log median tissue culture infective dose Standard Deviation 1.4374	-0.753 Log median tissue culture infective dose Standard Deviation 1.8251	-1.943 Log median tissue culture infective dose Standard Deviation 2.0079	-2.304 Log median tissue culture infective dose Standard Deviation 1.9351
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 Day 5	-2.534 Log median tissue culture infective dose Standard Deviation 1.4499	-2.172 Log median tissue culture infective dose Standard Deviation 1.9242	-2.467 Log median tissue culture infective dose Standard Deviation 1.8842	-3.108 Log median tissue culture infective dose Standard Deviation 2.0998
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 Day 8	-2.885 Log median tissue culture infective dose Standard Deviation 1.1877	-2.843 Log median tissue culture infective dose Standard Deviation 2.2061	-2.698 Log median tissue culture infective dose Standard Deviation 1.4621	-3.108 Log median tissue culture infective dose Standard Deviation 2.0998
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 Day 14	-2.564 Log median tissue culture infective dose Standard Deviation 1.4694	-2.260 Log median tissue culture infective dose Standard Deviation 1.8792	-2.614 Log median tissue culture infective dose Standard Deviation 1.5899	-3.108 Log median tissue culture infective dose Standard Deviation 2.0998

SECONDARY outcome

Timeframe: Up to Day 14

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

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.

Outcome measures

Outcome measures
Measure	Danirixin (DNX) 75 mg n=9 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=6 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=13 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
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 Day 1	1 Participants	0 Participants	0 Participants	2 Participants
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 Day 3	5 Participants	2 Participants	6 Participants	3 Participants
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 Day 5	7 Participants	3 Participants	10 Participants	5 Participants
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 Day 8	8 Participants	6 Participants	12 Participants	5 Participants
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 Day 14	9 Participants	5 Participants	12 Participants	5 Participants

Adverse Events

Danirixin (DNX) 75 Milligram (mg)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo (PBO)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Oseltamivir (OSV) 75 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Danirixin (DNX) 75 Milligram (mg) n=15 participants at risk 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	Placebo (PBO) n=7 participants at risk Participants received Danirixin matching placebo (PBO \[DNX\]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 participants at risk Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 participants at risk Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
Investigations Electrocardiogram T wave abnormal	6.7% 1/15 • Up to 28 days Safety population comprised of all randomized participants who received at least one dose of investigational product.	0.00% 0/7 • Up to 28 days Safety population comprised of all randomized participants who received at least one dose of investigational product.	0.00% 0/16 • Up to 28 days Safety population comprised of all randomized participants who received at least one dose of investigational product.	0.00% 0/7 • Up to 28 days Safety population comprised of all randomized participants who received at least one dose of investigational product.

Other adverse events

Other adverse events
Measure	Danirixin (DNX) 75 Milligram (mg) n=15 participants at risk 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	Placebo (PBO) n=7 participants at risk Participants received Danirixin matching placebo (PBO \[DNX\]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 participants at risk Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 participants at risk Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
Gastrointestinal disorders Diarrhoea	6.7% 1/15 • Up to 28 days Safety population comprised of all randomized participants who received at least one dose of investigational product.	14.3% 1/7 • Up to 28 days Safety population comprised of all randomized participants who received at least one dose of investigational product.	0.00% 0/16 • Up to 28 days Safety population comprised of all randomized participants who received at least one dose of investigational product.	0.00% 0/7 • Up to 28 days Safety population comprised of all randomized participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/15 • Up to 28 days Safety population comprised of all randomized participants who received at least one dose of investigational product.	14.3% 1/7 • Up to 28 days Safety population comprised of all randomized participants who received at least one dose of investigational product.	6.2% 1/16 • Up to 28 days Safety population comprised of all randomized participants who received at least one dose of investigational product.	0.00% 0/7 • Up to 28 days Safety population comprised of all randomized participants who received at least one dose of investigational product.
Gastrointestinal disorders Vomiting	0.00% 0/15 • Up to 28 days Safety population comprised of all randomized participants who received at least one dose of investigational product.	0.00% 0/7 • Up to 28 days Safety population comprised of all randomized participants who received at least one dose of investigational product.	12.5% 2/16 • Up to 28 days Safety population comprised of all randomized participants who received at least one dose of investigational product.	0.00% 0/7 • Up to 28 days Safety population comprised of all randomized participants who received at least one dose of investigational product.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
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 WBC count: Day 5	-0.94 Giga cells per litre (GI/L) Standard Deviation 2.408	-0.39 Giga cells per litre (GI/L) Standard Deviation 1.676	-0.17 Giga cells per litre (GI/L) Standard Deviation 1.618	0.18 Giga cells per litre (GI/L) Standard Deviation 1.221
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 Platelet count: Day 3	-9.5 Giga cells per litre (GI/L) Standard Deviation 16.13	4.3 Giga cells per litre (GI/L) Standard Deviation 17.68	-6.1 Giga cells per litre (GI/L) Standard Deviation 17.68	-3.0 Giga cells per litre (GI/L) Standard Deviation 16.08
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 Platelet count: Day 5	16.4 Giga cells per litre (GI/L) Standard Deviation 22.92	6.7 Giga cells per litre (GI/L) Standard Deviation 21.70	13.7 Giga cells per litre (GI/L) Standard Deviation 31.50	10.4 Giga cells per litre (GI/L) Standard Deviation 17.78
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 Platelet count: Day 8	64.3 Giga cells per litre (GI/L) Standard Deviation 45.02	62.1 Giga cells per litre (GI/L) Standard Deviation 58.12	53.3 Giga cells per litre (GI/L) Standard Deviation 61.73	66.2 Giga cells per litre (GI/L) Standard Deviation 22.20
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 WBC count: Day 3	-1.62 Giga cells per litre (GI/L) Standard Deviation 1.949	-1.64 Giga cells per litre (GI/L) Standard Deviation 0.879	-1.49 Giga cells per litre (GI/L) Standard Deviation 1.624	-0.06 Giga cells per litre (GI/L) Standard Deviation 0.691
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 Platelet count: Day 28/withdrawal	28.3 Giga cells per litre (GI/L) Standard Deviation 38.74	47.7 Giga cells per litre (GI/L) Standard Deviation 40.13	19.2 Giga cells per litre (GI/L) Standard Deviation 42.67	44.2 Giga cells per litre (GI/L) Standard Deviation 8.76
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 Basophils: Day 3	-0.011 Giga cells per litre (GI/L) Standard Deviation 0.0511	-0.002 Giga cells per litre (GI/L) Standard Deviation 0.0377	-0.008 Giga cells per litre (GI/L) Standard Deviation 0.0196	-0.008 Giga cells per litre (GI/L) Standard Deviation 0.0130
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 Basophils: Day 5	-0.009 Giga cells per litre (GI/L) Standard Deviation 0.0569	0.017 Giga cells per litre (GI/L) Standard Deviation 0.0427	-0.007 Giga cells per litre (GI/L) Standard Deviation 0.0172	-0.002 Giga cells per litre (GI/L) Standard Deviation 0.0110
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 Basophils: Day 8	-0.008 Giga cells per litre (GI/L) Standard Deviation 0.0634	0.013 Giga cells per litre (GI/L) Standard Deviation 0.0356	0.005 Giga cells per litre (GI/L) Standard Deviation 0.0190	0.008 Giga cells per litre (GI/L) Standard Deviation 0.0311
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 Basophils: Day 28/withdrawal	-0.007 Giga cells per litre (GI/L) Standard Deviation 0.0517	0.003 Giga cells per litre (GI/L) Standard Deviation 0.0287	0.030 Giga cells per litre (GI/L) Standard Deviation 0.0520	0.010 Giga cells per litre (GI/L) Standard Deviation 0.0332
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 Eosinophils: Day 3	0.017 Giga cells per litre (GI/L) Standard Deviation 0.0929	0.026 Giga cells per litre (GI/L) Standard Deviation 0.0477	-0.012 Giga cells per litre (GI/L) Standard Deviation 0.1378	-0.012 Giga cells per litre (GI/L) Standard Deviation 0.0661
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 Eosinophils: Day 5	0.034 Giga cells per litre (GI/L) Standard Deviation 0.1048	0.035 Giga cells per litre (GI/L) Standard Deviation 0.0846	0.012 Giga cells per litre (GI/L) Standard Deviation 0.1856	0.136 Giga cells per litre (GI/L) Standard Deviation 0.3057
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 Eosinophils: Day 8	0.074 Giga cells per litre (GI/L) Standard Deviation 0.1248	0.078 Giga cells per litre (GI/L) Standard Deviation 0.1332	0.036 Giga cells per litre (GI/L) Standard Deviation 0.1416	-0.000 Giga cells per litre (GI/L) Standard Deviation 0.0959
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 Eosinophils: Day 28/withdrawal	0.030 Giga cells per litre (GI/L) Standard Deviation 0.1335	0.163 Giga cells per litre (GI/L) Standard Deviation 0.2016	0.032 Giga cells per litre (GI/L) Standard Deviation 0.1432	-0.018 Giga cells per litre (GI/L) Standard Deviation 0.0487
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 Lymphocytes: Day 3	0.093 Giga cells per litre (GI/L) Standard Deviation 0.6701	0.778 Giga cells per litre (GI/L) Standard Deviation 0.5904	0.463 Giga cells per litre (GI/L) Standard Deviation 0.5443	0.432 Giga cells per litre (GI/L) Standard Deviation 0.5124
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 Lymphocytes: Day 5	0.557 Giga cells per litre (GI/L) Standard Deviation 0.7137	1.038 Giga cells per litre (GI/L) Standard Deviation 0.7784	0.813 Giga cells per litre (GI/L) Standard Deviation 0.6445	0.576 Giga cells per litre (GI/L) Standard Deviation 0.3765
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 Lymphocytes: Day 8	0.716 Giga cells per litre (GI/L) Standard Deviation 0.7584	1.275 Giga cells per litre (GI/L) Standard Deviation 0.8948	0.918 Giga cells per litre (GI/L) Standard Deviation 0.9233	0.722 Giga cells per litre (GI/L) Standard Deviation 0.5434
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 Lymphocytes: Day 28/withdrawal	0.564 Giga cells per litre (GI/L) Standard Deviation 0.5969	1.619 Giga cells per litre (GI/L) Standard Deviation 0.7884	0.903 Giga cells per litre (GI/L) Standard Deviation 0.6779	0.788 Giga cells per litre (GI/L) Standard Deviation 0.4467
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 Monocytes: Day 3	-0.117 Giga cells per litre (GI/L) Standard Deviation 0.1524	-0.178 Giga cells per litre (GI/L) Standard Deviation 0.1970	-0.105 Giga cells per litre (GI/L) Standard Deviation 0.1927	-0.070 Giga cells per litre (GI/L) Standard Deviation 0.1562
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 Monocytes: Day 5	-0.175 Giga cells per litre (GI/L) Standard Deviation 0.2817	-0.128 Giga cells per litre (GI/L) Standard Deviation 0.1631	-0.090 Giga cells per litre (GI/L) Standard Deviation 0.2479	-0.118 Giga cells per litre (GI/L) Standard Deviation 0.2104
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 Monocytes: Day 8	-0.104 Giga cells per litre (GI/L) Standard Deviation 0.2310	-0.097 Giga cells per litre (GI/L) Standard Deviation 0.1425	-0.108 Giga cells per litre (GI/L) Standard Deviation 0.2043	0.024 Giga cells per litre (GI/L) Standard Deviation 0.1730
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 Monocytes: Day 28/withdrawal	-0.061 Giga cells per litre (GI/L) Standard Deviation 0.1785	-0.011 Giga cells per litre (GI/L) Standard Deviation 0.2230	-0.016 Giga cells per litre (GI/L) Standard Deviation 0.2232	0.064 Giga cells per litre (GI/L) Standard Deviation 0.1343
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 Total neutrophils: Day 3	-1.614 Giga cells per litre (GI/L) Standard Deviation 2.1846	-2.276 Giga cells per litre (GI/L) Standard Deviation 1.5252	-1.791 Giga cells per litre (GI/L) Standard Deviation 1.9580	-0.416 Giga cells per litre (GI/L) Standard Deviation 1.0604
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 Total neutrophils: Day 5	-1.371 Giga cells per litre (GI/L) Standard Deviation 2.1110	-1.223 Giga cells per litre (GI/L) Standard Deviation 2.2278	-0.677 Giga cells per litre (GI/L) Standard Deviation 1.6269	-0.424 Giga cells per litre (GI/L) Standard Deviation 0.7956
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 Total neutrophils: Day 8	0.463 Giga cells per litre (GI/L) Standard Deviation 2.0336	-0.830 Giga cells per litre (GI/L) Standard Deviation 2.0826	-0.137 Giga cells per litre (GI/L) Standard Deviation 2.4279	1.766 Giga cells per litre (GI/L) Standard Deviation 2.4391
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 Total neutrophils:Day 28/withdrawal	-0.217 Giga cells per litre (GI/L) Standard Deviation 2.2068	-0.217 Giga cells per litre (GI/L) Standard Deviation 2.0710	-0.381 Giga cells per litre (GI/L) Standard Deviation 2.1920	0.970 Giga cells per litre (GI/L) Standard Deviation 1.8349
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 WBC count: Day 8	1.14 Giga cells per litre (GI/L) Standard Deviation 2.676	0.49 Giga cells per litre (GI/L) Standard Deviation 1.842	0.79 Giga cells per litre (GI/L) Standard Deviation 2.309	2.52 Giga cells per litre (GI/L) Standard Deviation 2.797
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 WBC count: Day 28/withdrawal	0.31 Giga cells per litre (GI/L) Standard Deviation 2.310	1.56 Giga cells per litre (GI/L) Standard Deviation 1.992	0.51 Giga cells per litre (GI/L) Standard Deviation 2.250	1.76 Giga cells per litre (GI/L) Standard Deviation 1.696

Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) ALP: Day 3	-5.0 International Units per litre (IU/L) Standard Deviation 6.59	-5.0 International Units per litre (IU/L) Standard Deviation 5.48	-4.5 International Units per litre (IU/L) Standard Deviation 6.52	-7.2 International Units per litre (IU/L) Standard Deviation 9.04
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) ALP: Day 5	-5.4 International Units per litre (IU/L) Standard Deviation 10.96	-1.9 International Units per litre (IU/L) Standard Deviation 6.12	-4.5 International Units per litre (IU/L) Standard Deviation 8.83	-5.8 International Units per litre (IU/L) Standard Deviation 5.26
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) ALP: Day 8	-4.4 International Units per litre (IU/L) Standard Deviation 8.30	-0.9 International Units per litre (IU/L) Standard Deviation 8.32	2.9 International Units per litre (IU/L) Standard Deviation 9.32	0.8 International Units per litre (IU/L) Standard Deviation 8.56
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) ALP: Day 28/withdrawal	-2.8 International Units per litre (IU/L) Standard Deviation 9.06	4.9 International Units per litre (IU/L) Standard Deviation 7.43	-3.8 International Units per litre (IU/L) Standard Deviation 7.94	-1.6 International Units per litre (IU/L) Standard Deviation 9.84
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) ALT: Day 3	7.9 International Units per litre (IU/L) Standard Deviation 28.12	-0.1 International Units per litre (IU/L) Standard Deviation 4.14	0.1 International Units per litre (IU/L) Standard Deviation 5.25	-8.4 International Units per litre (IU/L) Standard Deviation 8.38
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) ALT: Day 5	4.2 International Units per litre (IU/L) Standard Deviation 15.27	2.4 International Units per litre (IU/L) Standard Deviation 7.18	0.9 International Units per litre (IU/L) Standard Deviation 10.70	-11.8 International Units per litre (IU/L) Standard Deviation 12.50
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) ALT: Day 8	2.9 International Units per litre (IU/L) Standard Deviation 3.92	9.1 International Units per litre (IU/L) Standard Deviation 10.98	2.7 International Units per litre (IU/L) Standard Deviation 15.18	-11.0 International Units per litre (IU/L) Standard Deviation 20.65
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) ALT: Day 28/withdrawal	2.5 International Units per litre (IU/L) Standard Deviation 5.00	2.4 International Units per litre (IU/L) Standard Deviation 9.69	-2.9 International Units per litre (IU/L) Standard Deviation 11.84	-12.8 International Units per litre (IU/L) Standard Deviation 23.64
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) AST: Day 3	6.3 International Units per litre (IU/L) Standard Deviation 22.53	2.9 International Units per litre (IU/L) Standard Deviation 5.87	-0.9 International Units per litre (IU/L) Standard Deviation 4.60	-7.2 International Units per litre (IU/L) Standard Deviation 4.49
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) AST: Day 5	0.9 International Units per litre (IU/L) Standard Deviation 4.10	2.4 International Units per litre (IU/L) Standard Deviation 4.76	-2.8 International Units per litre (IU/L) Standard Deviation 8.33	-9.4 International Units per litre (IU/L) Standard Deviation 5.94
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) AST: Day 8	-0.8 International Units per litre (IU/L) Standard Deviation 5.48	3.4 International Units per litre (IU/L) Standard Deviation 4.54	-3.3 International Units per litre (IU/L) Standard Deviation 7.55	-10.4 International Units per litre (IU/L) Standard Deviation 8.91
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) AST: Day 28/withdrawal	-0.2 International Units per litre (IU/L) Standard Deviation 6.75	-1.9 International Units per litre (IU/L) Standard Deviation 4.18	-4.9 International Units per litre (IU/L) Standard Deviation 7.62	-9.8 International Units per litre (IU/L) Standard Deviation 11.48
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) GGT: Day 3	9.3 International Units per litre (IU/L) Standard Deviation 28.87	1.0 International Units per litre (IU/L) Standard Deviation 4.08	0.9 International Units per litre (IU/L) Standard Deviation 3.45	-2.6 International Units per litre (IU/L) Standard Deviation 3.13
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) GGT: Day 5	7.4 International Units per litre (IU/L) Standard Deviation 22.36	5.0 International Units per litre (IU/L) Standard Deviation 6.58	0.8 International Units per litre (IU/L) Standard Deviation 5.14	0.2 International Units per litre (IU/L) Standard Deviation 5.63
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) GGT: Day 8	3.3 International Units per litre (IU/L) Standard Deviation 11.11	7.4 International Units per litre (IU/L) Standard Deviation 8.12	1.5 International Units per litre (IU/L) Standard Deviation 7.50	0.2 International Units per litre (IU/L) Standard Deviation 10.50
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) GGT: Day 28/withdrawal	-7.6 International Units per litre (IU/L) Standard Deviation 17.60	-1.1 International Units per litre (IU/L) Standard Deviation 5.79	-3.5 International Units per litre (IU/L) Standard Deviation 10.62	-0.6 International Units per litre (IU/L) Standard Deviation 15.44

Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Direct Bilirubin: Day 3	-0.3 Micromole per Liter (UMOL/L) Standard Deviation 0.88	0.0 Micromole per Liter (UMOL/L) Standard Deviation 1.73	-0.5 Micromole per Liter (UMOL/L) Standard Deviation 0.74	0.2 Micromole per Liter (UMOL/L) Standard Deviation 0.45
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Direct Bilirubin: Day 5	-0.5 Micromole per Liter (UMOL/L) Standard Deviation 0.83	-0.6 Micromole per Liter (UMOL/L) Standard Deviation 1.13	-0.5 Micromole per Liter (UMOL/L) Standard Deviation 0.74	0.2 Micromole per Liter (UMOL/L) Standard Deviation 0.45
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Direct Bilirubin: Day 8	0.1 Micromole per Liter (UMOL/L) Standard Deviation 0.73	-0.1 Micromole per Liter (UMOL/L) Standard Deviation 1.46	-0.1 Micromole per Liter (UMOL/L) Standard Deviation 0.83	0.0 Micromole per Liter (UMOL/L) Standard Deviation 1.41
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Direct Bilirubin:Day 28/withdrawal	0.1 Micromole per Liter (UMOL/L) Standard Deviation 1.23	-0.1 Micromole per Liter (UMOL/L) Standard Deviation 1.21	-0.1 Micromole per Liter (UMOL/L) Standard Deviation 0.83	0.0 Micromole per Liter (UMOL/L) Standard Deviation 0.00
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Total Bilirubin: Day 3	-1.0 Micromole per Liter (UMOL/L) Standard Deviation 2.30	-2.0 Micromole per Liter (UMOL/L) Standard Deviation 7.46	-1.6 Micromole per Liter (UMOL/L) Standard Deviation 2.10	-0.8 Micromole per Liter (UMOL/L) Standard Deviation 1.79
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Total Bilirubin: Day 5	-1.2 Micromole per Liter (UMOL/L) Standard Deviation 2.73	-2.7 Micromole per Liter (UMOL/L) Standard Deviation 6.37	0.0 Micromole per Liter (UMOL/L) Standard Deviation 2.56	1.0 Micromole per Liter (UMOL/L) Standard Deviation 1.41
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Total Bilirubin: Day 8	-0.9 Micromole per Liter (UMOL/L) Standard Deviation 1.99	-0.9 Micromole per Liter (UMOL/L) Standard Deviation 6.72	0.5 Micromole per Liter (UMOL/L) Standard Deviation 3.09	2.2 Micromole per Liter (UMOL/L) Standard Deviation 3.49
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Total Bilirubin:Day 28/withdrawal	0.1 Micromole per Liter (UMOL/L) Standard Deviation 3.45	-0.3 Micromole per Liter (UMOL/L) Standard Deviation 6.13	0.5 Micromole per Liter (UMOL/L) Standard Deviation 3.11	2.0 Micromole per Liter (UMOL/L) Standard Deviation 2.45
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Creatinine: Day 3;	-1.47 Micromole per Liter (UMOL/L) Standard Deviation 7.891	-4.39 Micromole per Liter (UMOL/L) Standard Deviation 6.733	-6.58 Micromole per Liter (UMOL/L) Standard Deviation 12.081	-8.14 Micromole per Liter (UMOL/L) Standard Deviation 11.291
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Creatinine: Day 5	-4.38 Micromole per Liter (UMOL/L) Standard Deviation 6.330	-7.39 Micromole per Liter (UMOL/L) Standard Deviation 7.240	-10.16 Micromole per Liter (UMOL/L) Standard Deviation 14.060	-11.12 Micromole per Liter (UMOL/L) Standard Deviation 9.955
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Creatinine: Day 8	-5.79 Micromole per Liter (UMOL/L) Standard Deviation 7.262	-10.70 Micromole per Liter (UMOL/L) Standard Deviation 10.266	-8.87 Micromole per Liter (UMOL/L) Standard Deviation 13.815	-10.32 Micromole per Liter (UMOL/L) Standard Deviation 5.273
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Creatinine: Day 28/withdrawal	-2.54 Micromole per Liter (UMOL/L) Standard Deviation 5.166	-4.99 Micromole per Liter (UMOL/L) Standard Deviation 12.990	-8.24 Micromole per Liter (UMOL/L) Standard Deviation 11.771	-5.34 Micromole per Liter (UMOL/L) Standard Deviation 5.490
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Uric acid: Day 3	-15.1 Micromole per Liter (UMOL/L) Standard Deviation 31.18	-9.9 Micromole per Liter (UMOL/L) Standard Deviation 42.57	-15.1 Micromole per Liter (UMOL/L) Standard Deviation 39.17	-45.8 Micromole per Liter (UMOL/L) Standard Deviation 36.03
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Uric acid: Day 5	-18.0 Micromole per Liter (UMOL/L) Standard Deviation 27.46	-47.4 Micromole per Liter (UMOL/L) Standard Deviation 39.09	-16.3 Micromole per Liter (UMOL/L) Standard Deviation 45.05	-54.8 Micromole per Liter (UMOL/L) Standard Deviation 33.69
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Uric acid: Day 8	20.8 Micromole per Liter (UMOL/L) Standard Deviation 48.26	-14.3 Micromole per Liter (UMOL/L) Standard Deviation 53.04	0.9 Micromole per Liter (UMOL/L) Standard Deviation 27.41	-13.0 Micromole per Liter (UMOL/L) Standard Deviation 69.07
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Uric acid: Day 28/withdrawal	30.1 Micromole per Liter (UMOL/L) Standard Deviation 47.40	-0.4 Micromole per Liter (UMOL/L) Standard Deviation 48.19	12.5 Micromole per Liter (UMOL/L) Standard Deviation 45.09	40.6 Micromole per Liter (UMOL/L) Standard Deviation 63.50

Measure	Danirixin (DNX) 75 mg n=15 Participants Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Placebo (PBO) n=7 Participants Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n=16 Participants Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days	Oseltamivir (OSV) 75 mg n=7 Participants Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Calcium: Day 3	-0.036 Millimoles per Liter (MMOL/L) Standard Deviation 0.0735	0.020 Millimoles per Liter (MMOL/L) Standard Deviation 0.0370	-0.046 Millimoles per Liter (MMOL/L) Standard Deviation 0.1015	-0.092 Millimoles per Liter (MMOL/L) Standard Deviation 0.1101
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Calcium: Day 5	-0.029 Millimoles per Liter (MMOL/L) Standard Deviation 0.0917	0.019 Millimoles per Liter (MMOL/L) Standard Deviation 0.0672	-0.033 Millimoles per Liter (MMOL/L) Standard Deviation 0.1079	-0.052 Millimoles per Liter (MMOL/L) Standard Deviation 0.0642
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Calcium: Day 8	-0.010 Millimoles per Liter (MMOL/L) Standard Deviation 0.0842	0.053 Millimoles per Liter (MMOL/L) Standard Deviation 0.0720	0.030 Millimoles per Liter (MMOL/L) Standard Deviation 0.0994	0.004 Millimoles per Liter (MMOL/L) Standard Deviation 0.1178
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Calcium: Day 28/withdrawal	-0.019 Millimoles per Liter (MMOL/L) Standard Deviation 0.1077	0.099 Millimoles per Liter (MMOL/L) Standard Deviation 0.0334	0.031 Millimoles per Liter (MMOL/L) Standard Deviation 0.0842	0.098 Millimoles per Liter (MMOL/L) Standard Deviation 0.1274
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) CO2 / Bicarbonate: Day 3	0.1 Millimoles per Liter (MMOL/L) Standard Deviation 2.74	0.9 Millimoles per Liter (MMOL/L) Standard Deviation 2.34	0.3 Millimoles per Liter (MMOL/L) Standard Deviation 2.50	-1.8 Millimoles per Liter (MMOL/L) Standard Deviation 2.77
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) CO2 / Bicarbonate: Day 5	0.4 Millimoles per Liter (MMOL/L) Standard Deviation 2.35	0.9 Millimoles per Liter (MMOL/L) Standard Deviation 1.07	-0.5 Millimoles per Liter (MMOL/L) Standard Deviation 2.45	-1.4 Millimoles per Liter (MMOL/L) Standard Deviation 3.21
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) CO2 / Bicarbonate: Day 8	0.6 Millimoles per Liter (MMOL/L) Standard Deviation 3.10	-0.1 Millimoles per Liter (MMOL/L) Standard Deviation 1.95	0.4 Millimoles per Liter (MMOL/L) Standard Deviation 2.67	-0.2 Millimoles per Liter (MMOL/L) Standard Deviation 1.10
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) CO2 / Bicarbonate: Day 28/withdrawal	-0.4 Millimoles per Liter (MMOL/L) Standard Deviation 2.59	1.1 Millimoles per Liter (MMOL/L) Standard Deviation 3.13	-0.5 Millimoles per Liter (MMOL/L) Standard Deviation 2.44	-1.2 Millimoles per Liter (MMOL/L) Standard Deviation 1.64
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Glucose: Day 3	0.28 Millimoles per Liter (MMOL/L) Standard Deviation 1.084	0.23 Millimoles per Liter (MMOL/L) Standard Deviation 1.680	0.51 Millimoles per Liter (MMOL/L) Standard Deviation 1.385	0.62 Millimoles per Liter (MMOL/L) Standard Deviation 0.782
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Glucose: Day 5	0.13 Millimoles per Liter (MMOL/L) Standard Deviation 1.084	0.13 Millimoles per Liter (MMOL/L) Standard Deviation 1.529	0.29 Millimoles per Liter (MMOL/L) Standard Deviation 1.904	1.30 Millimoles per Liter (MMOL/L) Standard Deviation 2.374
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Glucose: Day 8	0.20 Millimoles per Liter (MMOL/L) Standard Deviation 1.301	-0.16 Millimoles per Liter (MMOL/L) Standard Deviation 1.042	-0.13 Millimoles per Liter (MMOL/L) Standard Deviation 1.669	0.48 Millimoles per Liter (MMOL/L) Standard Deviation 0.733
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Glucose: Day 28/withdrawal	0.27 Millimoles per Liter (MMOL/L) Standard Deviation 1.221	0.71 Millimoles per Liter (MMOL/L) Standard Deviation 2.685	0.43 Millimoles per Liter (MMOL/L) Standard Deviation 1.909	0.22 Millimoles per Liter (MMOL/L) Standard Deviation 0.760
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Potassium: Day 3	-0.12 Millimoles per Liter (MMOL/L) Standard Deviation 0.351	0.13 Millimoles per Liter (MMOL/L) Standard Deviation 0.411	0.01 Millimoles per Liter (MMOL/L) Standard Deviation 0.237	-0.12 Millimoles per Liter (MMOL/L) Standard Deviation 0.396
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Potassium: Day 5	-0.07 Millimoles per Liter (MMOL/L) Standard Deviation 0.401	0.16 Millimoles per Liter (MMOL/L) Standard Deviation 0.428	0.11 Millimoles per Liter (MMOL/L) Standard Deviation 0.317	0.08 Millimoles per Liter (MMOL/L) Standard Deviation 0.572
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Potassium: Day 8	0.08 Millimoles per Liter (MMOL/L) Standard Deviation 0.353	0.21 Millimoles per Liter (MMOL/L) Standard Deviation 0.285	0.15 Millimoles per Liter (MMOL/L) Standard Deviation 0.223	0.02 Millimoles per Liter (MMOL/L) Standard Deviation 0.409
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Potassium: Day 28/withdrawal	-0.04 Millimoles per Liter (MMOL/L) Standard Deviation 0.455	0.07 Millimoles per Liter (MMOL/L) Standard Deviation 0.419	0.14 Millimoles per Liter (MMOL/L) Standard Deviation 0.422	0.24 Millimoles per Liter (MMOL/L) Standard Deviation 0.635
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Sodium: Day 3	0.5 Millimoles per Liter (MMOL/L) Standard Deviation 1.77	0.1 Millimoles per Liter (MMOL/L) Standard Deviation 2.41	1.4 Millimoles per Liter (MMOL/L) Standard Deviation 1.64	2.0 Millimoles per Liter (MMOL/L) Standard Deviation 1.87
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Sodium: Day 5	0.3 Millimoles per Liter (MMOL/L) Standard Deviation 2.82	1.1 Millimoles per Liter (MMOL/L) Standard Deviation 1.86	0.7 Millimoles per Liter (MMOL/L) Standard Deviation 2.63	1.8 Millimoles per Liter (MMOL/L) Standard Deviation 2.39
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Sodium: Day 8	0.9 Millimoles per Liter (MMOL/L) Standard Deviation 2.64	0.3 Millimoles per Liter (MMOL/L) Standard Deviation 1.70	1.5 Millimoles per Liter (MMOL/L) Standard Deviation 2.33	2.4 Millimoles per Liter (MMOL/L) Standard Deviation 1.67
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Sodium: Day 28/withdrawal	-0.3 Millimoles per Liter (MMOL/L) Standard Deviation 1.82	0.6 Millimoles per Liter (MMOL/L) Standard Deviation 2.99	0.6 Millimoles per Liter (MMOL/L) Standard Deviation 2.50	1.6 Millimoles per Liter (MMOL/L) Standard Deviation 1.34
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Urea/BUN: Day 3	0.31 Millimoles per Liter (MMOL/L) Standard Deviation 0.956	-0.31 Millimoles per Liter (MMOL/L) Standard Deviation 0.888	0.29 Millimoles per Liter (MMOL/L) Standard Deviation 1.046	-0.24 Millimoles per Liter (MMOL/L) Standard Deviation 1.328
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Urea/BUN: Day 5	0.47 Millimoles per Liter (MMOL/L) Standard Deviation 0.830	-0.19 Millimoles per Liter (MMOL/L) Standard Deviation 1.194	0.32 Millimoles per Liter (MMOL/L) Standard Deviation 1.197	-0.88 Millimoles per Liter (MMOL/L) Standard Deviation 1.413
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Urea/BUN: Day 8	0.90 Millimoles per Liter (MMOL/L) Standard Deviation 1.563	0.17 Millimoles per Liter (MMOL/L) Standard Deviation 1.081	0.82 Millimoles per Liter (MMOL/L) Standard Deviation 1.050	0.32 Millimoles per Liter (MMOL/L) Standard Deviation 1.134
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) Urea/BUN: Day 28/withdrawal	0.60 Millimoles per Liter (MMOL/L) Standard Deviation 1.091	0.96 Millimoles per Liter (MMOL/L) Standard Deviation 2.082	1.19 Millimoles per Liter (MMOL/L) Standard Deviation 0.910	0.66 Millimoles per Liter (MMOL/L) Standard Deviation 1.324