Trial Outcomes & Findings for A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oseltamivir and Its Carboxylate Metabolite, RO0640802 in Healthy Participants (NCT NCT02717754)

NCT ID: NCT02717754

Last Updated: 2016-06-27

Results Overview

AUC is a measure of the plasma concentration of the drug over time. AUC is presented in nanogram times (\*) hour per milliliter (ng\*hour/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 99 participants
• Primary outcome timeframe: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5
• Results posted on: 2016-06-27

Participant Flow

In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).

Participant milestones

Measure	Placebo Participants received oseltamivir matched placebo twice daily (BID) for 5 days.	Oseltamivir 100 mg Participants received 100 milligrams (mg) oseltamivir intravenous BID for 5 days.	Oseltamivir 200 mg Participants received 200 mg oseltamivir intravenous BID for 5 days.	Placebo (Incorrect Infusion Duration) Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.	Oseltamivir 100 mg (Incorrect Infusion Duration) Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.	Oseltamivir 200 mg (Incorrect Infusion Duration) Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
Overall Study STARTED	10	19	20	10	20	20
Overall Study COMPLETED	10	19	20	0	0	0
Overall Study NOT COMPLETED	0	0	0	10	20	20

Reasons for withdrawal

Measure	Placebo Participants received oseltamivir matched placebo twice daily (BID) for 5 days.	Oseltamivir 100 mg Participants received 100 milligrams (mg) oseltamivir intravenous BID for 5 days.	Oseltamivir 200 mg Participants received 200 mg oseltamivir intravenous BID for 5 days.	Placebo (Incorrect Infusion Duration) Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.	Oseltamivir 100 mg (Incorrect Infusion Duration) Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.	Oseltamivir 200 mg (Incorrect Infusion Duration) Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
Overall Study Incorrect Infusion Duration	0	0	0	10	20	20

Baseline Characteristics

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oseltamivir and Its Carboxylate Metabolite, RO0640802 in Healthy Participants

Baseline characteristics by cohort

Measure	Placebo n=10 Participants Participants received oseltamivir matched placebo BID for 5 days.	Oseltamivir 100 mg n=19 Participants Participants received 100 mg oseltamivir intravenous BID for 5 days.	Oseltamivir 200 mg n=20 Participants Participants received 200 mg oseltamivir intravenous BID for 5 days.	Placebo (Incorrect Infusion Duration) n=10 Participants Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.	Oseltamivir 100 mg (Incorrect Infusion Duration) n=20 Participants Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.	Oseltamivir 200 mg (Incorrect Infusion Duration) n=20 Participants Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.	Total n=99 Participants Total of all reporting groups
Age, Continuous	28.1 years STANDARD_DEVIATION 6.19 • n=93 Participants	28.3 years STANDARD_DEVIATION 6.97 • n=4 Participants	30.2 years STANDARD_DEVIATION 7.73 • n=27 Participants	29.7 years STANDARD_DEVIATION 7.90 • n=483 Participants	31.1 years STANDARD_DEVIATION 7.80 • n=36 Participants	28.6 years STANDARD_DEVIATION 8.09 • n=10 Participants	29.4040 years STANDARD_DEVIATION 7.44904 • n=115 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	10 Participants n=4 Participants	4 Participants n=27 Participants	1 Participants n=483 Participants	3 Participants n=36 Participants	4 Participants n=10 Participants	27 Participants n=115 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	9 Participants n=4 Participants	16 Participants n=27 Participants	9 Participants n=483 Participants	17 Participants n=36 Participants	16 Participants n=10 Participants	72 Participants n=115 Participants

PRIMARY outcome

Timeframe: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5

Population: Pharmacokinetic (PK) analysis population included all participants who were dosed correctly. Only participants who received oseltamivir were analyzed.

AUC is a measure of the plasma concentration of the drug over time. AUC is presented in nanogram times (*) hour per milliliter (ng*hour/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.

Outcome measures

Measure	Oseltamivir 100 mg n=19 Participants Participants received 100 mg oseltamivir intravenous BID for 5 days.	Oseltamivir 200 mg n=20 Participants Participants received 200 mg oseltamivir intravenous BID for 5 days.
Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hour (AUC0-12h) of Oseltamivir and RO0640802 at Steady State Oseltamivir	581 ng*hour/mL Standard Deviation 178	1143 ng*hour/mL Standard Deviation 178
Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hour (AUC0-12h) of Oseltamivir and RO0640802 at Steady State RO0640802	4147 ng*hour/mL Standard Deviation 742	7966 ng*hour/mL Standard Deviation 1427

PRIMARY outcome

Timeframe: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5

Population: PK analysis population. Only participants who received oseltamivir were analyzed.

Cmax is the maximum observed plasma concentration, presented in nanogram per milliliter (ng/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.

Outcome measures

Measure	Oseltamivir 100 mg n=19 Participants Participants received 100 mg oseltamivir intravenous BID for 5 days.	Oseltamivir 200 mg n=20 Participants Participants received 200 mg oseltamivir intravenous BID for 5 days.
Maximum Plasma Concentration (Cmax) of Oseltamivir and RO0640802 at Steady State Oseltamivir	266 ng/mL Standard Deviation 73.1	496 ng/mL Standard Deviation 69.7
Maximum Plasma Concentration (Cmax) of Oseltamivir and RO0640802 at Steady State RO0640802	488 ng/mL Standard Deviation 84.1	960 ng/mL Standard Deviation 178

SECONDARY outcome

Timeframe: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1

Population: PK analysis population. Only participants who received oseltamivir were analyzed.

AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.

Outcome measures

Measure	Oseltamivir 100 mg n=19 Participants Participants received 100 mg oseltamivir intravenous BID for 5 days.	Oseltamivir 200 mg n=20 Participants Participants received 200 mg oseltamivir intravenous BID for 5 days.
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Oseltamivir and RO0640802 Oseltamivir	612 ng*hour/mL Standard Deviation 134	1139 ng*hour/mL Standard Deviation 220
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Oseltamivir and RO0640802 RO0640802	3606 ng*hour/mL Standard Deviation 761	7336 ng*hour/mL Standard Deviation 1952

SECONDARY outcome

Timeframe: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5

Population: PK analysis population. Only participants who received oseltamivir were analyzed.

AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.

Outcome measures

Measure	Oseltamivir 100 mg n=19 Participants Participants received 100 mg oseltamivir intravenous BID for 5 days.	Oseltamivir 200 mg n=20 Participants Participants received 200 mg oseltamivir intravenous BID for 5 days.
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Oseltamivir and RO0640802 Day 1: Oseltamivir	609 ng*hour/mL Standard Deviation 134	1136 ng*hour/mL Standard Deviation 220
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Oseltamivir and RO0640802 Day 1: RO0640802	2273 ng*hour/mL Standard Deviation 405	4566 ng*hour/mL Standard Deviation 714
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Oseltamivir and RO0640802 Day 5: Oseltamivir	580 ng*hour/mL Standard Deviation 178	1142 ng*hour/mL Standard Deviation 178
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Oseltamivir and RO0640802 Day 5: RO0640802	4127 ng*hour/mL Standard Deviation 738	7932 ng*hour/mL Standard Deviation 1417

SECONDARY outcome

Timeframe: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1

Population: PK analysis population. Only participants who received oseltamivir were analyzed.

Cmax is the maximum observed plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.

Outcome measures

Measure	Oseltamivir 100 mg n=19 Participants Participants received 100 mg oseltamivir intravenous BID for 5 days.	Oseltamivir 200 mg n=20 Participants Participants received 200 mg oseltamivir intravenous BID for 5 days.
Cmax of Oseltamivir and RO0640802 Oseltamivir	284 ng/mL Standard Deviation 54.3	503 ng/mL Standard Deviation 93.1
Cmax of Oseltamivir and RO0640802 RO0640802	301 ng/mL Standard Deviation 69.8	577 ng/mL Standard Deviation 88.9

SECONDARY outcome

Timeframe: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5

Population: PK analysis population. Only participants who received oseltamivir were analyzed.

Tmax is time of observed maximum plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.

Outcome measures

Measure	Oseltamivir 100 mg n=19 Participants Participants received 100 mg oseltamivir intravenous BID for 5 days.	Oseltamivir 200 mg n=20 Participants Participants received 200 mg oseltamivir intravenous BID for 5 days.
Time to Reach Maximum Plasma Concentration (Tmax) of Oseltamivir and RO0640802 Day 1: Oseltamivir	1.85 hour Standard Deviation 0.377	1.65 hour Standard Deviation 0.491
Time to Reach Maximum Plasma Concentration (Tmax) of Oseltamivir and RO0640802 Day 1: RO0640802	3.90 hour Standard Deviation 0.91	3.95 hour Standard Deviation 1.28
Time to Reach Maximum Plasma Concentration (Tmax) of Oseltamivir and RO0640802 Day 5: Oseltamivir	1.64 hour Standard Deviation 0.492	1.81 hour Standard Deviation 0.416
Time to Reach Maximum Plasma Concentration (Tmax) of Oseltamivir and RO0640802 Day 5: RO0640802	3.69 hour Standard Deviation 0.917	3.41 hour Standard Deviation 0.851

SECONDARY outcome

Timeframe: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5

Population: PK analysis population. Only participants who received oseltamivir were analyzed.

t1/2 is the time measured for the plasma concentration to decrease by one half. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.

Outcome measures

Measure	Oseltamivir 100 mg n=19 Participants Participants received 100 mg oseltamivir intravenous BID for 5 days.	Oseltamivir 200 mg n=20 Participants Participants received 200 mg oseltamivir intravenous BID for 5 days.
Half-Life (t1/2) of Oseltamivir and RO0640802 Day 1: Oseltamivir	1.22 hour Standard Deviation 0.32	1.53 hour Standard Deviation 0.293
Half-Life (t1/2) of Oseltamivir and RO0640802 Day 1: RO0640802	6.89 hour Standard Deviation 2.08	7.17 hour Standard Deviation 2.19
Half-Life (t1/2) of Oseltamivir and RO0640802 Day 5: Oseltamivir	1.40 hour Standard Deviation 0.327	1.88 hour Standard Deviation 0.457
Half-Life (t1/2) of Oseltamivir and RO0640802 Day 5: RO0640802	7.97 hour Standard Deviation 1.82	8.17 hour Standard Deviation 2.23

SECONDARY outcome

Timeframe: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5

Population: PK analysis population. Only participants who received oseltamivir were analyzed.

Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.

Outcome measures

Measure	Oseltamivir 100 mg n=19 Participants Participants received 100 mg oseltamivir intravenous BID for 5 days.	Oseltamivir 200 mg n=20 Participants Participants received 200 mg oseltamivir intravenous BID for 5 days.
Volume of Distribution (Vd) of Oseltamivir and RO0640802 Day 1: Oseltamivir	171 Liter Standard Deviation 36.4	183 Liter Standard Deviation 39
Volume of Distribution (Vd) of Oseltamivir and RO0640802 Day 1: RO0640802	250 Liter Standard Deviation 55	251 Liter Standard Deviation 45.7
Volume of Distribution (Vd) of Oseltamivir and RO0640802 Day 5: Oseltamivir	189 Liter Standard Deviation 103	192 Liter Standard Deviation 31.0
Volume of Distribution (Vd) of Oseltamivir and RO0640802 Day 5: RO0640802	266 Liter Standard Deviation 58.9	280 Liter Standard Deviation 65.9

SECONDARY outcome

Timeframe: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5

Population: PK analysis population. Only participants who received oseltamivir were analyzed.

CL is a quantitative measure of the rate at which a drug substance is removed from the body. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.

Outcome measures

Measure	Oseltamivir 100 mg n=19 Participants Participants received 100 mg oseltamivir intravenous BID for 5 days.	Oseltamivir 200 mg n=20 Participants Participants received 200 mg oseltamivir intravenous BID for 5 days.
Clearance (CL) of Oseltamivir and RO0640802 Day 1: Oseltamivir	289 Liters/hour Standard Deviation 55	393 Liters/hour Standard Deviation 67
Clearance (CL) of Oseltamivir and RO0640802 Day 1: RO0640802	26.0 Liters/hour Standard Deviation 5.4	25.4 Liters/hour Standard Deviation 6.1
Clearance (CL) of Oseltamivir and RO0640802 Day 5: Oseltamivir	192 Liters/hour Standard Deviation 74.6	179 Liters/hour Standard Deviation 30.3
Clearance (CL) of Oseltamivir and RO0640802 Day 5: RO0640802	21.7 Liters/hour Standard Deviation 3.80	22.6 Liters/hour Standard Deviation 3.9

SECONDARY outcome

Timeframe: 12-hour post dose on Day 1, 5 and predose on Day 2, 3, 4, 5

Population: PK analysis population. Only participants who received oseltamivir were analyzed.

Collection of the 12-hour post-dose sample took place prior to administration of the second daily dose of drug. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.

Outcome measures

Measure	Oseltamivir 100 mg n=19 Participants Participants received 100 mg oseltamivir intravenous BID for 5 days.	Oseltamivir 200 mg n=20 Participants Participants received 200 mg oseltamivir intravenous BID for 5 days.
Minimum Plasma Concentration (Cmin) of RO0640802 Day 1 (12-hour post dose)	131 ng/mL Standard Deviation 29.3	264 ng/mL Standard Deviation 59.1
Minimum Plasma Concentration (Cmin) of RO0640802 Day 2 (Pre dose)	209 ng/mL Standard Deviation 43.6	388 ng/mL Standard Deviation 95.4
Minimum Plasma Concentration (Cmin) of RO0640802 Day 3 (Pre dose)	235 ng/mL Standard Deviation 56.3	450 ng/mL Standard Deviation 101
Minimum Plasma Concentration (Cmin) of RO0640802 Day 4 (Pre dose)	277 ng/mL Standard Deviation 104	443 ng/mL Standard Deviation 143
Minimum Plasma Concentration (Cmin) of RO0640802 Day 5 (Pre dose)	262 ng/mL Standard Deviation 68.4	502 ng/mL Standard Deviation 130.4
Minimum Plasma Concentration (Cmin) of RO0640802 Day 5 (12-hour post dose)	238 ng/mL Standard Deviation 61.8	458 ng/mL Standard Deviation 110

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Oseltamivir 100 mg

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Oseltamivir 200 mg

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Placebo (Incorrect Infusion Duration)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Oseltamivir 100 mg (Incorrect Infusion Duration)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Oseltamivir 200 mg (Incorrect Infusion Duration)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=10 participants at risk Participants received oseltamivir matched placebo for 5 days.	Oseltamivir 100 mg n=19 participants at risk Participants received 100 mg oseltamivir intravenous BID for 5 days.	Oseltamivir 200 mg n=20 participants at risk Participants received 200 mg oseltamivir intravenous BID for 5 days.	Placebo (Incorrect Infusion Duration) n=10 participants at risk Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.	Oseltamivir 100 mg (Incorrect Infusion Duration) n=20 participants at risk Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.	Oseltamivir 200 mg (Incorrect Infusion Duration) n=20 participants at risk Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
General disorders Infusion site pain	30.0% 3/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	78.9% 15/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	75.0% 15/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
General disorders Infusion site erythema	10.0% 1/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	31.6% 6/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	50.0% 10/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	20.0% 4/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
General disorders Infusion site swelling	30.0% 3/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	15.8% 3/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
General disorders Infusion site induration	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	21.1% 4/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	10.0% 2/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
General disorders Vessel puncture site pain	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	10.5% 2/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	10.0% 2/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
General disorders Catheter site pain	10.0% 1/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.3% 1/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
General disorders Infusion site anaesthesia	10.0% 1/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
General disorders Catheter site swelling	10.0% 1/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
General disorders Feeling hot	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.3% 1/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
General disorders Infusion site coldness	10.0% 1/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
General disorders Infusion site extravasation	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.3% 1/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
General disorders Infusion site warmth	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
General disorders Vessel puncture site reaction	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Nervous system disorders Dizziness	10.0% 1/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	10.5% 2/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	10.0% 1/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Nervous system disorders Headache	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.3% 1/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	10.0% 2/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Nervous system disorders Paraesthesia	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Skin and subcutaneous tissue disorders Pruritus	10.0% 1/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	10.0% 2/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.3% 1/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.3% 1/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Gastrointestinal disorders Abdominal pain	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Gastrointestinal disorders Constipation	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.3% 1/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Gastrointestinal disorders Nausea	10.0% 1/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	10.0% 2/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Ear and labyrinth disorders Tinnitus	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.3% 1/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Eye disorders Visual impairment	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.3% 1/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Infections and infestations Nasopharyngitis	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Respiratory, thoracic and mediastinal disorders Sneezing	10.0% 1/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Vascular disorders Vein disorders	10.0% 1/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
General disorders Injection site pain	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	10.0% 2/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	45.0% 9/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
General disorders Injection site swelling	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	30.0% 6/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
General disorders Injection site erythema	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	10.0% 2/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	10.0% 2/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
General disorders Injection site oedema	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
General disorders Oedema peripheral	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Injury, poisoning and procedural complications Contusion	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Skin and subcutaneous tissue disorders Rash	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	5.0% 1/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/19 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	10.0% 1/10 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).	0.00% 0/20 • Up to 10 days after last dose of study drug (32 days) In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER