Trial Outcomes & Findings for Dose Ranging Pharmacokinetics and Pharmacodynamics Study With Mepolizumab in Asthma Patients With Elevated Eosinophils (NCT NCT01366521)

Last Updated: 2017-01-11

Results Overview

Change from Baseline in blood eosinophils was calculated as the post-Baseline value minus the Baseline value. The change from Baseline in log-transformed blood eosinophil levels at Week 12 was analyzed using both a linear and non-linear (Imax) dose response models. The dose response was found to be non-linear and hence only the results of the non-linear model are presented. Mepolizumab 75mg IV assumed to equate to 100 mg SC within model. Prior to log10-transformation, zero values were imputed with half the minimum value across all dose groups and time points. An adjustment for Baseline eosinophil count was also incorporated into the model.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

70 participants

Primary outcome timeframe

Baseline (Day 1 pre-dose) and Week 12

Results posted on

2017-01-11

Participant Flow

Participants (par.) were on a stable dose of their current asthma medications for 12 weeks prior to screening. Par. who met the eligibility criteria at screening were randomized to one of the four possible treatment arms. Total duration of participation in the study was up to approximately 22 weeks including screening, dosing and follow-up.

A total of 70 participants were enrolled into the study and 66 participants completed the study.

Participant milestones

Participant milestones
Measure	Mepolizumab 12.5 mg SC Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Overall Study STARTED	21	15	23	11
Overall Study COMPLETED	20	14	21	11
Overall Study NOT COMPLETED	1	1	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Mepolizumab 12.5 mg SC Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Overall Study Adverse Event	1	0	0
Overall Study Protocol Violation	0	0	1
Overall Study Physician Decision	0	0	1
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

Dose Ranging Pharmacokinetics and Pharmacodynamics Study With Mepolizumab in Asthma Patients With Elevated Eosinophils

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mepolizumab 12.5 mg SC n=21 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=23 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Total n=70 Participants Total of all reporting groups
Age, Continuous	43.1 Years STANDARD_DEVIATION 11.53 • n=5 Participants	37.0 Years STANDARD_DEVIATION 17.80 • n=7 Participants	43.9 Years STANDARD_DEVIATION 13.42 • n=5 Participants	44.8 Years STANDARD_DEVIATION 12.55 • n=4 Participants	42.3 Years STANDARD_DEVIATION 13.83 • n=21 Participants
Gender Female	13 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants	5 Participants n=4 Participants	37 Participants n=21 Participants
Gender Male	8 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	6 Participants n=4 Participants	33 Participants n=21 Participants
Race/Ethnicity, Customized African American/African Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Asian-South East Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized White-White/Caucasian/European Heritage	20 Participants n=5 Participants	14 Participants n=7 Participants	21 Participants n=5 Participants	11 Participants n=4 Participants	66 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1 pre-dose) and Week 12

Population: Pharmacodynamic (PD) Population: all participants randomized to treatment and who received at least one dose of study medication and who also had a Baseline PD or biomarker measurement and at least one post-treatment PD or biomarker measurement. Only participants who were available at the specified time point were analyzed.

Outcome measures

Outcome measures
Measure	Mepolizumab 12.5 mg SC n=20 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=14 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=21 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Change From Baseline in Blood Eosinophil Levels at Week 12 (Day 84)	0.43 Proportion of Baseline blood eosinophil Interval 0.31 to 0.58	0.14 Proportion of Baseline blood eosinophil Interval 0.11 to 0.17	0.12 Proportion of Baseline blood eosinophil Interval 0.1 to 0.15	0.14 Proportion of Baseline blood eosinophil Interval 0.12 to 0.17

PRIMARY outcome

Timeframe: Days 1, 3, 7, 28, 56, 70 and 84

Population: PD Population. Only participants with eosinophil data to Day 84 were analyzed.

Area under the absolute blood eosinophil time curve to Day 84 (AUECeos\[0-day 84\]) determined using the linear trapezoidal rule for subset of participants with blood eosinophil data to Day 84. Blood samples for the analyses of AUEC(eos) (0-day 84) were collected at Days 1, 3, 7, 28, 56, 70 and 84.

Outcome measures

Outcome measures
Measure	Mepolizumab 12.5 mg SC n=20 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=14 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=21 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Area Under the Blood Eosinophil Time Curve (AUEC) up to Day 84	21.551 Giga unit per liter per day (GI*d/L) Interval 15.486 to 29.991	7.198 Giga unit per liter per day (GI*d/L) Interval 5.29 to 9.796	6.381 Giga unit per liter per day (GI*d/L) Interval 4.915 to 8.284	7.556 Giga unit per liter per day (GI*d/L) Interval 5.459 to 10.459

PRIMARY outcome

Timeframe: Days 1, 3, 7, 28, 56, 70, 84, 112 and 140

Population: PD Population

Blood samples were collected at Days 1, 3, 7, 28, 56, 70, 84, 112 and 140 to assess the maximum reduction from Baseline in blood eosinophils between Day 1 pre-dose and last quantifiable study measurement. Change from Baseline was calculated as the ratio of the post-Baseline value divided by the Baseline value. The maximum reduction from Baseline in eosinophils is represented by the minimum ratio to Baseline.

Outcome measures

Outcome measures
Measure	Mepolizumab 12.5 mg SC n=21 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=23 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Maximum Change From Baseline in Blood Eosinophils (Emax)	0.203 Giga units per liter (GI/L) Interval 0.124 to 0.331	0.113 Giga units per liter (GI/L) Interval 0.079 to 0.162	0.082 Giga units per liter (GI/L) Interval 0.057 to 0.119	0.141 Giga units per liter (GI/L) Interval 0.085 to 0.233

PRIMARY outcome

Timeframe: Days 1, 3, 7, 28, 56, 70, 84, 112 and 140

Population: PD Population.

Blood samples were collected at Days 1, 3, 7, 28, 56, 70, 84, 112 and 140 to assess the time to first occurrence of maximum reduction from baseline in blood eosinophil levels between Day 1 pre-dose and last quantifiable study measurement.

Outcome measures

Outcome measures
Measure	Mepolizumab 12.5 mg SC n=21 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=23 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Time to Maximum Change in Blood Eosinophils Levels (Tmaxeos)	50.0 Days Interval 34.6 to 65.5	49.4 Days Interval 34.0 to 64.8	47.0 Days Interval 32.0 to 62.0	58.8 Days Interval 42.0 to 75.6

PRIMARY outcome

Timeframe: Days 1, 3, 7, 28, 56, 70, 84, 112 and 140

Population: PD Population

This summarizes the number of participants who returned to at least 50% of their Baseline blood eosinophil levels after maximum inhibition had been achieved and without any subsequent decrease in blood eosinophil levels. Blood samples were collected at Days 1, 3, 7, 28, 56, 70, 84, 112 and 140.

Outcome measures

Outcome measures
Measure	Mepolizumab 12.5 mg SC n=21 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=23 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Number of Participants Who Achieved >=50% Eosinophil Repletion by Day 140	8 Participants	1 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: Days 1, 3, 7, 28, 56, 70, 84, 112 and 140

Population: Pharmacokinetic (PK) Population: all participants randomized to treatment and who received at least one dose of study treatment and who have at least one PK sample taken and analyzed. Only those participants with the blood samples available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).

AUC of mepolizumab was estimated by population modeling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Individual cumulative plasma of mepolizumab AUC to Day 84 (cumAUC(0-day 84)), is the sum of the AUCs over each dosing interval after each of the three doses administered, for those participants with data up to Day 84. Individual cumulative plasma of mepolizumab AUC to Day 140 (cumAUC(0-day 140) is the sum of the AUCs over each dosing interval after each of the three doses administered plus the AUC post the last dose interval up to Day 140 (i.e. from Day 84 to Day 140). Blood samples for PK analyses were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 hour (h), 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).

Outcome measures

Outcome measures
Measure	Mepolizumab 12.5 mg SC n=21 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=22 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Mean Area Under the Plasma-concentration Time Curve (AUC) Following SC and IV Administration of Mepolizumab AUCtau, Dose1, n=21, 15, 22, 11	523632.6 Nanogramper milliliter per hour(ng*h/mL) Interval 345804.8 to 792906.9	5091456.4 Nanogramper milliliter per hour(ng*h/mL) Interval 4115689.6 to 6298562.4	8673608.7 Nanogramper milliliter per hour(ng*h/mL) Interval 7635120.8 to 9853346.0	3986009.4 Nanogramper milliliter per hour(ng*h/mL) Interval 3254498.2 to 4881941.8
Mean Area Under the Plasma-concentration Time Curve (AUC) Following SC and IV Administration of Mepolizumab AUCtau, Dose2, n=21, 14, 22, 11	793918.1 Nanogramper milliliter per hour(ng*h/mL) Interval 516885.5 to 1219430.6	8391130.1 Nanogramper milliliter per hour(ng*h/mL) Interval 7063697.1 to 9968018.6	13077585.6 Nanogramper milliliter per hour(ng*h/mL) Interval 11596103.1 to 14748337.6	5959275.6 Nanogramper milliliter per hour(ng*h/mL) Interval 4745685.2 to 7483211.5
Mean Area Under the Plasma-concentration Time Curve (AUC) Following SC and IV Administration of Mepolizumab AUCtau, Dose3, n=20, 14, 21, 11	908573.5 Nanogramper milliliter per hour(ng*h/mL) Interval 586393.8 to 1407767.0	8837913.1 Nanogramper milliliter per hour(ng*h/mL) Interval 7139982.5 to 10939621.6	14228122.9 Nanogramper milliliter per hour(ng*h/mL) Interval 12457557.9 to 16250334.3	6714105.0 Nanogramper milliliter per hour(ng*h/mL) Interval 5270701.1 to 8552791.3

PRIMARY outcome

Timeframe: Days 1, 3, 7, 28, 56, 70, 84, 112 and 140

Population: PK Population. Only those participants with the blood samples available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).

Maximum plasma concentration was estimated by population modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).

Outcome measures

Outcome measures
Measure	Mepolizumab 12.5 mg SC n=21 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=22 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Maximum Plasma Concentration (Cmax) From Pre-dose (Day 1) to Day 140 for Mepolizumab Cmax, Dose1, n=21, 15, 22, 11	1062.053 Nanogram per milliliter (ng/mL) Interval 672.28 to 1677.807	9904.234 Nanogram per milliliter (ng/mL) Interval 8108.129 to 12098.211	16112.461 Nanogram per milliliter (ng/mL) Interval 14138.105 to 18362.533	18103.887 Nanogram per milliliter (ng/mL) Interval 15189.165 to 21577.928
Maximum Plasma Concentration (Cmax) From Pre-dose (Day 1) to Day 140 for Mepolizumab Cmax, Dose2, n=21, 14, 22, 11	1579.160 Nanogram per milliliter (ng/mL) Interval 1012.39 to 2463.228	14860.706 Nanogram per milliliter (ng/mL) Interval 12282.82 to 17979.633	24069.046 Nanogram per milliliter (ng/mL) Interval 21302.445 to 27194.952	21931.891 Nanogram per milliliter (ng/mL) Interval 18171.592 to 26470.32
Maximum Plasma Concentration (Cmax) From Pre-dose (Day 1) to Day 140 for Mepolizumab Cmax, Dose3, n=20, 14, 21, 11	1784.626 Nanogram per milliliter (ng/mL) Interval 1134.38 to 2807.605	16574.716 Nanogram per milliliter (ng/mL) Interval 13650.258 to 20125.716	27307.211 Nanogram per milliliter (ng/mL) Interval 24043.561 to 31013.866	23576.215 Nanogram per milliliter (ng/mL) Interval 19424.78 to 28614.888

PRIMARY outcome

Timeframe: Days 1, 3, 7, 28, 56, 70, 84, 112 and 140

Population: PK Population. Only those participants with the blood samples available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).

Time to maximum plasma concentration was estimated by population modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).

Outcome measures

Outcome measures
Measure	Mepolizumab 12.5 mg SC n=21 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=22 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Time to Maximum Plasma Concentration (Tmax) From Pre-dose (Day 1) to Day 140 for Mepolizumab Tmax, Dose1, n=21, 15, 22, 11	200.490 hours Interval 36.85 to 761.68	190.680 hours Interval 105.82 to 457.17	193.665 hours Interval 100.89 to 378.01	0.600 hours Interval 0.5 to 0.75
Time to Maximum Plasma Concentration (Tmax) From Pre-dose (Day 1) to Day 140 for Mepolizumab Tmax, Dose2, n=21, 14, 22, 11	157.750 hours Interval 37.5 to 503.39	148.780 hours Interval 96.0 to 319.35	153.715 hours Interval 87.29 to 263.83	0.500 hours Interval 0.33 to 0.83
Time to Maximum Plasma Concentration (Tmax) From Pre-dose (Day 1) to Day 140 for Mepolizumab Tmax, Dose3, n=20, 14, 21, 11	143.310 hours Interval 37.42 to 455.15	147.810 hours Interval 93.42 to 256.29	140.940 hours Interval 88.51 to 217.12	0.533 hours Interval 0.42 to 0.75

PRIMARY outcome

Timeframe: Days 1, 3, 7, 28, 56, 70, 84, 112 and 140

Population: PK Population

Terminal half-life (t1/2) was estimated by modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters for mepolizumab from the sparse sampling. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).

Outcome measures

Outcome measures
Measure	Mepolizumab 12.5 mg SC n=21 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=22 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Terminal Half-life (t½) From Pre-dose (Day 1) to Day 140 for Mepolizumab	21.7676 Days Interval 20.007 to 23.5283	22.0979 Days Interval 20.4834 to 23.7125	21.7561 Days Interval 20.223 to 23.2892	28.2336 Days Interval 21.1455 to 35.3218

SECONDARY outcome

Timeframe: Baseline (Day 1 pre-dose), Weeks 4, 8, 12 and 20

Population: Safety Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).

Clinical chemistry laboratory parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TB) and direct bilirubin, creatinine, chloride, uric acid, glucose, total carbondioxide (CO2), gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP) and total protein assessed at Baseline, Weeks 4, 8, 12 and 20. Laboratory abnormalities outside the normal range (high and low values) at any time post-Baseline are presented.

Outcome measures

Outcome measures
Measure	Mepolizumab 12.5 mg SC n=21 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=23 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment ALP, High, n=21, 14, 22, 11	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment ALP, Low, n=21, 14, 22, 11	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment ALT, High, n=21, 14, 22, 11	1 Participants	0 Participants	2 Participants	3 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment AST, High, n=21, 14, 22, 11	1 Participants	1 Participants	2 Participants	4 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment Albumin, High, n=21,14,22,11	0 Participants	4 Participants	1 Participants	2 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment TB, High, n=18, 14, 22, 11	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment Calcium, High, n=21, 15, 23, 11	2 Participants	3 Participants	2 Participants	3 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment Chloride, High, n=21, 14, 22, 11	6 Participants	5 Participants	6 Participants	3 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment Chloride, Low, n=21, 14, 22, 11	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment CO2 content/bicarbonate, Low, n=21, 14, 22, 11	8 Participants	4 Participants	7 Participants	6 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment Creatinine, High, n=21, 14, 22, 11	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment Creatinine, Low, n=21, 14, 22, 11	4 Participants	2 Participants	5 Participants	2 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment GGT, High, n=21, 14, 22, 11	3 Participants	0 Participants	3 Participants	6 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment Glucose, High, n=21, 15, 23, 11	5 Participants	7 Participants	5 Participants	5 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment Glucose, Low, n=21, 15, 23, 11	1 Participants	2 Participants	5 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment Potassium, Low, n=20, 14, 21, 11	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment Sodium, High, n=20, 14, 21, 11	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment Sodium, Low, n=20, 14, 21, 11	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment Total Protein, High, n=18, 14, 21, 10	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment Urea/BUN, High, n=20, 14, 21, 11	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment Urea/BUN, Low, n=20, 14, 21, 11	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment Uric acid, High, n=21, 14, 22, 11	1 Participants	2 Participants	0 Participants	3 Participants
Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment Uric acid, Low, n=21, 14, 22, 11	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Days 1, 3, 7, 28, 56, 70, 84, 112 and 140 (follow-up visit)

Population: Safety Population

Hematology laboratory parameters included platelet count, red blood cells (RBC) count, white blood cell (WBC) count, hemoglobin, hematocrit, reticulocyte count, mean corpuscle volume (MCV), mean corpuscle hemoglobin (MCH), mean corpuscle hemoglobin concentration (MCHC), neutrophils, segmented neutrophils (SN), total neutrophils (TN), lymphocytes, monocytes, eosinophils and basophils assessed at Baseline, Weeks 4, 8, 12 and 20. Hematology abnormalities outside the normal range (high and low values) at any time post-Baseline are presented.

Outcome measures

Outcome measures
Measure	Mepolizumab 12.5 mg SC n=21 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=23 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Eosinophils, High	10 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Eosinophils, Low	4 Participants	6 Participants	11 Participants	4 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Eosinophils percentage, High	12 Participants	1 Participants	3 Participants	0 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Hemoglobin, High	1 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Hemoglobin, Low	5 Participants	3 Participants	2 Participants	2 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Hematocrit, High	2 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Hematocrit, Low	5 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Lymphocytes, High	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Lymphocytes, Low	2 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Lymphocytes-percentage, High	4 Participants	5 Participants	2 Participants	3 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Lymphocytes-percentage, Low	2 Participants	0 Participants	7 Participants	3 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment MCHC, Low	6 Participants	2 Participants	4 Participants	0 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment MCH, High	3 Participants	3 Participants	2 Participants	3 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment MCH, Low	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment MCV, High	2 Participants	3 Participants	0 Participants	2 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Monocytes, High	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Monocytes, Low	7 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Monocytes percentage, High	3 Participants	3 Participants	3 Participants	0 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment SN, High	3 Participants	0 Participants	3 Participants	2 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment SN, Low	4 Participants	4 Participants	4 Participants	1 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment SN-percentage, High	6 Participants	2 Participants	8 Participants	3 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment SN-percentage, Low	5 Participants	4 Participants	1 Participants	1 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment TN, High	3 Participants	0 Participants	3 Participants	2 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment TN, Low	4 Participants	4 Participants	4 Participants	1 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment TN-percentage, High	6 Participants	2 Participants	8 Participants	3 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment TN-percentage, Low	5 Participants	4 Participants	1 Participants	1 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Platelet count, High	0 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Platelet count, Low	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment RBC, High	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment RBC, Low	6 Participants	4 Participants	2 Participants	3 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Reticulocytes count, High	4 Participants	2 Participants	9 Participants	8 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment Reticulocytes count, Low	10 Participants	3 Participants	8 Participants	0 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment WBC, High	5 Participants	1 Participants	1 Participants	3 Participants
Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment WBC, Low	2 Participants	4 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1 pre-dose) and at Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140

Population: Safety Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).

Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Baseline (pre-dose Day 1), Day 1 (30 minutes, 1 h, 2 h), Day 28 (pre-dose, 30 minutes, 1 h, 2 h), Day 56 (pre-dose, 30 minutes, 1 h, 2 h), Day 84, Day 112 and follow-up (Day 140).

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1 pre-dose) and at Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140

Population: Safety Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).

Vital sign measurements including heart rate (HR) was measured at Baseline (Pre-dose Day 1), Day 1 (30 minutes, 1 h, 2 h), Day 28 (pre-dose, 30 minutes, 1 h, 2 h), Day 56 (pre-dose, 30 minutes, 1 h, 2 h), Day 84, Day 112 and follow-up (Day 140).

Outcome measures

Outcome measures
Measure	Mepolizumab 12.5 mg SC n=21 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=23 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 HR, Day 1, 30 min, n=21,15,23,11	-2.7 beats per minute (BPM) Standard Deviation 5.35	-3.7 beats per minute (BPM) Standard Deviation 9.37	-2.1 beats per minute (BPM) Standard Deviation 7.51	1.1 beats per minute (BPM) Standard Deviation 7.08
Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 HR, Day 1,1 H, n=21,15,23,11	-3.2 beats per minute (BPM) Standard Deviation 6.69	-3.9 beats per minute (BPM) Standard Deviation 9.88	-1.9 beats per minute (BPM) Standard Deviation 7.00	1.9 beats per minute (BPM) Standard Deviation 5.89
Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 HR, Day 1, 2 H, n=21,15,23,11	-1.7 beats per minute (BPM) Standard Deviation 7.36	-3.3 beats per minute (BPM) Standard Deviation 7.22	-0.4 beats per minute (BPM) Standard Deviation 6.21	11.3 beats per minute (BPM) Standard Deviation 21.47
Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 HR, Day 28, pre-dose, n=21,14,22,11	1.6 beats per minute (BPM) Standard Deviation 10.82	-2.5 beats per minute (BPM) Standard Deviation 11.27	-0.1 beats per minute (BPM) Standard Deviation 9.80	1.1 beats per minute (BPM) Standard Deviation 8.38
Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 HR, Day 28, 30 min, n=21,14,22,11	1.8 beats per minute (BPM) Standard Deviation 7.83	-3.4 beats per minute (BPM) Standard Deviation 11.21	-2.2 beats per minute (BPM) Standard Deviation 10.35	3.2 beats per minute (BPM) Standard Deviation 11.96
Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 HR, Day 28, 1 H, n=21,14,22,11	1.3 beats per minute (BPM) Standard Deviation 10.22	-4.2 beats per minute (BPM) Standard Deviation 10.53	-2.0 beats per minute (BPM) Standard Deviation 11.54	1.9 beats per minute (BPM) Standard Deviation 11.48
Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 HR, Day 28, 2 H, n=21,14,22,11	0.1 beats per minute (BPM) Standard Deviation 7.70	-2.2 beats per minute (BPM) Standard Deviation 9.93	1.4 beats per minute (BPM) Standard Deviation 10.60	2.5 beats per minute (BPM) Standard Deviation 12.07
Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 HR, Day 56, pre-dose, n=20,14,21,11	3.8 beats per minute (BPM) Standard Deviation 11.41	-3.3 beats per minute (BPM) Standard Deviation 10.32	-0.4 beats per minute (BPM) Standard Deviation 10.13	2.5 beats per minute (BPM) Standard Deviation 8.12
Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 HR, Day 56, 30 min, n=20,14,21,11	0.3 beats per minute (BPM) Standard Deviation 10.08	-3.3 beats per minute (BPM) Standard Deviation 11.84	-1.0 beats per minute (BPM) Standard Deviation 10.85	-0.4 beats per minute (BPM) Standard Deviation 9.29
Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 HR, Day 56, 1 H, n=20,14,21,11	0.5 beats per minute (BPM) Standard Deviation 9.71	-3.4 beats per minute (BPM) Standard Deviation 12.64	0.3 beats per minute (BPM) Standard Deviation 11.01	2.0 beats per minute (BPM) Standard Deviation 8.49
Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 HR, Day 56, 2 H, n=20,14,21,11	1.7 beats per minute (BPM) Standard Deviation 10.15	-4.1 beats per minute (BPM) Standard Deviation 15.73	-0.1 beats per minute (BPM) Standard Deviation 9.83	4.5 beats per minute (BPM) Standard Deviation 15.21
Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 HR, Day 84, n=20,14,21,11	1.9 beats per minute (BPM) Standard Deviation 9.37	-0.1 beats per minute (BPM) Standard Deviation 8.10	2.6 beats per minute (BPM) Standard Deviation 10.53	4.3 beats per minute (BPM) Standard Deviation 12.11
Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 HR, Day 112, n=20,14,21,11	2.7 beats per minute (BPM) Standard Deviation 10.72	-3.3 beats per minute (BPM) Standard Deviation 12.48	2.4 beats per minute (BPM) Standard Deviation 11.97	2.5 beats per minute (BPM) Standard Deviation 8.10
Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 HR, Follow-up, n=20,14,21,11	2.4 beats per minute (BPM) Standard Deviation 10.29	-1.7 beats per minute (BPM) Standard Deviation 10.77	1.1 beats per minute (BPM) Standard Deviation 8.78	7.0 beats per minute (BPM) Standard Deviation 15.13

SECONDARY outcome

Timeframe: Day 1, Day 112 and Day 140

Population: Safety Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).

Blood samples were collected for the determination of anti-mepolizumab antibodies by antibody detection (AD) and antibody neutralisation (AN) assay. For participants who prematurely withdrew from the study and had been dosed, immunogenicity testing occurred (if possible) at the time of premature withdrawal and at 16 weeks after dosing (or the end of the study, whichever came first). Serum was tested for the presence of anti-mepolizumab antibodies using the currently approved analytical methodology incorporating screening, confirmation and titration steps. Samples confirmed positive for the presence of anti-mepolizumab antibodies in the original assay were tested for the presence of neutralizing antibodies.

Outcome measures

Outcome measures
Measure	Mepolizumab 12.5 mg SC n=21 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=23 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Number of Participants With Levels of Anti-mepolizumab Antibodies at Indicated Time Points Follow-up, AD-Positive, n=20,14,21,10	2 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Levels of Anti-mepolizumab Antibodies at Indicated Time Points Follow-up, AN-Negative, n=2,1,2,0	2 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Levels of Anti-mepolizumab Antibodies at Indicated Time Points Day 1, AD-positive, n=21,15,22,11	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Levels of Anti-mepolizumab Antibodies at Indicated Time Points Day 1, AN-Negative, n=1,1,0,0	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Levels of Anti-mepolizumab Antibodies at Indicated Time Points Day 112, AD-Positive, n=20,13,21,11	1 Participants	2 Participants	3 Participants	0 Participants
Number of Participants With Levels of Anti-mepolizumab Antibodies at Indicated Time Points Day 112, AN-Negative, n=1,2,3,0	1 Participants	2 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening (SCR) and at Day 3

Population: Safety Population

The number of participants with normal, abnormal - clinically significant (CS), and abnormal - not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), at Screening (SCR) and Day 3 are presented. Findings were determined to be normal, abnormal CS, and NCS by the investigator.

Outcome measures

Outcome measures
Measure	Mepolizumab 12.5 mg SC n=21 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=23 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 3 Day 3, Normal, n=20, 14, 22, 11	15 Participants	11 Participants	16 Participants	7 Participants
Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 3 Day 3, NCS, n=20, 14, 22, 11	5 Participants	3 Participants	6 Participants	4 Participants
Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 3 SCR, Normal, n=21, 15, 23, 11	17 Participants	12 Participants	19 Participants	6 Participants
Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 3 SCR, NCS, n=21, 15, 23, 11	4 Participants	2 Participants	4 Participants	5 Participants
Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 3 SCR, NR, n=21, 15, 23, 11	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Days 1, 3, 7, 28, 56, 70, 84, 112 and 140

Population: PK Population

Population modelling techniques using non-linear mixed effect methods were used to estimate individual and population pharmacokinetic parameters from the sparse sampling. Log-transformed individual clearance estimates were analysed using an analysis of variance (ANOVA) model. The absolute bioavailability for each SC dose group and across SC doses will be estimated from the model together with associated 90% confidence intervals. Blood samples for PK analyses were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).

Outcome measures

Outcome measures
Measure	Mepolizumab 12.5 mg SC n=21 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=22 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=58 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Mean AUC to Assess the Absolute Bioavailability of SC Mepolizumab	81.04 Percentage Interval 56.5 to 116.23	81.59 Percentage Interval 55.54 to 119.85	63.82 Percentage Interval 44.62 to 91.28	74.15 Percentage Interval 53.92 to 101.97

SECONDARY outcome

Timeframe: Days 1, 3, 7, 28, 56, 70, 84, 112 and 140

Population: PK Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).

Maximum plasma concentration was estimated by population modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Log-transformed dose-normalized (DM) Cmax were be analyzed using an analysis of variance (ANOVA) model. The ratio for each SC dose group versus IV and across SC doses versus IV will be estimated from the model together with associated 90% confidence intervals. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).

Outcome measures

Outcome measures
Measure	Mepolizumab 12.5 mg SC n=21 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=22 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=58 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Mean Dose Normalized Cmax Ratio to Assess the Relative Bioavailability of SC Mepolizumab as Compared With IV Mepolizumab DM Cmax ratio (first dose), n=21, 15, 22, 58	46.93 Percentage Interval 32.05 to 68.73	43.77 Percentage Interval 29.14 to 65.74	35.60 Percentage Interval 24.38 to 51.98	41.50 Percentage Interval 29.63 to 58.14
Mean Dose Normalized Cmax Ratio to Assess the Relative Bioavailability of SC Mepolizumab as Compared With IV Mepolizumab DM Cmax ratio (third dose), n=20, 14, 21, 55	60.56 Percentage Interval 41.8 to 87.72	56.24 Percentage Interval 37.78 to 83.72	46.33 Percentage Interval 32.08 to 66.9	53.65 Percentage Interval 38.72 to 74.34

Adverse Events

Mepolizumab 12.5 mg SC

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Mepolizumab 125 mg SC

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Mepolizumab 250 mg SC

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Mepolizumab SC Overall

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Mepolizumab 75 mg IV

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mepolizumab 12.5 mg SC n=21 participants at risk Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 participants at risk Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=23 participants at risk Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab SC Overall n=59 participants at risk Combined results for participants receiving either mepolizumab 12.5 mg, 125 mg or 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 participants at risk Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.

Other adverse events

Other adverse events
Measure	Mepolizumab 12.5 mg SC n=21 participants at risk Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 participants at risk Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=23 participants at risk Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab SC Overall n=59 participants at risk Combined results for participants receiving either mepolizumab 12.5 mg, 125 mg or 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 participants at risk Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Infections and infestations Urinary tract infection	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Infections and infestations Cystitis	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	9.1% 1/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Infections and infestations Rhinitis	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	9.1% 1/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Infections and infestations Upper respiratory tract infection	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Infections and infestations Nasopharyngitis	14.3% 3/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	6.7% 1/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	8.7% 2/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	10.2% 6/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	9.1% 1/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Infections and infestations Bronchitis	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Infections and infestations Respiratory tract infection	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
General disorders Injection site reaction	14.3% 3/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	20.0% 3/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	11.9% 7/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
General disorders Pyrexia	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	6.7% 1/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	3.4% 2/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
General disorders Asthenia	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
General disorders Chest pain	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
General disorders Irritability	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
General disorders Pain	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Asthma	19.0% 4/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	6.7% 1/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	10.2% 6/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	9.1% 1/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	9.5% 2/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	3.4% 2/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Painful respiration	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	18.2% 2/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	9.1% 1/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	9.1% 1/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Injury, poisoning and procedural complications Burn oesophageal	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	6.7% 1/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	6.7% 1/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Injury, poisoning and procedural complications Fall	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	9.1% 1/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Nervous system disorders Headache	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	8.7% 2/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	3.4% 2/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Nervous system disorders Dizziness	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Nervous system disorders Paraesthesia	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	6.7% 1/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Erythema	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Onychoclasis	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Gastrointestinal disorders Abdominal distension	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Gastrointestinal disorders Dyspepsia	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Gastrointestinal disorders Toothache	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	9.1% 1/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Investigations Heart rate increased	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	6.7% 1/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	9.1% 1/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Reproductive system and breast disorders Menorrhagia	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Cardiac disorders Palpitations	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	6.7% 1/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Eye disorders Eye pruritus	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	4.3% 1/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Psychiatric disorders Nervousness	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
Psychiatric disorders Nightmare	4.8% 1/21 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/15 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/23 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	1.7% 1/59 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.	0.00% 0/11 • Adverse events (AEs) and Serious adverse events (SAEs) were collected from the administration of the first dose of study medication and until the final follow-up contact (up to Week 20). AEs and SAEs were collected in participants of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER

Measure	Mepolizumab 12.5 mg SC n=21 Participants Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 125 mg SC n=15 Participants Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 250 mg SC n=23 Participants Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.	Mepolizumab 75 mg IV n=11 Participants Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 SBP, Day 1, 30 min, n=21,15,23,11	0.0 Millimeter of mercury (mmHg) Standard Deviation 8.30	-4.0 Millimeter of mercury (mmHg) Standard Deviation 13.32	1.0 Millimeter of mercury (mmHg) Standard Deviation 6.91	0.3 Millimeter of mercury (mmHg) Standard Deviation 5.64
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 SBP, Day 1,1 H, n=21,15,23,11	0.1 Millimeter of mercury (mmHg) Standard Deviation 9.26	-2.9 Millimeter of mercury (mmHg) Standard Deviation 13.26	1.3 Millimeter of mercury (mmHg) Standard Deviation 9.46	0.0 Millimeter of mercury (mmHg) Standard Deviation 7.80
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 SBP, Day 1, 2 H, n=21,15,23,11	0.2 Millimeter of mercury (mmHg) Standard Deviation 10.26	0.2 Millimeter of mercury (mmHg) Standard Deviation 14.31	2.0 Millimeter of mercury (mmHg) Standard Deviation 8.69	0.0 Millimeter of mercury (mmHg) Standard Deviation 8.19
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 SBP, Day 28, pre-dose, n=21,14,22,11	-2.5 Millimeter of mercury (mmHg) Standard Deviation 11.46	-7.6 Millimeter of mercury (mmHg) Standard Deviation 9.50	-0.8 Millimeter of mercury (mmHg) Standard Deviation 10.24	4.0 Millimeter of mercury (mmHg) Standard Deviation 11.58
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 SBP, Day 28, 30 min, n=21,14,22,11	1.9 Millimeter of mercury (mmHg) Standard Deviation 13.39	-9.0 Millimeter of mercury (mmHg) Standard Deviation 9.12	-0.3 Millimeter of mercury (mmHg) Standard Deviation 11.44	1.6 Millimeter of mercury (mmHg) Standard Deviation 12.59
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 SBP, Day 28, 1 H, n=21,14,22,11	-0.7 Millimeter of mercury (mmHg) Standard Deviation 12.67	-9.8 Millimeter of mercury (mmHg) Standard Deviation 10.81	-0.3 Millimeter of mercury (mmHg) Standard Deviation 11.00	1.9 Millimeter of mercury (mmHg) Standard Deviation 10.72
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 SBP, Day 28, 2 H, n=21,14,22,11	2.8 Millimeter of mercury (mmHg) Standard Deviation 12.89	-6.3 Millimeter of mercury (mmHg) Standard Deviation 12.22	0.7 Millimeter of mercury (mmHg) Standard Deviation 8.89	4.7 Millimeter of mercury (mmHg) Standard Deviation 9.82
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 SBP, Day 56, pre-dose, n=20,14,21,11	-2.0 Millimeter of mercury (mmHg) Standard Deviation 11.50	-3.7 Millimeter of mercury (mmHg) Standard Deviation 11.26	-1.0 Millimeter of mercury (mmHg) Standard Deviation 12.09	1.0 Millimeter of mercury (mmHg) Standard Deviation 10.17
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 SBP, Day 56, 30 min, n=20,14,21,11	-1.8 Millimeter of mercury (mmHg) Standard Deviation 11.93	-5.0 Millimeter of mercury (mmHg) Standard Deviation 13.11	0.3 Millimeter of mercury (mmHg) Standard Deviation 10.47	1.8 Millimeter of mercury (mmHg) Standard Deviation 9.31
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 SBP, Day 56, 1 H, n=20,14,21,11	-3.7 Millimeter of mercury (mmHg) Standard Deviation 12.58	-3.5 Millimeter of mercury (mmHg) Standard Deviation 12.38	-0.2 Millimeter of mercury (mmHg) Standard Deviation 15.04	-0.4 Millimeter of mercury (mmHg) Standard Deviation 8.29
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 SBP, Day 56, 2 H, n=20,14,21,11	0.1 Millimeter of mercury (mmHg) Standard Deviation 12.76	-5.0 Millimeter of mercury (mmHg) Standard Deviation 14.38	3.7 Millimeter of mercury (mmHg) Standard Deviation 13.54	3.5 Millimeter of mercury (mmHg) Standard Deviation 9.17
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 SBP, Day 84, n=20,14,21,11	1.6 Millimeter of mercury (mmHg) Standard Deviation 12.42	-7.9 Millimeter of mercury (mmHg) Standard Deviation 11.73	0.0 Millimeter of mercury (mmHg) Standard Deviation 10.61	0.5 Millimeter of mercury (mmHg) Standard Deviation 8.48
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 SBP, Day 112, n=20,14,21,11	0.4 Millimeter of mercury (mmHg) Standard Deviation 11.32	-1.6 Millimeter of mercury (mmHg) Standard Deviation 12.77	-1.4 Millimeter of mercury (mmHg) Standard Deviation 11.02	0.8 Millimeter of mercury (mmHg) Standard Deviation 12.80
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 SBP, Follow-up, n=20,14,21,11	2.2 Millimeter of mercury (mmHg) Standard Deviation 14.33	-0.9 Millimeter of mercury (mmHg) Standard Deviation 15.13	-1.0 Millimeter of mercury (mmHg) Standard Deviation 12.52	3.3 Millimeter of mercury (mmHg) Standard Deviation 9.45
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 DBP, Day 1, 30 min, n=21,15,23,11	-1.1 Millimeter of mercury (mmHg) Standard Deviation 5.22	-2.1 Millimeter of mercury (mmHg) Standard Deviation 11.63	-0.9 Millimeter of mercury (mmHg) Standard Deviation 7.29	-0.9 Millimeter of mercury (mmHg) Standard Deviation 6.70
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 DBP, Day 1,1 H, n=21,15,23,11	-2.0 Millimeter of mercury (mmHg) Standard Deviation 5.77	-3.3 Millimeter of mercury (mmHg) Standard Deviation 11.12	-2.1 Millimeter of mercury (mmHg) Standard Deviation 7.46	-3.7 Millimeter of mercury (mmHg) Standard Deviation 4.31
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 DBP, Day 1, 2 H, n=21,15,23,11	-0.7 Millimeter of mercury (mmHg) Standard Deviation 5.26	0.1 Millimeter of mercury (mmHg) Standard Deviation 10.27	0.3 Millimeter of mercury (mmHg) Standard Deviation 8.36	-1.6 Millimeter of mercury (mmHg) Standard Deviation 6.77
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 DBP, Day 28, pre-dose, n=21,14,22,11	-1.4 Millimeter of mercury (mmHg) Standard Deviation 9.21	-3.6 Millimeter of mercury (mmHg) Standard Deviation 8.22	-1.8 Millimeter of mercury (mmHg) Standard Deviation 9.17	-3.7 Millimeter of mercury (mmHg) Standard Deviation 14.07
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 DBP, Day 28, 30 min, n=21,14,22,11	-0.7 Millimeter of mercury (mmHg) Standard Deviation 9.25	-3.4 Millimeter of mercury (mmHg) Standard Deviation 8.43	0.0 Millimeter of mercury (mmHg) Standard Deviation 12.15	-3.6 Millimeter of mercury (mmHg) Standard Deviation 12.92
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 DBP, Day 28, 1 H, n=21,14,22,11	-4.0 Millimeter of mercury (mmHg) Standard Deviation 8.95	-4.4 Millimeter of mercury (mmHg) Standard Deviation 10.43	-3.2 Millimeter of mercury (mmHg) Standard Deviation 9.78	-3.5 Millimeter of mercury (mmHg) Standard Deviation 12.91
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 DBP, Day 28, 2 H, n=21,14,22,11	1.1 Millimeter of mercury (mmHg) Standard Deviation 8.35	-3.9 Millimeter of mercury (mmHg) Standard Deviation 10.36	-0.7 Millimeter of mercury (mmHg) Standard Deviation 9.73	-3.9 Millimeter of mercury (mmHg) Standard Deviation 13.95
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 DBP, Day 56, pre-dose, n=20,14,21,11	0.8 Millimeter of mercury (mmHg) Standard Deviation 6.24	-0.1 Millimeter of mercury (mmHg) Standard Deviation 8.19	-3.2 Millimeter of mercury (mmHg) Standard Deviation 7.57	-1.9 Millimeter of mercury (mmHg) Standard Deviation 11.47
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 DBP, Day 56, 30 min, n=20,14,21,11	-0.4 Millimeter of mercury (mmHg) Standard Deviation 8.32	-0.9 Millimeter of mercury (mmHg) Standard Deviation 11.18	-1.8 Millimeter of mercury (mmHg) Standard Deviation 7.03	-1.9 Millimeter of mercury (mmHg) Standard Deviation 12.19
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 DBP, Day 56, 1 H, n=20,14,21,11	-0.8 Millimeter of mercury (mmHg) Standard Deviation 7.37	-0.8 Millimeter of mercury (mmHg) Standard Deviation 10.87	-3.7 Millimeter of mercury (mmHg) Standard Deviation 6.34	-4.0 Millimeter of mercury (mmHg) Standard Deviation 11.37
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 DBP, Day 56, 2 H, n=20,14,21,11	2.1 Millimeter of mercury (mmHg) Standard Deviation 8.26	-0.4 Millimeter of mercury (mmHg) Standard Deviation 11.24	0.1 Millimeter of mercury (mmHg) Standard Deviation 9.65	-2.1 Millimeter of mercury (mmHg) Standard Deviation 10.30
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 DBP, Day 84, n=20,14,21,11	-0.6 Millimeter of mercury (mmHg) Standard Deviation 8.56	-2.4 Millimeter of mercury (mmHg) Standard Deviation 8.79	-1.7 Millimeter of mercury (mmHg) Standard Deviation 7.90	-1.4 Millimeter of mercury (mmHg) Standard Deviation 10.94
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 DBP, Day 112, n=20,14,21,11	0.3 Millimeter of mercury (mmHg) Standard Deviation 8.07	1.9 Millimeter of mercury (mmHg) Standard Deviation 13.20	-2.8 Millimeter of mercury (mmHg) Standard Deviation 10.65	0.8 Millimeter of mercury (mmHg) Standard Deviation 13.59
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140 DBP, Follow-up, n=20,14,21,11	1.3 Millimeter of mercury (mmHg) Standard Deviation 8.63	4.0 Millimeter of mercury (mmHg) Standard Deviation 10.86	-1.6 Millimeter of mercury (mmHg) Standard Deviation 11.38	-2.3 Millimeter of mercury (mmHg) Standard Deviation 9.74