Trial Outcomes & Findings for Efficacy, Safety, Pharmacokinetics and Pharmacodynamics Study, Assessing Multiple LNP023 Doses in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (NCT NCT03896152)

Last Updated: 2024-06-18

Results Overview

A responder was defined as a patient with at least 60% reduction in LDH compared to Baseline or LDH below the upper limit of normal at any time up to and including Week 12 for that patient.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Week 2, week 4, week 8 and week 12

Results posted on

2024-06-18

Participant Flow

Participants took part in 5 investigative sites in 4 countries

Participants underwent a screening period of up to 8 weeks

Participant milestones

Participant milestones
Measure	LNP023 25 mg Bid/100 mg Bid Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.
Overall Study STARTED	7	6
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	LNP023 25 mg Bid/100 mg Bid Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.
Overall Study Patient/guardian decision	1	1
Overall Study Adverse Event	0	1
Overall Study Physician Decision	1	0
Overall Study Technical problems	1	0

Baseline Characteristics

Efficacy, Safety, Pharmacokinetics and Pharmacodynamics Study, Assessing Multiple LNP023 Doses in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LNP023 25 mg Bid/100 mg Bid n=7 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=6 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	Total n=13 Participants Total of all reporting groups
Age, Continuous	34.4 years STANDARD_DEVIATION 15.27 • n=5 Participants	42.5 years STANDARD_DEVIATION 11.98 • n=7 Participants	38.2 years STANDARD_DEVIATION 13.93 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 2, week 4, week 8 and week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of LDH. The Pharmacodynamic (PD) analysis set is defined as patients with available PD data, who received any study drug and with no protocol deviations with relevant impact on PD data. The number analyzed per row represents the participants with a valid LDH value for that particular visit.

A responder was defined as a patient with at least 60% reduction in LDH compared to Baseline or LDH below the upper limit of normal at any time up to and including Week 12 for that patient.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=7 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=5 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Summary of Lactate Dehydrogenase (LDH) Responders Responders at week 12	7 Participants	5 Participants	—	—
Summary of Lactate Dehydrogenase (LDH) Responders Responders at week 2	6 Participants	5 Participants	—	—
Summary of Lactate Dehydrogenase (LDH) Responders Responders at week 4	7 Participants	5 Participants	—	—
Summary of Lactate Dehydrogenase (LDH) Responders Responders at week 8	7 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: Baseline, week 2, week 4, week 8 and week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of LDH. The number analyzed per row represents the participants with a valid LDH value at both baseline and that particular visit.

LDH was used as a hemolysis marker to determine the dose-response effect of iptacopan on the reduction of Paroxysmal nocturnal hemoglobinuria (PNH)-associated hemolysis. Active hemolysis is defined by an LDH value ≥ 1.5x upper limit of normal (ULN) Baseline LDH was calculated as the average of the last three screening values prior to randomization. Serum was used to calculate the LDH values

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=7 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=5 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Percent Change From Baseline in LDH Levels Week 2	-76.52 Percent change in LDH levels Standard Deviation 18.478	-84.98 Percent change in LDH levels Standard Deviation 8.186	—	—
Percent Change From Baseline in LDH Levels Week 4	-79.75 Percent change in LDH levels Standard Deviation 16.025	-89.72 Percent change in LDH levels Standard Deviation 5.430	—	—
Percent Change From Baseline in LDH Levels Week 8	-81.73 Percent change in LDH levels Standard Deviation 22.832	-88.30 Percent change in LDH levels Standard Deviation 8.744	—	—
Percent Change From Baseline in LDH Levels Week 12	-86.17 Percent change in LDH levels Standard Deviation 8.896	-85.92 Percent change in LDH levels Standard Deviation 9.013	—	—

SECONDARY outcome

Timeframe: Baseline, Week 2, week 4, week 8 and week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of hemoglobin. The number analyzed per row represents the participants with a valid hemoglobin value both baseline and that particular visit.

Hemoglobin was used as a hemolysis marker to determine the dose-response effect of iptacopan on the reduction of PNH-associated hemolysis. Whole blood was used to calculate the hemoglobin values.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=7 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=4 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Change From Baseline in Hemoglobin Week 2	6.88 g/L Standard Deviation 5.812	31.83 g/L Standard Deviation 10.362	—	—
Change From Baseline in Hemoglobin Week 4	9.61 g/L Standard Deviation 11.857	36.58 g/L Standard Deviation 17.875	—	—
Change From Baseline in Hemoglobin Week 8	15.02 g/L Standard Deviation 9.154	38.08 g/L Standard Deviation 25.956	—	—
Change From Baseline in Hemoglobin Week 12	23.36 g/L Standard Deviation 14.378	37.11 g/L Standard Deviation 26.171	—	—

SECONDARY outcome

Timeframe: Baseline, Week 2, week 4, week 8 and week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of free hemoglobin. The number analyzed per row represents the participants with a valid free hemoglobin value both at baseline and that particular visit.

Free hemoglobin was used as a hemolysis marker to determine the dose-response effect of iptacopan on the reduction of PNH-associated hemolysis. Whole blood was used to calculate the hemoglobin values.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=6 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=4 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Change From Baseline in Free Hemoglobin Week 2	-39.84 mg/dL Standard Deviation 26.521	-13.53 mg/dL Standard Deviation 5.093	—	—
Change From Baseline in Free Hemoglobin Week 4	-31.88 mg/dL Standard Deviation 35.314	-29.26 mg/dL Standard Deviation 24.218	—	—
Change From Baseline in Free Hemoglobin Week 8	-31.85 mg/dL Standard Deviation 27.517	-16.31 mg/dL Standard Deviation 48.877	—	—
Change From Baseline in Free Hemoglobin Week 12	-39.58 mg/dL Standard Deviation 31.612	-14.75 mg/dL Standard Deviation 6.293	—	—

SECONDARY outcome

Timeframe: Baseline, Week 2, week 4, week 8 and week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of carboxyhemoglobin. The number analyzed per row represents the participants with a valid carboxyhemoglobin value both at baseline and that particular visit

Carboxyhemoglobin was used as a marker of intravascular and extravascular hemolysis to assess the effect of iptacopan. Whole blood was used to calculate the carboxyhemoglobin values.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=7 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=5 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Change From Baseline in Carboxyhemoglobin Week 2	-0.01 Percentage of carboxyhemoglobin Standard Deviation 0.516	-0.72 Percentage of carboxyhemoglobin Standard Deviation 0.697	—	—
Change From Baseline in Carboxyhemoglobin Week 4	-0.36 Percentage of carboxyhemoglobin Standard Deviation 0.472	-0.98 Percentage of carboxyhemoglobin Standard Deviation 0.582	—	—
Change From Baseline in Carboxyhemoglobin Week 8	-0.50 Percentage of carboxyhemoglobin Standard Deviation 0.664	-1.12 Percentage of carboxyhemoglobin Standard Deviation 0.916	—	—
Change From Baseline in Carboxyhemoglobin Week 12	-0.95 Percentage of carboxyhemoglobin Standard Deviation 0.316	-0.78 Percentage of carboxyhemoglobin Standard Deviation 1.704	—	—

SECONDARY outcome

Timeframe: Baseline, week 2, week 4, week 8 and week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of reticulocyte count. The number analyzed per row represents the participants with a valid reticulocyte count value both at baseline and that particular visit

Reticulocyte count was used as a marker of intravascular and extravascular hemolysis to assess the effect of iptacopan. Whole blood was used to calculate the absolute reticulocyte count.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=7 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=5 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Change From Baseline in Absolute Reticulocyte Count (ARC) Week 2	-83.00 10^9 cells/L Standard Deviation 78.750	-94.23 10^9 cells/L Standard Deviation 112.649	—	—
Change From Baseline in Absolute Reticulocyte Count (ARC) Week 4	-118.44 10^9 cells/L Standard Deviation 76.736	-132.63 10^9 cells/L Standard Deviation 91.109	—	—
Change From Baseline in Absolute Reticulocyte Count (ARC) Week 8	-113.71 10^9 cells/L Standard Deviation 72.300	-119.43 10^9 cells/L Standard Deviation 117.048	—	—
Change From Baseline in Absolute Reticulocyte Count (ARC) Week 12	-93.00 10^9 cells/L Standard Deviation 93.425	-84.92 10^9 cells/L Standard Deviation 123.408	—	—

SECONDARY outcome

Timeframe: Baseline, week 2, week 4, week 8 and week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of erythrocytes. The number analyzed per row represents the participants with a valid erythrocytes value both at baseline and that particular visit.

Erythrocytes were used as a marker of intravascular and extravascular hemolysis to assess the effect of iptacopan. Whole blood was used to calculate erythrocytes values.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=7 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=5 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Red Blood Cell Count: Change From Baseline in Erythrocytes Week 2	0.49 10^12 cells/L Standard Deviation 0.194	1.02 10^12 cells/L Standard Deviation 0.407	—	—
Red Blood Cell Count: Change From Baseline in Erythrocytes Week 4	0.74 10^12 cells/L Standard Deviation 0.401	1.26 10^12 cells/L Standard Deviation 0.619	—	—
Red Blood Cell Count: Change From Baseline in Erythrocytes Week 8	1.16 10^12 cells/L Standard Deviation 0.396	1.38 10^12 cells/L Standard Deviation 0.796	—	—
Red Blood Cell Count: Change From Baseline in Erythrocytes Week 12	1.38 10^12 cells/L Standard Deviation 0.531	1.38 10^12 cells/L Standard Deviation 0.770	—	—

SECONDARY outcome

Timeframe: Baseline, week 2, week 4, week 8 and week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of C3 fragment deposition. The number analyzed per row represents the participants with a valid C3 fragment deposition value both at baseline and that particular visit.

C3 fragment deposition on paroxysmal nocturnal hemoglobinuria red blood cell (PNH RBC) was used as a marker of intravascular and extravascular hemolysis to assess the effect of iptacopan. Accumulation of C3 fragments on red blood cells make them prone to phagocytosis causing extravascular hemolysis. Whole blood was used to calculate C3 fragment deposition on PNH RBC values.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=6 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=5 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Change From Baseline in C3 Fragment Deposition on PNH RBC Week 2	-1.31 % C3 fragment deposition on PNH RBC Standard Deviation 0.932	-1.88 % C3 fragment deposition on PNH RBC Standard Deviation 1.457	—	—
Change From Baseline in C3 Fragment Deposition on PNH RBC Week 4	-1.43 % C3 fragment deposition on PNH RBC Standard Deviation 1.217	-2.74 % C3 fragment deposition on PNH RBC Standard Deviation 2.584	—	—
Change From Baseline in C3 Fragment Deposition on PNH RBC Week 8	-1.85 % C3 fragment deposition on PNH RBC Standard Deviation 1.293	-2.90 % C3 fragment deposition on PNH RBC Standard Deviation 2.654	—	—
Change From Baseline in C3 Fragment Deposition on PNH RBC Week 12	-1.65 % C3 fragment deposition on PNH RBC Standard Deviation 1.221	-2.75 % C3 fragment deposition on PNH RBC Standard Deviation 3.002	—	—

SECONDARY outcome

Timeframe: Baseline, week 2, week 4, week 8 and week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of haptoglobin. The number analyzed per row represents the participants with a valid haptoglobin value for that particular visit.

Haptoglobin levels were used as a hemolysis marker to determine the effect of iptacopan on the reduction of PNH-associated hemolysis. Serum was used to calculate haptoglobin levels.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=7 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=6 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Mean Haptoglobin Levels Baseline	0.05 g/L Standard Deviation 0.000	0.05 g/L Standard Deviation 0.000	—	—
Mean Haptoglobin Levels Week 2	0.27 g/L Standard Deviation 0.251	0.41 g/L Standard Deviation 0.499	—	—
Mean Haptoglobin Levels Week 4	0.24 g/L Standard Deviation 0.255	0.49 g/L Standard Deviation 0.490	—	—
Mean Haptoglobin Levels Week 8	0.38 g/L Standard Deviation 0.456	0.41 g/L Standard Deviation 0.374	—	—
Mean Haptoglobin Levels Week 12	0.25 g/L Standard Deviation 0.356	0.18 g/L Standard Deviation 0.225	—	—

SECONDARY outcome

Timeframe: Baseline, week 2, week 4, week 8 and week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of bilirubin. The number analyzed per row represents the participants with a valid bilirubin value both at baseline and that particular visit.

Bilirubin levels were used as a hemolysis marker to determine the effect of iptacopan on the reduction of PNH-associated hemolysis. Serum was used to calculate bilirubin levels.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=7 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=5 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Change From Baseline in Total Bilirubin Week 2	-19.81 umol/L Standard Deviation 7.855	-23.93 umol/L Standard Deviation 16.735	—	—
Change From Baseline in Total Bilirubin Week 4	-19.95 umol/L Standard Deviation 10.620	-25.93 umol/L Standard Deviation 15.992	—	—
Change From Baseline in Total Bilirubin Week 8	-20.24 umol/L Standard Deviation 12.612	-25.53 umol/L Standard Deviation 16.471	—	—
Change From Baseline in Total Bilirubin Week 12	-21.61 umol/L Standard Deviation 5.998	-23.17 umol/L Standard Deviation 18.195	—	—

SECONDARY outcome

Timeframe: Baseline, week 2, week 4, week 8 and week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of platelets count. The number analyzed per row represents the participants with a valid platelets count value for that particular visit.

Platelet counts were used as a marker of intravascular and extravascular hemolysis to assess the effect of iptacopan. Whole blood was used to calculate platelets count.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=7 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=6 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Mean Platelets Count Baseline	190.45 10^9 cells/L Standard Deviation 59.938	156.42 10^9 cells/L Standard Deviation 52.321	—	—
Mean Platelets Count Week 2	223.71 10^9 cells/L Standard Deviation 76.707	158.20 10^9 cells/L Standard Deviation 62.683	—	—
Mean Platelets Count Week 4	203.17 10^9 cells/L Standard Deviation 68.520	138.20 10^9 cells/L Standard Deviation 57.085	—	—
Mean Platelets Count Week 8	184.43 10^9 cells/L Standard Deviation 50.856	141.20 10^9 cells/L Standard Deviation 46.569	—	—
Mean Platelets Count Week 12	189.33 10^9 cells/L Standard Deviation 54.617	140.75 10^9 cells/L Standard Deviation 59.618	—	—

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8 and week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of ferritin. The number analyzed per row represents the participants with a valid ferritin value for that particular visit.

Ferritin levels were used as a marker of intravascular and extravascular hemolysis to assess the effect of iptacopan. Serum was used to calculate ferritin levels.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=7 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=6 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Mean Ferritin Levels Baseline	176.97 ug/L Standard Deviation 404.254	258.90 ug/L Standard Deviation 418.114	—	—
Mean Ferritin Levels Week 4	174.21 ug/L Standard Deviation 431.042	287.88 ug/L Standard Deviation 517.901	—	—
Mean Ferritin Levels Week 8	178.31 ug/L Standard Deviation 443.346	304.74 ug/L Standard Deviation 521.535	—	—
Mean Ferritin Levels Week 12	203.22 ug/L Standard Deviation 454.296	320.40 ug/L Standard Deviation 526.783	—	—

SECONDARY outcome

Timeframe: Baseline, week 2, week 4, week 8 and week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of clone size. The number analyzed per row represents the participants with a valid clone size value for that particular visit.

PNH clone size was used as a marker of intravascular and extravascular hemolysis to assess the effect of iptacopan. Whole blood was used to calculate clone size values.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=7 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=6 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Mean Clone Size Week 2	54.95 Percentage of PNH Red Blood Cells Standard Deviation 12.943	65.65 Percentage of PNH Red Blood Cells Standard Deviation 29.279	—	—
Mean Clone Size Week 4	65.88 Percentage of PNH Red Blood Cells Standard Deviation 12.907	73.74 Percentage of PNH Red Blood Cells Standard Deviation 24.616	—	—
Mean Clone Size Week 8	79.62 Percentage of PNH Red Blood Cells Standard Deviation 14.308	85.06 Percentage of PNH Red Blood Cells Standard Deviation 16.381	—	—
Mean Clone Size Week 12	82.87 Percentage of PNH Red Blood Cells Standard Deviation 11.903	91.08 Percentage of PNH Red Blood Cells Standard Deviation 7.842	—	—
Mean Clone Size Baseline	33.63 Percentage of PNH Red Blood Cells Standard Deviation 18.149	49.13 Percentage of PNH Red Blood Cells Standard Deviation 29.701	—	—

SECONDARY outcome

Timeframe: Day 29 and 57

Population: The overall number of participants analyzed represents the participants in the PK analysis set who had at least one valid measurement of Cmax. The Pharmacokinetic (PK) analysis set is defined as patients with at least one available valid PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data. The number analyzed per row represents the participants with a valid Cmax value for that particular visit.

Cmax is the maximum (peak) observed plasma drug concentration after single dose administration (mass x volume-1). PK parameters were determined, using non-compartmental method(s) with Phoenix WinNonlin (Version 8.3), from the plasma concentration-time data.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=6 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=5 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid n=6 Participants treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid n=5 Participants Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Pharmacokinetics Profile: Maximum Plasma Concentration (Cmax) Day 29	1240 ng/mL Standard Deviation 372	1800 ng/mL Standard Deviation 368	—	—
Pharmacokinetics Profile: Maximum Plasma Concentration (Cmax) Day 57	—	—	2640 ng/mL Standard Deviation 590	4520 ng/mL Standard Deviation 1520

SECONDARY outcome

Timeframe: Days 29 and 57

Population: The overall number of participants analyzed represents the participants in the PK analysis set who had at least one valid measurement of AUCtau. The number analyzed per row represents the participants with a valid AUCtau value for that particular visit.

The AUCtau is the area under the plasma concentration-time curve calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1). AUCtau was estimated by imputing the 12-hour iptacopan plasma concentration as the PK profile's corresponding pre-dose (0-hour) value, that is, by assuming that at steady-state the iptacopan plasma concentration is the same as the beginning (pre-dose) and end (12 hours postdose) of the dosing interval. PK parameters were determined, using non-compartmental method(s) with Phoenix WinNonlin (Version 8.3), from the plasma concentration-time data.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=6 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=5 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid n=6 Participants treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid n=5 Participants Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Pharmacokinetics Profile: Area Under the Curve Tau (AUCtau) Day 29	9630 h*ng/mL Standard Deviation 3870	15200 h*ng/mL Standard Deviation 2390	—	—
Pharmacokinetics Profile: Area Under the Curve Tau (AUCtau) Day 57	—	—	19800 h*ng/mL Standard Deviation 4900	33300 h*ng/mL Standard Deviation 8830

SECONDARY outcome

Timeframe: Days 29 and 57

Population: The overall number of participants analyzed represents the participants in the PK analysis set who had at least one valid measurement of Cmin. The number analyzed per row represents the participants with a valid Cmin value for that particular visit.

Cmin is the lowest plasma concentration observed during a dosing interval at steady state \[mass / volume\]. PK parameters were determined, using non-compartmental method(s) with Phoenix WinNonlin (Version 8.3), from the plasma concentration-time data.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=6 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=5 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid n=6 Participants treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid n=5 Participants Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Pharmacokinetics Profile: Minimum Plasma Concentration (Cmin) Day 29	520 ng/mL Standard Deviation 299	809 ng/mL Standard Deviation 239	—	—
Pharmacokinetics Profile: Minimum Plasma Concentration (Cmin) Day 57	—	—	931 ng/mL Standard Deviation 460	1510 ng/mL Standard Deviation 416

SECONDARY outcome

Timeframe: Days 29 and 57

Population: The overall number of participants analyzed represents the participants in the PK analysis set who had at least one valid measurement of Tmax. The number analyzed per row represents the participants with a valid Tmax value for that particular visit.

Tmax is the time to reach maximum (peak) plasma drug concentration after single dose administration (time). PK parameters were determined, using non-compartmental method(s) with Phoenix WinNonlin (Version 8.3), from the plasma concentration-time data.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=6 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=5 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid n=6 Participants treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid n=5 Participants Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Pharmacokinetics Profile: Time to Reach Maximum Plasma Concentration (Tmax) Day 29	1.50 hours Interval 1.0 to 4.0	2.00 hours Interval 1.0 to 2.0	—	—
Pharmacokinetics Profile: Time to Reach Maximum Plasma Concentration (Tmax) Day 57	—	—	1.53 hours Interval 0.83 to 2.0	2.00 hours Interval 1.0 to 4.13

SECONDARY outcome

Timeframe: Baseline, week 2, week 4, week 8 and week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of fibrinogen. The number analyzed per row represents the participants with a valid fibrinogen value for that particular visit.

Fibrinogen level was used as a marker associated with risk of thrombosis. Plasma was used to calculate fibrinogen levels.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=7 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=6 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Mean Fibrinogen Levels Baseline	3.44 g/L Standard Deviation 0.851	3.50 g/L Standard Deviation 1.178	—	—
Mean Fibrinogen Levels Week 2	3.27 g/L Standard Deviation 0.935	2.93 g/L Standard Deviation 0.445	—	—
Mean Fibrinogen Levels Week 4	2.80 g/L Standard Deviation 0.338	2.78 g/L Standard Deviation 0.566	—	—
Mean Fibrinogen Levels Week 8	2.77 g/L Standard Deviation 0.399	3.19 g/L Standard Deviation 0.531	—	—
Mean Fibrinogen Levels Week 12	2.94 g/L Standard Deviation 0.802	3.09 g/L Standard Deviation 0.699	—	—

SECONDARY outcome

Timeframe: Baseline, week 2, week 4, week 8 and week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of prothrombin time. The number analyzed per row represents the participants with a valid prothrombin time value for that particular visit.

Prothrombin time was used as a marker associated with risk of thrombosis. Plasma was used to calculate prothrombin time.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=7 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=6 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Mean Prothrombin Time (PT) Week 8	10.66 seconds Standard Deviation 0.665	10.98 seconds Standard Deviation 1.678	—	—
Mean Prothrombin Time (PT) Baseline	10.04 seconds Standard Deviation 0.474	9.84 seconds Standard Deviation 0.210	—	—
Mean Prothrombin Time (PT) Week 2	10.51 seconds Standard Deviation 0.426	10.18 seconds Standard Deviation 0.179	—	—
Mean Prothrombin Time (PT) Week 4	10.29 seconds Standard Deviation 0.593	10.22 seconds Standard Deviation 0.311	—	—
Mean Prothrombin Time (PT) Week 12	10.33 seconds Standard Deviation 0.501	10.13 seconds Standard Deviation 0.359	—	—

SECONDARY outcome

Timeframe: Baseline, week 2, week 4, week 8 and week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of aPTT. The number analyzed per row represents the participants with a valid aPTT value for that particular visit.

Activated partial thromboplastin time was used as a marker associated with risk of thrombosis. Plasma was used to calculate activated partial thromboplastin time.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=7 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=6 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Mean Activated Partial Thromboplastin Time (aPTT) Baseline	23.63 seconds Standard Deviation 2.280	23.32 seconds Standard Deviation 2.470	—	—
Mean Activated Partial Thromboplastin Time (aPTT) Week 2	25.83 seconds Standard Deviation 2.039	25.66 seconds Standard Deviation 1.454	—	—
Mean Activated Partial Thromboplastin Time (aPTT) Week 4	26.10 seconds Standard Deviation 2.156	26.46 seconds Standard Deviation 1.802	—	—
Mean Activated Partial Thromboplastin Time (aPTT) Week 8	27.04 seconds Standard Deviation 2.914	26.84 seconds Standard Deviation 3.389	—	—
Mean Activated Partial Thromboplastin Time (aPTT) Week 12	26.48 seconds Standard Deviation 3.396	24.95 seconds Standard Deviation 1.279	—	—

SECONDARY outcome

Timeframe: Baseline, week 2, week 4, week 8 and week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of D-dimer. The number analyzed per row represents the participants with a valid D-dimer value for that particular visit.

D-dimer levels were used as a marker associated with risk of thrombosis. Plasma was used to calculate D-dimer levels.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=7 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=6 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Mean D-dimer Levels Baseline	0.39 mg fibrinogen-equivalent unit (FEU)/L Standard Deviation 0.236	0.84 mg fibrinogen-equivalent unit (FEU)/L Standard Deviation 0.345	—	—
Mean D-dimer Levels Week 2	0.32 mg fibrinogen-equivalent unit (FEU)/L Standard Deviation 0.230	0.49 mg fibrinogen-equivalent unit (FEU)/L Standard Deviation 0.189	—	—
Mean D-dimer Levels Week 4	0.29 mg fibrinogen-equivalent unit (FEU)/L Standard Deviation 0.199	0.43 mg fibrinogen-equivalent unit (FEU)/L Standard Deviation 0.172	—	—
Mean D-dimer Levels Week 8	0.24 mg fibrinogen-equivalent unit (FEU)/L Standard Deviation 0.225	0.36 mg fibrinogen-equivalent unit (FEU)/L Standard Deviation 0.215	—	—
Mean D-dimer Levels Week 12	0.25 mg fibrinogen-equivalent unit (FEU)/L Standard Deviation 0.184	0.31 mg fibrinogen-equivalent unit (FEU)/L Standard Deviation 0.147	—	—

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8 and Week 12

Population: The overall number of participants analyzed represents the participants in the PD analysis set who had at least one valid measurement of thrombin clotting time. The number analyzed per row represents the participants with a valid thrombin clotting time value for that particular visit.

thrombin clotting time was used as a marker associated with risk of thrombosis. Plasma was used to calculate thrombin clotting time.

Outcome measures

Outcome measures
Measure	LNP023 25 mg Bid/100 mg Bid n=7 Participants Four weeks of treatment with iptacopan 25 mg bid in Period 1 followed by treatment with 100 mg bid in Period 2 and Period 3.	LNP023 50 mg Bid/200 mg Bid n=6 Participants Four weeks of treatment with iptacopan 50 mg bid in Period 1 followed by treatment with 200 mg bid in Period 2 and Period 3.	LNP023 100 mg Bid treatment with iptacopan 100 mg bid in Period 2 and Period 3.	LNP023 200 mg Bid Treatment with iptacopan 200 mg bid in Period 2 and Period 3.
Mean Thrombin Clotting Time Baseline	14.77 seconds Standard Deviation 1.994	14.83 seconds Standard Deviation 0.916	—	—
Mean Thrombin Clotting Time Week 4	14.93 seconds Standard Deviation 0.642	15.58 seconds Standard Deviation 1.293	—	—
Mean Thrombin Clotting Time Week 8	14.90 seconds Standard Deviation 0.624	15.48 seconds Standard Deviation 0.923	—	—
Mean Thrombin Clotting Time Week 12	16.08 seconds Standard Deviation 1.530	15.35 seconds Standard Deviation 0.526	—	—

Adverse Events

LNP023 25mg Bid - Period 1

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

LNP023 50mg Bid - Period 1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

LNP023 100mg Bid - Period 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

LNP023 200mg Bid - Period 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

LNP023 100mg Bid - Period 3

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

LNP023 200mg Bid - Period 3

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	LNP023 25mg Bid - Period 1 n=7 participants at risk Four weeks of treatment with iptacopan 25 mg bid in Period 1	LNP023 50mg Bid - Period 1 n=6 participants at risk Four weeks of treatment with iptacopan 50 mg bid in Period 1	LNP023 100mg Bid - Period 2 n=7 participants at risk Eight weeks of treatment with iptacopan 100 mg bid in Period 2	LNP023 200mg Bid - Period 2 n=5 participants at risk Eight weeks of treatment with iptacopan 200 mg bid in Period 2	LNP023 100mg Bid - Period 3 n=7 participants at risk Two years of Extension Treatment with iptacopan 100 mg bid in Period 3	LNP023 200mg Bid - Period 3 n=5 participants at risk Two years of Extension Treatment with iptacopan 200 mg bid in Period 3
Gastrointestinal disorders Dry mouth	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Gastrointestinal disorders Dyspepsia	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Gastrointestinal disorders Enterocolitis	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	20.0% 1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Gastrointestinal disorders Flatulence	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Blood and lymphatic system disorders Breakthrough haemolysis	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	20.0% 1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Blood and lymphatic system disorders Haemolysis	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Blood and lymphatic system disorders Neutropenia	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Ear and labyrinth disorders Vertigo	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	20.0% 1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Endocrine disorders Autoimmune thyroiditis	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Endocrine disorders Hypothyroidism	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	28.6% 2/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Gastrointestinal disorders Abdominal distension	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	28.6% 2/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Gastrointestinal disorders Nausea	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
General disorders Pain	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
General disorders Pyrexia	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	28.6% 2/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	20.0% 1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Infections and infestations COVID-19	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	20.0% 1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Infections and infestations Gastroenteritis	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	20.0% 1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Infections and infestations Nasopharyngitis	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	20.0% 1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Infections and infestations Upper respiratory tract infection	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	28.6% 2/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Infections and infestations Urinary tract infection	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Investigations Alanine aminotransferase increased	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	20.0% 1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Investigations Antinuclear antibody increased	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Investigations Blood alkaline phosphatase increased	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	16.7% 1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	20.0% 1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Investigations Blood creatinine increased	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Investigations Blood luteinising hormone increased	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Investigations Blood uric acid increased	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Investigations Blood urine present	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Investigations Gamma-glutamyltransferase increased	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	20.0% 1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Investigations Haematocrit increased	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Investigations Haemoglobin increased	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Investigations Reverse tri-iodothyronine increased	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Investigations Thyroxine free increased	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Metabolism and nutrition disorders Gout	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Metabolism and nutrition disorders Impaired fasting glucose	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	20.0% 1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	20.0% 1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Nervous system disorders Headache	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	50.0% 3/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	20.0% 1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Renal and urinary disorders Chromaturia	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Renal and urinary disorders Haematuria	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Renal and urinary disorders Nocturia	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Respiratory, thoracic and mediastinal disorders Cough	28.6% 2/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	20.0% 1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.
Skin and subcutaneous tissue disorders Rash	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	14.3% 1/7 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.	0.00% 0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 7 days post treatment, up to a maximum duration of 115 weeks. AEs are reported by period.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER