Trial Outcomes & Findings for Dose Escalation Study of MLN0128 in Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid Malignancies (NCT NCT01351350)

NCT ID: NCT01351350

Last Updated: 2019-08-08

Results Overview

MTD is the highest dose level at which the participants tolerate treatment without dose-limiting toxicities during the first cycle (28 days) of therapy.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 68 participants
• Primary outcome timeframe: Cycle 1: Days 1 to 28
• Results posted on: 2019-08-08

Participant Flow

Participants took part in the study at three investigative sites in the United States from 28 February 2011 to 15 Sep 2017.

Participants with advanced solid malignancies enrolled in the dose escalation phase to establish MTD: MLN0128 6,7,8,9,10 mg QDx3d QW, 7mg QDx5d QW or 30, 40 mg QW. The expansion phase enrolled participants in either A: HER2- cancer participants, MLN0128 at MTD+paclitaxel or B: HER2+ cancer participants, MLN0128 at MTD+paclitaxel+trastuzumab.

Participant milestones

Measure	MLN0128P 30 or 40 mg QW MLN0128 and paclitaxel (MLN0128P): MLN0128 30 or 40 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 15.3 weeks).	MLN0128P 6, 7, 8, 9 or 10 mg QD×3d QW MLN0128 and paclitaxel (MLN0128P): MLN0128 6 , 7, 8, 9 or 10 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up to 87.4 weeks).	MLN0128P 7 mg QD×5d QW MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).	Expansion Cohort MLN0128P 8 mg QD×3d QW HER2- MLN0128 and paclitaxel (MLN0128P): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in human epidermal growth factor receptor 2 negative (HER-) cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 61.6 weeks).	Expansion Cohort MLN0128PH 8mg QD×3d QW HER2+ Plus Trastuzumab MLN0128 + paclitaxel + trastuzumab (MLN0128PH): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 plus trastuzumab 4 mg/kg loading dose on Day 1 followed by 2 mg/kg, intravenous each week of a 4-week cycle in HER+ cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 23.4 weeks).
Overall Study STARTED	8	29	11	13	7
Overall Study Treated	8	29	10	13	7
Overall Study Dose-escalation Evaluable	7	23	10	0	0
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	8	29	11	13	7

Reasons for withdrawal

Measure	MLN0128P 30 or 40 mg QW MLN0128 and paclitaxel (MLN0128P): MLN0128 30 or 40 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 15.3 weeks).	MLN0128P 6, 7, 8, 9 or 10 mg QD×3d QW MLN0128 and paclitaxel (MLN0128P): MLN0128 6 , 7, 8, 9 or 10 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up to 87.4 weeks).	MLN0128P 7 mg QD×5d QW MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).	Expansion Cohort MLN0128P 8 mg QD×3d QW HER2- MLN0128 and paclitaxel (MLN0128P): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in human epidermal growth factor receptor 2 negative (HER-) cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 61.6 weeks).	Expansion Cohort MLN0128PH 8mg QD×3d QW HER2+ Plus Trastuzumab MLN0128 + paclitaxel + trastuzumab (MLN0128PH): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 plus trastuzumab 4 mg/kg loading dose on Day 1 followed by 2 mg/kg, intravenous each week of a 4-week cycle in HER+ cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 23.4 weeks).
Overall Study Disease Progression	5	13	6	8	5
Overall Study Adverse Event	1	10	1	2	0
Overall Study Participant Decision	2	6	3	3	2
Overall Study Enrolled but not Treated	0	0	1	0	0

Baseline Characteristics

Dose Escalation Study of MLN0128 in Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid Malignancies

Baseline characteristics by cohort

Measure	MLN0128P 30 or 40 mg QW n=8 Participants MLN0128 and paclitaxel (MLN0128P): MLN0128 30 or 40 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 15.3 weeks).	MLN0128P 6, 7, 8, 9 or 10 mg QD×3d QW n=29 Participants MLN0128 and paclitaxel (MLN0128P): MLN0128 6 , 7, 8, 9 or 10 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up to 87.4 weeks).	MLN0128P 7 mg QD×5d QW n=10 Participants MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).	Expansion Cohort MLN0128P 8 mg QD×3d QW HER2- n=13 Participants MLN0128 and paclitaxel (MLN0128P): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in human epidermal growth factor receptor 2 negative (HER-) cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 61.6 weeks).	Expansion Cohort MLN0128PH 8mg QDx3d QW HER2+ Plus Trastuzumab n=7 Participants MLN0128 + paclitaxel + trastuzumab (MLN0128PH): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 plus trastuzumab 4 mg/kg loading dose on Day 1 followed by 2 mg/kg, intravenous each week of a 4-week cycle in HER+ cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 23.4 weeks).	Total n=67 Participants Total of all reporting groups
Age, Continuous	57.3 years STANDARD_DEVIATION 14.34 • n=5 Participants	62.9 years STANDARD_DEVIATION 9.57 • n=7 Participants	58.1 years STANDARD_DEVIATION 14.70 • n=5 Participants	54.2 years STANDARD_DEVIATION 14.46 • n=4 Participants	58.1 years STANDARD_DEVIATION 8.03 • n=21 Participants	59.3 years STANDARD_DEVIATION 12.07 • n=10 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	14 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	38 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	15 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	1 Participants n=21 Participants	29 Participants n=10 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	8 Participants n=5 Participants	28 Participants n=7 Participants	10 Participants n=5 Participants	12 Participants n=4 Participants	6 Participants n=21 Participants	64 Participants n=10 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants	27 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	7 Participants n=21 Participants	62 Participants n=10 Participants
Region of Enrollment United States	8 Participants n=5 Participants	29 Participants n=7 Participants	10 Participants n=5 Participants	13 Participants n=4 Participants	7 Participants n=21 Participants	67 Participants n=10 Participants

PRIMARY outcome

Timeframe: Cycle 1: Days 1 to 28

Population: Safety Population included all participants who received at least one dose of study drug.

MTD is the highest dose level at which the participants tolerate treatment without dose-limiting toxicities during the first cycle (28 days) of therapy.

Outcome measures

Measure	Dose Escalation n=40 Participants Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\^2) on Days 1, 8, and 15 of Cycle 1.	MLN0128P 40 mg QW MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 6 mg QD×3d QW MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×3d QW MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 8 mg QD×3d QW MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 9 mg QD×3d QW MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 10 mg QD×3d QW MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×5d QW MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
Dose Escalation Phase: Maximum Tolerated Dose (MTD)	8 mg (QD×3d QW)	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1: Days 1 to 28

Population: Dose-Escalation evaluable population included participants who received ≥ 75% of planned doses of MLN0128 in Cycle 1 or stopped study drug before receiving 75% of doses because of study drug-related AEs (considered as DLT).

DLT was defined as any of the following occurring during Cycle 1 (Days 1-28) and attributable to MLN0128P: Grade ≥ 3 nonhematologic toxicity; Grade 3 thrombocytopenia with hemorrhage; Grade 4 neutropenia lasting > 7 days in the absence of growth factor support; Grade 4 neutropenia of any duration associated with fever 38.5 degrees C and/or infection; Any other Grade 4 hematologic toxicity; Inability to administer at least 75 % of doses of MLN0128 within Cycle 1 due to drug-related toxicity; Any clinically significant occurrence which the investigators and sponsor agree would place participants at undue safety risk; Participants who experienced an adverse event (AE) that met the definition for a DLT.

Outcome measures

Measure	Dose Escalation n=5 Participants Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\^2) on Days 1, 8, and 15 of Cycle 1.	MLN0128P 40 mg QW n=2 Participants MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 6 mg QD×3d QW n=3 Participants MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×3d QW n=3 Participants MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 8 mg QD×3d QW n=3 Participants MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 9 mg QD×3d QW n=5 Participants MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 10 mg QD×3d QW n=9 Participants MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×5d QW n=10 Participants MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
Dose Escalation Phase: Number of Participants With at Least 1 Dose Limiting Toxicity (DLT)	0 participants	2 participants	0 participants	0 participants	0 participants	2 participants	2 participants	2 participants

PRIMARY outcome

Timeframe: At screening and thereafter every 2 cycles of treatment until disease progression (Up to 65.8 weeks)

Population: Full Analysis Set (FAS) included all participants who received 1 or more doses of MLN0128 and have adequate baseline and post-baseline data collected.

ORR was defined as the percentage of participants with Complete Response (CR) and Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Each cycle was a 28 day cycle. CR was defined as the disappearance of all target lesions and for non-target lesions, the disappearance of all non-target lesions and normalization of tumor marker level. PR was defined of at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD and for non-target lesions.

Outcome measures

Measure	Dose Escalation n=8 Participants Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\^2) on Days 1, 8, and 15 of Cycle 1.	MLN0128P 40 mg QW n=22 Participants MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 6 mg QD×3d QW n=9 Participants MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×3d QW n=10 Participants MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 8 mg QD×3d QW n=5 Participants MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 9 mg QD×3d QW MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 10 mg QD×3d QW MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×5d QW MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
Objective Response Rate (ORR)	0 percentage of participants	9 percentage of participants	44 percentage of participants	10 percentage of participants	20 percentage of participants	—	—	—

PRIMARY outcome

Timeframe: First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks)

Population: All Subjects as Treated (ASaT) population consisted of all enrolled participants who received at least 1 dose of MLN0128, was used in the safety analyses.

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

Outcome measures

Measure	Dose Escalation n=8 Participants Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\^2) on Days 1, 8, and 15 of Cycle 1.	MLN0128P 40 mg QW n=29 Participants MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 6 mg QD×3d QW n=10 Participants MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×3d QW n=13 Participants MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 8 mg QD×3d QW n=7 Participants MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 9 mg QD×3d QW MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 10 mg QD×3d QW MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×5d QW MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events(SAEs), AEs Resulting in Discontinuation of MLN0128 and Fatal AEs Within 30 Days of Last Dose of Study Drug TEAE	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants	—	—	—
Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events(SAEs), AEs Resulting in Discontinuation of MLN0128 and Fatal AEs Within 30 Days of Last Dose of Study Drug SAE	63 percentage of participants	41 percentage of participants	60 percentage of participants	31 percentage of participants	43 percentage of participants	—	—	—
Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events(SAEs), AEs Resulting in Discontinuation of MLN0128 and Fatal AEs Within 30 Days of Last Dose of Study Drug Fatal AEs within 30 Days of Last Dose Study Drug	25 percentage of participants	7 percentage of participants	20 percentage of participants	15 percentage of participants	14 percentage of participants	—	—	—
Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events(SAEs), AEs Resulting in Discontinuation of MLN0128 and Fatal AEs Within 30 Days of Last Dose of Study Drug AEs Resulting in Discontinuation of MLN0128	13 percentage of participants	34 percentage of participants	10 percentage of participants	15 percentage of participants	0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Cycles 1 and 2: Day 1 or 2

Population: Pharmacokinetic (PK) population included all participants enrolled during Dose Escalation phase, received at least 1 dose of MLN0128 and had sufficient concentration-time data to calculate PK parameters, with data available for Cmax. Here, number analyzed is the number of participants with data available for analysis at the given time-point.

Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i e, C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms.

Outcome measures

Measure	Dose Escalation n=6 Participants Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\^2) on Days 1, 8, and 15 of Cycle 1.	MLN0128P 40 mg QW n=2 Participants MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 6 mg QD×3d QW n=3 Participants MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×3d QW n=4 Participants MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 8 mg QD×3d QW n=3 Participants MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 9 mg QD×3d QW n=6 Participants MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 10 mg QD×3d QW n=13 Participants MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×5d QW n=10 Participants MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
Cmax: Maximum Observed Plasma Concentration for MLN0128 Cycle 2	242.2 ng/mL Interval 105.0 to 356.0	107.0 ng/mL Interval 107.0 to 107.0	33.8 ng/mL Interval 14.7 to 58.7	45.5 ng/mL Interval 40.4 to 50.5	53.1 ng/mL Interval 46.0 to 57.2	23.0 ng/mL Interval 10.8 to 36.6	80.1 ng/mL Interval 21.0 to 166.0	45.3 ng/mL Interval 11.6 to 79.5
Cmax: Maximum Observed Plasma Concentration for MLN0128 Cycle 1	245.0 ng/mL Interval 136.0 to 456.0	345.5 ng/mL Interval 306.0 to 385.0	26.7 ng/mL Interval 19.1 to 40.3	31.1 ng/mL Interval 20.4 to 52.4	41.8 ng/mL Interval 19.8 to 79.7	34.2 ng/mL Interval 23.9 to 47.1	100.0 ng/mL Interval 57.5 to 162.0	53.5 ng/mL Interval 26.7 to 101.0

SECONDARY outcome

Timeframe: Cycles 1 and 2: Day 1 or 2

Population: Due to the change in planned analysis, minimum plasma concentration data was not collected.

Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i e, C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycles 1 and 2: Day 1 or 2

Population: PK population included all participants enrolled during Dose Escalation phase, received at least 1 dose of MLN0128 and had sufficient concentration-time data to calculate PK parameters, with data available for Tmax. Here, number analyzed is the number of participants with data available for analysis at the given time-point.

Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i.e., C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms.

Outcome measures

Measure	Dose Escalation n=6 Participants Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\^2) on Days 1, 8, and 15 of Cycle 1.	MLN0128P 40 mg QW n=2 Participants MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 6 mg QD×3d QW n=3 Participants MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×3d QW n=4 Participants MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 8 mg QD×3d QW n=3 Participants MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 9 mg QD×3d QW n=6 Participants MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 10 mg QD×3d QW n=13 Participants MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×5d QW n=10 Participants MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0128 Cycle 1	3.0 hours Interval 0.5 to 5.92	3.0 hours Interval 2.0 to 4.0	2.0 hours Interval 2.0 to 3.83	3.0 hours Interval 1.03 to 4.08	5.6 hours Interval 1.02 to 5.65	4.1 hours Interval 3.67 to 6.0	1.0 hours Interval 0.53 to 2.17	1.6 hours Interval 0.65 to 5.53
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0128 Cycle 2	2.0 hours Interval 1.87 to 3.9	4.0 hours Interval 4.0 to 4.0	4.0 hours Interval 2.0 to 4.02	2.0 hours Interval 1.97 to 2.0	1.0 hours Interval 0.92 to 4.0	5.5 hours Interval 2.0 to 6.0	2.0 hours Interval 1.0 to 5.75	2.7 hours Interval 0.5 to 5.72

SECONDARY outcome

Timeframe: Cycle 1 Day 1

Population: PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of MLN0128 and had sufficient concentration-time data to calculate 1 or more PK parameters. T1/2 data is only available for 2 participants in the MLN0128P 6 mg QD×3d QW and 2 participants in the MLN0128P 7 mg QD×3d QW arm.

Outcome measures

Measure	Dose Escalation n=2 Participants Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\^2) on Days 1, 8, and 15 of Cycle 1.	MLN0128P 40 mg QW n=2 Participants MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 6 mg QD×3d QW MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×3d QW MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 8 mg QD×3d QW MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 9 mg QD×3d QW MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 10 mg QD×3d QW MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×5d QW MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
Terminal Phase Elimination Half-life (T1/2) for MLN0128	6.6 hours Interval 6.36 to 6.91	7.2 hours Interval 7.03 to 7.3	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1

Population: PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of MLN0128 and had sufficient concentration-time data to calculate 1 or more PK parameters. AUC∞ data is only available for 2 participants in each the MLN0128P 6 mg QD×3d QW and MLN0128P 7 mg QD×3d QW arms.

Outcome measures

Measure	Dose Escalation n=2 Participants Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\^2) on Days 1, 8, and 15 of Cycle 1.	MLN0128P 40 mg QW n=2 Participants MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 6 mg QD×3d QW MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×3d QW MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 8 mg QD×3d QW MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 9 mg QD×3d QW MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 10 mg QD×3d QW MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×5d QW MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN0128	206.5 ng*hr/mL Interval 183.0 to 230.0	286.0 ng*hr/mL Interval 269.0 to 303.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycles 1 and 2: Day 1 or 2

Population: PK population included all participants enrolled during Dose Escalation phase, received at least 1 dose of MLN0128 and had sufficient concentration-time data to calculate PK parameters. Here, number analyzed is the number of participants with data available for analysis at the given time-point.

Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i e, C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 30 and 40 mg QW arms.

Outcome measures

Measure	Dose Escalation n=6 Participants Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\^2) on Days 1, 8, and 15 of Cycle 1.	MLN0128P 40 mg QW n=2 Participants MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 6 mg QD×3d QW n=3 Participants MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×3d QW n=4 Participants MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 8 mg QD×3d QW n=3 Participants MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 9 mg QD×3d QW n=6 Participants MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 10 mg QD×3d QW n=13 Participants MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×5d QW MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
AUC(0-6): Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours for MLN0128 Cycle 1	753.7 ng*hr/mL Interval 428.0 to 1290.0	1325.0 ng*hr/mL Interval 1210.0 to 1440.0	104.4 ng*hr/mL Interval 73.7 to 146.0	121.7 ng*hr/mL Interval 82.7 to 187.0	139.9 ng*hr/mL Interval 58.0 to 282.0	146.2 ng*hr/mL Interval 99.2 to 229.0	347.0 ng*hr/mL Interval 203.0 to 505.0	—
AUC(0-6): Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours for MLN0128 Cycle 2	883.6 ng*hr/mL Interval 464.0 to 1340.0	505.0 ng*hr/mL Interval 505.0 to 505.0	106.8 ng*hr/mL Interval 55.5 to 165.0	174.0 ng*hr/mL Interval 162.0 to 186.0	210.3 ng*hr/mL Interval 143.0 to 253.0	72.6 ng*hr/mL Interval 28.1 to 144.0	283.9 ng*hr/mL Interval 65.6 to 660.0	—

SECONDARY outcome

Timeframe: Cycles 1 and 2: Day 1

Population: PK population included all participants enrolled during Dose Escalation phase, received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate PK parameters, with data available for Cmax. Here, number analyzed is the number of participants with data available for analysis at the given time-point.

Outcome measures

Measure	Dose Escalation n=5 Participants Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\^2) on Days 1, 8, and 15 of Cycle 1.	MLN0128P 40 mg QW n=2 Participants MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 6 mg QD×3d QW n=3 Participants MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×3d QW n=4 Participants MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 8 mg QD×3d QW n=3 Participants MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 9 mg QD×3d QW n=6 Participants MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 10 mg QD×3d QW n=13 Participants MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×5d QW n=10 Participants MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
Cmax: Maximum Observed Plasma Concentration for Paclitaxel Cycle 1, Day 1	2538.0 ng/mL Interval 1090.0 to 3220.0	2355.0 ng/mL Interval 2210.0 to 2500.0	1933.3 ng/mL Interval 1280.0 to 3170.0	1942.5 ng/mL Interval 1540.0 to 2420.0	1620.0 ng/mL Interval 1290.0 to 1990.0	3798.3 ng/mL Interval 1270.0 to 11100.0	2906.9 ng/mL Interval 2090.0 to 4020.0	1637.7 ng/mL Interval 410.0 to 2770.0
Cmax: Maximum Observed Plasma Concentration for Paclitaxel Cycle 2, Day 1	3462.5 ng/mL Interval 2300.0 to 4210.0	1500.0 ng/mL Interval 1500.0 to 1500.0	1200.3 ng/mL Interval 421.0 to 2090.0	1550.0 ng/mL Interval 1550.0 to 1550.0	3103.3 ng/mL Interval 1440.0 to 4890.0	1602.3 ng/mL Interval 597.0 to 2350.0	2964.0 ng/mL Interval 1560.0 to 4070.0	1765.7 ng/mL Interval 654.0 to 2670.0

SECONDARY outcome

Timeframe: Cycles 1 and 2: Day 1 or 2

Population: Due to the change in planned analysis, minimum plasma concentration data was not collected.

Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i e, C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycles 1 and 2: Day 1

Population: PK population consisted of all participants enrolled during Dose Escalation phase of study who received at least 1 dose of MLN0128 or paclitaxel and had sufficient concentration-time data to calculate PK parameters for either compound. Here, number analyzed is the number of participants with data available for analysis at the given time-point.

Outcome measures

Measure	Dose Escalation n=5 Participants Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\^2) on Days 1, 8, and 15 of Cycle 1.	MLN0128P 40 mg QW n=2 Participants MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 6 mg QD×3d QW n=3 Participants MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×3d QW n=4 Participants MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 8 mg QD×3d QW n=3 Participants MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 9 mg QD×3d QW n=6 Participants MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 10 mg QD×3d QW n=13 Participants MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×5d QW n=10 Participants MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Paclitaxel Cycle 1, Day 1	1.1 hours Interval 1.02 to 1.17	1.1 hours Interval 1.03 to 1.17	1.1 hours Interval 1.0 to 1.15	1.2 hours Interval 0.87 to 1.55	1.2 hours Interval 1.08 to 1.62	1.1 hours Interval 1.0 to 2.22	1.1 hours Interval 0.52 to 1.87	1.5 hours Interval 1.0 to 1.88
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Paclitaxel Cycle 2, Day 1	1.1 hours Interval 1.0 to 1.47	1.2 hours Interval 1.2 to 1.2	1.6 hours Interval 1.0 to 1.6	1.4 hours Interval 1.2 to 1.5	1.2 hours Interval 1.07 to 1.75	1.2 hours Interval 1.08 to 1.83	1.0 hours Interval 0.95 to 1.17	1.1 hours Interval 1.02 to 1.55

SECONDARY outcome

Timeframe: Cycle 1 Day 1

Population: PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters. T1/2 data is only available for participants in the MLN0128P 6,7,9 and 10 mg QD×3d QW arms.

Outcome measures

Measure	Dose Escalation n=2 Participants Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\^2) on Days 1, 8, and 15 of Cycle 1.	MLN0128P 40 mg QW n=3 Participants MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 6 mg QD×3d QW n=5 Participants MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×3d QW n=2 Participants MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 8 mg QD×3d QW MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 9 mg QD×3d QW MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 10 mg QD×3d QW MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×5d QW MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
Terminal Phase Elimination Half-life (T1/2) for Paclitaxel	10.0 hours Interval 9.93 to 10.0	9.1 hours Interval 8.83 to 9.48	9.6 hours Interval 8.19 to 11.6	9.3 hours Interval 9.1 to 9.53	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1

Population: PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters. AUC∞ data is only available for participants in the MLN0128P 6,7,9 and 10 mg QD×3d QW arms.

Outcome measures

Measure	Dose Escalation n=2 Participants Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\^2) on Days 1, 8, and 15 of Cycle 1.	MLN0128P 40 mg QW n=3 Participants MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 6 mg QD×3d QW n=5 Participants MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×3d QW n=2 Participants MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 8 mg QD×3d QW MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 9 mg QD×3d QW MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 10 mg QD×3d QW MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×5d QW MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Paclitaxel	4590.0 ng*hr/mL Interval 3440.0 to 5740.0	4790.0 ng*hr/mL Interval 4040.0 to 6270.0	5002.0 ng*hr/mL Interval 2910.0 to 6330.0	5485.0 ng*hr/mL Interval 4550.0 to 6420.0	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1

Population: Participants from the PK population, all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters, with data available for analyses.

Outcome measures

Measure	Dose Escalation n=6 Participants Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\^2) on Days 1, 8, and 15 of Cycle 1.	MLN0128P 40 mg QW n=2 Participants MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 6 mg QD×3d QW n=3 Participants MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×3d QW n=4 Participants MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 8 mg QD×3d QW n=3 Participants MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 9 mg QD×3d QW n=6 Participants MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 10 mg QD×3d QW n=13 Participants MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×5d QW n=10 Participants MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
AUC(0-6): Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours for Paclitaxel	3198.3 ng*hr/mL Interval 1560.0 to 4140.0	3515.0 ng*hr/mL Interval 2930.0 to 4100.0	2620.0 ng*hr/mL Interval 1800.0 to 3970.0	3157.5 ng*hr/mL Interval 2810.0 to 3550.0	2683.3 ng*hr/mL Interval 1820.0 to 3630.0	5315.0 ng*hr/mL Interval 1880.0 to 15100.0	3683.8 ng*hr/mL Interval 2600.0 to 5330.0	2657.0 ng*hr/mL Interval 1140.0 to 5350.0

SECONDARY outcome

Timeframe: Cycle 1 Day 1

Population: PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters. AUC0-24 data is only available for participants in the MLN0128P 6,7,9 and 10 mg QD×3d QW arms.

Outcome measures

Measure	Dose Escalation n=3 Participants Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\^2) on Days 1, 8, and 15 of Cycle 1.	MLN0128P 40 mg QW n=4 Participants MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 6 mg QD×3d QW n=6 Participants MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×3d QW n=2 Participants MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 8 mg QD×3d QW MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 9 mg QD×3d QW MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 10 mg QD×3d QW MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×5d QW MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
AUC(0-24): Area Under the Plasma Concentration-time Curve Extrapolated to 24 Hours for Paclitaxel	3583.3 ng*hr/mL Interval 2510.0 to 5160.0	4332.5 ng*hr/mL Interval 3670.0 to 5510.0	6415.0 ng*hr/mL Interval 2550.0 to 15900.0	5135.0 ng*hr/mL Interval 4290.0 to 5980.0	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1

Population: PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters. CL data is only available for participants in the MLN0128P 6,7,9 and 10 mg QD×3d QW arms.

Outcome measures

Measure	Dose Escalation n=2 Participants Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\^2) on Days 1, 8, and 15 of Cycle 1.	MLN0128P 40 mg QW n=3 Participants MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 6 mg QD×3d QW n=5 Participants MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×3d QW n=2 Participants MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 8 mg QD×3d QW MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 9 mg QD×3d QW MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 10 mg QD×3d QW MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×5d QW MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
CL: Total Clearance Calculated Using the Observed Value of the Last Quantifiable Concentration for Paclitaxel	36.2 L/hr Interval 24.7 to 47.7	34.8 L/hr Interval 22.3 to 45.3	31.2 L/hr Interval 22.3 to 48.2	25.8 L/hr Interval 19.3 to 32.3	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1

Population: PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters. Vss data is only available for participants in the MLN0128P 6,7,9 and 10 mg QD×3d QW arms.

Outcome measures

Measure	Dose Escalation n=2 Participants Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\^2) on Days 1, 8, and 15 of Cycle 1.	MLN0128P 40 mg QW n=3 Participants MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 6 mg QD×3d QW n=5 Participants MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×3d QW n=2 Participants MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 8 mg QD×3d QW MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 9 mg QD×3d QW MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 10 mg QD×3d QW MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.	MLN0128P 7 mg QD×5d QW MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).
Vss: Volume of Distribution at Steady State Calculated Using the Observed Value of the Last Quantifiable Concentration for Paclitaxel	313.5 L Interval 189.0 to 438.0	262.0 L Interval 219.0 to 306.0	252.2 L Interval 149.0 to 441.0	150.0 L Interval 120.0 to 180.0	—	—	—	—

Adverse Events

MLN0128P 30 or 40 mg QW

Serious events: 5 serious events

Other events: 8 other events

Deaths: 2 deaths

MLN0128P 6, 7, 8, 9 or 10 mg QD×3d QW

Serious events: 12 serious events

Other events: 29 other events

Deaths: 2 deaths

MLN0128P 7 mg QD×5d QW

Serious events: 6 serious events

Other events: 10 other events

Deaths: 2 deaths

Expansion Cohort MLN0128P 8 mg QD×3d QW HER2-

Serious events: 4 serious events

Other events: 13 other events

Deaths: 2 deaths

Expansion Cohort MLN0128PH 8mg QD×3d QW HER2+ Plus Trastuzumab

Serious events: 3 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Measure	MLN0128P 30 or 40 mg QW n=8 participants at risk MLN0128 and paclitaxel (MLN0128P): MLN0128 30 or 40 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 15.3 weeks).	MLN0128P 6, 7, 8, 9 or 10 mg QD×3d QW n=29 participants at risk MLN0128 and paclitaxel (MLN0128P): MLN0128 6 , 7, 8, 9 or 10 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up to 87.4 weeks).	MLN0128P 7 mg QD×5d QW n=10 participants at risk MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).	Expansion Cohort MLN0128P 8 mg QD×3d QW HER2- n=13 participants at risk MLN0128 and paclitaxel (MLN0128P): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in human epidermal growth factor receptor 2 negative (HER-) cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 61.6 weeks).	Expansion Cohort MLN0128PH 8mg QD×3d QW HER2+ Plus Trastuzumab n=7 participants at risk MLN0128 + paclitaxel + trastuzumab (MLN0128PH): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 plus trastuzumab 4 mg/kg loading dose on Day 1 followed by 2 mg/kg, intravenous each week of a 4-week cycle in HER+ cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 23.4 weeks).
Gastrointestinal disorders Oesophageal ulcer	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Vomiting	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Stomatitis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Diverticular perforation	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Haematemesis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Pneumonia	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	20.0% 2/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Sepsis	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Device related infection	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Gastroenteritis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Urinary tract infection	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Progression	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Cerebrovascular accident	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Psychiatric disorders Confusional state	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Vascular disorders Embolism	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Vascular disorders Deep vein thrombosis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.3% 3/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
General disorders Fatigue	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
General disorders Non-cardiac chest pain	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Tracheal obstruction extrinsic	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Cardiac disorders Myocardial infarction	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Renal and urinary disorders Haematuria	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Blood and lymphatic system disorders Neutropenia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Injury, poisoning and procedural complications Wound	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
General disorders Disease Progression	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.

Other adverse events

Measure	MLN0128P 30 or 40 mg QW n=8 participants at risk MLN0128 and paclitaxel (MLN0128P): MLN0128 30 or 40 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 15.3 weeks).	MLN0128P 6, 7, 8, 9 or 10 mg QD×3d QW n=29 participants at risk MLN0128 and paclitaxel (MLN0128P): MLN0128 6 , 7, 8, 9 or 10 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up to 87.4 weeks).	MLN0128P 7 mg QD×5d QW n=10 participants at risk MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).	Expansion Cohort MLN0128P 8 mg QD×3d QW HER2- n=13 participants at risk MLN0128 and paclitaxel (MLN0128P): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in human epidermal growth factor receptor 2 negative (HER-) cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 61.6 weeks).	Expansion Cohort MLN0128PH 8mg QD×3d QW HER2+ Plus Trastuzumab n=7 participants at risk MLN0128 + paclitaxel + trastuzumab (MLN0128PH): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 plus trastuzumab 4 mg/kg loading dose on Day 1 followed by 2 mg/kg, intravenous each week of a 4-week cycle in HER+ cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 23.4 weeks).
General disorders Pyrexia	25.0% 2/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	13.8% 4/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	23.1% 3/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Metabolism and nutrition disorders Hyperglycaemia	62.5% 5/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	48.3% 14/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.0% 3/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	23.1% 3/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	57.1% 4/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Metabolism and nutrition disorders Hypokalaemia	37.5% 3/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	27.6% 8/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.0% 3/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.8% 4/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Metabolism and nutrition disorders Decreased appetite	25.0% 2/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	41.4% 12/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	70.0% 7/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.8% 4/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	57.1% 4/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Metabolism and nutrition disorders Hypomagnesaemia	25.0% 2/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Metabolism and nutrition disorders Hypophosphataemia	25.0% 2/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	24.1% 7/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.0% 3/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Metabolism and nutrition disorders Hyperammonaemia	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Metabolism and nutrition disorders Hypoalbuminaemia	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Metabolism and nutrition disorders Hypocalcaemia	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Metabolism and nutrition disorders Hypophagia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Metabolism and nutrition disorders Fluid overload	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Metabolism and nutrition disorders Hypoglycaemia	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Nausea	50.0% 4/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	62.1% 18/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	60.0% 6/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	46.2% 6/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	85.7% 6/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Constipation	37.5% 3/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	13.8% 4/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	20.0% 2/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	42.9% 3/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Dry mouth	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.3% 3/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Oesophagitis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.3% 3/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	38.5% 5/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Gastrooesophageal reflux disease	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	28.6% 2/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Dyspepsia	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	20.0% 2/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	42.9% 3/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Gastritis	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Oral pain	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Retching	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Mouth ulceration	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Sensitivity of teeth	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Dysphagia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Haematochezia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Hyperchlorhydria	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Lip swelling	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Oesophageal obstruction	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Blood and lymphatic system disorders Anaemia	50.0% 4/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	41.4% 12/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.0% 3/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.8% 4/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	28.6% 2/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Blood and lymphatic system disorders Leukopenia	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.3% 3/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	20.0% 2/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Blood and lymphatic system disorders Thrombocytopenia	37.5% 3/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.0% 3/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	28.6% 2/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.0% 2/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	20.7% 6/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	17.2% 5/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.8% 4/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	13.8% 4/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Hypoxia	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Respiratory tract infection	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Dyspnoea paroxysmal nocturnal	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Pharyngeal lesion	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Alopecia	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	13.8% 4/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.0% 3/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.8% 4/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Rash	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	13.8% 4/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.0% 3/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	38.5% 5/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Rash maculo-papular	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	13.8% 4/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	42.9% 3/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.3% 3/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Pruritus	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	20.0% 2/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.8% 4/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Hyperhidrosis	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Swelling face	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Nail bed tenderness	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Hirsutism	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
General disorders Asthenia	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	37.9% 11/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	40.0% 4/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.8% 4/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	28.6% 2/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
General disorders Oedema peripheral	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.3% 3/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	20.0% 2/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
General disorders Chills	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
General disorders Pain	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	20.0% 2/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
General disorders Feeling jittery	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
General disorders Puncture site haemorrhage	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Dizziness	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	24.1% 7/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.8% 4/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	28.6% 2/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Peripheral sensory neuropathy	25.0% 2/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	17.2% 5/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	23.1% 3/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	28.6% 2/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Dysgeusia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	13.8% 4/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Headache	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	13.8% 4/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	23.1% 3/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Neuropathy peripheral	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	38.5% 5/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Syncope	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Dysarthria	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Tremor	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	28.6% 2/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Peripheral motor neuropathy	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Hyperaesthesia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Paraesthesia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Restless legs syndrome	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Somnolence	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Amnesia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Aphasia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Hemiparesis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Oral candidiasis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Sinusitis	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	20.0% 2/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Pharyngitis streptococcal	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Respiratory tract infection	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Herpes zoster	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Conjunctivitis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Folliculitis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Gastroenteritis viral	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Pharyngitis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Tooth infection	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Abscess neck	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Bronchitis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Catheter site cellulitis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Hordeolum	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Influenza	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Labyrinthitis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Laryngitis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Rhinitis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Skin infection	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Tooth abscess	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Weight decreased	25.0% 2/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	20.7% 6/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	38.5% 5/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	28.6% 2/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Blood alkaline phosphatase increased	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Blood creatinine increased	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.0% 3/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Low density lipoprotein increased	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations White blood cell count decreased	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations White blood cells urine positive	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Blood triglycerides increased	25.0% 2/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Blood bilirubin increased	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations High density lipoprotein decreased	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Protein total decreased	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Aspartate aminotransferase increased	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Blood cholosterol increased	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Blood chloride decreased	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Blood lactate dehydrogenase increased	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Alanine aminotransferase increased	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Blood chloride increased	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Blood urea increased	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Carbon dioxide increased	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Electrocardiogram abnormal	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations International normalised ratio increased	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Prothrombin time prolonged	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Vascular disorders Flushing	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	13.8% 4/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	20.0% 2/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Vascular disorders Hypotension	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	13.8% 4/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Vascular disorders Orthostatic hypotension	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Vascular disorders Hot flush	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Vascular disorders Hypertension	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	13.8% 4/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.8% 4/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Musculoskeletal and connective tissue disorders Back pain	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Musculoskeletal and connective tissue disorders Neck pain	25.0% 2/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Musculoskeletal and connective tissue disorders Pain in jaw	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	25.0% 2/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Musculoskeletal and connective tissue disorders Muscle tightness	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Renal and urinary disorders Dysuria	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Renal and urinary disorders Pollakiuria	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Renal and urinary disorders Proteinuria	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Renal and urinary disorders Nephrolithiasis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Renal and urinary disorders Urine odour abnormal	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Cardiac disorders Tachycardia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Cardiac disorders Angina pectoris	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Eye disorders Vision blurred	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Eye disorders Visual impairment	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Eye disorders Dry eye	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Eye disorders Orbital Oedema	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Eye disorders Photophobia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Injury, poisoning and procedural complications Fall	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Injury, poisoning and procedural complications Contusion	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Injury, poisoning and procedural complications Corneal abrasion	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Injury, poisoning and procedural complications Arhropod bite	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Psychiatric disorders Anxiety	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	28.6% 2/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Psychiatric disorders Insomnia	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	20.0% 2/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	28.6% 2/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Psychiatric disorders Claustrophobia	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Psychiatric disorders Adjustment disorder with depressed mood	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Psychiatric disorders Depression	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	28.6% 2/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Psychiatric disorders Sleep disorder	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Ear and labyrinth disorders Hypoacusis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Ear and labyrinth disorders Ear pain	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Ear and labyrinth disorders Tinnitus	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Ear and labyrinth disorders Vertigo	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Immune system disorders Hypersensitivity	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Diarrhoea	37.5% 3/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	51.7% 15/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	60.0% 6/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	53.8% 7/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	57.1% 4/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Vomiting	62.5% 5/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	34.5% 10/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.0% 3/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	53.8% 7/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	85.7% 6/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Stomatitis	25.0% 2/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	44.8% 13/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	40.0% 4/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	38.5% 5/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	42.9% 3/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Haemorrhoids	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Metabolism and nutrition disorders Dehydration	50.0% 4/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	41.4% 12/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	20.0% 2/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	23.1% 3/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
General disorders Fatigue	50.0% 4/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	65.5% 19/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	80.0% 8/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	69.2% 9/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	57.1% 4/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
General disorders Non-cardiac chest pain	25.0% 2/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
General disorders Peripheral swelling	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
General disorders Chest discomfort	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
General disorders Chest pain	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
General disorders Oedema	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Blood and lymphatic system disorders Neutropenia	25.0% 2/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	27.6% 8/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	40.0% 4/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	23.1% 3/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Urinary tract infection	37.5% 3/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	17.2% 5/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	40.0% 4/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	30.8% 4/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	28.6% 2/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Sepsis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	6.9% 2/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Pneumonia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Paranasal Sinus discomfort	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Pleural effusion	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Facial paralysis	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Migraine	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Nervous system disorders Visual field defect	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Weight increased	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Psychiatric disorders Confusional state	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.3% 3/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Renal and urinary disorders Haematuria	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	13.8% 4/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	15.4% 2/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Renal and urinary disorders Acute kidney injury	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	3.4% 1/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Vascular disorders Superior vena cava occlusion	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Injury, poisoning and procedural complications Burn oral cavity	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Eye disorders Photopsia	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Infections and infestations Gastrointestinal viral infection	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Investigations Blood cholesterol increased	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	10.0% 1/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Injury, poisoning and procedural complications Arthropod bite	12.5% 1/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Endocrine disorders Cushingoid	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	14.3% 1/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Endocrine disorders Hypothyroidism	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/8 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/29 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/10 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	7.7% 1/13 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.	0.00% 0/7 • First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. According to the protocol analysis planned, data was collected as per the dosing schedule.

Additional Information

Medical Director, Clinical Science

Takeda

Phone: +1-866-835-2233

Email: trialdisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
• Publication restrictions are in place

Restriction type: OTHER