Trial Outcomes & Findings for Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (NCT NCT01619085)

NCT ID: NCT01619085

Last Updated: 2022-03-25

Results Overview

This is the measure for percentage of patients with adverse events (AEs) observed during the trial. The incidence of adverse events (% of patients) over the course of the trial, including the incidence of serious AEs, AEs leading to discontinuation, and fatal AEs are presented.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 752 participants
• Primary outcome timeframe: From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days.
• Results posted on: 2022-03-25

Participant Flow

This was a prospective, open-label extension trial in which patients with Idiopathic pulmonary fibrosis (IPF), who had completed 52 weeks of treatment and the follow-up period in the randomised, double-blind, placebo-controlled parent trials 1199.32(NCT01335464)/.34(NCT01335477) and who needed access to nintedanib outside of the discontinued parent trials 1199.35(NCT01170065)/.187(NCT01979952).

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Measure	Total (1199.32/.34/.35/.187) For patients participated in parent trials 1199.32/.34 (both were randomized, placebo-controlled): patients were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study. For patients participated in parent trials 1199.35/.187 (1199.35: open label; 1199.187: randomized placebo-control): patients were to receive the same daily dosage of soft gelatin capsules of nintedanib (orally) as in the parent trials (100 mg bid or 150 mg bid) in this study. In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.
Overall Study STARTED	752
Overall Study Treated	751
Overall Study COMPLETED	227
Overall Study NOT COMPLETED	525

Reasons for withdrawal

Measure	Total (1199.32/.34/.35/.187) For patients participated in parent trials 1199.32/.34 (both were randomized, placebo-controlled): patients were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study. For patients participated in parent trials 1199.35/.187 (1199.35: open label; 1199.187: randomized placebo-control): patients were to receive the same daily dosage of soft gelatin capsules of nintedanib (orally) as in the parent trials (100 mg bid or 150 mg bid) in this study. In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.
Overall Study Adverse Event	231
Overall Study Protocol Violation	4
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	45
Overall Study Other than specified	96
Overall Study Not treated	1
Overall Study Death	145

Baseline Characteristics

Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

Baseline characteristics by cohort

Measure	Total (1199.32/.34) n=734 Participants This group included patients originated from parent trials 1199.32/.34. For patients participated in parent trials 1199.32/.34, they were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study. In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.
Age, Continuous	67.2 Years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	147 Participants n=5 Participants
Sex: Female, Male Male	587 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	214 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	431 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	86 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days.

Population: Treated set (TS): The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 parent trials.

This is the measure for percentage of patients with adverse events (AEs) observed during the trial. The incidence of adverse events (% of patients) over the course of the trial, including the incidence of serious AEs, AEs leading to discontinuation, and fatal AEs are presented.

Outcome measures

Measure	Total (1199.32/.34) n=734 Participants This group included patients originated from parent trials 1199.32/.34. For patients participated in parent trials 1199.32/.34, they were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study. In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.
Incidence of Adverse Events (AEs) Serious AEs	68.9 Percentage of patients (%)
Incidence of Adverse Events (AEs) Any AEs	98.5 Percentage of patients (%)
Incidence of Adverse Events (AEs) AEs leading to discontinuation of trial drug	42.6 Percentage of patients (%)
Incidence of Adverse Events (AEs) Fatal AEs	23.8 Percentage of patients (%)

Adverse Events

Total (1199.32/.34)

Serious events: 509 serious events

Other events: 671 other events

Deaths: 182 deaths

Placebo (1199.32/.34)

Serious events: 208 serious events

Other events: 281 other events

Deaths: 78 deaths

Nintedanib 150 Bid (1199.32/.34)

Serious events: 301 serious events

Other events: 390 other events

Deaths: 104 deaths

Placebo (1199.187)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Nintedanib 100 Bid (1199.35)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Nintedanib 150 Bid (1199.35/.187)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Total (1199.35/.187)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Total (1199.32/.34/.35/.187)

Serious events: 510 serious events

Other events: 677 other events

Deaths: 182 deaths

Serious adverse events

Measure	Total (1199.32/.34) n=734 participants at risk This group included patients originated from parent trials 1199.32/.34. For patients participated in parent trials 1199.32/.34, they were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study. In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.	Placebo (1199.32/.34) n=304 participants at risk Patients in this group are those who were randomized to placebo arm in parent trials 1199.32/.34 and were treated with 100 milligrams or 150 milligrams of nintedanib orally twice daily in this study.	Nintedanib 150 Bid (1199.32/.34) n=430 participants at risk Patients in this group are those who were randomized to 150 milligrams nintedanib twice daily (bid) arm in the parent trials 1199.32/.34 and were treated with 100 milligrams or 150 milligrams of nintedanib orally twice daily in this study.	Placebo (1199.187) n=7 participants at risk Patients in this group are those who were randomized to placebo arm in parent trial 1199.187 and were treated with 150 milligrams or 100 milligrams of nintedanib twice daily in this study.	Nintedanib 100 Bid (1199.35) n=2 participants at risk Patients in this group are those who were participated in the parent trial 1199.35 and were treated with 100 milligrams of nintedanib twice daily (bid) in this study.	Nintedanib 150 Bid (1199.35/.187) n=8 participants at risk Patients in this group are those who were treated with 150 milligrams (mg) of nintedanib twice daily (bid) in this study and were participated in parent trial 1199.35 plus those who were randomized to 150 mg nintedanib bid arm in the parent trial 1199.187 and were treated with 150 mg or 100 mg nintedanib bid in this study.	Total (1199.35/.187) n=17 participants at risk This group included patients originated from parent trials 1199.35/.187. For patients participated in parent trials 1199.35/.187, they were to receive the same daily dosage of soft gelatin capsules of nintedanib (orally) as in the parent trials (100 milligrams (mg) twice daily (bid) or 150 mg bid) in this study. In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.	Total (1199.32/.34/.35/.187) n=751 participants at risk For patients participated in parent trials 1199.32/.34 (both were randomized, placebo-controlled): patients were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study. For patients participated in parent trials 1199.35/.187 (1199.35: open label; 1199.187: randomized placebo-control): patients were to receive the same daily dosage of soft gelatin capsules of nintedanib (orally) as in the parent trials (100 mg bid or 150 mg bid) in this study. In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.
Cardiac disorders Myocarditis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Acute coronary syndrome	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Acute myocardial infarction	0.82% 6/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.2% 5/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.80% 6/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Angina pectoris	0.68% 5/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.99% 3/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.67% 5/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Angina unstable	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Arrhythmia	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Arteriosclerosis coronary artery	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Atrial fibrillation	1.2% 9/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	2.0% 6/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.2% 9/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Inguinal hernia	0.54% 4/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.3% 4/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.53% 4/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Atrial flutter	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Atrioventricular block complete	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Bradycardia	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Cardiac arrest	0.54% 4/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.99% 3/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.53% 4/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Cardiac failure	1.6% 12/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	2.0% 6/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.4% 6/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.6% 12/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Cardiac failure acute	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Cardiac failure congestive	0.95% 7/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.4% 6/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.93% 7/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Cardio-respiratory arrest	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Cardiogenic shock	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Cardiomyopathy	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Conduction disorder	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Cor pulmonale	1.1% 8/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.6% 7/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.1% 8/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Cor pulmonale chronic	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Coronary artery disease	1.2% 9/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.6% 7/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.2% 9/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Coronary artery occlusion	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Coronary artery stenosis	0.82% 6/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.93% 4/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.80% 6/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Mitral valve incompetence	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Myocardial infarction	0.54% 4/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.53% 4/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Myocardial ischaemia	0.68% 5/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.99% 3/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.67% 5/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Right ventricular failure	0.68% 5/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.99% 3/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.67% 5/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Tachycardia	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.99% 3/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Congenital, familial and genetic disorders Porokeratosis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Gait disturbance	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Ear and labyrinth disorders Deafness	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Ear and labyrinth disorders Deafness unilateral	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Ear and labyrinth disorders Sudden hearing loss	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Ear and labyrinth disorders Vestibular disorder	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Endocrine disorders Thyroid mass	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Pulmonary tuberculosis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Eye disorders Amaurosis fugax	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Eye disorders Retinal vein occlusion	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Eye disorders Blindness transient	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Eye disorders Cataract	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Eye disorders Dry age-related macular degeneration	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Eye disorders Glaucoma	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Eye disorders Optic ischaemic neuropathy	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Eye disorders Panophthalmitis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Eye disorders Periorbital fat herniation	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Eye disorders Posterior capsule opacification	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Eye disorders Retinal artery occlusion	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Eye disorders Retinal detachment	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Eye disorders Vision blurred	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Abdominal pain	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.99% 3/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Abdominal pain upper	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Anal fistula	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Anal haemorrhage	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Ascites	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Colitis	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Constipation	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Diarrhoea	1.4% 10/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.6% 5/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.2% 5/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.3% 10/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Duodenal ulcer	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Dyspepsia	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Dysphagia	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Enteritis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Enterocolitis	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Erosive oesophagitis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Gastritis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.54% 4/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.53% 4/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Haematochezia	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Haemorrhoids	0.54% 4/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.53% 4/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Ileus	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Inguinal hernia, obstructive	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Intestinal obstruction	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Large intestine perforation	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Nausea	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Obstruction gastric	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Pancreatic pseudocyst	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Pancreatitis	0.54% 4/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.53% 4/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Pancreatitis acute	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Pancreatitis necrotising	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Protein-losing gastroenteropathy	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Rectal haemorrhage	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Small intestinal obstruction	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Vomiting	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Asthenia	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Chest discomfort	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Chest pain	1.5% 11/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.99% 3/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.9% 8/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.5% 11/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Complication associated with device	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Condition aggravated	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Death	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Disease progression	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders General physical health deterioration	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Malaise	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Multiple organ dysfunction syndrome	0.54% 4/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.53% 4/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Oedema peripheral	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Pyrexia	0.54% 4/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.53% 4/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Sudden death	0.68% 5/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.93% 4/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.67% 5/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Hepatobiliary disorders Bile duct stone	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Hepatobiliary disorders Biliary colic	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Hepatobiliary disorders Biliary dyskinesia	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Hepatobiliary disorders Cholangitis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Hepatobiliary disorders Cholecystitis	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Hepatobiliary disorders Cholecystitis acute	0.82% 6/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.3% 4/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.80% 6/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Hepatobiliary disorders Cholelithiasis	1.2% 9/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.3% 4/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.2% 5/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	12.5% 1/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.9% 1/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.3% 10/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Hepatobiliary disorders Drug-induced liver injury	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Hepatobiliary disorders Hepatic cirrhosis	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Hepatobiliary disorders Hepatic function abnormal	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Hepatobiliary disorders Hepatitis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Hepatobiliary disorders Hepatocellular injury	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Hepatobiliary disorders Liver disorder	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Hepatobiliary disorders Liver injury	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Hepatobiliary disorders Non-alcoholic steatohepatitis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Bacteraemia	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Biliary sepsis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Bronchitis	1.6% 12/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	2.3% 10/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.6% 12/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Bronchitis bacterial	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Bronchopulmonary aspergillosis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Cellulitis	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Cholecystitis infective	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Diverticulitis	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Enteritis infectious	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Gastroenteritis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Gastroenteritis viral	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Hepatitis A	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Herpes simplex encephalitis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Herpes zoster	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Infected cyst	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Influenza	0.95% 7/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.3% 4/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.93% 7/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Intervertebral discitis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Lower respiratory tract infection	1.2% 9/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.3% 4/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.2% 5/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.2% 9/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Oral fungal infection	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Paraspinal abscess	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Peritonitis	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Pleural infection	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Pneumocystis jirovecii pneumonia	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Pneumonia	13.5% 99/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	13.2% 40/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	13.7% 59/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	13.2% 99/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Pneumonia bacterial	0.68% 5/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.93% 4/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.67% 5/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Pneumonia influenzal	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Postoperative abscess	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Pulmonary mycosis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Pulmonary sepsis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Pyelonephritis	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Respiratory syncytial virus infection	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Respiratory tract infection	1.8% 13/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	2.6% 8/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.2% 5/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.7% 13/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Metabolism and nutrition disorders Malnutrition	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Respiratory tract infection bacterial	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Rhinovirus infection	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Sepsis	1.1% 8/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.99% 3/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.2% 5/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.1% 8/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Renal and urinary disorders Obstructive nephropathy	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Septic shock	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Sinusitis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Spinal cord abscess	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Subcutaneous abscess	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Tinea capitis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Tuberculosis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Upper respiratory tract infection	0.95% 7/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.4% 6/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.93% 7/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Urinary tract infection	0.54% 4/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.53% 4/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Urosepsis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Viral infection	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Chest injury	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Fall	0.82% 6/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.3% 4/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.80% 6/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Femoral neck fracture	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Femur fracture	0.54% 4/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.3% 4/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.53% 4/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Head injury	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Hip fracture	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Hypobarism	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Intentional overdose	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Joint dislocation	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Ligament rupture	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Postoperative delirium	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Radiation pneumonitis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Rib fracture	0.54% 4/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.99% 3/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.53% 4/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Road traffic accident	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Spinal compression fracture	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Tendon rupture	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Traumatic haemothorax	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Investigations Alanine aminotransferase increased	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Investigations Aspartate aminotransferase increased	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Neuropathy peripheral	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Investigations Blood alkaline phosphatase increased	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Investigations Blood urea increased	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Investigations Body temperature increased	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Investigations C-reactive protein increased	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Investigations Fibrin D dimer increased	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Investigations Glycosylated haemoglobin increased	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Investigations Hepatic enzyme increased	0.68% 5/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.67% 5/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Investigations Transaminases increased	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Investigations Weight decreased	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Metabolism and nutrition disorders Decreased appetite	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Metabolism and nutrition disorders Dehydration	0.54% 4/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.53% 4/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Metabolism and nutrition disorders Diabetes mellitus	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Skin and subcutaneous tissue disorders Urticaria	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Metabolism and nutrition disorders Hyperglycaemia	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Metabolism and nutrition disorders Hyperkalaemia	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Metabolism and nutrition disorders Hypoglycaemia	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Metabolism and nutrition disorders Hyponatraemia	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Metabolism and nutrition disorders Hypophagia	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Vascular disorders Arterial thrombosis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Metabolism and nutrition disorders Hypovolaemia	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Metabolism and nutrition disorders Metabolic acidosis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Musculoskeletal and connective tissue disorders Arthralgia	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Musculoskeletal and connective tissue disorders Arthritis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Musculoskeletal and connective tissue disorders Back pain	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Musculoskeletal and connective tissue disorders Chondropathy	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Musculoskeletal and connective tissue disorders Exostosis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Musculoskeletal and connective tissue disorders Groin pain	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Musculoskeletal and connective tissue disorders Spinal pain	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.1% 8/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.4% 6/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.1% 8/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Cerebral artery stenosis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.95% 7/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.3% 4/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.93% 7/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Cerebral atrophy	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	1.8% 13/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.3% 4/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	2.1% 9/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.7% 13/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to eye	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural neoplasm	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.68% 5/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.93% 4/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.67% 5/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.82% 6/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.93% 4/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.80% 6/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	1.1% 8/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.3% 4/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.93% 4/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.1% 8/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.54% 4/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.53% 4/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour of ampulla of Vater	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Balance disorder	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Brain hypoxia	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Carotid artery stenosis	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Cerebral artery occlusion	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Cerebral infarction	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Cerebrovascular accident	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Coma	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Dizziness	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Encephalopathy	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.0% 15/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	2.0% 6/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	2.1% 9/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	2.0% 15/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Epilepsy	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Hepatic encephalopathy	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Ischaemic stroke	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Lacunar infarction	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Loss of consciousness	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Radiculopathy	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Sciatica	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Seizure	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Syncope	1.2% 9/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.99% 3/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.4% 6/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.2% 9/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Transient ischaemic attack	0.68% 5/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.67% 5/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Psychiatric disorders Completed suicide	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Psychiatric disorders Confusional state	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Psychiatric disorders Delirium	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Psychiatric disorders Disorientation	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Psychiatric disorders Hallucination	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Psychiatric disorders Mental status changes	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Psychiatric disorders Suicide attempt	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Renal and urinary disorders Acute kidney injury	0.95% 7/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.99% 3/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.93% 4/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.93% 7/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Renal and urinary disorders Anuria	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Renal and urinary disorders Azotaemia	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Renal and urinary disorders Calculus urinary	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Renal and urinary disorders Chronic kidney disease	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Renal and urinary disorders Glomerulonephritis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Renal and urinary disorders Glomerulonephritis chronic	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Renal and urinary disorders Haematuria	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Renal and urinary disorders Lower urinary tract symptoms	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Renal and urinary disorders Nephrolithiasis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Renal and urinary disorders Prerenal failure	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Renal and urinary disorders Renal colic	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Renal and urinary disorders Renal failure	0.68% 5/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.99% 3/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.67% 5/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Renal and urinary disorders Ureterolithiasis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Renal and urinary disorders Urethral stenosis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.68% 5/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.99% 3/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.67% 5/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Reproductive system and breast disorders Genital prolapse	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Reproductive system and breast disorders Ovarian cyst	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	2.0% 15/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.3% 4/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	2.6% 11/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	2.0% 15/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Bronchopleural fistula	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Cough	0.68% 5/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.93% 4/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.67% 5/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.2% 38/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.3% 16/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.1% 22/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.1% 38/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.54% 4/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.53% 4/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.8% 13/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	3.0% 9/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.93% 4/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.7% 13/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	20.8% 153/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	21.1% 64/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	20.7% 89/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	20.4% 153/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	1.4% 10/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.99% 3/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.6% 7/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.3% 10/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Productive cough	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	1.5% 11/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.6% 5/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.4% 6/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.5% 11/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.3% 17/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	3.6% 11/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.4% 6/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	2.3% 17/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	1.6% 12/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.99% 3/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	2.1% 9/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	1.6% 12/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary granuloma	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	6.5% 48/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	7.2% 22/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.0% 26/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.4% 48/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.54% 4/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.53% 4/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.8% 35/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	3.0% 9/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.0% 26/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	4.7% 35/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Respiratory tract haemorrhage	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Skin and subcutaneous tissue disorders Dermatitis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Surgical and medical procedures Knee arthroplasty	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Surgical and medical procedures Transurethral prostatectomy	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Vascular disorders Aortic dissection	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Vascular disorders Aortic stenosis	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Vascular disorders Deep vein thrombosis	0.41% 3/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.70% 3/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.40% 3/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Vascular disorders Hypotension	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Vascular disorders Orthostatic hypotension	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Vascular disorders Peripheral arterial occlusive disease	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Vascular disorders Peripheral artery occlusion	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Vascular disorders Peripheral ischaemia	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Vascular disorders Shock	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.66% 2/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Vascular disorders Thrombosis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Blood and lymphatic system disorders Blood loss anaemia	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Cardiac disorders Prosthetic cardiac valve thrombosis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Gastric haemorrhage	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Obstructive pancreatitis	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Vascular stent stenosis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Hepatobiliary disorders Congestive hepatopathy	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Hepatobiliary disorders Hepatic mass	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.47% 2/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Complicated appendicitis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Infective exacerbation of bronchiectasis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Large intestine infection	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Injury, poisoning and procedural complications Post procedural fever	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Investigations Imaging procedure abnormal	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cutaneous T-cell lymphoma	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Vascular disorders Cyanosis	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Blood and lymphatic system disorders Anaemia	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Blood and lymphatic system disorders Febrile neutropenia	0.14% 1/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.13% 1/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Blood and lymphatic system disorders Thrombocytopenia	0.27% 2/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.33% 1/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.23% 1/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.27% 2/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.

Other adverse events

Measure	Total (1199.32/.34) n=734 participants at risk This group included patients originated from parent trials 1199.32/.34. For patients participated in parent trials 1199.32/.34, they were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study. In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.	Placebo (1199.32/.34) n=304 participants at risk Patients in this group are those who were randomized to placebo arm in parent trials 1199.32/.34 and were treated with 100 milligrams or 150 milligrams of nintedanib orally twice daily in this study.	Nintedanib 150 Bid (1199.32/.34) n=430 participants at risk Patients in this group are those who were randomized to 150 milligrams nintedanib twice daily (bid) arm in the parent trials 1199.32/.34 and were treated with 100 milligrams or 150 milligrams of nintedanib orally twice daily in this study.	Placebo (1199.187) n=7 participants at risk Patients in this group are those who were randomized to placebo arm in parent trial 1199.187 and were treated with 150 milligrams or 100 milligrams of nintedanib twice daily in this study.	Nintedanib 100 Bid (1199.35) n=2 participants at risk Patients in this group are those who were participated in the parent trial 1199.35 and were treated with 100 milligrams of nintedanib twice daily (bid) in this study.	Nintedanib 150 Bid (1199.35/.187) n=8 participants at risk Patients in this group are those who were treated with 150 milligrams (mg) of nintedanib twice daily (bid) in this study and were participated in parent trial 1199.35 plus those who were randomized to 150 mg nintedanib bid arm in the parent trial 1199.187 and were treated with 150 mg or 100 mg nintedanib bid in this study.	Total (1199.35/.187) n=17 participants at risk This group included patients originated from parent trials 1199.35/.187. For patients participated in parent trials 1199.35/.187, they were to receive the same daily dosage of soft gelatin capsules of nintedanib (orally) as in the parent trials (100 milligrams (mg) twice daily (bid) or 150 mg bid) in this study. In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.	Total (1199.32/.34/.35/.187) n=751 participants at risk For patients participated in parent trials 1199.32/.34 (both were randomized, placebo-controlled): patients were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study. For patients participated in parent trials 1199.35/.187 (1199.35: open label; 1199.187: randomized placebo-control): patients were to receive the same daily dosage of soft gelatin capsules of nintedanib (orally) as in the parent trials (100 mg bid or 150 mg bid) in this study. In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.
Gastrointestinal disorders Constipation	7.8% 57/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	8.6% 26/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	7.2% 31/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	7.6% 57/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Abdominal pain	8.6% 63/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	10.5% 32/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	7.2% 31/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	8.4% 63/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Abdominal pain upper	6.5% 48/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.9% 21/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.3% 27/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.4% 48/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Diarrhoea	70.0% 514/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	70.1% 213/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	70.0% 301/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	28.6% 2/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	11.8% 2/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	68.7% 516/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Nausea	19.9% 146/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	23.0% 70/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	17.7% 76/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	19.4% 146/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Gastrointestinal disorders Vomiting	12.1% 89/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	11.8% 36/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	12.3% 53/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	11.9% 89/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Asthenia	5.3% 39/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.9% 18/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	4.9% 21/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.2% 39/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Chest pain	5.3% 39/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	4.9% 15/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.6% 24/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.2% 39/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Fatigue	9.3% 68/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	10.5% 32/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	8.4% 36/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	9.1% 68/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Oedema peripheral	6.8% 50/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.6% 17/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	7.7% 33/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.7% 50/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
General disorders Pyrexia	5.7% 42/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	4.9% 15/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.3% 27/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.6% 42/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Bronchitis	19.8% 145/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	17.8% 54/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	21.2% 91/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	19.3% 145/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Lower respiratory tract infection	5.4% 40/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	4.6% 14/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.0% 26/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.3% 40/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Respiratory tract infection	6.4% 47/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	4.9% 15/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	7.4% 32/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.3% 47/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Rhinitis	5.3% 39/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.9% 18/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	4.9% 21/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.2% 39/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Upper respiratory tract infection	14.9% 109/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	12.5% 38/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	16.5% 71/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	14.5% 109/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Investigations Weight decreased	16.8% 123/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	20.7% 63/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	14.0% 60/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	16.4% 123/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Metabolism and nutrition disorders Decreased appetite	14.2% 104/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	19.1% 58/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	10.7% 46/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	13.8% 104/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Musculoskeletal and connective tissue disorders Arthralgia	6.7% 49/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.9% 18/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	7.2% 31/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.5% 49/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Musculoskeletal and connective tissue disorders Back pain	7.8% 57/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	9.2% 28/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.7% 29/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	7.6% 57/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Dizziness	6.5% 48/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	7.6% 23/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.8% 25/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.4% 48/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Nervous system disorders Headache	5.7% 42/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.9% 18/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.6% 24/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.6% 42/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Cough	22.6% 166/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	21.7% 66/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	23.3% 100/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	22.1% 166/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.1% 118/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	15.8% 48/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	16.3% 70/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	12.5% 1/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.9% 1/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	15.8% 119/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	10.9% 80/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	10.5% 32/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	11.2% 48/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	10.7% 80/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Vascular disorders Hypertension	6.7% 49/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	7.6% 23/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.0% 26/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	14.3% 1/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.9% 1/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.7% 50/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Eye disorders Cataract	3.5% 26/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	2.6% 8/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	4.2% 18/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	12.5% 1/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.9% 1/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	3.6% 27/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Influenza	4.8% 35/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	3.6% 11/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.6% 24/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	50.0% 1/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.9% 1/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	4.8% 36/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Nasopharyngitis	20.7% 152/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	20.4% 62/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	20.9% 90/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	20.2% 152/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Infections and infestations Pneumonia	6.1% 45/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.2% 19/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.0% 26/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	6.0% 45/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Musculoskeletal and connective tissue disorders Myalgia	2.9% 21/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	3.3% 10/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	2.6% 11/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	12.5% 1/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.9% 1/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	2.9% 22/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Psychiatric disorders Anxiety	3.5% 26/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.6% 17/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	2.1% 9/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	3.5% 26/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Psychiatric disorders Insomnia	4.9% 36/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	4.6% 14/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.1% 22/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	4.8% 36/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
Respiratory, thoracic and mediastinal disorders Productive cough	4.9% 36/734 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	3.9% 12/304 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	5.6% 24/430 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/7 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/2 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/8 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	0.00% 0/17 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.	4.8% 36/751 • From first drug administration in this study until 28 days after the last drug, up to 7.5 years. Treated set (TS) \[and TS35; TS187\]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 \[in 1199.35 for TS35; in 1199.187 for TS187\] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.

Additional Information

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Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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