Trial Outcomes & Findings for Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009) (NCT NCT00704405)

Last Updated: 2018-10-09

Results Overview

The percentage of non-cirrhotic participants with undetectable Hepatits C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment was determined for each Vaniprevir 600 mg b.i.d. and control regimen. Results for Vaniprevir 300 mg are presented as a Secondary Outcome Measure.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

285 participants

Primary outcome timeframe

Up to 72 weeks

Results posted on

2018-10-09

Participant Flow

Non-cirrhotic (NC) and cirrhotic (C) participants were screened and enrolled separately in this study. The NC population was used for all safety, tolerability, and efficacy outcome measures. Primary analyses of the outcome measures only included the NC population. Adverse events (AEs) were monitored in both the NC and C populations.

Participant milestones

Participant milestones
Measure	24-wk Vaniprevir 600 mg + Peg-IFN/RBV Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.	24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.	48-wk Vaniprevir 300 mg + Peg-IFN/RBV Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk Vaniprevir 600 mg + Peg-IFN/RBV Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk PBO + Peg-IFN/RBV PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Overall Study (NC Population) STARTED	42	44	41	42	42
Overall Study (NC Population) COMPLETED	37	40	38	38	37
Overall Study (NC Population) NOT COMPLETED	5	4	3	4	5
Overall Study (C Population) STARTED	16	14	15	15	14
Overall Study (C Population) COMPLETED	15	11	14	14	14
Overall Study (C Population) NOT COMPLETED	1	3	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	24-wk Vaniprevir 600 mg + Peg-IFN/RBV Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.	24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.	48-wk Vaniprevir 300 mg + Peg-IFN/RBV Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk Vaniprevir 600 mg + Peg-IFN/RBV Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk PBO + Peg-IFN/RBV PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Overall Study (NC Population) Adverse Event	1	0	0	0	0
Overall Study (NC Population) Lost to Follow-up	2	1	1	2	2
Overall Study (NC Population) Withdrawal by Subject	2	3	2	2	2
Overall Study (NC Population) Other	0	0	0	0	1
Overall Study (C Population) Withdrawal by Subject	1	1	1	1	0
Overall Study (C Population) Lost to Follow-up	0	2	0	0	0

Baseline Characteristics

Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	24-wk Vaniprevir 600 mg + Peg-IFN/RBV n=58 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.	24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV n=58 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.	48-wk Vaniprevir 300 mg + Peg-IFN/RBV n=56 Participants Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk Vaniprevir 600 mg + Peg-IFN/RBV n=57 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk PBO + Peg-IFN/RBV n=56 Participants PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.	Total n=285 Participants Total of all reporting groups
Age, Continuous	50.0 Years STANDARD_DEVIATION 8.4 • n=5 Participants	51.6 Years STANDARD_DEVIATION 8.1 • n=7 Participants	50.6 Years STANDARD_DEVIATION 7.5 • n=5 Participants	52.1 Years STANDARD_DEVIATION 8.7 • n=4 Participants	49.9 Years STANDARD_DEVIATION 7.8 • n=21 Participants	50.8 Years STANDARD_DEVIATION 8.1 • n=8 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	24 Participants n=7 Participants	16 Participants n=5 Participants	19 Participants n=4 Participants	21 Participants n=21 Participants	105 Participants n=8 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	34 Participants n=7 Participants	40 Participants n=5 Participants	38 Participants n=4 Participants	35 Participants n=21 Participants	180 Participants n=8 Participants

PRIMARY outcome

Timeframe: Up to 72 weeks

Population: The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.

Outcome measures

Outcome measures
Measure	24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV n=38 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.	24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV n=38 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.	48-wk Vaniprevir 600 mg + Peg-IFN/RBV n=41 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk PBO + Peg-IFN/RBV n=42 Participants PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk PBO + Peg-IFN/RBV PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d.	71.1 Percentage of participants	84.2 Percentage of participants	78.0 Percentage of participants	19.0 Percentage of participants	—

PRIMARY outcome

Timeframe: Up to 73 weeks

Population: The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all non-cirrhotic randomized patients who received at least one dose of study treatment.

The number of non-cirrhotic participants experiencing AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.

Outcome measures

Outcome measures
Measure	24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV n=40 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.	24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV n=42 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.	48-wk Vaniprevir 600 mg + Peg-IFN/RBV n=41 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk PBO + Peg-IFN/RBV n=46 Participants PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk PBO + Peg-IFN/RBV n=42 Participants PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Number of Participants Experiencing an Adverse Event (AE)	38 Number of participants	42 Number of participants	40 Number of participants	46 Number of participants	41 Number of participants

PRIMARY outcome

Timeframe: Up to 48 weeks

Population: The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all randomized non-cirrhotic patients who received at least one dose of study treatment.

The number of non-cirrhotic participants withdrawing from study treatment due to AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen.

Outcome measures

Outcome measures
Measure	24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV n=40 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.	24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV n=42 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.	48-wk Vaniprevir 600 mg + Peg-IFN/RBV n=41 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk PBO + Peg-IFN/RBV n=46 Participants PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk PBO + Peg-IFN/RBV n=42 Participants PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Number of Participants Discontinuing From Study Treatment Due to AEs	2 Number of participants	3 Number of participants	2 Number of participants	4 Number of participants	1 Number of participants

SECONDARY outcome

Timeframe: 72 weeks

The percentage of non-cirrhotic participants treated with Vaniprevir 300 mg b.i.d. with undetectable HCV RNA 24 weeks after completing treatment was determined.

Outcome measures

Outcome measures
Measure	24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV n=39 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.	24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV n=42 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.	48-wk Vaniprevir 600 mg + Peg-IFN/RBV Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk PBO + Peg-IFN/RBV PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk PBO + Peg-IFN/RBV PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d.	66.7 Percentage of participants	19.0 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to Week 60

The percentage of non-cirrhotic participants with complete early viral response (cEVR; undetectable HCV RNA at Week 12) was determined for each Vaniprevir dose. Since each of the Vaniprevir 600 mg arms had the same treatment history at this point in the study, the data were pooled for analysis.

Outcome measures

Outcome measures
Measure	24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV n=125 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.	24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV n=41 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.	48-wk Vaniprevir 600 mg + Peg-IFN/RBV n=42 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk PBO + Peg-IFN/RBV PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk PBO + Peg-IFN/RBV PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Percentage of Participants Achieving cEVR	92.0 Percentage of participants	85.4 Percentage of participants	9.5 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 48

The percentage of participants achieving SVR24 after the 24-week Vaniprevir 600 mg b.i.d. regimen at Week 48 was compared to the control regimen.

Outcome measures

Outcome measures
Measure	24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV n=38 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.	24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV n=41 Participants Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.	48-wk Vaniprevir 600 mg + Peg-IFN/RBV Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk PBO + Peg-IFN/RBV PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk PBO + Peg-IFN/RBV PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d.	71.1 Percentage of participants	36.6 Percentage of participants	—	—	—

Adverse Events

24-wk Vaniprevir 600 mg + Peg-IFN/RBV

Serious events: 2 serious events

Other events: 53 other events

Deaths: 0 deaths

24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV

Serious events: 5 serious events

Other events: 56 other events

Deaths: 0 deaths

48-wk Vaniprevir 300 mg + Peg-IFN/RBV

Serious events: 6 serious events

Other events: 55 other events

Deaths: 0 deaths

48-wk Vaniprevir 600 mg + Peg-IFN/RBV

Serious events: 9 serious events

Other events: 61 other events

Deaths: 0 deaths

48-wk PBO + Peg-IFN/RBV

Serious events: 1 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	24-wk Vaniprevir 600 mg + Peg-IFN/RBV n=56 participants at risk Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.	24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV n=56 participants at risk Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.	48-wk Vaniprevir 300 mg + Peg-IFN/RBV n=56 participants at risk Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk Vaniprevir 600 mg + Peg-IFN/RBV n=61 participants at risk Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk PBO + Peg-IFN/RBV n=56 participants at risk PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Cardiac disorders Cardiac failure congestive	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Eye disorders Retinal detachment	1.8% 1/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Eye disorders Retinal vascular thorombosis	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
General disorders General physical health deterioration	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Immune system disorders Anaphylactic reaction	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Infections and infestations Arthritis infective	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Infections and infestations Cellulitis	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Infections and infestations Gastroenteritis	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Infections and infestations Pneumonia	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Infections and infestations Pyelonephritis	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Infections and infestations Pyelonephritis acute	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Injury, poisoning and procedural complications Joint dislocation	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Nervous system disorders Dizziness	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Nervous system disorders Syncope	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Psychiatric disorders Completed suicide	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Psychiatric disorders Confusional state	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Renal and urinary disorders Nephrolithiasis	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Skin and subcutaneous tissue disorders Dermatomyositis	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Vascular disorders Hypertensive crisis	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.

Other adverse events

Other adverse events
Measure	24-wk Vaniprevir 600 mg + Peg-IFN/RBV n=56 participants at risk Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.	24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV n=56 participants at risk Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.	48-wk Vaniprevir 300 mg + Peg-IFN/RBV n=56 participants at risk Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk Vaniprevir 600 mg + Peg-IFN/RBV n=61 participants at risk Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.	48-wk PBO + Peg-IFN/RBV n=56 participants at risk PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Blood and lymphatic system disorders Anaemia	14.3% 8/56 • Number of events 8 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	26.8% 15/56 • Number of events 23 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	21.4% 12/56 • Number of events 16 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	13.1% 8/61 • Number of events 9 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	14.3% 8/56 • Number of events 11 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Blood and lymphatic system disorders Leukopenia	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Blood and lymphatic system disorders Neutropenia	16.1% 9/56 • Number of events 12 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	14.3% 8/56 • Number of events 14 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	14.3% 8/56 • Number of events 25 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	14.8% 9/61 • Number of events 9 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Blood and lymphatic system disorders Thrombocytopenia	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	4.9% 3/61 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Cardiac disorders Palpitations	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	6.6% 4/61 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Ear and labyrinth disorders Vertigo	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	4.9% 3/61 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Endocrine disorders Hypothyroidism	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	6.6% 4/61 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Eye disorders Conjunctivitis	5.4% 3/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.3% 2/61 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Eye disorders Dry eye	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.9% 5/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	6.6% 4/61 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Abdominal distension	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.2% 5/61 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Abdominal pain	8.9% 5/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.9% 5/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	7.1% 4/56 • Number of events 10 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	13.1% 8/61 • Number of events 8 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Abdominal pain lower	3.6% 2/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Abdominal pain upper	10.7% 6/56 • Number of events 7 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	16.1% 9/56 • Number of events 10 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.9% 5/56 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	16.4% 10/61 • Number of events 11 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	12.5% 7/56 • Number of events 7 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Aphthous stomatitis	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Constipation	5.4% 3/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	4.9% 3/61 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Diarrhoea	41.1% 23/56 • Number of events 40 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	46.4% 26/56 • Number of events 34 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	26.8% 15/56 • Number of events 41 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	54.1% 33/61 • Number of events 48 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	16.1% 9/56 • Number of events 10 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Dry mouth	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	4.9% 3/61 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Dyspepsia	26.8% 15/56 • Number of events 20 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	21.4% 12/56 • Number of events 13 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	21.4% 12/56 • Number of events 14 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	11.5% 7/61 • Number of events 11 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	14.3% 8/56 • Number of events 9 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Flatulence	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.3% 2/61 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Gastrooesophageal reflux disease	14.3% 8/56 • Number of events 9 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	7.1% 4/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.9% 5/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.2% 5/61 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Gingivitis	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Haemorrhoidal haemorrhage	5.4% 3/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Haemorrhoids	3.6% 2/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.3% 2/61 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Mouth ulceration	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.2% 5/61 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.9% 5/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Nausea	46.4% 26/56 • Number of events 31 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	44.6% 25/56 • Number of events 27 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	35.7% 20/56 • Number of events 30 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	63.9% 39/61 • Number of events 50 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	17.9% 10/56 • Number of events 10 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Toothache	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.3% 2/61 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Gastrointestinal disorders Vomiting	32.1% 18/56 • Number of events 20 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	28.6% 16/56 • Number of events 30 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	14.3% 8/56 • Number of events 11 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	27.9% 17/61 • Number of events 26 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
General disorders Asthenia	21.4% 12/56 • Number of events 12 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	25.0% 14/56 • Number of events 14 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	19.6% 11/56 • Number of events 13 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	21.3% 13/61 • Number of events 14 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	19.6% 11/56 • Number of events 12 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
General disorders Chest pain	1.8% 1/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.3% 2/61 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
General disorders Chills	7.1% 4/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.9% 5/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.9% 5/56 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.3% 2/61 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
General disorders Fatigue	46.4% 26/56 • Number of events 31 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	39.3% 22/56 • Number of events 26 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	44.6% 25/56 • Number of events 29 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	31.1% 19/61 • Number of events 19 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	32.1% 18/56 • Number of events 20 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
General disorders Feeling hot	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.3% 2/61 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
General disorders Influenza like illness	21.4% 12/56 • Number of events 16 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	17.9% 10/56 • Number of events 10 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	30.4% 17/56 • Number of events 18 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	24.6% 15/61 • Number of events 21 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	21.4% 12/56 • Number of events 14 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
General disorders Injection site erythema	3.6% 2/56 • Number of events 7 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.3% 2/61 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
General disorders Injection site reaction	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
General disorders Irritability	7.1% 4/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	10.7% 6/56 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	10.7% 6/56 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	13.1% 8/61 • Number of events 8 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	14.3% 8/56 • Number of events 8 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
General disorders Mucosal dryness	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
General disorders Pain	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.3% 2/61 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	7.1% 4/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
General disorders Pyrexia	14.3% 8/56 • Number of events 9 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	14.3% 8/56 • Number of events 8 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	16.1% 9/56 • Number of events 12 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	19.7% 12/61 • Number of events 13 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	25.0% 14/56 • Number of events 18 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Hepatobiliary disorders Hepatomegaly	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Infections and infestations Bronchitis	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.3% 2/61 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Infections and infestations Nasopharyngitis	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	10.7% 6/56 • Number of events 10 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	7.1% 4/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	6.6% 4/61 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Infections and infestations Oral herpes	1.8% 1/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	4.9% 3/61 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	7.1% 4/56 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Infections and infestations Sinusitis	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	6.6% 4/61 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Infections and infestations Upper respiratory tract infection	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.9% 5/56 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	4.9% 3/61 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.9% 5/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Injury, poisoning and procedural complications Excoriation	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	7.1% 4/56 • Number of events 8 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Investigations Haemoglobin decreased	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Investigations Weight decreased	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.9% 5/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	6.6% 4/61 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Metabolism and nutrition disorders Decreased appetite	16.1% 9/56 • Number of events 11 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	25.0% 14/56 • Number of events 15 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	16.1% 9/56 • Number of events 10 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	13.1% 8/61 • Number of events 8 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.9% 5/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Musculoskeletal and connective tissue disorders Arthralgia	17.9% 10/56 • Number of events 11 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	14.3% 8/56 • Number of events 8 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	14.3% 8/56 • Number of events 10 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	18.0% 11/61 • Number of events 12 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	19.6% 11/56 • Number of events 13 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Musculoskeletal and connective tissue disorders Back pain	10.7% 6/56 • Number of events 9 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	10.7% 6/56 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	7.1% 4/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	13.1% 8/61 • Number of events 10 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	7.1% 4/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Musculoskeletal and connective tissue disorders Muscle spasms	1.8% 1/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	10.7% 6/56 • Number of events 7 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	9.8% 6/61 • Number of events 8 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.2% 5/61 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Musculoskeletal and connective tissue disorders Myalgia	8.9% 5/56 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	12.5% 7/56 • Number of events 8 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	26.8% 15/56 • Number of events 16 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	18.0% 11/61 • Number of events 11 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	21.4% 12/56 • Number of events 12 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Musculoskeletal and connective tissue disorders Neck pain	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Musculoskeletal and connective tissue disorders Pain in extremity	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	4.9% 3/61 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Nervous system disorders Dizziness	7.1% 4/56 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	12.5% 7/56 • Number of events 7 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.9% 5/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	11.5% 7/61 • Number of events 7 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	10.7% 6/56 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Nervous system disorders Dysgeusia	8.9% 5/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	7.1% 4/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	10.7% 6/56 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Nervous system disorders Headache	41.1% 23/56 • Number of events 36 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	32.1% 18/56 • Number of events 19 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	50.0% 28/56 • Number of events 40 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	37.7% 23/61 • Number of events 34 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	35.7% 20/56 • Number of events 26 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Nervous system disorders Paraesthesia	3.6% 2/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	7.1% 4/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Psychiatric disorders Anxiety	8.9% 5/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.9% 5/56 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.3% 2/61 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Psychiatric disorders Depressed mood	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	12.5% 7/56 • Number of events 9 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	4.9% 3/61 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	7.1% 4/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Psychiatric disorders Depression	7.1% 4/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	12.5% 7/56 • Number of events 8 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	19.6% 11/56 • Number of events 11 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	16.4% 10/61 • Number of events 10 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Psychiatric disorders Insomnia	12.5% 7/56 • Number of events 9 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	14.3% 8/56 • Number of events 10 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	30.4% 17/56 • Number of events 18 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	13.1% 8/61 • Number of events 15 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	25.0% 14/56 • Number of events 14 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Psychiatric disorders Mood swings	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Psychiatric disorders Sleep disorder	12.5% 7/56 • Number of events 8 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	14.3% 8/56 • Number of events 8 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	12.5% 7/56 • Number of events 7 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	13.1% 8/61 • Number of events 9 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	7.1% 4/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Reproductive system and breast disorders Erectile dysfunction	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 8/56 • Number of events 8 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	35.7% 20/56 • Number of events 28 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	16.1% 9/56 • Number of events 10 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	27.9% 17/61 • Number of events 19 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	25.0% 14/56 • Number of events 14 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.1% 4/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	14.3% 8/56 • Number of events 8 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	16.1% 9/56 • Number of events 9 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	14.8% 9/61 • Number of events 9 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	14.3% 8/56 • Number of events 8 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.9% 5/56 • Number of events 7 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	4.9% 3/61 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	7.1% 4/56 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	4.9% 3/61 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.4% 3/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	7.1% 4/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	9.8% 6/61 • Number of events 7 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Skin and subcutaneous tissue disorders Alopecia	14.3% 8/56 • Number of events 9 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	10.7% 6/56 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	16.1% 9/56 • Number of events 9 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	19.7% 12/61 • Number of events 12 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.9% 5/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Skin and subcutaneous tissue disorders Dermatitis	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	7.1% 4/56 • Number of events 4 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	10.7% 6/56 • Number of events 7 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	4.9% 3/61 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Skin and subcutaneous tissue disorders Dry skin	17.9% 10/56 • Number of events 12 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	14.3% 8/56 • Number of events 8 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	16.1% 9/56 • Number of events 10 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	16.4% 10/61 • Number of events 10 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	17.9% 10/56 • Number of events 11 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Skin and subcutaneous tissue disorders Eczema	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.9% 5/56 • Number of events 6 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	10.7% 6/56 • Number of events 7 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	11.5% 7/61 • Number of events 7 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	8.9% 5/56 • Number of events 5 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.6% 1/61 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	3.6% 2/56 • Number of events 2 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Skin and subcutaneous tissue disorders Pruritus	32.1% 18/56 • Number of events 21 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	33.9% 19/56 • Number of events 21 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	30.4% 17/56 • Number of events 23 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	34.4% 21/61 • Number of events 23 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	25.0% 14/56 • Number of events 15 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Skin and subcutaneous tissue disorders Rash	14.3% 8/56 • Number of events 10 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	12.5% 7/56 • Number of events 10 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	14.3% 8/56 • Number of events 9 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	32.8% 20/61 • Number of events 22 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	17.9% 10/56 • Number of events 10 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.
Respiratory, thoracic and mediastinal disorders Productive cough	5.4% 3/56 • Number of events 3 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	1.8% 1/56 • Number of events 1 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/61 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.	0.00% 0/56 • AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months. AEs were monitored and presented for the combined NC and C participant populations.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER