Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (NCT NCT01306617)

NCT ID: NCT01306617

Last Updated: 2015-01-08

Results Overview

Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of detection (\< 15 IU/mL).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: Week 4 through Week 12
• Results posted on: 2015-01-08

Participant Flow

Participant milestones

Measure	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
Overall Study STARTED	19	14	17
Overall Study COMPLETED	18	13	12
Overall Study NOT COMPLETED	1	1	5

Reasons for withdrawal

Measure	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
Overall Study Adverse Event	1	0	0
Overall Study Virologic Failure	0	0	5
Overall Study Non-compliance	0	1	0

Baseline Characteristics

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Baseline characteristics by cohort

Measure	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=19 Participants ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=14 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders n=17 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.	Total n=50 Participants Total of all reporting groups
Age, Continuous	53.6 years STANDARD_DEVIATION 9.78 • n=5 Participants	50.9 years STANDARD_DEVIATION 10.45 • n=7 Participants	52.3 years STANDARD_DEVIATION 9.03 • n=5 Participants	52.4 years STANDARD_DEVIATION 9.59 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	14 Participants n=7 Participants	11 Participants n=5 Participants	35 Participants n=4 Participants
Hepatitis C Virus (HCV) Genotype/ Subtype 1A	17 participants n=5 Participants	11 participants n=7 Participants	16 participants n=5 Participants	44 participants n=4 Participants
Hepatitis C Virus (HCV) Genotype/ Subtype 1B	2 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	6 participants n=4 Participants
Interleukin 28B (IL28B) Genotype CC	10 participants n=5 Participants	5 participants n=7 Participants	0 participants n=5 Participants	15 participants n=4 Participants
Interleukin 28B (IL28B) Genotype CT	7 participants n=5 Participants	7 participants n=7 Participants	12 participants n=5 Participants	26 participants n=4 Participants
Interleukin 28B (IL28B) Genotype TT	2 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants	9 participants n=4 Participants

PRIMARY outcome

Timeframe: Week 4 through Week 12

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of detection (< 15 IU/mL).

Outcome measures

Measure	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=19 Participants ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=14 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders n=17 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Detection (LLOD) From Week 4 Through Week 12	89.5 percentage of participants	78.6 percentage of participants	58.8 percentage of participants

SECONDARY outcome

Timeframe: Week 2

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.

Outcome measures

Measure	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=19 Participants ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=14 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders n=17 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
Percentage of Participants With HCV RNA < 1000 International Units Per Milliliter (IU/mL)	100 percentage of participants	92.9 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Week 4

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).

Outcome measures

Measure	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=19 Participants ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=14 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders n=17 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
Percentage of Participants With HCV RNA Below the Lower Limit of Quantitation (LLOQ; <25 IU/mL) at Week 4	100 percentage of participants	92.9 percentage of participants	88.2 percentage of participants

SECONDARY outcome

Timeframe: Post-treatment Day 1 to Post-treatment Week 12

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

Sustained virologic response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.

Outcome measures

Measure	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=19 Participants ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=14 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders n=17 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment	94.7 percentage of participants	92.9 percentage of participants	47.1 percentage of participants

SECONDARY outcome

Timeframe: Post-treatment Day 1 to Post-treatment Week 24

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

Sustained virologic response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug.

Outcome measures

Measure	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=19 Participants ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=14 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders n=17 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment	94.7 percentage of participants	85.7 percentage of participants	47.1 percentage of participants

SECONDARY outcome

Timeframe: Day 1 through Week 12

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).

Time to failure to achieve a 2 log10 IU/mL HCV RNA decrease at Week 1, failure to achieve HCV RNA < Lower Limit of Detection (LLOD) at Week 6, or a confirmed increase of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA > lower limit of quantitation (LLOQ) for participants who previously achieved HCV RNA < LLOQ.

Outcome measures

Measure	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=19 Participants ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=14 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders n=17 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
Time to Failure to Suppress or Rebound During Treatment	43.0 days Standard Error NA Cannot be estimated as only one participant experienced virologic failure during treatment.	NA days Standard Error NA Mean and standard error cannot be estimated as no participants experienced virologic failure during treatment in this arm.	62.6 days Standard Error 5.44

SECONDARY outcome

Timeframe: Post-treatment Day 1 to post-treatment week 48

Population: All randomized participants who received at least 1 dose of study drug with HCV RNA \< LLOQ at the final treatment visit who completed treatment.

Time to the first of 2 consecutive measurements of confirmed HCV RNA ≥ lower limit of quantitation (LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment.

Outcome measures

Measure	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=18 Participants ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=13 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders n=11 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
Time to Virologic Relapse Post-treatment	NA days Standard Error NA Mean and standard error cannot be estimated as no participants experience relapse in this arm.	NA days Standard Error NA Mean and standard error cannot be estimated as no participants experience relapse in this arm.	15.8 days Standard Error 0.21

SECONDARY outcome

Timeframe: Day 1 to post-treatment week 48

Population: Resistance analyses included all participants who receive at least one dose of study drug (intent-to-treat \[ITT\] population).

Baseline samples were analyzed for resistance-associated amino acid variants using population sequencing. Phenotypic resistance to ABT-450 or ABT-333 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Participants not achieving SVR12 were analyzed for resistance-associated variants at the time of failure using population sequencing and were compared with the baseline and appropriate reference sequences to assess amino acid changes. Phenotypic resistance to ABT-450 or ABT-333 at the time of failure was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance at baseline and at the time of failure are presented.

Outcome measures

Measure	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=19 Participants ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=14 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders n=17 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
Resistance-Associated Variants and Phenotypic Resistance Baseline Variants in NS3; n=49	0 participants	0 participants	1 participants
Resistance-Associated Variants and Phenotypic Resistance Baseline Resistance to ABT-450 >10-fold; n=40	0 participants	0 participants	1 participants
Resistance-Associated Variants and Phenotypic Resistance Baseline Variants in NS5B; n=49	2 participants	2 participants	0 participants
Resistance-Associated Variants and Phenotypic Resistance Baseline Resistance to ABT-333 >10-fold; n=49	0 participants	1 participants	0 participants
Resistance-Associated Variants and Phenotypic Resistance Post-treatment resistant variants in NS3; n=11	0 participants	0 participants	8 participants
Resistance-Associated Variants and Phenotypic Resistance Post-treatment resistance to ABT-450 >10-fold; n=9	0 participants	0 participants	6 participants
Resistance-Associated Variants and Phenotypic Resistance Post-treatment resistant variants in NS5B; n=11	0 participants	0 participants	8 participants
Resistance-Associated Variants and Phenotypic Resistance Post-treatment resistance to ABT-333 >10-fold;n=11	0 participants	0 participants	8 participants

SECONDARY outcome

Timeframe: Day 1 to Week 12

Population: Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.

Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.

Outcome measures

Measure	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=14 Participants ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=11 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders n=9 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
Pharmacokinetics (C Trough) of ABT 450 in HCV Infected Participants	53.21 nanograms (ng) per milliliter (mL) Interval 4.64 to 1978.89	16.81 nanograms (ng) per milliliter (mL) Interval 2.7 to 191.23	16.15 nanograms (ng) per milliliter (mL) Interval 2.33 to 174.6

SECONDARY outcome

Timeframe: Day 1 to Week 12

Population: Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.

Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.

Outcome measures

Measure	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=14 Participants ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=11 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders n=10 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
Pharmacokinetics (C Trough) of ABT-333 in HCV Infected Participants	148.44 nanograms (ng) per milliliter (mL) Interval 50.04 to 816.89	162.57 nanograms (ng) per milliliter (mL) Interval 76.92 to 579.67	166.15 nanograms (ng) per milliliter (mL) Interval 89.8 to 527.0

SECONDARY outcome

Timeframe: Day 1 to Week 12

Population: Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.

Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.

Outcome measures

Measure	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=14 Participants ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=11 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders n=9 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
Pharmacokinetics (C Trough) of Ritonavir in HCV Infected Participants	43.92 nanograms (ng) per milliliter (mL) Interval 9.45 to 384.88	42.35 nanograms (ng) per milliliter (mL) Interval 12.07 to 1099.4	44.21 nanograms (ng) per milliliter (mL) Interval 23.73 to 73.76

SECONDARY outcome

Timeframe: Day 1 to Week 12

Population: Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.

Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.

Outcome measures

Measure	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=14 Participants ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve n=11 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders n=10 Participants ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
Pharmacokinetics (C Trough) of Ribavirin in HCV Infected Participants	2480 nanograms (ng) per milliliter (mL) Interval 1100.0 to 4800.0	2280 nanograms (ng) per milliliter (mL) Interval 1580.0 to 3760.0	2000 nanograms (ng) per milliliter (mL) Interval 1210.0 to 3880.0

Adverse Events

ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naive

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naive

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naive n=19 participants at risk ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naive n=14 participants at risk ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders n=17 participants at risk ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
Blood and lymphatic system disorders ANAEMIA	10.5% 2/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Blood and lymphatic system disorders LEUKOCYTOSIS	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Blood and lymphatic system disorders LYMPHADENOPATHY	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Cardiac disorders TACHYCARDIA	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Ear and labyrinth disorders EAR PAIN	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Eye disorders EYE HAEMORRHAGE	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Eye disorders LACRIMATION INCREASED	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Eye disorders PHOTOPHOBIA	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Gastrointestinal disorders ABDOMINAL DISCOMFORT	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Gastrointestinal disorders ABDOMINAL DISTENSION	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Gastrointestinal disorders CHEILITIS	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Gastrointestinal disorders CONSTIPATION	10.5% 2/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Gastrointestinal disorders DENTAL CARIES	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Gastrointestinal disorders DIARRHOEA	10.5% 2/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	11.8% 2/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Gastrointestinal disorders DYSPEPSIA	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Gastrointestinal disorders EPIGASTRIC DISCOMFORT	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Gastrointestinal disorders FLATULENCE	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Gastrointestinal disorders FREQUENT BOWEL MOVEMENTS	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Gastrointestinal disorders GASTRITIS	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	10.5% 2/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Gastrointestinal disorders NAUSEA	21.1% 4/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	21.4% 3/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	23.5% 4/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Gastrointestinal disorders VOMITING	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	21.4% 3/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
General disorders ASTHENIA	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
General disorders CHEST PAIN	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
General disorders CHILLS	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
General disorders ENERGY INCREASED	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
General disorders FATIGUE	47.4% 9/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	42.9% 6/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	35.3% 6/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
General disorders FEELING ABNORMAL	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
General disorders HUNGER	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
General disorders INFLUENZA LIKE ILLNESS	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
General disorders INJECTION SITE REACTION	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
General disorders IRRITABILITY	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	14.3% 2/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
General disorders NON-CARDIAC CHEST PAIN	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
General disorders OEDEMA PERIPHERAL	15.8% 3/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
General disorders PAIN	10.5% 2/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
General disorders PYREXIA	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Hepatobiliary disorders HYPERBILIRUBINAEMIA	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Immune system disorders SEASONAL ALLERGY	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Infections and infestations BODY TINEA	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Infections and infestations BRONCHITIS	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Infections and infestations CELLULITIS	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Infections and infestations FOLLICULITIS	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Infections and infestations GASTROENTERITIS	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Infections and infestations HORDEOLUM	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Infections and infestations INFLUENZA	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Infections and infestations PNEUMONIA	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Infections and infestations SINUSITIS	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Infections and infestations TINEA PEDIS	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	10.5% 2/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Infections and infestations URINARY TRACT INFECTION	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Injury, poisoning and procedural complications LACERATION	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Injury, poisoning and procedural complications MUSCLE STRAIN	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Injury, poisoning and procedural complications SUNBURN	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Investigations ALANINE AMINOTRANSFERASE INCREASED	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Investigations BLOOD CREATININE INCREASED	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Investigations BLOOD OESTROGEN INCREASED	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Investigations CREATININE RENAL CLEARANCE DECREASED	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Investigations ELECTROCARDIOGRAM QT PROLONGED	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Investigations HEART RATE INCREASED	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Metabolism and nutrition disorders DECREASED APPETITE	10.5% 2/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	14.3% 2/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Metabolism and nutrition disorders DIABETES MELLITUS	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Metabolism and nutrition disorders HYPERGLYCAEMIA	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Musculoskeletal and connective tissue disorders ARTHRALGIA	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	14.3% 2/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Musculoskeletal and connective tissue disorders BACK PAIN	10.5% 2/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Skin and subcutaneous tissue disorders ALOPECIA	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Musculoskeletal and connective tissue disorders FLANK PAIN	10.5% 2/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Nervous system disorders COGNITIVE DISORDER	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Nervous system disorders COORDINATION ABNORMAL	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Nervous system disorders DIZZINESS	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	28.6% 4/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	23.5% 4/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Nervous system disorders DYSGEUSIA	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Nervous system disorders HEADACHE	26.3% 5/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	14.3% 2/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	17.6% 3/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Nervous system disorders HYPOAESTHESIA	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Nervous system disorders LETHARGY	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Nervous system disorders MEMORY IMPAIRMENT	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Nervous system disorders MIGRAINE	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Nervous system disorders PARAESTHESIA	10.5% 2/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	14.3% 2/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Nervous system disorders POOR QUALITY SLEEP	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	14.3% 2/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Nervous system disorders SINUS HEADACHE	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Nervous system disorders TREMOR	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Psychiatric disorders ABNORMAL DREAMS	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Psychiatric disorders AFFECT LABILITY	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Psychiatric disorders AGITATION	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Psychiatric disorders ANXIETY	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Psychiatric disorders CONFUSIONAL STATE	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Psychiatric disorders DEPRESSED MOOD	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Psychiatric disorders DEPRESSION	10.5% 2/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Psychiatric disorders DISORIENTATION	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Psychiatric disorders HYPERVIGILANCE	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Psychiatric disorders INSOMNIA	26.3% 5/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	21.4% 3/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Psychiatric disorders LIBIDO DECREASED	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Psychiatric disorders NERVOUSNESS	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Psychiatric disorders SLEEP DISORDER	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Renal and urinary disorders DYSURIA	10.5% 2/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Renal and urinary disorders MICTURITION URGENCY	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Renal and urinary disorders POLLAKIURIA	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Renal and urinary disorders RENAL FAILURE ACUTE	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Reproductive system and breast disorders DYSPAREUNIA	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Reproductive system and breast disorders VULVOVAGINAL DRYNESS	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Respiratory, thoracic and mediastinal disorders COUGH	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Respiratory, thoracic and mediastinal disorders DYSPNOEA	10.5% 2/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Respiratory, thoracic and mediastinal disorders PARANASAL SINUS HYPERSECRETION	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Respiratory, thoracic and mediastinal disorders RESPIRATORY TRACT CONGESTION	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Skin and subcutaneous tissue disorders COLD SWEAT	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Skin and subcutaneous tissue disorders DERMATITIS CONTACT	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Skin and subcutaneous tissue disorders DRY SKIN	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Skin and subcutaneous tissue disorders DYSHIDROSIS	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Skin and subcutaneous tissue disorders PRURITUS	21.1% 4/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	11.8% 2/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Skin and subcutaneous tissue disorders PRURITUS GENERALISED	15.8% 3/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Skin and subcutaneous tissue disorders RASH	21.1% 4/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Skin and subcutaneous tissue disorders SKIN ODOUR ABNORMAL	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Skin and subcutaneous tissue disorders URTICARIA	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Vascular disorders FLUSHING	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Vascular disorders HOT FLUSH	5.3% 1/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	7.1% 1/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).
Vascular disorders HYPERTENSION	0.00% 0/19 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	0.00% 0/14 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). Serious Adverse Events (SAEs) were also collected from the time that informed consent was obtained through the end of the study (approximately 64 weeks).

Additional Information

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