Trial Outcomes & Findings for BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (NCT NCT00835770)

NCT ID: NCT00835770

Last Updated: 2020-12-31

Results Overview

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1736 participants
• Primary outcome timeframe: Day 1 up to Week 561
• Results posted on: 2020-12-31

Participant Flow

Participants were enrolled at 298 investigative sites from 03 February 2009 to 08 November 2019.

The study included participants who completed studies NCT00420212 and NCT00451451. A total of 1736 participants were treated in the open label phase extension study NCT00835770, out of which 759 completed the study.

Participant milestones

Measure	BG00012 240 mg BID Participants received BG00012 240 milligram (mg), 2 capsules (120 mg each) orally, twice a day (BID) and 2 matching placebo capsules once a day (QD) for up to 8 years.	BG00012 240 mg TID Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, three times a day (TID) for up to 8 years.
Overall Study STARTED	868	868
Overall Study COMPLETED	384	375
Overall Study NOT COMPLETED	484	493

Reasons for withdrawal

Measure	BG00012 240 mg BID Participants received BG00012 240 milligram (mg), 2 capsules (120 mg each) orally, twice a day (BID) and 2 matching placebo capsules once a day (QD) for up to 8 years.	BG00012 240 mg TID Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, three times a day (TID) for up to 8 years.
Overall Study MS Relapse	17	23
Overall Study MS Progression	14	9
Overall Study Adverse Event	113	124
Overall Study Lost to Follow-up	22	19
Overall Study Consent Withdrawn	144	156
Overall Study Investigator Decision	42	42
Overall Study Participant Non-Compliance	11	9
Overall Study Death	4	6
Overall Study Other	2	1

Baseline Characteristics

BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)

Baseline characteristics by cohort

Measure	BG00012 240 mg BID n=868 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=868 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	Total n=1736 Participants Total of all reporting groups
Age, Continuous	39.6 years STANDARD_DEVIATION 8.93 • n=5 Participants	40.1 years STANDARD_DEVIATION 9.23 • n=7 Participants	39.8 years STANDARD_DEVIATION 9.08 • n=5 Participants
Sex: Female, Male Female	616 Participants n=5 Participants	596 Participants n=7 Participants	1212 Participants n=5 Participants
Sex: Female, Male Male	252 Participants n=5 Participants	272 Participants n=7 Participants	524 Participants n=5 Participants
Race/Ethnicity, Customized White	285 Participants n=5 Participants	309 Participants n=7 Participants	594 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Asian	82 Participants n=5 Participants	80 Participants n=7 Participants	162 Participants n=5 Participants
Race/Ethnicity, Customized Other	32 Participants n=5 Participants	24 Participants n=7 Participants	56 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported Due To Confidentiality Regulations	459 Participants n=5 Participants	439 Participants n=7 Participants	898 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 up to Week 561

Population: Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Outcome measures

Measure	BG00012 240 mg BID n=868 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=868 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	BG00012 240 mg BID (Prior BG00012 Matched Placebo) Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior BG00012 Matched Placebo) Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Number of Participants With Treatment-Emergent Adverse Events (AEs)	824 Participants	814 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 up to Week 384

Population: ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. Data for this outcome measure (OM) was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours.

Outcome measures

Measure	BG00012 240 mg BID n=501 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=502 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	BG00012 240 mg BID (Prior BG00012 Matched Placebo) n=249 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior BG00012 Matched Placebo) n=248 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) n=118 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) n=118 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Percentage of Participants Who Had Relapses	40 percentage of participants	41 percentage of participants	34 percentage of participants	36 percentage of participants	31 percentage of participants	31 percentage of participants

SECONDARY outcome

Timeframe: Day 1 up to Week 384

Population: ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

The annualized relapse rate is calculated as the total number of relapses occurred during the period for all participants, divided by the total number of participant-years followed in the period.

Outcome measures

Measure	BG00012 240 mg BID n=501 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=502 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	BG00012 240 mg BID (Prior BG00012 Matched Placebo) n=249 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior BG00012 Matched Placebo) n=248 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) n=118 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) n=118 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Annualized Relapse Rate (ARR)	0.159 relapses per participant-years	0.179 relapses per participant-years	0.200 relapses per participant-years	0.199 relapses per participant-years	0.184 relapses per participant-years	0.212 relapses per participant-years

SECONDARY outcome

Timeframe: Baseline, Week 384

Population: ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

EDSS scale ranges from 0 (Normal neurological exam, no disability) to 10 (Death) in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. Sustained disability progression was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS ≥1.0 that was sustained for at least 24 weeks, or a 1.5 point increase on the EDSS from a baseline EDSS =0 that was sustained for at least 24 weeks.

Outcome measures

Measure	BG00012 240 mg BID n=501 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=502 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	BG00012 240 mg BID (Prior BG00012 Matched Placebo) n=249 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior BG00012 Matched Placebo) n=248 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) n=118 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) n=118 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 Change at Week 384	0.28 score on a scale Standard Deviation 1.160	0.26 score on a scale Standard Deviation 1.213	0.37 score on a scale Standard Deviation 1.328	0.53 score on a scale Standard Deviation 1.278	0.39 score on a scale Standard Deviation 1.217	0.49 score on a scale Standard Deviation 1.319
Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 Baseline	2.44 score on a scale Standard Deviation 1.251	2.43 score on a scale Standard Deviation 1.144	2.50 score on a scale Standard Deviation 1.135	2.54 score on a scale Standard Deviation 1.218	2.57 score on a scale Standard Deviation 1.249	2.68 score on a scale Standard Deviation 1.231

SECONDARY outcome

Timeframe: Baseline up to Week 288

Population: MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

The Gd-enhancing lesions was evaluated using MRI technique.

Outcome measures

Measure	BG00012 240 mg BID n=213 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=222 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	BG00012 240 mg BID (Prior BG00012 Matched Placebo) n=105 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior BG00012 Matched Placebo) n=103 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) n=49 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) n=60 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 48	0.4 lesions Standard Deviation 1.87	0.4 lesions Standard Deviation 1.29	0.2 lesions Standard Deviation 0.66	0.3 lesions Standard Deviation 1.14	0.5 lesions Standard Deviation 1.19	0.4 lesions Standard Deviation 1.14
Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 96	0.4 lesions Standard Deviation 1.77	0.4 lesions Standard Deviation 1.28	0.1 lesions Standard Deviation 0.38	0.2 lesions Standard Deviation 0.82	0.6 lesions Standard Deviation 1.33	0.3 lesions Standard Deviation 0.73
Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 144	0.3 lesions Standard Deviation 1.66	0.4 lesions Standard Deviation 1.30	0.2 lesions Standard Deviation 0.44	0.1 lesions Standard Deviation 0.29	0.5 lesions Standard Deviation 2.48	0.3 lesions Standard Deviation 1.59
Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 192	0.4 lesions Standard Deviation 2.02	0.5 lesions Standard Deviation 1.85	0.5 lesions Standard Deviation 1.72	0.3 lesions Standard Deviation 0.96	0.2 lesions Standard Deviation 0.60	0.6 lesions Standard Deviation 2.01
Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 240	0.5 lesions Standard Deviation 3.14	0.5 lesions Standard Deviation 2.29	0.2 lesions Standard Deviation 0.50	0.2 lesions Standard Deviation 0.51	0.2 lesions Standard Deviation 0.58	0.3 lesions Standard Deviation 0.75
Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 288	0.2 lesions Standard Deviation 0.74	0.5 lesions Standard Deviation 1.81	0.1 lesions Standard Deviation 0.40	0.7 lesions Standard Deviation 2.76	0.0 lesions Standard Deviation 0.00	0.3 lesions Standard Deviation 0.77

SECONDARY outcome

Timeframe: Baseline up to Week 288

Population: MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

The Gd-enhancing lesions was evaluated using MRI technique.

Outcome measures

Measure	BG00012 240 mg BID n=213 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=222 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	BG00012 240 mg BID (Prior BG00012 Matched Placebo) n=105 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior BG00012 Matched Placebo) n=103 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) n=49 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) n=60 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) Baseline	31.7 millimeter cube (mm^3) Standard Deviation 179.28	48.6 millimeter cube (mm^3) Standard Deviation 205.43	96.0 millimeter cube (mm^3) Standard Deviation 260.79	142.5 millimeter cube (mm^3) Standard Deviation 459.76	37.1 millimeter cube (mm^3) Standard Deviation 138.82	41.7 millimeter cube (mm^3) Standard Deviation 116.55
Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 48	59.6 millimeter cube (mm^3) Standard Deviation 526.51	70.0 millimeter cube (mm^3) Standard Deviation 366.63	18.8 millimeter cube (mm^3) Standard Deviation 91.47	25.3 millimeter cube (mm^3) Standard Deviation 108.19	42.5 millimeter cube (mm^3) Standard Deviation 123.67	42.7 millimeter cube (mm^3) Standard Deviation 148.11
Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 96	49.1 millimeter cube (mm^3) Standard Deviation 245.14	56.1 millimeter cube (mm^3) Standard Deviation 271.29	27.7 millimeter cube (mm^3) Standard Deviation 204.80	13.3 millimeter cube (mm^3) Standard Deviation 67.01	64.3 millimeter cube (mm^3) Standard Deviation 183.16	22.3 millimeter cube (mm^3) Standard Deviation 60.83
Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 144	44.1 millimeter cube (mm^3) Standard Deviation 291.14	47.0 millimeter cube (mm^3) Standard Deviation 169.68	18.8 millimeter cube (mm^3) Standard Deviation 66.15	3.8 millimeter cube (mm^3) Standard Deviation 25.03	42.6 millimeter cube (mm^3) Standard Deviation 142.55	92.9 millimeter cube (mm^3) Standard Deviation 397.69
Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 192	39.1 millimeter cube (mm^3) Standard Deviation 217.89	54.5 millimeter cube (mm^3) Standard Deviation 251.31	45.8 millimeter cube (mm^3) Standard Deviation 156.88	19.9 millimeter cube (mm^3) Standard Deviation 79.19	12.0 millimeter cube (mm^3) Standard Deviation 40.56	55.1 millimeter cube (mm^3) Standard Deviation 169.16
Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 240	96.8 millimeter cube (mm^3) Standard Deviation 650.06	69.3 millimeter cube (mm^3) Standard Deviation 374.67	21.7 millimeter cube (mm^3) Standard Deviation 77.87	14.1 millimeter cube (mm^3) Standard Deviation 45.22	17.5 millimeter cube (mm^3) Standard Deviation 46.19	17.1 millimeter cube (mm^3) Standard Deviation 48.41
Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 288	18.2 millimeter cube (mm^3) Standard Deviation 93.28	53.1 millimeter cube (mm^3) Standard Deviation 250.87	7.9 millimeter cube (mm^3) Standard Deviation 30.09	230.2 millimeter cube (mm^3) Standard Deviation 1092.11	0.0 millimeter cube (mm^3) Standard Deviation 0.00	34.1 millimeter cube (mm^3) Standard Deviation 102.87

SECONDARY outcome

Timeframe: Baseline up to Week 288

Population: MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

The T2 lesions was evaluated using MRI technique.

Outcome measures

Measure	BG00012 240 mg BID n=213 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=222 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	BG00012 240 mg BID (Prior BG00012 Matched Placebo) n=105 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior BG00012 Matched Placebo) n=103 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) n=49 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) n=60 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 48	1.6 lesions Standard Deviation 4.07	2.2 lesions Standard Deviation 6.15	2.7 lesions Standard Deviation 4.96	2.4 lesions Standard Deviation 5.45	3.4 lesions Standard Deviation 6.57	2.1 lesions Standard Deviation 3.83
Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 96	3.4 lesions Standard Deviation 8.35	4.1 lesions Standard Deviation 10.01	3.8 lesions Standard Deviation 7.24	2.9 lesions Standard Deviation 6.78	4.9 lesions Standard Deviation 8.51	3.4 lesions Standard Deviation 5.13
Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 144	4.2 lesions Standard Deviation 9.81	5.2 lesions Standard Deviation 10.01	4.0 lesions Standard Deviation 7.27	4.3 lesions Standard Deviation 10.12	5.7 lesions Standard Deviation 9.45	5.2 lesions Standard Deviation 9.68
Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 192	5.8 lesions Standard Deviation 14.04	7.5 lesions Standard Deviation 15.14	5.6 lesions Standard Deviation 10.09	5.6 lesions Standard Deviation 14.19	5.5 lesions Standard Deviation 9.94	5.6 lesions Standard Deviation 13.35
Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 240	7.4 lesions Standard Deviation 17.09	9.5 lesions Standard Deviation 20.33	8.2 lesions Standard Deviation 14.87	7.7 lesions Standard Deviation 17.89	6.8 lesions Standard Deviation 11.74	7.5 lesions Standard Deviation 16.76
Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 288	8.2 lesions Standard Deviation 18.53	12.4 lesions Standard Deviation 28.23	7.5 lesions Standard Deviation 13.89	10.4 lesions Standard Deviation 22.05	8.9 lesions Standard Deviation 15.04	6.0 lesions Standard Deviation 8.90

SECONDARY outcome

Timeframe: Baseline up to Week 288

Population: MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

The T2 lesions was evaluated using MRI technique.

Outcome measures

Measure	BG00012 240 mg BID n=213 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=222 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	BG00012 240 mg BID (Prior BG00012 Matched Placebo) n=105 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior BG00012 Matched Placebo) n=103 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) n=49 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) n=60 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) Baseline	10231.9 mm^3 Standard Deviation 11214.17	10408.3 mm^3 Standard Deviation 12166.80	8883.7 mm^3 Standard Deviation 8570.10	10806.3 mm^3 Standard Deviation 12060.05	12628.9 mm^3 Standard Deviation 11258.69	13044.4 mm^3 Standard Deviation 14608.50
Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 48	9951.9 mm^3 Standard Deviation 10750.15	9849.6 mm^3 Standard Deviation 10986.36	8992.1 mm^3 Standard Deviation 7952.13	10114.5 mm^3 Standard Deviation 10121.61	11160.7 mm^3 Standard Deviation 9565.55	12979.0 mm^3 Standard Deviation 14415.86
Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 96	10331.3 mm^3 Standard Deviation 11359.81	10434.0 mm^3 Standard Deviation 12201.38	8645.2 mm^3 Standard Deviation 7787.60	9985.7 mm^3 Standard Deviation 10715.73	11318.1 mm^3 Standard Deviation 9873.73	13974.1 mm^3 Standard Deviation 15432.10
Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 144	9930.1 mm^3 Standard Deviation 10686.26	10280.7 mm^3 Standard Deviation 11324.58	8829.4 mm^3 Standard Deviation 7482.93	9792.3 mm^3 Standard Deviation 9842.28	10188.5 mm^3 Standard Deviation 8064.09	12949.7 mm^3 Standard Deviation 14036.15
Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 192	9837.7 mm^3 Standard Deviation 10845.04	10760.0 mm^3 Standard Deviation 11987.16	9077.6 mm^3 Standard Deviation 7794.52	10576.3 mm^3 Standard Deviation 12029.26	10421.9 mm^3 Standard Deviation 8773.41	11671.5 mm^3 Standard Deviation 13124.47
Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 240	10611.2 mm^3 Standard Deviation 11633.95	11087.5 mm^3 Standard Deviation 12464.90	9711.1 mm^3 Standard Deviation 8709.46	10591.4 mm^3 Standard Deviation 11613.26	11009.9 mm^3 Standard Deviation 9551.94	12254.4 mm^3 Standard Deviation 13732.10
Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 288	9611.8 mm^3 Standard Deviation 9447.18	9800.8 mm^3 Standard Deviation 11279.84	8819.8 mm^3 Standard Deviation 8866.90	10537.6 mm^3 Standard Deviation 10684.47	11586.3 mm^3 Standard Deviation 9728.19	10404.8 mm^3 Standard Deviation 12245.75

SECONDARY outcome

Timeframe: Baseline up to Week 288

Population: MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

The T1 hypointense lesions was evaluated using MRI technique.

Outcome measures

Measure	BG00012 240 mg BID n=213 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=222 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	BG00012 240 mg BID (Prior BG00012 Matched Placebo) n=105 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior BG00012 Matched Placebo) n=103 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) n=49 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) n=60 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 48	0.8 lesions Standard Deviation 2.13	1.0 lesions Standard Deviation 2.37	1.8 lesions Standard Deviation 3.81	1.7 lesions Standard Deviation 3.71	2.0 lesions Standard Deviation 4.22	1.3 lesions Standard Deviation 2.64
Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 96	1.7 lesions Standard Deviation 3.63	1.9 lesions Standard Deviation 3.91	1.8 lesions Standard Deviation 3.33	2.1 lesions Standard Deviation 5.00	3.0 lesions Standard Deviation 5.85	1.9 lesions Standard Deviation 3.44
Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 144	2.0 lesions Standard Deviation 4.61	2.8 lesions Standard Deviation 5.19	2.0 lesions Standard Deviation 3.69	2.6 lesions Standard Deviation 7.02	3.1 lesions Standard Deviation 6.20	2.9 lesions Standard Deviation 5.19
Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 192	2.9 lesions Standard Deviation 7.03	3.4 lesions Standard Deviation 6.79	2.9 lesions Standard Deviation 5.12	3.8 lesions Standard Deviation 10.71	3.3 lesions Standard Deviation 6.74	3.0 lesions Standard Deviation 7.14
Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 240	3.4 lesions Standard Deviation 8.25	4.8 lesions Standard Deviation 9.39	4.0 lesions Standard Deviation 7.52	4.9 lesions Standard Deviation 13.30	4.0 lesions Standard Deviation 8.06	4.2 lesions Standard Deviation 10.20
Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 288	2.7 lesions Standard Deviation 5.72	5.9 lesions Standard Deviation 12.02	4.5 lesions Standard Deviation 7.38	3.6 lesions Standard Deviation 4.51	1.0 lesions Standard Deviation 1.10	5.6 lesions Standard Deviation 6.81

SECONDARY outcome

Timeframe: Baseline up to Week 288

Population: MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

The T1 hypointense lesions was evaluated using MRI technique.

Outcome measures

Measure	BG00012 240 mg BID n=213 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=222 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	BG00012 240 mg BID (Prior BG00012 Matched Placebo) n=105 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior BG00012 Matched Placebo) n=103 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) n=49 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) n=60 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) Baseline	3640.1 mm^3 Standard Deviation 5598.31	3447.3 mm^3 Standard Deviation 4900.96	2754.2 mm^3 Standard Deviation 3552.30	3623.1 mm^3 Standard Deviation 5549.13	3204.3 mm^3 Standard Deviation 4221.55	3572.6 mm^3 Standard Deviation 4915.24
Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 48	3829.5 mm^3 Standard Deviation 5824.26	3715.5 mm^3 Standard Deviation 5112.21	2891.9 mm^3 Standard Deviation 3034.00	3936.0 mm^3 Standard Deviation 5271.89	3271.0 mm^3 Standard Deviation 4157.24	3743.3 mm^3 Standard Deviation 5374.24
Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 96	3841.2 mm^3 Standard Deviation 5682.74	3853.7 mm^3 Standard Deviation 5428.66	2921.0 mm^3 Standard Deviation 3327.93	3849.4 mm^3 Standard Deviation 5167.13	3510.4 mm^3 Standard Deviation 4672.80	3949.7 mm^3 Standard Deviation 5018.63
Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 144	3767.4 mm^3 Standard Deviation 4969.23	4074.0 mm^3 Standard Deviation 5413.85	3145.6 mm^3 Standard Deviation 3366.27	4006.9 mm^3 Standard Deviation 5062.08	3499.2 mm^3 Standard Deviation 4198.50	4126.1 mm^3 Standard Deviation 5695.44
Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 192	3834.9 mm^3 Standard Deviation 4942.19	4177.4 mm^3 Standard Deviation 5301.68	3385.4 mm^3 Standard Deviation 3575.44	4330.0 mm^3 Standard Deviation 5136.67	3592.0 mm^3 Standard Deviation 4069.39	4089.3 mm^3 Standard Deviation 4996.13
Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 240	4038.6 mm^3 Standard Deviation 5145.85	4238.2 mm^3 Standard Deviation 5248.84	3406.4 mm^3 Standard Deviation 3936.73	3823.9 mm^3 Standard Deviation 4274.82	3503.4 mm^3 Standard Deviation 3933.75	4057.7 mm^3 Standard Deviation 5223.62
Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) Week 288	3603.3 mm^3 Standard Deviation 4394.60	3973.1 mm^3 Standard Deviation 5202.05	3350.6 mm^3 Standard Deviation 4140.34	4187.5 mm^3 Standard Deviation 4835.43	3264.9 mm^3 Standard Deviation 3639.91	2959.1 mm^3 Standard Deviation 3918.62

SECONDARY outcome

Timeframe: Baseline up to Week 288

Population: MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Brain atrophy was measured using magnetic resonance imaging (MRI) technique.

Outcome measures

Measure	BG00012 240 mg BID n=213 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=222 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	BG00012 240 mg BID (Prior BG00012 Matched Placebo) n=105 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior BG00012 Matched Placebo) n=103 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) n=49 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) n=60 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Percent Change From Baseline in Brain Atrophy Change at Week 48	-1.206 percent change Standard Deviation 1.1006	-1.263 percent change Standard Deviation 1.0848	-1.487 percent change Standard Deviation 1.3086	-1.320 percent change Standard Deviation 1.4021	-1.496 percent change Standard Deviation 1.1316	-1.414 percent change Standard Deviation 1.1882
Percent Change From Baseline in Brain Atrophy Change at Week 96	-1.372 percent change Standard Deviation 1.1382	-1.500 percent change Standard Deviation 1.0893	-1.589 percent change Standard Deviation 1.3630	-1.775 percent change Standard Deviation 1.7191	-1.883 percent change Standard Deviation 1.2383	-1.810 percent change Standard Deviation 1.4556
Percent Change From Baseline in Brain Atrophy Change at Week 144	-1.708 percent change Standard Deviation 1.4109	-1.876 percent change Standard Deviation 1.2604	-2.139 percent change Standard Deviation 1.5884	-2.353 percent change Standard Deviation 1.7897	-2.386 percent change Standard Deviation 1.3168	-2.252 percent change Standard Deviation 2.2124
Percent Change From Baseline in Brain Atrophy Change at Week 192	-2.138 percent change Standard Deviation 1.6831	-2.117 percent change Standard Deviation 1.4000	-2.230 percent change Standard Deviation 1.7755	-2.476 percent change Standard Deviation 1.7062	-2.645 percent change Standard Deviation 1.2284	-2.417 percent change Standard Deviation 2.0486
Percent Change From Baseline in Brain Atrophy Change at Week 240	-2.313 percent change Standard Deviation 1.6309	-2.253 percent change Standard Deviation 1.3721	-2.271 percent change Standard Deviation 1.4817	-2.593 percent change Standard Deviation 1.9043	-2.249 percent change Standard Deviation 1.2985	-2.790 percent change Standard Deviation 2.2188
Percent Change From Baseline in Brain Atrophy Change at Week 288	-2.216 percent change Standard Deviation 1.5744	-2.271 percent change Standard Deviation 1.2193	-2.470 percent change Standard Deviation 1.6757	-2.849 percent change Standard Deviation 1.9648	-2.657 percent change Standard Deviation 1.7051	-2.496 percent change Standard Deviation 1.3699

SECONDARY outcome

Timeframe: Baseline up to Week 288

Population: MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Magnetization Transfer Ratio (MTR) was measured using MRI technique.

Outcome measures

Measure	BG00012 240 mg BID n=213 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=222 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	BG00012 240 mg BID (Prior BG00012 Matched Placebo) n=105 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior BG00012 Matched Placebo) n=103 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) n=49 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) n=60 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Percent Change From Baseline in Magnetization Transfer Ratio (MTR) Change at Week 48	-0.325 percent change Standard Deviation 5.4932	-0.383 percent change Standard Deviation 4.8621	1.034 percent change Standard Deviation 7.3548	-0.567 percent change Standard Deviation 4.4766	-0.081 percent change Standard Deviation 13.6416	-0.334 percent change Standard Deviation 1.5103
Percent Change From Baseline in Magnetization Transfer Ratio (MTR) Change at Week 96	-0.427 percent change Standard Deviation 6.6493	-0.532 percent change Standard Deviation 4.9880	1.630 percent change Standard Deviation 7.6584	-0.947 percent change Standard Deviation 7.0771	-4.269 percent change Standard Deviation 12.6065	0.215 percent change Standard Deviation 1.4270
Percent Change From Baseline in Magnetization Transfer Ratio (MTR) Change at Week 144	-0.042 percent change Standard Deviation 9.2548	0.509 percent change Standard Deviation 7.2692	1.525 percent change Standard Deviation 8.6421	1.411 percent change Standard Deviation 12.2825	-4.460 percent change Standard Deviation 10.3887	3.119 percent change Standard Deviation 8.1676
Percent Change From Baseline in Magnetization Transfer Ratio (MTR) Change at Week 192	1.038 percent change Standard Deviation 10.8680	0.955 percent change Standard Deviation 8.6105	3.012 percent change Standard Deviation 9.3831	3.103 percent change Standard Deviation 13.0046	1.384 percent change Standard Deviation 15.7611	3.841 percent change Standard Deviation 10.8600
Percent Change From Baseline in Magnetization Transfer Ratio (MTR) Change at Week 240	-0.002 percent change Standard Deviation 15.6190	1.647 percent change Standard Deviation 8.3094	3.213 percent change Standard Deviation 9.6621	4.108 percent change Standard Deviation 13.8103	2.959 percent change Standard Deviation 16.8386	0.673 percent change Standard Deviation 25.9962
Percent Change From Baseline in Magnetization Transfer Ratio (MTR) Change at Week 288	0.002 percent change Standard Deviation 4.0206	-0.391 percent change Standard Deviation 4.6415	-0.666 percent change Standard Deviation 2.0741	-0.622 percent change Standard Deviation 2.2922	-0.466 percent change Standard Deviation 0.9410	-1.114 percent change Standard Deviation 2.4539

SECONDARY outcome

Timeframe: Baseline, Week 384

Population: ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

The SF-36 is a brief (36-item) scale reflecting the impact of both dysfunctions and general health perception the questionnaire measures: 1.physical function (PF),2. role physical (RF),3. bodily pain (BP),4. role emotional (RE),5. social function (SF), 6. general health (GH),7. vitality (VT), 8. mental health (MH). Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. The questions related to each dimension are scored on a scale from 0 (worst score) to 100 (best score), with higher scores indicating better function.

Outcome measures

Measure	BG00012 240 mg BID n=501 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=502 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	BG00012 240 mg BID (Prior BG00012 Matched Placebo) n=249 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior BG00012 Matched Placebo) n=248 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) n=118 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) n=118 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Baseline: Physical Functioning Score	68.48 score on a scale Standard Deviation 25.938	71.78 score on a scale Standard Deviation 24.849	69.67 score on a scale Standard Deviation 24.481	67.97 score on a scale Standard Deviation 26.279	69.10 score on a scale Standard Deviation 25.226	68.20 score on a scale Standard Deviation 25.370
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Change at Week 384: Physical Functioning Score	0.73 score on a scale Standard Deviation 21.972	-4.79 score on a scale Standard Deviation 24.641	-7.37 score on a scale Standard Deviation 22.253	-6.89 score on a scale Standard Deviation 23.194	-6.19 score on a scale Standard Deviation 21.719	-6.25 score on a scale Standard Deviation 28.350
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Baseline: Role-Physical Score	56.46 score on a scale Standard Deviation 41.254	58.42 score on a scale Standard Deviation 41.280	56.35 score on a scale Standard Deviation 40.896	59.87 score on a scale Standard Deviation 41.747	55.26 score on a scale Standard Deviation 40.390	53.57 score on a scale Standard Deviation 42.029
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Change at Week 384: Role-Physical Score	3.20 score on a scale Standard Deviation 48.259	-2.75 score on a scale Standard Deviation 47.283	-10.00 score on a scale Standard Deviation 43.188	-8.24 score on a scale Standard Deviation 53.177	-12.21 score on a scale Standard Deviation 40.595	-1.04 score on a scale Standard Deviation 54.568
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Baseline: Bodily-Pain Score	69.68 score on a scale Standard Deviation 25.587	70.42 score on a scale Standard Deviation 24.688	68.51 score on a scale Standard Deviation 26.163	69.44 score on a scale Standard Deviation 26.016	69.30 score on a scale Standard Deviation 25.766	68.59 score on a scale Standard Deviation 26.102
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Change at Week 384: Bodily-Pain Score	1.32 score on a scale Standard Deviation 28.525	-1.47 score on a scale Standard Deviation 25.779	-2.92 score on a scale Standard Deviation 23.486	-4.36 score on a scale Standard Deviation 25.935	-3.60 score on a scale Standard Deviation 22.138	-4.46 score on a scale Standard Deviation 33.297
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Baseline: General Health Score	53.99 score on a scale Standard Deviation 21.563	55.44 score on a scale Standard Deviation 20.768	54.45 score on a scale Standard Deviation 18.690	52.42 score on a scale Standard Deviation 20.028	51.21 score on a scale Standard Deviation 18.707	52.58 score on a scale Standard Deviation 19.675
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Change at Week 384: General Health Score	0.87 score on a scale Standard Deviation 18.744	-2.12 score on a scale Standard Deviation 20.595	-2.28 score on a scale Standard Deviation 16.752	-0.52 score on a scale Standard Deviation 22.035	-5.64 score on a scale Standard Deviation 18.270	1.21 score on a scale Standard Deviation 21.674
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Baseline: Vitality Score	50.48 score on a scale Standard Deviation 20.966	52.21 score on a scale Standard Deviation 19.842	50.63 score on a scale Standard Deviation 19.130	50.64 score on a scale Standard Deviation 21.069	51.30 score on a scale Standard Deviation 19.703	50.33 score on a scale Standard Deviation 20.019
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Change at Week 384: Vitality Score	1.11 score on a scale Standard Deviation 19.857	-0.73 score on a scale Standard Deviation 19.033	-4.67 score on a scale Standard Deviation 17.934	0.40 score on a scale Standard Deviation 20.822	-6.71 score on a scale Standard Deviation 20.236	1.03 score on a scale Standard Deviation 19.829
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Baseline: Social Functioning Score	71.46 score on a scale Standard Deviation 24.451	71.53 score on a scale Standard Deviation 24.394	69.67 score on a scale Standard Deviation 24.581	72.23 score on a scale Standard Deviation 24.699	69.02 score on a scale Standard Deviation 24.688	69.53 score on a scale Standard Deviation 25.100
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Change at Week 384: Social Functioning Score	-2.16 score on a scale Standard Deviation 25.575	-3.30 score on a scale Standard Deviation 24.912	-5.69 score on a scale Standard Deviation 22.184	-2.08 score on a scale Standard Deviation 27.724	-10.76 score on a scale Standard Deviation 34.350	-0.52 score on a scale Standard Deviation 25.780
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Baseline: Role-Emotional Score	64.87 score on a scale Standard Deviation 40.653	65.57 score on a scale Standard Deviation 40.015	62.86 score on a scale Standard Deviation 42.715	62.61 score on a scale Standard Deviation 41.280	60.29 score on a scale Standard Deviation 41.393	64.26 score on a scale Standard Deviation 41.854
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Change at Week 384: Role-Emotional Score	0.43 score on a scale Standard Deviation 49.950	0.47 score on a scale Standard Deviation 43.513	-12.22 score on a scale Standard Deviation 42.532	4.17 score on a scale Standard Deviation 44.656	-13.18 score on a scale Standard Deviation 42.501	-3.55 score on a scale Standard Deviation 48.769
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Baseline: Mental Health Score	65.01 score on a scale Standard Deviation 19.818	66.24 score on a scale Standard Deviation 19.060	65.42 score on a scale Standard Deviation 17.658	65.15 score on a scale Standard Deviation 19.233	62.30 score on a scale Standard Deviation 17.347	63.61 score on a scale Standard Deviation 18.414
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Change at Week 384: Mental Health Score	1.32 score on a scale Standard Deviation 19.715	2.31 score on a scale Standard Deviation 18.095	-3.91 score on a scale Standard Deviation 19.897	2.33 score on a scale Standard Deviation 17.524	-0.29 score on a scale Standard Deviation 21.989	-2.06 score on a scale Standard Deviation 20.066
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Baseline: Mental Component Score	45.40 score on a scale Standard Deviation 11.130	45.63 score on a scale Standard Deviation 10.272	45.13 score on a scale Standard Deviation 10.932	45.31 score on a scale Standard Deviation 10.907	44.00 score on a scale Standard Deviation 10.702	45.03 score on a scale Standard Deviation 10.642
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Change at Week 384: Mental Component Score	0.05 score on a scale Standard Deviation 12.415	0.87 score on a scale Standard Deviation 10.028	-2.55 score on a scale Standard Deviation 10.328	1.97 score on a scale Standard Deviation 10.657	-2.59 score on a scale Standard Deviation 12.895	0.08 score on a scale Standard Deviation 10.328
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Baseline: Physical Component Score	43.53 score on a scale Standard Deviation 9.884	44.44 score on a scale Standard Deviation 10.048	43.74 score on a scale Standard Deviation 9.739	43.56 score on a scale Standard Deviation 10.267	43.68 score on a scale Standard Deviation 10.359	43.15 score on a scale Standard Deviation 10.091
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 Change at Week 384: Physical Component Score	0.55 score on a scale Standard Deviation 9.373	-1.94 score on a scale Standard Deviation 10.532	-2.29 score on a scale Standard Deviation 8.929	-3.25 score on a scale Standard Deviation 9.998	-2.70 score on a scale Standard Deviation 8.860	-1.59 score on a scale Standard Deviation 10.765

SECONDARY outcome

Timeframe: Baseline, Week 384

Population: ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. The EQ-5D provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has (1) "no problems", (2) "some problems", or (3) "severe problems". A positive change from baseline indicates improvement.

Outcome measures

Measure	BG00012 240 mg BID n=501 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=502 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	BG00012 240 mg BID (Prior BG00012 Matched Placebo) n=249 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior BG00012 Matched Placebo) n=248 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) n=118 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) n=118 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 Baseline	0.73 score on a scale Standard Deviation 0.210	0.73 score on a scale Standard Deviation 0.222	0.72 score on a scale Standard Deviation 0.223	0.71 score on a scale Standard Deviation 0.244	0.71 score on a scale Standard Deviation 0.246	0.72 score on a scale Standard Deviation 0.189
Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 Change at Week 384	0.01 score on a scale Standard Deviation 0.251	0.00 score on a scale Standard Deviation 0.233	-0.07 score on a scale Standard Deviation 0.269	0.00 score on a scale Standard Deviation 0.249	-0.04 score on a scale Standard Deviation 0.253	-0.03 score on a scale Standard Deviation 0.241

SECONDARY outcome

Timeframe: Baseline, Week 384

Population: ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. In EQ-VAS participants are asked to rate their current health on a 20 centimeter (cm) scale from 0 to 100 where 0 represents "worst imaginable health state" and 100 represents "best imaginable health state". A positive change from baseline indicates improvement.

Outcome measures

Measure	BG00012 240 mg BID n=501 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=502 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	BG00012 240 mg BID (Prior BG00012 Matched Placebo) n=249 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior BG00012 Matched Placebo) n=248 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) n=118 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) n=118 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 Baseline	70.97 score on a scale Standard Deviation 18.460	70.48 score on a scale Standard Deviation 19.993	70.40 score on a scale Standard Deviation 17.630	69.44 score on a scale Standard Deviation 19.907	66.80 score on a scale Standard Deviation 18.846	69.07 score on a scale Standard Deviation 20.094
Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 Change at Week 384	-0.48 score on a scale Standard Deviation 19.631	-1.67 score on a scale Standard Deviation 18.855	-7.24 score on a scale Standard Deviation 18.419	-3.17 score on a scale Standard Deviation 22.003	-1.71 score on a scale Standard Deviation 25.330	-4.11 score on a scale Standard Deviation 16.270

SECONDARY outcome

Timeframe: Baseline, Week 384

Population: ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Participants were tested using the contrast level of 100%, 2.5%, and 1.25% charts, and the scores were defined as the number of letters identified correctly for each chart (the maximum score was 60). Higher scores indicate better functioning. A positive change from baseline indicates better functioning.

Outcome measures

Measure	BG00012 240 mg BID n=501 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=502 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	BG00012 240 mg BID (Prior BG00012 Matched Placebo) n=249 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior BG00012 Matched Placebo) n=248 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) n=118 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) n=118 Participants Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Change From Baseline in Visual Function Test Scores at Week 384 Baseline: 100% Chart	54.7 score on a scale Standard Deviation 7.95	55.0 score on a scale Standard Deviation 7.84	55.1 score on a scale Standard Deviation 7.26	54.8 score on a scale Standard Deviation 7.12	54.3 score on a scale Standard Deviation 8.26	55.0 score on a scale Standard Deviation 6.73
Change From Baseline in Visual Function Test Scores at Week 384 Change at Week 384: 100% Chart	-0.4 score on a scale Standard Deviation 6.76	-1.9 score on a scale Standard Deviation 6.81	-1.4 score on a scale Standard Deviation 8.48	-1.2 score on a scale Standard Deviation 7.53	-1.6 score on a scale Standard Deviation 8.05	-0.7 score on a scale Standard Deviation 5.17
Change From Baseline in Visual Function Test Scores at Week 384 Baseline: 2.5% Chart	32.4 score on a scale Standard Deviation 12.17	32.6 score on a scale Standard Deviation 11.76	32.4 score on a scale Standard Deviation 11.42	32.3 score on a scale Standard Deviation 11.99	31.8 score on a scale Standard Deviation 12.36	31.7 score on a scale Standard Deviation 12.41
Change From Baseline in Visual Function Test Scores at Week 384 Change at Week 384: 2.5% Chart	-2.4 score on a scale Standard Deviation 10.77	-3.3 score on a scale Standard Deviation 10.43	-1.5 score on a scale Standard Deviation 11.77	-4.9 score on a scale Standard Deviation 11.14	-4.0 score on a scale Standard Deviation 11.90	-2.1 score on a scale Standard Deviation 9.86
Change From Baseline in Visual Function Test Scores at Week 384 Baseline: 1.25% Chart	24.1 score on a scale Standard Deviation 12.45	24.2 score on a scale Standard Deviation 12.28	23.8 score on a scale Standard Deviation 12.11	23.7 score on a scale Standard Deviation 12.96	23.4 score on a scale Standard Deviation 11.76	22.2 score on a scale Standard Deviation 13.25
Change From Baseline in Visual Function Test Scores at Week 384 Change at Week 384: 1.25% Chart	-5.8 score on a scale Standard Deviation 13.39	-6.0 score on a scale Standard Deviation 11.77	-4.1 score on a scale Standard Deviation 13.04	-7.4 score on a scale Standard Deviation 12.42	-6.7 score on a scale Standard Deviation 13.78	-5.0 score on a scale Standard Deviation 12.74

Adverse Events

BG00012 240 mg BID

Serious events: 279 serious events

Other events: 779 other events

Deaths: 5 deaths

BG00012 240 mg TID

Serious events: 272 serious events

Other events: 767 other events

Deaths: 6 deaths

Serious adverse events

Measure	BG00012 240 mg BID n=868 participants at risk Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=868 participants at risk Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.
Blood and lymphatic system disorders Anaemia	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Blood and lymphatic system disorders Iron deficiency anaemia	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Blood and lymphatic system disorders Leukopenia	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Blood and lymphatic system disorders Lymphopenia	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Blood and lymphatic system disorders Neutropenia	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Blood and lymphatic system disorders Thrombocytopenia	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Cardiac disorders Acute coronary syndrome	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Cardiac disorders Acute myocardial infarction	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Cardiac disorders Atrial fibrillation	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Cardiac disorders Cardiac arrest	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Cardiac disorders Cardiac failure congestive	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Cardiac disorders Coronary artery disease	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Cardiac disorders Left ventricular dysfunction	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Cardiac disorders Mitral valve prolapse	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Cardiac disorders Myocardial infarction	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.58% 5/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Cardiac disorders Myocardial ischaemia	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Cardiac disorders Wolff-parkinson-white syndrome	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Congenital, familial and genetic disorders Cytogenetic abnormality	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Congenital, familial and genetic disorders Limb malformation	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Ear and labyrinth disorders Hypoacusis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Ear and labyrinth disorders Vertigo positional	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Endocrine disorders Autoimmune thyroiditis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Endocrine disorders Basedow's disease	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Endocrine disorders Goitre	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Endocrine disorders Hyperthyroidism	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Eye disorders Cataract	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Eye disorders Glaucoma	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Eye disorders Retinal ischaemia	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Eye disorders Ulcerative keratitis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Eye disorders Vision blurred	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Abdominal hernia	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Abdominal pain	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Colitis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Colitis ulcerative	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Crohn's disease	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Diarrhoea	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Duodenal ulcer perforation	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Duodenitis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Gastric haemorrhage	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Gastritis	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Gastrointestinal inflammation	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Gastrointestinal mucosal disorder	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Gastrointestinal necrosis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Haemorrhoids	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Inguinal hernia	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Pancreatitis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Peritonitis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Small intestinal obstruction	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Subileus	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Umbilical hernia	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Volvulus	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
General disorders Capsular contracture associated with breast implant	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
General disorders Chest pain	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
General disorders Gait disturbance	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
General disorders Impaired healing	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
General disorders Non-cardiac chest pain	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
General disorders Oedema peripheral	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
General disorders Pyrexia	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
General disorders Serositis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
General disorders Treatment failure	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Hepatobiliary disorders Bile duct stone	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Hepatobiliary disorders Biliary colic	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Hepatobiliary disorders Cholecystitis	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Hepatobiliary disorders Cholecystitis acute	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Hepatobiliary disorders Cholelithiasis	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.81% 7/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Hepatobiliary disorders Chronic hepatitis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Hepatobiliary disorders Hepatic failure	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Immune system disorders Anaphylactic reaction	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Immune system disorders Drug hypersensitivity	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Appendicitis	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.46% 4/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Bacterial infection	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Bacteriuria	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Bronchitis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Bronchopneumonia	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Bronchopulmonary aspergillosis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Cellulitis	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Herpes simplex	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Chronic sinusitis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Chronic tonsillitis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Dengue fever	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Diarrhoea infectious	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Diverticulitis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Endometritis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Escherichia infection	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Gastroenteritis	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Gastroenteritis norovirus	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Gastrointestinal bacterial infection	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Genital herpes	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Haematoma infection	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Herpes zoster	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Infected skin ulcer	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Lower respiratory tract infection	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Meningitis viral	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Nasopharyngitis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Oesophageal candidiasis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Oral candidiasis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Osteomyelitis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Papilloma viral infection	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Pelvic abscess	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Peritonsillar abscess	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Peritonsillitis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Pneumonia	0.69% 6/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Pneumonia bacterial	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Post procedural infection	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Progressive multifocal leukoencephalopathy (PML)	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Pulmonary tuberculoma	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Pyelonephritis acute	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Pyelonephritis chronic	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Pyothorax	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Rectal abscess	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Respiratory tract infection	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Respiratory tract infection viral	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Scrub typhus	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Septic shock	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Sinusitis	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Subcutaneous abscess	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Tooth abscess	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Upper respiratory tract infection	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Urinary tract infection	1.2% 10/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.46% 4/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Urosepsis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Vaginal infection	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Vestibular neuronitis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Viral infection	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Accident	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Accident at work	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumour	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Animal bite	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Ankle fracture	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Avulsion fracture	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Brain contusion	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Concussion	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Contusion	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Drug toxicity	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Fall	1.5% 13/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	2.1% 18/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Femoral neck fracture	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.46% 4/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Femur fracture	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Foot fracture	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Hip fracture	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.46% 4/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Incision site haematoma	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Joint dislocation	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Joint injury	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Ligament injury	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Ligament rupture	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Lower limb fracture	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Meniscus lesion	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Multiple injuries	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Overdose	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Postoperative hernia	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Pubis fracture	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Radius fracture	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Respiratory fume inhalation disorder	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Road traffic accident	0.46% 4/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.58% 5/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Skeletal injury	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Tibia fracture	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.58% 5/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Wound	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Investigations Anticoagulation drug level above therapeutic	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Investigations Investigation	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Investigations Lymphocyte count decreased	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Metabolism and nutrition disorders Dehydration	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Metabolism and nutrition disorders Diabetes mellitus	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Metabolism and nutrition disorders Obesity	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Arthritis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Back pain	0.46% 4/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Bursitis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Chondropathy	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Foot deformity	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.58% 5/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Myositis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.58% 5/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.46% 4/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Periarthritis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Spinal deformity	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenolymphoma	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowenoid papulosis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.46% 4/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.92% 8/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage II	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour of the pancreas	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix neoplasm	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroma	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioma	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyoma	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage II	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage unspecified	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma malignant	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pharyngeal neoplasm benign	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the cervix	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous endometrial carcinoma	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.69% 6/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Cerebral haemorrhage	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Cerebral ischaemia	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Cerebrovascular insufficiency	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Complex partial seizures	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Convulsion	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Dementia	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Disturbance in attention	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Dysarthria	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Epilepsy	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Headache	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Hemiparesis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Hypoaesthesia	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Intracranial aneurysm	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Lumbar radiculopathy	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Migraine	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Multiple sclerosis	0.46% 4/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Multiple sclerosis relapse	13.4% 116/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	14.1% 122/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Muscle spasticity	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Neuralgia	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Optic neuritis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Paraesthesia	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Paraparesis	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Parkinson's disease	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Quadriparesis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Radiculitis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Relapsing-remitting multiple sclerosis	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Sciatica	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Subarachnoid haemorrhage	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Syncope	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Transient global amnesia	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Trigeminal neuralgia	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Uhthoff's phenomenon	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Pregnancy, puerperium and perinatal conditions Complication of pregnancy	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Acute psychosis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Alcoholism	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Anorexia nervosa	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Anxiety disorder	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Burnout syndrome	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Catatonia	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Completed suicide	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Delirium	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Depression	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Drug abuse	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Hallucination	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Major depression	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Mood disorder due to a general medical condition	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Morbid thoughts	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Neurosis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Psychiatric decompensation	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Psychotic behaviour	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Psychotic disorder	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Psychotic disorder due to a general medical condition	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Stress	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Suicide attempt	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Renal and urinary disorders Haematuria	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Renal and urinary disorders Hydronephrosis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Renal and urinary disorders Nephrolithiasis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Renal and urinary disorders Nephrotic syndrome	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Renal and urinary disorders Neurogenic bladder	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Renal and urinary disorders Renal failure acute	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Reproductive system and breast disorders Breast necrosis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Reproductive system and breast disorders Cystocele	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Reproductive system and breast disorders Endometrial hyperplasia	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Reproductive system and breast disorders Endometriosis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Reproductive system and breast disorders Fibrocystic breast disease	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Reproductive system and breast disorders Menorrhagia	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Reproductive system and breast disorders Metrorrhagia	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.35% 3/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Reproductive system and breast disorders Ovarian cyst	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Reproductive system and breast disorders Pelvic adhesions	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Reproductive system and breast disorders Pelvic pain	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Reproductive system and breast disorders Uterine polyp	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Respiratory, thoracic and mediastinal disorders Asthma	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Respiratory, thoracic and mediastinal disorders Choking	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Respiratory, thoracic and mediastinal disorders Paranasal cyst	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.23% 2/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Respiratory, thoracic and mediastinal disorders Pulmonary sarcoidosis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Skin and subcutaneous tissue disorders Skin ulcer	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Abdominoplasty	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Aortic valve replacement	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Appendicectomy	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Bladder neck suspension	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Bunion operation	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Caesarean section	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Carpal tunnel decompression	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Cholecystectomy	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Thyroidectomy	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Cochlea implant	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Cystocele repair	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Female sterilisation	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Hip arthroplasty	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Hysterectomy	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Knee arthroplasty	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Mammoplasty	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Medical device change	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Medical device removal	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Ovarian cystectomy	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Percutaneous coronary intervention	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Postoperative care	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Surgery	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Umbilical hernia repair	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Surgical and medical procedures Varicose vein operation	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Vascular disorders Circulatory collapse	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Vascular disorders Deep vein thrombosis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Vascular disorders Hypertension	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Vascular disorders Hypertensive crisis	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Vascular disorders Venous thrombosis	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Vascular disorders Venous thrombosis limb	0.00% 0/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	0.12% 1/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.

Other adverse events

Measure	BG00012 240 mg BID n=868 participants at risk Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	BG00012 240 mg TID n=868 participants at risk Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.
Blood and lymphatic system disorders Lymphopenia	6.0% 52/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	4.8% 42/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Abdominal pain	5.8% 50/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	6.3% 55/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Abdominal pain upper	7.9% 69/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	8.8% 76/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Diarrhoea	12.8% 111/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	13.6% 118/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Nausea	6.5% 56/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	7.0% 61/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Gastrointestinal disorders Vomiting	4.8% 42/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	5.2% 45/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
General disorders Fatigue	11.5% 100/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	11.8% 102/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
General disorders Pyrexia	5.4% 47/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	5.0% 43/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Bronchitis	9.4% 82/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	11.3% 98/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Gastroenteritis	6.0% 52/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	3.8% 33/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Herpes zoster	5.4% 47/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	4.4% 38/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Influenza	10.0% 87/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	7.7% 67/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Nasopharyngitis	25.3% 220/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	26.0% 226/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Pharyngitis	5.1% 44/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	5.8% 50/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Sinusitis	7.5% 65/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	7.3% 63/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Upper respiratory tract infection	16.5% 143/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	15.7% 136/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Infections and infestations Urinary tract infection	22.6% 196/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	18.9% 164/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Injury, poisoning and procedural complications Fall	6.9% 60/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	7.3% 63/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Investigations Alanine aminotransferase increased	6.1% 53/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	6.8% 59/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Investigations Albumin urine present	7.6% 66/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	7.1% 62/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Investigations Lymphocyte count decreased	6.5% 56/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	4.8% 42/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Arthralgia	11.2% 97/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	13.2% 115/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Back pain	14.4% 125/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	14.4% 125/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Muscle spasms	4.4% 38/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	5.6% 49/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.0% 35/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	5.6% 49/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Musculoskeletal and connective tissue disorders Pain in extremity	11.8% 102/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	10.6% 92/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Dizziness	6.9% 60/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	5.2% 45/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Headache	16.7% 145/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	15.1% 131/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Hypoaesthesia	7.4% 64/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	5.6% 49/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Multiple sclerosis relapse	37.3% 324/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	38.6% 335/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Nervous system disorders Paraesthesia	6.6% 57/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	6.8% 59/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Anxiety	3.6% 31/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	5.3% 46/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Depression	11.8% 102/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	10.0% 87/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Psychiatric disorders Insomnia	6.0% 52/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	5.9% 51/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Renal and urinary disorders Haematuria	5.6% 49/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	7.0% 61/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Renal and urinary disorders Microalbuminuria	6.3% 55/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	7.0% 61/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Renal and urinary disorders Proteinuria	8.8% 76/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	9.3% 81/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 54/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	7.6% 66/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Skin and subcutaneous tissue disorders Erythema	5.4% 47/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	3.7% 32/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Skin and subcutaneous tissue disorders Pruritus	5.8% 50/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	4.4% 38/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Skin and subcutaneous tissue disorders Rash	5.2% 45/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	4.6% 40/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Vascular disorders Flushing	19.6% 170/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	19.0% 165/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Vascular disorders Hot flush	5.1% 44/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	6.1% 53/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Vascular disorders Hypertension	5.9% 51/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.	5.0% 43/868 • From start of the study up to follow-up (up to Week 561) Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.

Additional Information

US Biogen Clinical Trial Center

Biogen

Phone: 866-633-4636

Email: clinicaltrials@biogen.com

Results disclosure agreements

• Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
• Publication restrictions are in place

Restriction type: OTHER