Trial Outcomes & Findings for Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis (NCT NCT00413699)

NCT ID: NCT00413699

Last Updated: 2018-10-30

Results Overview

Treatment-emergent non serious AEs by System Organ Class (SOC) (all causalities) and Laboratory Test Abnormalities (without regard to baseline) The stated number of participants analyzed was the total number of participants in each group (AEs). The actual number of participants analyzed for each laboratory parameter varied, and is provided for each. Abs=absolute; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ESR=erythrocyte sedimentation rate; GGT=gamma glutamyl transferase; hgb=hemoglobin; HDL=high density lipids; LDL=low density lipids; LLN=lower limit of normal; qual=qualitative; Tot=total; ULN=upper limit of normal; WBC=white blood cell

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 4488 participants
• Primary outcome timeframe: Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug
• Results posted on: 2018-10-30

Participant Flow

Initial period (IP): conducted at multiple sites, participants were assigned to Tofacitinib 5 mg and 10 mg BID. Extension period (EP): participants who took part initially in IP, completed 2 years of lymphocyte assessment in IP, given consent, were enrolled in EP and assigned to "Extension Period: Tofacitinib 5 mg". EP was conducted in 2 countries.

Participants had previously participated in qualifying studies (A3921019, A3921025, A3921032, A3921035, A3921044, A3921045, A3921046, A3921064, A3921068, A3921069, A3921073, A3921109, A3921129, A3921130, A3921152, A3921237) prior to enrollment in initial period.

Participant milestones

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Extension Period: Tofacitinib 5 mg Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.
Initial Period STARTED	1123	3358	0
Initial Period COMPLETED	484	1653	0
Initial Period NOT COMPLETED	639	1705	0
Extension Period STARTED	0	0	48
Extension Period COMPLETED	0	0	43
Extension Period NOT COMPLETED	0	0	5

Reasons for withdrawal

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Extension Period: Tofacitinib 5 mg Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.
Initial Period Death	25	30	0
Initial Period Lack of Efficacy	59	115	0
Initial Period Lost to Follow-up	31	101	0
Initial Period Protocol Violation	38	89	0
Initial Period Pregnancy	10	8	0
Initial Period Did not meet entrance criteria	2	2	0
Initial Period Medication error without adverse event	0	1	0
Initial Period Study terminated by Sponsor	0	1	0
Initial Period Other	67	211	0
Initial Period Adverse event related to study drug	178	527	0
Initial Period Adverse event not related to study drug	113	248	0
Initial Period Missing end of study page	0	4	0
Initial Period No longer willing to participate	116	368	0
Extension Period No Longer Willing to Participate	0	0	2
Extension Period Protocol Violation	0	0	1
Extension Period Adverse Event	0	0	2

Baseline Characteristics

Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis

Baseline characteristics by cohort

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=1123 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=3358 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Total n=4481 Participants Total of all reporting groups
Age, Customized <18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 18 to 64 years	916 Participants n=5 Participants	2838 Participants n=7 Participants	3754 Participants n=5 Participants
Age, Customized >=65 years	207 Participants n=5 Participants	520 Participants n=7 Participants	727 Participants n=5 Participants
Sex/Gender, Customized Female	927 Participants n=5 Participants	2744 Participants n=7 Participants	3671 Participants n=5 Participants
Sex/Gender, Customized Male	196 Participants n=5 Participants	614 Participants n=7 Participants	810 Participants n=5 Participants

PRIMARY outcome

Timeframe: Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug

Population: For abnormal laboratory results, those listed include both mandatory and optional laboratory tests. The number of participants analyzed is the number with at least one evaluable observation of the given laboratory test. Fasting lipids were only collected from participants who enrolled more than 14 days after last visit of their qualifying study.

Treatment-emergent non serious AEs by System Organ Class (SOC) (all causalities) and Laboratory Test Abnormalities (without regard to baseline) The stated number of participants analyzed was the total number of participants in each group (AEs). The actual number of participants analyzed for each laboratory parameter varied, and is provided for each.

Abs=absolute; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ESR=erythrocyte sedimentation rate; GGT=gamma glutamyl transferase; hgb=hemoglobin; HDL=high density lipids; LDL=low density lipids; LLN=lower limit of normal; qual=qualitative; Tot=total; ULN=upper limit of normal; WBC=white blood cell

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=1123 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=3358 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib n=4481 Participants All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Participants with non-serious AEs	991 Number of participants	2963 Number of participants	3954 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Blood and lymphatic system disorders	159 Number of participants	395 Number of participants	554 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Cardiac disorders	93 Number of participants	185 Number of participants	278 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Congenital, familial and genetic disorders	6 Number of participants	16 Number of participants	22 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Ear and labyrinth disorders	67 Number of participants	138 Number of participants	205 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Endocrine disorders	29 Number of participants	94 Number of participants	123 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Eye disorders	117 Number of participants	259 Number of participants	376 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Gastrointestinal disorders	393 Number of participants	1011 Number of participants	1404 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports General disorders and admin site conditions	169 Number of participants	477 Number of participants	646 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Hepatobiliary disorders	60 Number of participants	176 Number of participants	236 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Immune system disorders	18 Number of participants	87 Number of participants	105 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Infections and infestations	704 Number of participants	2200 Number of participants	2904 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Injury, poisoning and procedural complications	244 Number of participants	721 Number of participants	965 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Investigations	402 Number of participants	995 Number of participants	1397 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Metabolism and nutrition disorders	184 Number of participants	562 Number of participants	746 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Musculoskeletal and connective tissue disorders	425 Number of participants	1314 Number of participants	1739 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Neoplasms benign, malignant and unspecified	80 Number of participants	219 Number of participants	299 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Nervous system disorders	222 Number of participants	639 Number of participants	861 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Pregnancy, puerperium and perinatal conditions	1 Number of participants	0 Number of participants	1 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Product issues	2 Number of participants	8 Number of participants	10 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Psychiatric disorders	97 Number of participants	280 Number of participants	377 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Renal and urinary disorders	123 Number of participants	265 Number of participants	388 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Reproductive system and breast disorders	89 Number of participants	206 Number of participants	295 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Respiratory, thoracic and mediastinal disorders	208 Number of participants	634 Number of participants	842 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Skin and subcutaneous tissue disorders	201 Number of participants	682 Number of participants	883 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Social circumstances	1 Number of participants	5 Number of participants	6 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Surgical and medical procedures	2 Number of participants	4 Number of participants	6 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Vascular disorders	207 Number of participants	468 Number of participants	675 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Participants evaluable for lab abnormalities	1118 Number of participants	3346 Number of participants	4464 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Participants with laboratory abnormalities	1095 Number of participants	3208 Number of participants	4303 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Hemoglobin <0.8x LLN	57 Number of participants	148 Number of participants	205 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Hematocrit <0.8x LLN	29 Number of participants	67 Number of participants	96 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Red blood cell count <0.8x LLN	32 Number of participants	142 Number of participants	174 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Reticulocytes (Abs) <0.5x LLN	44 Number of participants	5 Number of participants	49 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Reticulocytes (Abs) >1.5x ULN	49 Number of participants	9 Number of participants	58 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Platelets <0.5x LLN	5 Number of participants	2 Number of participants	7 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Platelets >1.75x ULN	5 Number of participants	25 Number of participants	30 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Reticulocyte count (%) <0.5x LLN	1 Number of participants	1 Number of participants	2 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Reticulocyte count (%) >1.5x ULN	24 Number of participants	17 Number of participants	41 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports WBC count <0.6x LLN	21 Number of participants	33 Number of participants	54 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports WBC count >1.5x ULN	29 Number of participants	71 Number of participants	100 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Lymphocytes (Abs) <0.8x LLN	254 Number of participants	789 Number of participants	1043 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Lymphocytes (Abs) >1.2x ULN	23 Number of participants	94 Number of participants	117 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Lymphocytes (%) <0.8x LLN	401 Number of participants	1267 Number of participants	1668 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Lymphocytes (%) >1.2x ULN	23 Number of participants	75 Number of participants	98 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Tot neutrophils (Abs) <0.8x LLN	105 Number of participants	305 Number of participants	410 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Tot neutrophils (Abs) >1.2x ULN	239 Number of participants	617 Number of participants	856 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Neutrophils (%) <0.8x LLN	23 Number of participants	75 Number of participants	98 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Neutrophils (%) >1.2x ULN	29 Number of participants	93 Number of participants	122 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Basophils (Abs) >1.2x ULN	19 Number of participants	10 Number of participants	29 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Basophils (%) >1.2x ULN	76 Number of participants	221 Number of participants	297 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Eosinophils (Abs) >1.2x ULN	24 Number of participants	58 Number of participants	82 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Eosinophils (%) >1.2x ULN	36 Number of participants	118 Number of participants	154 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Monocytes (Abs) >1.2x ULN	65 Number of participants	107 Number of participants	172 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Monocytes (%) >1.2x ULN	128 Number of participants	405 Number of participants	533 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports ESR >1.5x ULN	872 Number of participants	2411 Number of participants	3283 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Total bilirubin >1.5x ULN	18 Number of participants	38 Number of participants	56 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Direct bilirubin >1.5x ULN	5 Number of participants	14 Number of participants	19 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Indirect bilirubin >1.5x ULN	4 Number of participants	18 Number of participants	22 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports AST >3.0x ULN	52 Number of participants	111 Number of participants	163 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports ALT >3.0x ULN	87 Number of participants	189 Number of participants	276 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports GGT >3.0x ULN	82 Number of participants	239 Number of participants	321 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Alkaline phosphatase >3.0x ULN	3 Number of participants	10 Number of participants	13 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Total protein <0.8x LLN	1 Number of participants	0 Number of participants	1 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Total protein >1.2x ULN	2 Number of participants	4 Number of participants	6 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Albumin <0.8x LLN	11 Number of participants	28 Number of participants	39 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Albumin >1.2x ULN	0 Number of participants	0 Number of participants	0 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Blood urea nitrogen >1.3x ULN	87 Number of participants	126 Number of participants	213 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Creatinine >1.3x ULN	52 Number of participants	95 Number of participants	147 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Cholesterol >1.3x ULN	42 Number of participants	130 Number of participants	172 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports HDL Cholesterol <0.8x LLN	32 Number of participants	59 Number of participants	91 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports LDL Cholesterol >1.2x ULN	69 Number of participants	145 Number of participants	214 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Triglycerides >1.3x ULN	196 Number of participants	373 Number of participants	569 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Sodium <0.95x LLN	6 Number of participants	19 Number of participants	25 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Sodium >1.05x ULN	11 Number of participants	18 Number of participants	29 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Potassium <0.9x LLN	28 Number of participants	62 Number of participants	90 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Potassium >1.1x ULN	11 Number of participants	25 Number of participants	36 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Chloride <0.9x LLN	3 Number of participants	5 Number of participants	8 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Chloride >1.1x ULN	0 Number of participants	1 Number of participants	1 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Calcium <0.9x LLN	2 Number of participants	8 Number of participants	10 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Calcium >1.1x ULN	6 Number of participants	9 Number of participants	15 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Bicarbonate (venous) <0.9x LLN	106 Number of participants	277 Number of participants	383 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Bicarbonate (venous) >1.1x ULN	1 Number of participants	5 Number of participants	6 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Glucose <0.6x LLN	3 Number of participants	4 Number of participants	7 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Glucose >1.5x ULN	125 Number of participants	345 Number of participants	470 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Creatine Kinase >2.0x ULN	203 Number of participants	908 Number of participants	1111 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports C-reactive protein >1.25x ULN	365 Number of participants	106 Number of participants	471 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Urine specific gravity <1.003	2 Number of participants	7 Number of participants	9 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Urine specific gravity >1.030	203 Number of participants	303 Number of participants	506 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Urine pH <4.5	0 Number of participants	0 Number of participants	0 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Urine pH >8	20 Number of participants	17 Number of participants	37 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Urine glucose (qual) ≥1	60 Number of participants	148 Number of participants	208 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Urine ketones (qual) ≥1	2 Number of participants	1 Number of participants	3 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Urine protein (qual) ≥1	65 Number of participants	222 Number of participants	287 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Urine blood/hgb (qual) ≥1	444 Number of participants	1260 Number of participants	1704 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Urine leukocyte esterase ≥1	158 Number of participants	23 Number of participants	181 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Urine red blood cells ≥20	198 Number of participants	491 Number of participants	689 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Urine WBC ≥20	219 Number of participants	507 Number of participants	726 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Urine epithelial cells ≥6	205 Number of participants	20 Number of participants	225 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Urine casts >1	0 Number of participants	0 Number of participants	0 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Urine granular casts >1	—	0 Number of participants	0 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Urine hyaline casts >1	0 Number of participants	0 Number of participants	0 Number of participants	—	—	—
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports Urine bacteria >20	0 Number of participants	0 Number of participants	0 Number of participants	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)

Population: Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=48 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) Participants with AEs	16 Participants	—	—	—	—	—
Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) Participants with SAEs	5 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)

Population: Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period.

Criteria for laboratory abnormalities: hemoglobin (Hg), hematocrit, red blood cell (RBC), high density lipoprotein (HDL) cholesterol:<0.8*lower limit of normal (LLN), platelet<0.5*LLN/>1.75*upper limit of normal (ULN), white blood cell (WBC)<0.6*LLN/>1.5*ULN, lymphocyte, neutrophil, protein, albumin <0.8*LLN/>1.2*ULN, basophil, eosinophil, monocyte, low density lipoprotein (LDL) cholesterol: >1.2*ULN; bilirubin>1.5*ULN, aspartate amino transferase(AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:>3.0*ULN; blood urea nitrogen, creatinine, cholesterol, triglyceride:>1.3*ULN; sodium <0.95*LLN/>1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN/>1.1*ULN; glucose<0.6*LLN/>1.5*ULN; Urine (specific gravity<1.003/>1.030, pH<4.5/>8, glucose, ketone, protein, blood/Hg(>=1; RBC, WBC>=20; creatinine kinase>2*ULN).

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=48 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Extension Period: Number of Participants With Laboratory Test Abnormalities	30 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Includes AEs for every visit and up to 999 days after last dose of study drug

Population: The stated number of participants analyzed is the total number of participants enrolled in each group. The number of evaluable participants is the number remaining in the study in the given time period.

Treatment-emergent AEs by SOC (all causalities) - all participants, by time. Data presented for Post Month 96 includes data up to and including Month 114.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=1123 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=3358 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib n=4481 Participants All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Evaluable for AEs at Months 78 to 84	302 Number of participants	86 Number of participants	388 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Evaluable for AEs at Months 72 to 78	336 Number of participants	262 Number of participants	598 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent with AEs at Months 72 to 78	33.6 Number of participants	22.5 Number of participants	28.8 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Evaluable for AEs at Months 0 to 6	1123 Number of participants	3358 Number of participants	4481 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent with AEs at Months 0 to 6	59.4 Number of participants	61.8 Number of participants	61.2 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent discontinued due to AEs at Months 0 to 6	4.2 Number of participants	4.0 Number of participants	4.0 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Evaluable for AEs at Months 6 to 12	1033 Number of participants	3121 Number of participants	4154 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent with AEs at Months 6 to 12	45.1 Number of participants	47.7 Number of participants	47.1 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent discontinued due to AEs at Months 6 to 12	2.1 Number of participants	3.7 Number of participants	3.3 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Evaluable for AEs at Months 12 to 18	969 Number of participants	2865 Number of participants	3834 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent with AEs at Months 12 to 18	41.2 Number of participants	46.8 Number of participants	45.4 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent discontinued due to AEs at Months 12 to 18	3.2 Number of participants	3.4 Number of participants	3.3 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Evaluable at Months 18 to 24	896 Number of participants	2660 Number of participants	3556 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent with AEs at Months 18 to 24	38.1 Number of participants	43.2 Number of participants	41.9 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent discontinued due to AEs at Months 18 to 24	2.8 Number of participants	2.9 Number of participants	2.9 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Evaluable for AEs at Months 24 to 30	820 Number of participants	2461 Number of participants	3281 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent with AEs at Months 24 to 30	40.7 Number of participants	44.5 Number of participants	43.5 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent discontinued due to AEs at Months 24 to 30	3.2 Number of participants	2.8 Number of participants	2.9 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Evaluable for AEs at Months 30 to 36	774 Number of participants	2288 Number of participants	3062 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent with AEs at Months 30 to 36	39.0 Number of participants	40.7 Number of participants	40.3 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent discontinued due to AEs at Months 30 to 36	2.6 Number of participants	2.5 Number of participants	2.5 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Evaluable for AEs at Months 36 to 42	729 Number of participants	2162 Number of participants	2891 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent with AEs at Months 36 to 42	38.1 Number of participants	37.5 Number of participants	37.6 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent discontinued due to AEs at Months 36 to 42	2.5 Number of participants	2.5 Number of participants	2.5 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Evaluable for AEs at Months 42 to 48	652 Number of participants	1843 Number of participants	2495 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent with AEs at Months 42 to 48	37.9 Number of participants	34.3 Number of participants	35.3 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent discontinued due to AEs at Months 42 to 48	2.8 Number of participants	2.9 Number of participants	2.9 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Evaluable for AEs at Months 48 to 54	558 Number of participants	1471 Number of participants	2029 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent with AEs at Months 48 to 54	36.0 Number of participants	36.4 Number of participants	36.3 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent discontinued due to AEs at Months 48 to 54	2.0 Number of participants	2.5 Number of participants	2.4 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Evaluable for AEs at Months 54 to 60	466 Number of participants	1172 Number of participants	1638 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent with AEs at Months 54 to 60	37.1 Number of participants	35.4 Number of participants	35.9 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent discontinued due to AEs at Months 54 to 60	3.6 Number of participants	2.7 Number of participants	3.0 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Evaluable for AEs at Months 60 to 66	414 Number of participants	918 Number of participants	1332 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent with AEs at Months 60 to 66	33.8 Number of participants	31.4 Number of participants	32.1 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent discontinued due to AEs at Months 60 to 66	2.4 Number of participants	1.9 Number of participants	2.0 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Evaluable for AEs at Months 66 to 72	379 Number of participants	670 Number of participants	1049 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent with AEs at Months 66 to 72	33.5 Number of participants	21.6 Number of participants	25.9 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent discontinued due to AEs at Months 66 to 72	3.2 Number of participants	0.7 Number of participants	1.6 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent discontinued due to AEs at Months 72 to 78	0.9 Number of participants	0.4 Number of participants	0.7 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent with AEs at Months 78 to 84	36.8 Number of participants	26.7 Number of participants	34.5 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent discontinued due to AEs at Months 78 to 84	3.3 Number of participants	1.2 Number of participants	2.8 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Evaluable for AEs at Months 84 to 90	273 Number of participants	42 Number of participants	315 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent with AEs at Months 84 to 90	30.8 Number of participants	35.7 Number of participants	31.4 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent discontinued due to AEs at Months 84 to 90	1.8 Number of participants	0 Number of participants	1.6 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Evaluable for AEs at Months 90 to 96	234 Number of participants	34 Number of participants	268 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent with AEs at Months 90 to 96	21.8 Number of participants	29.4 Number of participants	22.8 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent discontinued due to AEs at Months 90 to 96	0.9 Number of participants	0 Number of participants	0.7 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Evaluable for AEs post Month 96	130 Number of participants	15 Number of participants	145 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent with AEs post Month 96	20.8 Number of participants	46.7 Number of participants	23.4 Number of participants	—	—	—
Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis Percent discontinued due to AEs post Month 96	1.5 Number of participants	0 Number of participants	1.4 Number of participants	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period

Population: Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, "Number Analyzed" signifies number of participants evaluable for specified categories.

Long term safety and tolerability of Tofacitinib was measured as following: percentage (%) of participants with AEs, percentage of participants who discontinued due to AEs. An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=48 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib Baseline to Month 6: % of Participants with AEs	31.3 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib Baseline to Month6:% of Participants Discontinued	4.2 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib Month 6 to 12: % of Participants with AEs	17.6 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib Month 6 to 12: % of Participants Discontinued	0 Percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Every visit until study completion

Population: The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.

The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented. ACR20 is defined as a 20% improvement from baseline in tender/painful joint count and swollen joint count, and at least 3 of the following 5 variables: Subject's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, Subject's Assessment of Arthritis Pain, Health Assessment Questionnaire - Disability Index, C-Reactive Protein (CRP). ACR50 is a 50% improvement and ACR70 a 70% improvement in these variables.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=1123 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=3358 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib n=4481 Participants All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 60	62.53 Percent of participants	60.65 Percent of participants	61.23 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 63	64.39 Percent of participants	61.99 Percent of participants	62.76 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 66	60.73 Percent of participants	60.85 Percent of participants	60.81 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 69	58.10 Percent of participants	61.11 Percent of participants	59.83 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 72	62.54 Percent of participants	59.93 Percent of participants	61.34 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 75	61.49 Percent of participants	56.14 Percent of participants	59.58 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 78	60.00 Percent of participants	58.24 Percent of participants	59.59 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 81	63.99 Percent of participants	51.85 Percent of participants	62.06 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 84	63.10 Percent of participants	54.55 Percent of participants	61.90 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 87	67.05 Percent of participants	43.90 Percent of participants	63.93 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 90	61.00 Percent of participants	46.15 Percent of participants	58.93 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 93	61.22 Percent of participants	57.14 Percent of participants	60.71 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 96	61.11 Percent of participants	56.25 Percent of participants	60.63 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 99	53.85 Percent of participants	54.55 Percent of participants	53.95 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 102	54.55 Percent of participants	25.00 Percent of participants	50.00 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 105	66.67 Percent of participants	33.33 Percent of participants	61.11 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 108	50.00 Percent of participants	0.00 Percent of participants	44.44 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 105	73.33 Percent of participants	66.67 Percent of participants	72.22 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 108	62.50 Percent of participants	100.00 Percent of participants	66.67 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 111	100.00 Percent of participants	0.00 Percent of participants	75.00 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 114	100.00 Percent of participants	—	100.00 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 1	26.66 Percent of participants	28.82 Percent of participants	28.27 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 2	27.78 Percent of participants	31.53 Percent of participants	30.60 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 3	29.37 Percent of participants	33.09 Percent of participants	32.16 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 6	31.06 Percent of participants	33.75 Percent of participants	33.08 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 9	31.80 Percent of participants	34.91 Percent of participants	34.14 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 12	31.38 Percent of participants	35.84 Percent of participants	34.71 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 96	78.47 Percent of participants	81.25 Percent of participants	78.75 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 99	83.08 Percent of participants	90.91 Percent of participants	84.21 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 102	77.27 Percent of participants	50.00 Percent of participants	73.08 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 21	54.77 Percent of participants	59.10 Percent of participants	58.01 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 15	32.94 Percent of participants	36.54 Percent of participants	35.63 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 1	70.65 Percent of participants	73.60 Percent of participants	72.86 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 2	74.81 Percent of participants	76.06 Percent of participants	75.75 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 3	75.68 Percent of participants	78.00 Percent of participants	77.43 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 6	75.58 Percent of participants	77.36 Percent of participants	76.92 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 9	76.57 Percent of participants	77.53 Percent of participants	77.29 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 12	77.88 Percent of participants	78.24 Percent of participants	78.15 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 15	76.76 Percent of participants	78.67 Percent of participants	78.18 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 18	77.91 Percent of participants	78.46 Percent of participants	78.32 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 21	77.91 Percent of participants	79.42 Percent of participants	79.04 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 24	79.61 Percent of participants	78.37 Percent of participants	78.68 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 27	79.15 Percent of participants	79.16 Percent of participants	79.16 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 30	80.00 Percent of participants	79.90 Percent of participants	79.92 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 33	80.51 Percent of participants	79.81 Percent of participants	79.99 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 36	81.78 Percent of participants	79.37 Percent of participants	79.98 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 39	78.55 Percent of participants	81.23 Percent of participants	80.56 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 42	78.69 Percent of participants	80.49 Percent of participants	80.03 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 45	82.14 Percent of participants	79.55 Percent of participants	80.26 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 48	78.31 Percent of participants	80.69 Percent of participants	80.02 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 51	83.47 Percent of participants	80.30 Percent of participants	81.14 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 54	79.19 Percent of participants	78.97 Percent of participants	79.04 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 57	80.73 Percent of participants	82.37 Percent of participants	81.87 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 60	81.75 Percent of participants	82.39 Percent of participants	82.19 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 63	80.30 Percent of participants	82.97 Percent of participants	82.11 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 66	79.84 Percent of participants	81.42 Percent of participants	80.86 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 69	82.68 Percent of participants	83.54 Percent of participants	83.18 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 72	82.01 Percent of participants	82.58 Percent of participants	82.27 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 75	82.20 Percent of participants	78.95 Percent of participants	81.04 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 78	81.69 Percent of participants	80.22 Percent of participants	81.35 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 81	82.52 Percent of participants	79.63 Percent of participants	82.06 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 84	82.66 Percent of participants	81.82 Percent of participants	82.54 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 87	84.47 Percent of participants	70.73 Percent of participants	82.62 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 90	82.57 Percent of participants	74.36 Percent of participants	81.43 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 93	82.14 Percent of participants	78.57 Percent of participants	81.70 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 12	52.98 Percent of participants	56.73 Percent of participants	55.79 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 2	50.19 Percent of participants	53.29 Percent of participants	52.51 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 3	51.45 Percent of participants	54.52 Percent of participants	53.76 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 6	52.79 Percent of participants	55.75 Percent of participants	55.01 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 9	53.24 Percent of participants	55.96 Percent of participants	55.28 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 15	55.76 Percent of participants	56.61 Percent of participants	56.40 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 18	55.16 Percent of participants	57.30 Percent of participants	56.76 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 24	57.77 Percent of participants	57.67 Percent of participants	57.69 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 27	56.91 Percent of participants	58.58 Percent of participants	58.16 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 30	58.83 Percent of participants	58.65 Percent of participants	58.70 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 33	57.68 Percent of participants	59.31 Percent of participants	58.89 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 36	58.49 Percent of participants	58.51 Percent of participants	58.50 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 39	59.28 Percent of participants	59.29 Percent of participants	59.28 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 42	58.60 Percent of participants	59.99 Percent of participants	59.63 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 45	59.42 Percent of participants	60.07 Percent of participants	59.89 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 48	58.00 Percent of participants	57.60 Percent of participants	57.72 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 51	62.45 Percent of participants	59.19 Percent of participants	60.05 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 54	58.60 Percent of participants	59.44 Percent of participants	59.20 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 57	61.45 Percent of participants	61.12 Percent of participants	61.22 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 111	100.00 Percent of participants	100.00 Percent of participants	100.00 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 114	100.00 Percent of participants	—	100.00 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 1	47.67 Percent of participants	49.56 Percent of participants	49.08 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 60	37.96 Percent of participants	38.91 Percent of participants	38.62 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 18	35.82 Percent of participants	36.40 Percent of participants	36.25 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 21	33.49 Percent of participants	37.66 Percent of participants	36.61 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 24	35.44 Percent of participants	38.15 Percent of participants	37.47 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 27	36.06 Percent of participants	38.33 Percent of participants	37.76 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 30	37.27 Percent of participants	38.99 Percent of participants	38.55 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 33	33.64 Percent of participants	38.26 Percent of participants	37.10 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 36	36.71 Percent of participants	37.41 Percent of participants	37.24 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 39	38.41 Percent of participants	38.88 Percent of participants	38.76 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 42	35.77 Percent of participants	38.91 Percent of participants	38.10 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 45	36.69 Percent of participants	38.18 Percent of participants	37.77 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 48	35.97 Percent of participants	37.01 Percent of participants	36.72 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 51	39.59 Percent of participants	37.34 Percent of participants	37.94 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 54	36.73 Percent of participants	39.32 Percent of participants	38.59 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 57	38.78 Percent of participants	39.47 Percent of participants	39.26 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 63	38.64 Percent of participants	39.33 Percent of participants	39.11 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 66	38.22 Percent of participants	40.14 Percent of participants	39.47 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 69	38.55 Percent of participants	41.56 Percent of participants	40.28 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 72	40.12 Percent of participants	36.59 Percent of participants	38.50 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 75	40.13 Percent of participants	36.84 Percent of participants	38.96 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 78	42.37 Percent of participants	32.97 Percent of participants	40.16 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 81	41.26 Percent of participants	35.19 Percent of participants	40.29 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 84	42.07 Percent of participants	31.82 Percent of participants	40.63 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 87	42.80 Percent of participants	21.95 Percent of participants	40.00 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 90	38.17 Percent of participants	25.64 Percent of participants	36.43 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 93	41.84 Percent of participants	39.29 Percent of participants	41.52 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 96	43.75 Percent of participants	31.25 Percent of participants	42.50 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 99	40.00 Percent of participants	18.18 Percent of participants	36.84 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 102	40.91 Percent of participants	25.00 Percent of participants	38.46 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 105	46.67 Percent of participants	33.33 Percent of participants	44.44 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 108	25.00 Percent of participants	0.00 Percent of participants	22.22 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 111	100.00 Percent of participants	0.00 Percent of participants	75.00 Percent of participants	—	—	—
Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 114	100.00 Percent of participants	—	100.00 Percent of participants	—	—	—

SECONDARY outcome

Timeframe: Month 3, 6, 9 and 12 of Extension Period

Population: Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, "Number Analyzed" signifies number of participants who were evaluable for specified categories.

ACR20=20 percent (%) improvement from baseline (Month 0 at entry of Initial Period) in tender/painful joint count and swollen joint count, and in at least 3 of 5 variables: participant's global assessment of arthritis (PtGA), physician's global assessment of arthritis (PGA), participant's assessment of arthritis pain (PtA), HAQ-DI, C-reactive protein. ACR50 is a 50% improvement and ACR70 is a 70% improvement in these variables. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PtA: participant assessed arthritis pain by 100 millimeter (mm) visual analogue scale, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=48 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 3	70.21 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 6	66.67 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 9	86.67 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR20 at Month 12	50.00 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 3	48.94 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 6	55.56 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 9	60.00 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR50 at Month 12	50.00 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 3	23.40 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 6	36.11 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 9	40.00 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses ACR70 at Month 12	50.00 Percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Not applicable as no data were collected for this endpoint.

Population: No data were collected for this endpoint as it was removed from the protocol in a protocol amendment.

No data were collected for this endpoint because it was removed from the protocol in a previous amendment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every visit until study completion

Population: The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.

Descriptive statistics for DAS28-3 (CRP) and DAS28-4 (ESR). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.

DAS28 is a composite score, calculated using a mathematical formula, and is derived from the number of tender/painful joints (out of 28), number of swollen joints (out of 28), and a blood marker of inflammation (ESR or CRP). DAS28-4 also includes a score of general health in the formula.

The score range is from 0 to 9.4, with a higher score indicating more disease activity. A score of >5.1 indicates active disease, a score of ≤3.2 indicates low disease activity, and a score of <2.6 indicates disease remission.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=1123 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=3358 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib n=4481 Participants All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 96	3.30 Score calculated from formula Standard Deviation 1.12	3.48 Score calculated from formula Standard Deviation 1.06	3.32 Score calculated from formula Standard Deviation 1.11	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 99	3.26 Score calculated from formula Standard Deviation 1.07	3.04 Score calculated from formula Standard Deviation 1.24	3.23 Score calculated from formula Standard Deviation 1.09	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 102	3.34 Score calculated from formula Standard Deviation 1.47	3.10 Score calculated from formula Standard Deviation 1.76	3.30 Score calculated from formula Standard Deviation 1.48	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 105	3.64 Score calculated from formula Standard Deviation 1.52	2.65 Score calculated from formula Standard Deviation 0.97	3.46 Score calculated from formula Standard Deviation 1.46	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 108	3.36 Score calculated from formula Standard Deviation 1.76	4.65 Score calculated from formula Standard Deviation 0	3.51 Score calculated from formula Standard Deviation 1.70	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 111	2.03 Score calculated from formula Standard Deviation 0.69	3.59 Score calculated from formula Standard Deviation 0	2.42 Score calculated from formula Standard Deviation 0.96	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 114	1.28 Score calculated from formula Standard Deviation 0	—	1.28 Score calculated from formula Standard Deviation 0	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Baseline	5.31 Score calculated from formula Standard Deviation 0.95	5.34 Score calculated from formula Standard Deviation 0.98	5.33 Score calculated from formula Standard Deviation 0.97	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 1	3.10 Score calculated from formula Standard Deviation 1.19	2.96 Score calculated from formula Standard Deviation 1.22	2.99 Score calculated from formula Standard Deviation 1.21	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 2	3.01 Score calculated from formula Standard Deviation 1.15	2.87 Score calculated from formula Standard Deviation 1.17	2.90 Score calculated from formula Standard Deviation 1.17	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 3	2.98 Score calculated from formula Standard Deviation 1.15	2.81 Score calculated from formula Standard Deviation 1.15	2.85 Score calculated from formula Standard Deviation 1.15	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 6	2.89 Score calculated from formula Standard Deviation 1.16	2.79 Score calculated from formula Standard Deviation 1.15	2.81 Score calculated from formula Standard Deviation 1.16	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 9	2.82 Score calculated from formula Standard Deviation 1.12	2.74 Score calculated from formula Standard Deviation 1.16	2.76 Score calculated from formula Standard Deviation 1.15	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 12	2.81 Score calculated from formula Standard Deviation 1.11	2.72 Score calculated from formula Standard Deviation 1.13	2.74 Score calculated from formula Standard Deviation 1.13	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 15	2.73 Score calculated from formula Standard Deviation 1.10	2.69 Score calculated from formula Standard Deviation 1.13	2.70 Score calculated from formula Standard Deviation 1.12	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 18	2.72 Score calculated from formula Standard Deviation 1.11	2.66 Score calculated from formula Standard Deviation 1.11	2.68 Score calculated from formula Standard Deviation 1.11	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 21	2.75 Score calculated from formula Standard Deviation 1.12	2.62 Score calculated from formula Standard Deviation 1.09	2.65 Score calculated from formula Standard Deviation 1.09	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 24	2.96 Score calculated from formula Standard Deviation 1.07	2.63 Score calculated from formula Standard Deviation 1.11	2.64 Score calculated from formula Standard Deviation 1.10	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 27	2.66 Score calculated from formula Standard Deviation 1.06	2.60 Score calculated from formula Standard Deviation 1.09	2.62 Score calculated from formula Standard Deviation 1.08	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 30	2.65 Score calculated from formula Standard Deviation 1.07	2.59 Score calculated from formula Standard Deviation 1.09	2.60 Score calculated from formula Standard Deviation 1.08	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 33	2.64 Score calculated from formula Standard Deviation 1.06	2.58 Score calculated from formula Standard Deviation 1.10	2.60 Score calculated from formula Standard Deviation 1.09	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 36	2.64 Score calculated from formula Standard Deviation 1.07	2.59 Score calculated from formula Standard Deviation 1.08	2.60 Score calculated from formula Standard Deviation 1.08	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 39	2.65 Score calculated from formula Standard Deviation 1.10	2.57 Score calculated from formula Standard Deviation 1.07	2.59 Score calculated from formula Standard Deviation 1.08	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 42	2.63 Score calculated from formula Standard Deviation 1.09	2.57 Score calculated from formula Standard Deviation 1.09	2.59 Score calculated from formula Standard Deviation 1.09	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 45	2.57 Score calculated from formula Standard Deviation 1.04	2.53 Score calculated from formula Standard Deviation 1.03	2.54 Score calculated from formula Standard Deviation 1.03	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 48	2.59 Score calculated from formula Standard Deviation 1.03	2.54 Score calculated from formula Standard Deviation 1.05	2.56 Score calculated from formula Standard Deviation 1.04	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 51	2.59 Score calculated from formula Standard Deviation 0.99	2.57 Score calculated from formula Standard Deviation 1.07	2.57 Score calculated from formula Standard Deviation 1.05	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 54	2.68 Score calculated from formula Standard Deviation 1.07	2.56 Score calculated from formula Standard Deviation 1.05	2.59 Score calculated from formula Standard Deviation 1.06	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 57	2.63 Score calculated from formula Standard Deviation 1.03	2.54 Score calculated from formula Standard Deviation 1.04	2.56 Score calculated from formula Standard Deviation 1.03	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 60	2.66 Score calculated from formula Standard Deviation 1.09	2.53 Score calculated from formula Standard Deviation 1.03	2.57 Score calculated from formula Standard Deviation 1.05	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 63	2.67 Score calculated from formula Standard Deviation 1.01	2.51 Score calculated from formula Standard Deviation 0.98	2.56 Score calculated from formula Standard Deviation 0.99	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 66	2.70 Score calculated from formula Standard Deviation 1.02	2.53 Score calculated from formula Standard Deviation 1.01	2.59 Score calculated from formula Standard Deviation 1.02	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 69	2.67 Score calculated from formula Standard Deviation 1.06	2.55 Score calculated from formula Standard Deviation 1.00	2.60 Score calculated from formula Standard Deviation 1.03	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 72	2.65 Score calculated from formula Standard Deviation 1.04	2.64 Score calculated from formula Standard Deviation 1.03	2.64 Score calculated from formula Standard Deviation 1.04	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 75	2.63 Score calculated from formula Standard Deviation 1.05	2.59 Score calculated from formula Standard Deviation 1.02	2.61 Score calculated from formula Standard Deviation 1.04	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 78	2.59 Score calculated from formula Standard Deviation 1.02	2.68 Score calculated from formula Standard Deviation 1.01	2.61 Score calculated from formula Standard Deviation 1.02	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 81	2.54 Score calculated from formula Standard Deviation 0.96	2.82 Score calculated from formula Standard Deviation 1.13	2.59 Score calculated from formula Standard Deviation 0.99	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 84	2.49 Score calculated from formula Standard Deviation 0.94	2.84 Score calculated from formula Standard Deviation 1.20	2.54 Score calculated from formula Standard Deviation 0.99	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 87	2.52 Score calculated from formula Standard Deviation 0.97	2.56 Score calculated from formula Standard Deviation 0.91	2.52 Score calculated from formula Standard Deviation 0.96	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 90	2.55 Score calculated from formula Standard Deviation 1.00	2.58 Score calculated from formula Standard Deviation 0.95	2.55 Score calculated from formula Standard Deviation 0.99	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 93	2.59 Score calculated from formula Standard Deviation 1.00	2.59 Score calculated from formula Standard Deviation 0.85	2.59 Score calculated from formula Standard Deviation 0.98	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 96	2.59 Score calculated from formula Standard Deviation 0.93	2.68 Score calculated from formula Standard Deviation 0.80	2.60 Score calculated from formula Standard Deviation 0.92	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 99	2.58 Score calculated from formula Standard Deviation 0.89	2.49 Score calculated from formula Standard Deviation 1.12	2.57 Score calculated from formula Standard Deviation 0.92	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 102	2.66 Score calculated from formula Standard Deviation 0.78	2.29 Score calculated from formula Standard Deviation 1.01	2.59 Score calculated from formula Standard Deviation 0.81	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 105	3.31 Score calculated from formula Standard Deviation 1.23	1.76 Score calculated from formula Standard Deviation 0.34	3.09 Score calculated from formula Standard Deviation 1.26	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 108	3.46 Score calculated from formula Standard Deviation 1.59	3.70 Score calculated from formula Standard Deviation 0	3.49 Score calculated from formula Standard Deviation 1.47	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 111	1.82 Score calculated from formula Standard Deviation 0.50	2.49 Score calculated from formula Standard Deviation 0	1.98 Score calculated from formula Standard Deviation 0.53	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-3 (CRP) Month 114	2.67 Score calculated from formula Standard Deviation 0	—	2.67 Score calculated from formula Standard Deviation 0	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Baseline	6.27 Score calculated from formula Standard Deviation 1.02	6.39 Score calculated from formula Standard Deviation 1.04	6.36 Score calculated from formula Standard Deviation 1.04	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 1	3.81 Score calculated from formula Standard Deviation 1.32	3.78 Score calculated from formula Standard Deviation 1.36	3.79 Score calculated from formula Standard Deviation 1.35	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 2	3.72 Score calculated from formula Standard Deviation 1.27	3.66 Score calculated from formula Standard Deviation 1.32	3.68 Score calculated from formula Standard Deviation 1.31	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 3	3.75 Score calculated from formula Standard Deviation 1.32	3.61 Score calculated from formula Standard Deviation 1.30	3.65 Score calculated from formula Standard Deviation 1.31	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 6	3.67 Score calculated from formula Standard Deviation 1.33	3.61 Score calculated from formula Standard Deviation 1.30	3.62 Score calculated from formula Standard Deviation 1.31	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 9	3.60 Score calculated from formula Standard Deviation 1.31	3.58 Score calculated from formula Standard Deviation 1.32	3.59 Score calculated from formula Standard Deviation 1.31	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 12	3.61 Score calculated from formula Standard Deviation 1.26	3.56 Score calculated from formula Standard Deviation 1.30	3.57 Score calculated from formula Standard Deviation 1.29	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 15	3.54 Score calculated from formula Standard Deviation 1.26	3.53 Score calculated from formula Standard Deviation 1.30	3.53 Score calculated from formula Standard Deviation 1.29	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 18	3.57 Score calculated from formula Standard Deviation 1.26	3.50 Score calculated from formula Standard Deviation 1.28	3.52 Score calculated from formula Standard Deviation 1.28	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 21	3.58 Score calculated from formula Standard Deviation 1.25	3.45 Score calculated from formula Standard Deviation 1.27	3.48 Score calculated from formula Standard Deviation 1.26	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 24	3.54 Score calculated from formula Standard Deviation 1.21	3.46 Score calculated from formula Standard Deviation 1.26	3.48 Score calculated from formula Standard Deviation 1.25	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 27	3.52 Score calculated from formula Standard Deviation 1.20	3.44 Score calculated from formula Standard Deviation 1.25	3.46 Score calculated from formula Standard Deviation 1.24	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 30	3.54 Score calculated from formula Standard Deviation 1.23	3.43 Score calculated from formula Standard Deviation 1.25	3.46 Score calculated from formula Standard Deviation 1.24	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 33	3.51 Score calculated from formula Standard Deviation 1.22	3.42 Score calculated from formula Standard Deviation 1.27	3.45 Score calculated from formula Standard Deviation 1.26	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 36	3.51 Score calculated from formula Standard Deviation 1.23	3.42 Score calculated from formula Standard Deviation 1.27	3.44 Score calculated from formula Standard Deviation 1.26	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 39	3.56 Score calculated from formula Standard Deviation 1.27	3.39 Score calculated from formula Standard Deviation 1.24	3.43 Score calculated from formula Standard Deviation 1.25	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 42	3.53 Score calculated from formula Standard Deviation 1.26	3.40 Score calculated from formula Standard Deviation 1.26	3.43 Score calculated from formula Standard Deviation 1.26	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 45	3.45 Score calculated from formula Standard Deviation 1.20	3.37 Score calculated from formula Standard Deviation 1.21	3.39 Score calculated from formula Standard Deviation 1.20	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 48	3.46 Score calculated from formula Standard Deviation 1.16	3.36 Score calculated from formula Standard Deviation 1.21	3.39 Score calculated from formula Standard Deviation 1.20	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 51	3.43 Score calculated from formula Standard Deviation 1.20	3.39 Score calculated from formula Standard Deviation 1.24	3.40 Score calculated from formula Standard Deviation 1.23	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 54	3.54 Score calculated from formula Standard Deviation 1.23	3.38 Score calculated from formula Standard Deviation 1.25	3.42 Score calculated from formula Standard Deviation 1.25	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 57	3.48 Score calculated from formula Standard Deviation 1.19	3.36 Score calculated from formula Standard Deviation 1.21	3.40 Score calculated from formula Standard Deviation 1.20	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 60	3.51 Score calculated from formula Standard Deviation 1.27	3.34 Score calculated from formula Standard Deviation 1.20	3.39 Score calculated from formula Standard Deviation 1.22	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 63	3.51 Score calculated from formula Standard Deviation 1.15	3.30 Score calculated from formula Standard Deviation 1.16	3.37 Score calculated from formula Standard Deviation 1.16	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 66	3.58 Score calculated from formula Standard Deviation 1.12	3.34 Score calculated from formula Standard Deviation 1.17	3.42 Score calculated from formula Standard Deviation 1.15	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 69	3.51 Score calculated from formula Standard Deviation 1.18	3.35 Score calculated from formula Standard Deviation 1.20	3.41 Score calculated from formula Standard Deviation 1.19	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 72	3.45 Score calculated from formula Standard Deviation 1.20	3.42 Score calculated from formula Standard Deviation 1.19	3.44 Score calculated from formula Standard Deviation 1.20	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 75	3.43 Score calculated from formula Standard Deviation 1.11	3.41 Score calculated from formula Standard Deviation 1.14	3.43 Score calculated from formula Standard Deviation 1.12	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 78	3.44 Score calculated from formula Standard Deviation 1.14	3.32 Score calculated from formula Standard Deviation 1.20	3.41 Score calculated from formula Standard Deviation 1.16	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 81	3.40 Score calculated from formula Standard Deviation 1.11	3.56 Score calculated from formula Standard Deviation 1.24	3.42 Score calculated from formula Standard Deviation 1.13	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 84	3.32 Score calculated from formula Standard Deviation 1.13	3.42 Score calculated from formula Standard Deviation 1.37	3.34 Score calculated from formula Standard Deviation 1.16	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 87	3.33 Score calculated from formula Standard Deviation 1.13	3.19 Score calculated from formula Standard Deviation 1.15	3.31 Score calculated from formula Standard Deviation 1.13	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 90	3.34 Score calculated from formula Standard Deviation 1.14	3.28 Score calculated from formula Standard Deviation 1.10	3.33 Score calculated from formula Standard Deviation 1.13	—	—	—
Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) DAS28-4 (ESR) Month 93	3.33 Score calculated from formula Standard Deviation 1.14	3.23 Score calculated from formula Standard Deviation 1.12	3.32 Score calculated from formula Standard Deviation 1.13	—	—	—

SECONDARY outcome

Timeframe: Baseline (Month 0 at the entry of Initial period); Month 3, 6, 9 and 12 of Extension Period

Population: Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, "Number Analyzed" signifies number of participants who were evaluable for specified categories.

DAS28 is composite score, calculated using mathematical formula, derived from: 1) tender/painful joints count, out of 28 joints (TJC28), 2) swollen joints count, out of 28 joints (SJC28), 3) blood marker of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]). DAS28-4 also include score of general health (GH). GH is general health or participants' global assessment of disease activity on 100 mm visual analog scale (GH score: 0 mm [very well] to 100 mm [extremely bad], higher scores = worse health condition). DAS28-3(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) *1.10 + 1.15) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm. DAS28-4 ESR and DAS28-3 CRP: score ranges from 0 (none) to 9.4 (extreme disease activity), with a higher score indicating more disease activity. Score of <=3.2 indicate low disease activity and score of <2.6 indicate disease remission.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=48 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12 DAS28-4 (ESR) Baseline	5.68 Scores on a scale Standard Deviation 1.26	—	—	—	—	—
Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12 DAS28-4 (ESR): Change at Month 3	-2.82 Scores on a scale Standard Deviation 1.52	—	—	—	—	—
Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12 DAS28-4 (ESR): Change at Month 6	-3.02 Scores on a scale Standard Deviation 1.50	—	—	—	—	—
Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12 DAS28-4 (ESR): Change at Month 9	-3.13 Scores on a scale Standard Deviation 1.66	—	—	—	—	—
Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12 DAS28-4 (ESR): Change at Month 12	-2.55 Scores on a scale Standard Deviation 3.70	—	—	—	—	—
Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12 DAS28-3 (CRP): Baseline	4.67 Scores on a scale Standard Deviation 1.24	—	—	—	—	—
Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12 DAS28-3 (CRP): Change at Month 3	-2.36 Scores on a scale Standard Deviation 1.25	—	—	—	—	—
Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12 DAS28-3 (CRP): Change at Month 6	-2.49 Scores on a scale Standard Deviation 1.30	—	—	—	—	—
Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12 DAS28-3 (CRP): Change at Month 9	-3.04 Scores on a scale Standard Deviation 1.49	—	—	—	—	—
Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12 DAS28-3 (CRP): Change at Month 12	0.29 Scores on a scale Standard Deviation NA Standard deviation was not estimable as only 1 participant was evaluable.	—	—	—	—	—

SECONDARY outcome

Timeframe: Every visit until study completion

Population: Full Analysis Set - No Imputation. The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.

Percent participants with DAS28-4 (ESR) <2.6 and ≤3.2 and percent participants with DAS28-3 (CRP) <2.6 and ≤3.2. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.

DAS28 is a composite score, calculated using a mathematical formula, and is derived from the number of tender/painful joints (out of 28), number of swollen joints (out of 28), and a blood marker of inflammation (ESR or CRP). DAS28-4 also includes a score of general health in the formula.

The score range is from 0 to 9.4, with a higher score indicating more disease activity. A score of >5.1 indicates active disease, a score of ≤3.2 indicates low disease activity, and a score of <2.6 indicates disease remission.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=1123 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=3358 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib n=4481 Participants All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Baseline	0.2 Percent of participants	0.3 Percent of participants	0.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 1	19.9 Percent of participants	20.4 Percent of participants	20.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 2	20.5 Percent of participants	22.5 Percent of participants	22.0 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 3	20.0 Percent of participants	22.9 Percent of participants	22.2 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 6	22.9 Percent of participants	23.4 Percent of participants	23.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 9	24.4 Percent of participants	25.1 Percent of participants	24.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 12	22.3 Percent of participants	24.4 Percent of participants	23.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 15	23.8 Percent of participants	25.7 Percent of participants	25.2 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 18	25.3 Percent of participants	26.9 Percent of participants	26.4 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 21	22.2 Percent of participants	27.1 Percent of participants	25.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 24	22.7 Percent of participants	26.8 Percent of participants	25.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 27	22.6 Percent of participants	27.9 Percent of participants	26.5 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 30	24.6 Percent of participants	27.7 Percent of participants	26.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 33	23.7 Percent of participants	28.3 Percent of participants	27.1 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 36	25.6 Percent of participants	28.9 Percent of participants	28.1 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 39	23.9 Percent of participants	28.4 Percent of participants	27.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 42	24.3 Percent of participants	27.9 Percent of participants	27.0 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 45	24.1 Percent of participants	27.5 Percent of participants	26.6 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 48	23.5 Percent of participants	28.0 Percent of participants	26.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 51	28.3 Percent of participants	27.3 Percent of participants	27.6 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 54	21.4 Percent of participants	28.3 Percent of participants	26.4 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 57	23.1 Percent of participants	28.0 Percent of participants	26.5 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 60	24.0 Percent of participants	28.6 Percent of participants	27.2 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 63	22.4 Percent of participants	29.5 Percent of participants	27.2 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 66	19.5 Percent of participants	26.9 Percent of participants	24.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 69	23.9 Percent of participants	26.3 Percent of participants	25.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 72	25.7 Percent of participants	25.0 Percent of participants	25.4 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 75	23.7 Percent of participants	26.0 Percent of participants	24.6 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 78	24.7 Percent of participants	33.0 Percent of participants	26.7 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 81	24.6 Percent of participants	22.2 Percent of participants	24.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 84	27.3 Percent of participants	27.3 Percent of participants	27.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 87	31.2 Percent of participants	31.7 Percent of participants	31.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 90	28.7 Percent of participants	25.6 Percent of participants	28.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 93	28.3 Percent of participants	28.6 Percent of participants	28.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 96	25.4 Percent of participants	18.8 Percent of participants	24.7 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 99	27.7 Percent of participants	36.4 Percent of participants	28.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 102	31.8 Percent of participants	50.0 Percent of participants	34.6 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 105	28.6 Percent of participants	33.3 Percent of participants	29.4 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) <2.6 Month 108	25.0 Percent of participants	0 Percent of participants	22.2 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Baseline	0.4 Percent of participants	0.7 Percent of participants	0.6 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 1	34.2 Percent of participants	37.6 Percent of participants	36.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 2	36.7 Percent of participants	40.5 Percent of participants	39.6 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 3	36.6 Percent of participants	41.6 Percent of participants	40.4 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 6	39.8 Percent of participants	42.5 Percent of participants	41.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 9	41.3 Percent of participants	43.8 Percent of participants	43.2 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 12	42.1 Percent of participants	42.5 Percent of participants	42.4 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 18	42.7 Percent of participants	45.0 Percent of participants	44.4 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 21	41.9 Percent of participants	47.2 Percent of participants	45.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 24	42.5 Percent of participants	46.5 Percent of participants	45.5 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 27	44.9 Percent of participants	46.9 Percent of participants	46.4 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 30	42.8 Percent of participants	47.4 Percent of participants	46.2 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 33	42.8 Percent of participants	47.5 Percent of participants	46.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 36	44.6 Percent of participants	48.4 Percent of participants	47.5 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 39	42.6 Percent of participants	48.3 Percent of participants	46.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 42	45.8 Percent of participants	49.2 Percent of participants	48.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 45	45.3 Percent of participants	48.4 Percent of participants	47.6 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 48	46.1 Percent of participants	49.4 Percent of participants	48.5 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 51	44.9 Percent of participants	49.0 Percent of participants	47.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 54	43.7 Percent of participants	49.4 Percent of participants	47.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 57	45.2 Percent of participants	50.3 Percent of participants	48.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 60	46.3 Percent of participants	49.9 Percent of participants	48.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 63	41.0 Percent of participants	49.9 Percent of participants	47.1 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 66	38.8 Percent of participants	49.7 Percent of participants	45.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 69	45.6 Percent of participants	50.3 Percent of participants	48.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 72	44.7 Percent of participants	48.2 Percent of participants	46.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 75	43.1 Percent of participants	48.5 Percent of participants	45.1 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 78	44.7 Percent of participants	45.1 Percent of participants	44.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 81	49.3 Percent of participants	48.1 Percent of participants	49.1 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 84	47.2 Percent of participants	45.5 Percent of participants	47.0 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 87	47.9 Percent of participants	46.3 Percent of participants	47.7 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 90	46.0 Percent of participants	46.2 Percent of participants	46.0 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 93	48.2 Percent of participants	50.0 Percent of participants	48.4 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 96	47.2 Percent of participants	43.8 Percent of participants	46.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 99	43.1 Percent of participants	54.5 Percent of participants	44.7 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 102	45.5 Percent of participants	50.0 Percent of participants	46.2 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 105	42.9 Percent of participants	66.7 Percent of participants	47.1 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (ESR) </=3.2 Month 108	50.0 Percent of participants	0 Percent of participants	44.4 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Baseline	0.5 Percent of participants	0.9 Percent of participants	0.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 1	38.0 Percent of participants	43.0 Percent of participants	41.7 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 2	39.7 Percent of participants	47.1 Percent of participants	45.2 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 3	42.3 Percent of participants	47.5 Percent of participants	46.2 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 6	45.2 Percent of participants	49.0 Percent of participants	48.1 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 9	47.1 Percent of participants	50.7 Percent of participants	49.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 12	47.8 Percent of participants	51.8 Percent of participants	50.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 15	50.6 Percent of participants	52.3 Percent of participants	51.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 18	51.3 Percent of participants	54.1 Percent of participants	53.4 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 21	51.1 Percent of participants	55.5 Percent of participants	54.4 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 24	51.9 Percent of participants	55.3 Percent of participants	54.4 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 27	53.2 Percent of participants	55.8 Percent of participants	55.2 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 30	53.3 Percent of participants	56.8 Percent of participants	55.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 33	54.1 Percent of participants	56.0 Percent of participants	55.6 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 36	52.9 Percent of participants	55.6 Percent of participants	54.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 39	54.2 Percent of participants	56.9 Percent of participants	56.2 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 42	54.2 Percent of participants	56.8 Percent of participants	56.2 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 45	56.3 Percent of participants	58.6 Percent of participants	58.0 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 48	55.4 Percent of participants	59.3 Percent of participants	58.2 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 51	56.1 Percent of participants	57.3 Percent of participants	56.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 54	52.6 Percent of participants	57.8 Percent of participants	56.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 57	55.6 Percent of participants	57.7 Percent of participants	57.0 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 60	55.0 Percent of participants	57.9 Percent of participants	57.0 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 63	51.0 Percent of participants	58.1 Percent of participants	55.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 66	51.9 Percent of participants	59.3 Percent of participants	56.7 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 69	53.5 Percent of participants	57.8 Percent of participants	56.0 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 72	52.2 Percent of participants	55.4 Percent of participants	53.7 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 75	53.9 Percent of participants	53.5 Percent of participants	53.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 78	58.2 Percent of participants	51.6 Percent of participants	56.7 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 81	58.6 Percent of participants	51.9 Percent of participants	57.5 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 84	61.7 Percent of participants	43.2 Percent of participants	59.1 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 87	60.2 Percent of participants	48.8 Percent of participants	58.7 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 90	60.8 Percent of participants	46.2 Percent of participants	58.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 93	56.1 Percent of participants	53.6 Percent of participants	55.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 96	56.3 Percent of participants	37.5 Percent of participants	54.4 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 99	50.0 Percent of participants	63.6 Percent of participants	52.0 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 102	46.2 Percent of participants	66.7 Percent of participants	50.0 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 105	33.3 Percent of participants	100 Percent of participants	42.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 108	42.9 Percent of participants	0 Percent of participants	37.5 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) <2.6 Month 111	100 Percent of participants	100 Percent of participants	100 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 1	55.3 Percent of participants	61.9 Percent of participants	60.2 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 2	60.7 Percent of participants	64.5 Percent of participants	63.6 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 3	60.6 Percent of participants	66.3 Percent of participants	64.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 6	64.4 Percent of participants	67.1 Percent of participants	66.4 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 9	66.4 Percent of participants	68.3 Percent of participants	67.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 12	66.1 Percent of participants	70.0 Percent of participants	69.0 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 15	70.0 Percent of participants	70.0 Percent of participants	70.0 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 18	69.2 Percent of participants	71.7 Percent of participants	71.1 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 21	69.5 Percent of participants	72.5 Percent of participants	71.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 24	71.7 Percent of participants	72.5 Percent of participants	72.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 27	72.6 Percent of participants	73.0 Percent of participants	72.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 30	73.0 Percent of participants	73.8 Percent of participants	73.6 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 33	72.2 Percent of participants	74.5 Percent of participants	73.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 36	73.8 Percent of participants	73.4 Percent of participants	73.5 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 39	73.2 Percent of participants	74.6 Percent of participants	74.2 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 42	73.8 Percent of participants	74.7 Percent of participants	74.5 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 45	74.6 Percent of participants	75.2 Percent of participants	75.1 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 48	74.6 Percent of participants	75.0 Percent of participants	74.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 51	74.3 Percent of participants	75.1 Percent of participants	74.9 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 54	71.4 Percent of participants	76.4 Percent of participants	75.0 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 57	73.6 Percent of participants	75.2 Percent of participants	74.7 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 60	72.5 Percent of participants	77.0 Percent of participants	75.6 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 63	72.8 Percent of participants	76.5 Percent of participants	75.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 66	71.5 Percent of participants	78.1 Percent of participants	75.8 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 69	69.9 Percent of participants	77.0 Percent of participants	74.0 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 72	74.8 Percent of participants	73.3 Percent of participants	74.1 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 75	77.0 Percent of participants	72.9 Percent of participants	75.5 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 78	74.3 Percent of participants	70.3 Percent of participants	73.4 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 81	75.8 Percent of participants	68.5 Percent of participants	74.6 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 84	79.2 Percent of participants	68.2 Percent of participants	77.6 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-4 (CRP) </=3.2 Month 87	81.1 Percent of participants	70.7 Percent of participants	79.7 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 90	77.1 Percent of participants	74.4 Percent of participants	76.7 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 93	75.0 Percent of participants	67.9 Percent of participants	74.1 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 96	77.1 Percent of participants	87.5 Percent of participants	78.1 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 99	76.6 Percent of participants	81.8 Percent of participants	77.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 102	84.6 Percent of participants	66.7 Percent of participants	81.3 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 105	50.0 Percent of participants	100 Percent of participants	57.1 Percent of participants	—	—	—
Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 DAS28-3 (CRP) </=3.2 Month 108	42.9 Percent of participants	0 Percent of participants	37.5 Percent of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 at the entry of Extension period); Month 3, 6, 9 and 12 of Extension Period

Population: Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, "Number Analyzed" signifies number of participants who were evaluable for specified categories.

DAS28 is composite score, calculated using mathematical formula, derived from: 1) tender/painful joints count, out of 28 joints (TJC28), 2) swollen joints count, out of 28 joints (SJC28), 3) blood marker of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]). DAS28-4 also include score of GH. GH is general health or participants' global assessment of disease activity on 100 mm visual analog scale (GH score: 0 mm [very well] to 100 mm [extremely bad], higher scores = worse health condition). DAS28-3(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) *1.10 + 1.15) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm. DAS28-4 ESR and DAS28-3 CRP: score range is from 0 (none) to 9.4 (extreme disease activity), with a higher score indicating more disease activity. Score of <=3.2 indicate low disease activity and score of <2.6 indicate disease remission.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=48 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-4 (ESR) <2.6: Baseline	12.5 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-4 (ESR) <2.6: Month 3	40.9 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-4 (ESR) <2.6: Month 6	45.7 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-4 (ESR) <2.6: Month 9	46.7 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-4 (ESR) <2.6: Month 12	50.0 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-4 (ESR) <=3.2: Baseline	29.2 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-4 (ESR) <=3.2: Month 3	68.2 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-4 (ESR) <=3.2: Month 6	68.6 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-4 (ESR) <=3.2: Month 9	66.7 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-4 (ESR) <=3.2: Month 12	50.0 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-3 (CRP) <2.6: Baseline	27.7 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-3 (CRP) <2.6: Month 3	61.9 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-3 (CRP) <2.6: Month 6	67.6 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-3 (CRP) <2.6: Month 9	80.0 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-3 (CRP) <2.6: Month 12	0 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-3 (CRP) <=3.2: Baseline	53.2 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-3 (CRP) <=3.2: Month 3	85.7 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-3 (CRP) <=3.2: Month 6	85.3 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-3 (CRP) <=3.2: Month 9	80.0 Percentage of participants	—	—	—	—	—
Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 DAS28-3 (CRP) <=3.2: Month 12	0 Percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Every visit until study completion

Population: The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.

Change from baseline by visit. HAQ-DI scores range from 0 to 3, where lower score implies less disease. A reduction from baseline in score indicates an improvement in condition. A clinically meaningful decrease from baseline is defined as a decrease of at least 0.22 units. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=1123 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=3358 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib n=4481 Participants All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 1	-0.57 Units on scale Standard Deviation 0.62	-0.61 Units on scale Standard Deviation 0.63	-0.60 Units on scale Standard Deviation 0.63	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 2	-0.58 Units on scale Standard Deviation 0.62	-0.65 Units on scale Standard Deviation 0.65	-0.63 Units on scale Standard Deviation 0.65	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 3	-0.58 Units on scale Standard Deviation 0.63	-0.66 Units on scale Standard Deviation 0.65	-0.64 Units on scale Standard Deviation 0.65	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 6	-0.58 Units on scale Standard Deviation 0.65	-0.65 Units on scale Standard Deviation 0.66	-0.64 Units on scale Standard Deviation 0.66	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 9	-0.58 Units on scale Standard Deviation 0.64	-0.66 Units on scale Standard Deviation 0.66	-0.64 Units on scale Standard Deviation 0.66	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 12	-0.58 Units on scale Standard Deviation 0.65	-0.66 Units on scale Standard Deviation 0.67	-0.64 Units on scale Standard Deviation 0.67	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 15	-0.61 Units on scale Standard Deviation 0.65	-0.68 Units on scale Standard Deviation 0.68	-0.66 Units on scale Standard Deviation 0.67	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 18	-0.60 Units on scale Standard Deviation 0.65	-0.68 Units on scale Standard Deviation 0.67	-0.66 Units on scale Standard Deviation 0.67	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 21	-0.60 Units on scale Standard Deviation 0.67	-0.69 Units on scale Standard Deviation 0.68	-0.67 Units on scale Standard Deviation 0.68	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 24	-0.60 Units on scale Standard Deviation 0.65	-0.69 Units on scale Standard Deviation 0.68	-0.67 Units on scale Standard Deviation 0.67	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 27	-0.62 Units on scale Standard Deviation 0.65	-0.69 Units on scale Standard Deviation 0.68	-0.67 Units on scale Standard Deviation 0.67	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 30	-0.58 Units on scale Standard Deviation 0.66	-0.68 Units on scale Standard Deviation 0.69	-0.66 Units on scale Standard Deviation 0.68	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 33	-0.60 Units on scale Standard Deviation 0.66	-0.67 Units on scale Standard Deviation 0.69	-0.66 Units on scale Standard Deviation 0.68	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 36	-0.63 Units on scale Standard Deviation 0.66	-0.67 Units on scale Standard Deviation 0.68	-0.66 Units on scale Standard Deviation 0.67	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 39	-0.59 Units on scale Standard Deviation 0.67	-0.68 Units on scale Standard Deviation 0.69	-0.66 Units on scale Standard Deviation 0.69	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 42	-0.59 Units on scale Standard Deviation 0.67	-0.66 Units on scale Standard Deviation 0.68	-0.65 Units on scale Standard Deviation 0.68	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 45	-0.59 Units on scale Standard Deviation 0.69	-0.64 Units on scale Standard Deviation 0.69	-0.63 Units on scale Standard Deviation 0.69	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 48	-0.58 Units on scale Standard Deviation 0.69	-0.64 Units on scale Standard Deviation 0.69	-0.62 Units on scale Standard Deviation 0.68	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 51	-0.59 Units on scale Standard Deviation 0.69	-0.63 Units on scale Standard Deviation 0.66	-0.62 Units on scale Standard Deviation 0.67	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 54	-0.57 Units on scale Standard Deviation 0.68	-0.65 Units on scale Standard Deviation 0.67	-0.63 Units on scale Standard Deviation 0.67	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 57	-0.57 Units on scale Standard Deviation 0.69	-0.66 Units on scale Standard Deviation 0.68	-0.63 Units on scale Standard Deviation 0.68	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 60	-0.59 Units on scale Standard Deviation 0.68	-0.66 Units on scale Standard Deviation 0.69	-0.64 Units on scale Standard Deviation 0.69	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 63	-0.57 Units on scale Standard Deviation 0.68	-0.68 Units on scale Standard Deviation 0.70	-0.64 Units on scale Standard Deviation 0.69	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 66	-0.54 Units on scale Standard Deviation 0.70	-0.67 Units on scale Standard Deviation 0.69	-0.63 Units on scale Standard Deviation 0.70	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 69	-0.55 Units on scale Standard Deviation 0.70	-0.66 Units on scale Standard Deviation 0.71	-0.61 Units on scale Standard Deviation 0.71	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 72	-0.57 Units on scale Standard Deviation 0.71	-0.62 Units on scale Standard Deviation 0.73	-0.59 Units on scale Standard Deviation 0.72	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 75	-0.57 Units on scale Standard Deviation 0.72	-0.58 Units on scale Standard Deviation 0.73	-0.57 Units on scale Standard Deviation 0.72	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 78	-0.54 Units on scale Standard Deviation 0.73	-0.61 Units on scale Standard Deviation 0.78	-0.56 Units on scale Standard Deviation 0.74	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 81	-0.55 Units on scale Standard Deviation 0.73	-0.64 Units on scale Standard Deviation 0.68	-0.56 Units on scale Standard Deviation 0.72	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 84	-0.53 Units on scale Standard Deviation 0.73	-0.56 Units on scale Standard Deviation 0.68	-0.53 Units on scale Standard Deviation 0.72	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 87	-0.53 Units on scale Standard Deviation 0.70	-0.53 Units on scale Standard Deviation 0.60	-0.53 Units on scale Standard Deviation 0.69	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 90	-0.52 Units on scale Standard Deviation 0.72	-0.54 Units on scale Standard Deviation 0.61	-0.52 Units on scale Standard Deviation 0.70	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 93	-0.52 Units on scale Standard Deviation 0.75	-0.50 Units on scale Standard Deviation 0.60	-0.52 Units on scale Standard Deviation 0.73	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 96	-0.54 Units on scale Standard Deviation 0.77	-0.48 Units on scale Standard Deviation 0.58	-0.53 Units on scale Standard Deviation 0.75	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 99	-0.53 Units on scale Standard Deviation 0.80	-0.44 Units on scale Standard Deviation 0.51	-0.52 Units on scale Standard Deviation 0.76	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 102	-0.61 Units on scale Standard Deviation 0.82	-0.29 Units on scale Standard Deviation 0.85	-0.58 Units on scale Standard Deviation 0.81	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 105	-0.65 Units on scale Standard Deviation 0.91	-0.50 Units on scale Standard Deviation 0.99	-0.63 Units on scale Standard Deviation 0.90	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 108	-0.89 Units on scale Standard Deviation 0.97	0.13 Units on scale Standard Deviation 0	-0.78 Units on scale Standard Deviation 0.97	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 111	-1.29 Units on scale Standard Deviation 1.34	0.25 Units on scale Standard Deviation 0	-0.91 Units on scale Standard Deviation 1.34	—	—	—
Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Month 114	-0.13 Units on scale Standard Deviation 0	—	-0.13 Units on scale Standard Deviation 0	—	—	—

SECONDARY outcome

Timeframe: Baseline (Month 0 at the entry of Initial Period); Month 3, 6, 9, and 12 of Extension Period

Population: Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, "Number Analyzed" signifies number of participants who were evaluable for specified categories.

HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities. Each activity category consisted of 2-3 questionnaire. Each questionnaire was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity that required assistance from another individual or required the use of an assistive device was adjusted to a score of 2 to represent a more limited functional status. Overall score was computed as the sum of total scores divided by the number of questionnaire answered. Total possible HAQ-DI score range: 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=48 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Extension Period: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 3, 6, 9 and 12 Baseline	1.35 Units on a scale Standard Deviation 0.63	—	—	—	—	—
Extension Period: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 3, 6, 9 and 12 Change at Month 3	-0.48 Units on a scale Standard Deviation 0.58	—	—	—	—	—
Extension Period: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 3, 6, 9 and 12 Change at Month 6	-0.55 Units on a scale Standard Deviation 0.65	—	—	—	—	—
Extension Period: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 3, 6, 9 and 12 Change at Month 9	-0.58 Units on a scale Standard Deviation 0.70	—	—	—	—	—
Extension Period: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 3, 6, 9 and 12 Change at Month 12	-1.50 Units on a scale Standard Deviation 1.94	—	—	—	—	—

SECONDARY outcome

Timeframe: Every visit until study completion

Population: The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.

Change from Baseline for Physical Component and Mental Component Scores by visit. SF-36 is a health status measure of 8 general health domains, each scored on a 0 to 100 scale: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These domains can be summarized as physical and mental component scores. The domain scores were "normed" and the resulting component scores treated as Z-scores with a scale of negative to positive infinity. A higher score implies less disease. The greater the change from baseline, the greater the improvement. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=1123 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=3358 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib n=4481 Participants All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 3	7.90 Scores on scale Standard Deviation 8.70	8.85 Scores on scale Standard Deviation 8.92	8.60 Scores on scale Standard Deviation 8.87	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 6	8.10 Scores on scale Standard Deviation 8.94	9.02 Scores on scale Standard Deviation 9.11	8.77 Scores on scale Standard Deviation 9.07	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 9	8.60 Scores on scale Standard Deviation 9.07	8.80 Scores on scale Standard Deviation 9.20	8.77 Scores on scale Standard Deviation 9.18	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 12	8.44 Scores on scale Standard Deviation 8.53	8.78 Scores on scale Standard Deviation 9.26	8.69 Scores on scale Standard Deviation 9.07	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 15	8.43 Scores on scale Standard Deviation 8.88	8.98 Scores on scale Standard Deviation 9.05	8.85 Scores on scale Standard Deviation 9.01	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 18	8.14 Scores on scale Standard Deviation 8.89	8.99 Scores on scale Standard Deviation 9.18	8.75 Scores on scale Standard Deviation 9.11	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 21	8.00 Scores on scale Standard Deviation 8.70	8.85 Scores on scale Standard Deviation 8.96	8.62 Scores on scale Standard Deviation 8.90	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 24	8.28 Scores on scale Standard Deviation 8.73	9.00 Scores on scale Standard Deviation 9.30	8.80 Scores on scale Standard Deviation 9.15	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 27	8.41 Scores on scale Standard Deviation 8.84	8.64 Scores on scale Standard Deviation 9.16	8.57 Scores on scale Standard Deviation 9.06	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 30	7.78 Scores on scale Standard Deviation 8.81	8.56 Scores on scale Standard Deviation 9.06	8.32 Scores on scale Standard Deviation 8.99	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 33	8.17 Scores on scale Standard Deviation 8.87	8.39 Scores on scale Standard Deviation 9.31	8.32 Scores on scale Standard Deviation 9.17	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 36	8.31 Scores on scale Standard Deviation 8.97	8.43 Scores on scale Standard Deviation 9.22	8.40 Scores on scale Standard Deviation 9.14	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 39	8.05 Scores on scale Standard Deviation 9.26	8.13 Scores on scale Standard Deviation 9.14	8.10 Scores on scale Standard Deviation 9.18	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 42	7.81 Scores on scale Standard Deviation 9.32	8.07 Scores on scale Standard Deviation 9.13	7.97 Scores on scale Standard Deviation 9.21	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 45	8.40 Scores on scale Standard Deviation 9.87	8.33 Scores on scale Standard Deviation 9.40	8.36 Scores on scale Standard Deviation 9.61	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 48	8.12 Scores on scale Standard Deviation 9.56	8.27 Scores on scale Standard Deviation 9.23	8.22 Scores on scale Standard Deviation 9.34	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 51	7.88 Scores on scale Standard Deviation 9.69	8.55 Scores on scale Standard Deviation 9.70	8.16 Scores on scale Standard Deviation 9.69	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 54	7.72 Scores on scale Standard Deviation 9.41	8.82 Scores on scale Standard Deviation 9.47	8.06 Scores on scale Standard Deviation 9.43	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 57	7.57 Scores on scale Standard Deviation 9.72	8.12 Scores on scale Standard Deviation 9.69	7.69 Scores on scale Standard Deviation 9.71	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 60	7.94 Scores on scale Standard Deviation 9.74	9.29 Scores on scale Standard Deviation 9.43	8.49 Scores on scale Standard Deviation 9.63	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 63	7.73 Scores on scale Standard Deviation 9.76	7.90 Scores on scale Standard Deviation 8.98	7.76 Scores on scale Standard Deviation 9.63	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 66	7.92 Scores on scale Standard Deviation 9.41	7.58 Scores on scale Standard Deviation 7.88	7.87 Scores on scale Standard Deviation 9.20	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 69	7.68 Scores on scale Standard Deviation 9.32	9.12 Scores on scale Standard Deviation 7.06	7.87 Scores on scale Standard Deviation 9.06	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 72	7.90 Scores on scale Standard Deviation 9.93	8.70 Scores on scale Standard Deviation 10.24	8.02 Scores on scale Standard Deviation 9.97	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 75	9.03 Scores on scale Standard Deviation 10.96	5.75 Scores on scale Standard Deviation 9.05	8.62 Scores on scale Standard Deviation 10.75	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 78	10.22 Scores on scale Standard Deviation 11.10	7.39 Scores on scale Standard Deviation 7.09	9.90 Scores on scale Standard Deviation 10.72	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 81	10.51 Scores on scale Standard Deviation 10.17	7.90 Scores on scale Standard Deviation 13.05	10.31 Scores on scale Standard Deviation 10.28	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 84	8.93 Scores on scale Standard Deviation 11.56	7.14 Scores on scale Standard Deviation 8.01	8.74 Scores on scale Standard Deviation 11.22	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 87	11.92 Scores on scale Standard Deviation 10.49	15.23 Scores on scale Standard Deviation 3.64	12.16 Scores on scale Standard Deviation 10.15	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 90	13.50 Scores on scale Standard Deviation 10.98	16.50 Scores on scale Standard Deviation 0	13.73 Scores on scale Standard Deviation 10.55	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 93	26.71 Scores on scale Standard Deviation 0	—	26.71 Scores on scale Standard Deviation 0	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 96	4.61 Scores on scale Standard Deviation 9.75	—	4.61 Scores on scale Standard Deviation 9.75	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Physical Component Month 99	-8.26 Scores on scale Standard Deviation 0	—	-8.26 Scores on scale Standard Deviation 0	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 3	4.37 Scores on scale Standard Deviation 10.88	4.91 Scores on scale Standard Deviation 11.18	4.77 Scores on scale Standard Deviation 11.10	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 6	3.94 Scores on scale Standard Deviation 10.85	4.81 Scores on scale Standard Deviation 11.12	4.58 Scores on scale Standard Deviation 11.06	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 9	4.65 Scores on scale Standard Deviation 10.78	5.04 Scores on scale Standard Deviation 11.17	4.97 Scores on scale Standard Deviation 11.10	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 12	3.77 Scores on scale Standard Deviation 11.03	4.81 Scores on scale Standard Deviation 11.43	4.53 Scores on scale Standard Deviation 11.33	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 15	4.14 Scores on scale Standard Deviation 11.21	4.79 Scores on scale Standard Deviation 11.52	4.63 Scores on scale Standard Deviation 11.45	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 18	4.12 Scores on scale Standard Deviation 11.11	4.87 Scores on scale Standard Deviation 11.41	4.66 Scores on scale Standard Deviation 11.33	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 21	4.21 Scores on scale Standard Deviation 11.08	4.87 Scores on scale Standard Deviation 11.22	4.68 Scores on scale Standard Deviation 11.18	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 24	4.12 Scores on scale Standard Deviation 11.06	5.08 Scores on scale Standard Deviation 11.32	4.82 Scores on scale Standard Deviation 11.26	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 27	3.67 Scores on scale Standard Deviation 10.53	4.91 Scores on scale Standard Deviation 11.28	4.53 Scores on scale Standard Deviation 11.07	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 30	3.58 Scores on scale Standard Deviation 11.14	4.68 Scores on scale Standard Deviation 11.71	4.34 Scores on scale Standard Deviation 11.54	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 33	3.91 Scores on scale Standard Deviation 10.65	4.82 Scores on scale Standard Deviation 11.74	4.53 Scores on scale Standard Deviation 11.40	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 36	3.83 Scores on scale Standard Deviation 10.94	4.81 Scores on scale Standard Deviation 11.60	4.51 Scores on scale Standard Deviation 11.40	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 39	3.60 Scores on scale Standard Deviation 11.02	4.59 Scores on scale Standard Deviation 11.75	4.25 Scores on scale Standard Deviation 11.51	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 42	3.23 Scores on scale Standard Deviation 11.40	4.55 Scores on scale Standard Deviation 11.63	4.04 Scores on scale Standard Deviation 11.56	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 45	3.16 Scores on scale Standard Deviation 11.63	4.40 Scores on scale Standard Deviation 11.64	3.83 Scores on scale Standard Deviation 11.56	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 48	3.48 Scores on scale Standard Deviation 11.71	4.73 Scores on scale Standard Deviation 11.83	4.31 Scores on scale Standard Deviation 11.80	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 51	3.61 Scores on scale Standard Deviation 12.12	4.83 Scores on scale Standard Deviation 11.82	4.13 Scores on scale Standard Deviation 12.00	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 54	3.44 Scores on scale Standard Deviation 11.77	6.49 Scores on scale Standard Deviation 12.67	4.38 Scores on scale Standard Deviation 12.12	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 57	3.24 Scores on scale Standard Deviation 12.24	5.10 Scores on scale Standard Deviation 11.74	3.65 Scores on scale Standard Deviation 12.15	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 60	3.05 Scores on scale Standard Deviation 12.06	5.18 Scores on scale Standard Deviation 12.22	3.93 Scores on scale Standard Deviation 12.16	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 63	3.04 Scores on scale Standard Deviation 11.61	4.22 Scores on scale Standard Deviation 10.32	3.23 Scores on scale Standard Deviation 11.40	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 66	2.96 Scores on scale Standard Deviation 11.32	3.47 Scores on scale Standard Deviation 8.33	3.04 Scores on scale Standard Deviation 10.93	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 69	3.90 Scores on scale Standard Deviation 12.35	4.90 Scores on scale Standard Deviation 9.84	4.03 Scores on scale Standard Deviation 12.04	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 72	3.78 Scores on scale Standard Deviation 11.48	5.32 Scores on scale Standard Deviation 12.80	4.00 Scores on scale Standard Deviation 11.68	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 75	5.04 Scores on scale Standard Deviation 12.22	1.52 Scores on scale Standard Deviation 11.38	4.60 Scores on scale Standard Deviation 12.12	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 78	4.12 Scores on scale Standard Deviation 13.37	1.05 Scores on scale Standard Deviation 13.28	3.77 Scores on scale Standard Deviation 13.29	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 81	6.09 Scores on scale Standard Deviation 10.40	2.60 Scores on scale Standard Deviation 14.75	5.83 Scores on scale Standard Deviation 10.64	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 84	5.73 Scores on scale Standard Deviation 13.07	-2.36 Scores on scale Standard Deviation 11.63	4.87 Scores on scale Standard Deviation 13.11	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 87	7.52 Scores on scale Standard Deviation 13.03	16.93 Scores on scale Standard Deviation 2.66	8.19 Scores on scale Standard Deviation 12.79	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 90	4.61 Scores on scale Standard Deviation 11.75	18.75 Scores on scale Standard Deviation 0	5.65 Scores on scale Standard Deviation 11.86	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 93	14.03 Scores on scale Standard Deviation 0	—	14.03 Scores on scale Standard Deviation 0	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 96	7.58 Scores on scale Standard Deviation 9.73	—	7.58 Scores on scale Standard Deviation 9.73	—	—	—
Initial Period: Short-Form-36 Health Survey (SF-36) Score Mental Component Month 99	22.28 Scores on scale Standard Deviation 0	—	22.28 Scores on scale Standard Deviation 0	—	—	—

SECONDARY outcome

Timeframe: Every visit until study completion

Population: The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.

Change from Baseline Scores for each: FACIT Fatigue Scale (score range 0 to 52, higher score indicates higher quality of life and an increase from baseline score indicates improvement), EuroQol EQ 5D (index values derived from a measure of central tendency and a measure of dispersion, an increase from baseline indicates improvement, score range 0 to 1), Work Limitations (WL) Physical Demands (covers ability to perform job tasks that involve bodily strength, a decrease from baseline indicates improvement, score range 0 to 100, higher scores indicating greater limitation), and RA Healthcare Resource Utilization Work Performance in Past 3 Months on Days Bothered by RA (assesses healthcare use over previous 3 months, a decrease from baseline indicates improvement, score range 0 to 10).

The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=1123 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=3358 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib n=4481 Participants All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) FACIT Month 6	6.29 Scores on a scale Standard Deviation 8.98	7.33 Scores on a scale Standard Deviation 10.57	7.19 Scores on a scale Standard Deviation 10.39	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) FACIT Month 12	5.98 Scores on a scale Standard Deviation 9.74	7.33 Scores on a scale Standard Deviation 10.56	7.06 Scores on a scale Standard Deviation 10.41	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) FACIT Month 18	6.14 Scores on a scale Standard Deviation 10.06	7.40 Scores on a scale Standard Deviation 10.65	7.09 Scores on a scale Standard Deviation 10.51	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) FACIT Month 24	5.90 Scores on a scale Standard Deviation 9.76	7.42 Scores on a scale Standard Deviation 10.56	7.03 Scores on a scale Standard Deviation 10.38	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) FACIT Month 30	5.36 Scores on a scale Standard Deviation 10.08	7.00 Scores on a scale Standard Deviation 10.91	6.52 Scores on a scale Standard Deviation 10.70	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) FACIT Month 36	5.95 Scores on a scale Standard Deviation 9.87	6.87 Scores on a scale Standard Deviation 10.94	6.61 Scores on a scale Standard Deviation 10.66	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) FACIT Month 42	5.35 Scores on a scale Standard Deviation 10.36	6.83 Scores on a scale Standard Deviation 10.86	6.31 Scores on a scale Standard Deviation 10.71	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) FACIT Month 48	6.01 Scores on a scale Standard Deviation 10.33	6.88 Scores on a scale Standard Deviation 10.95	6.61 Scores on a scale Standard Deviation 10.77	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) FACIT Month 54	6.16 Scores on a scale Standard Deviation 10.49	8.51 Scores on a scale Standard Deviation 11.58	6.96 Scores on a scale Standard Deviation 10.92	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) FACIT Month 60	5.96 Scores on a scale Standard Deviation 10.69	8.88 Scores on a scale Standard Deviation 11.65	7.27 Scores on a scale Standard Deviation 11.21	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) FACIT Month 66	5.64 Scores on a scale Standard Deviation 10.93	6.67 Scores on a scale Standard Deviation 10.58	5.81 Scores on a scale Standard Deviation 10.86	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) FACIT Month 72	5.73 Scores on a scale Standard Deviation 11.10	8.63 Scores on a scale Standard Deviation 10.71	6.18 Scores on a scale Standard Deviation 11.07	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) FACIT Month 78	12.06 Scores on a scale Standard Deviation 11.15	0.71 Scores on a scale Standard Deviation 14.84	10.03 Scores on a scale Standard Deviation 12.48	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) FACIT Month 84	9.13 Scores on a scale Standard Deviation 12.88	2.91 Scores on a scale Standard Deviation 12.36	8.32 Scores on a scale Standard Deviation 12.91	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) FACIT Month 90	18.67 Scores on a scale Standard Deviation 9.14	10.00 Scores on a scale Standard Deviation 0	17.43 Scores on a scale Standard Deviation 8.96	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) FACIT Month 96	6.00 Scores on a scale Standard Deviation 2.65	—	6.00 Scores on a scale Standard Deviation 2.65	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) EuroQol Month 6	0.20 Scores on a scale Standard Deviation 0.31	0.22 Scores on a scale Standard Deviation 0.32	0.22 Scores on a scale Standard Deviation 0.32	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) EuroQol Month 12	0.22 Scores on a scale Standard Deviation 0.30	0.22 Scores on a scale Standard Deviation 0.33	0.22 Scores on a scale Standard Deviation 0.32	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) EuroQol Month 18	0.20 Scores on a scale Standard Deviation 0.32	0.23 Scores on a scale Standard Deviation 0.33	0.22 Scores on a scale Standard Deviation 0.33	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) EuroQol Month 24	0.20 Scores on a scale Standard Deviation 0.31	0.23 Scores on a scale Standard Deviation 0.33	0.22 Scores on a scale Standard Deviation 0.32	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) EuroQol Month 30	0.19 Scores on a scale Standard Deviation 0.31	0.22 Scores on a scale Standard Deviation 0.33	0.21 Scores on a scale Standard Deviation 0.32	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) EuroQol Month 36	0.21 Scores on a scale Standard Deviation 0.30	0.23 Scores on a scale Standard Deviation 0.33	0.22 Scores on a scale Standard Deviation 0.32	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) EuroQol Month 42	0.18 Scores on a scale Standard Deviation 0.31	0.24 Scores on a scale Standard Deviation 0.33	0.22 Scores on a scale Standard Deviation 0.32	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) EuroQol Month 48	0.19 Scores on a scale Standard Deviation 0.31	0.23 Scores on a scale Standard Deviation 0.33	0.22 Scores on a scale Standard Deviation 0.32	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) EuroQol Month 54	0.22 Scores on a scale Standard Deviation 0.32	0.32 Scores on a scale Standard Deviation 0.36	0.22 Scores on a scale Standard Deviation 0.32	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) EuroQol Month 60	0.20 Scores on a scale Standard Deviation 0.33	0.27 Scores on a scale Standard Deviation 0.35	0.23 Scores on a scale Standard Deviation 0.34	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) EuroQol Month 66	0.21 Scores on a scale Standard Deviation 0.33	0.24 Scores on a scale Standard Deviation 0.34	0.21 Scores on a scale Standard Deviation 0.33	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) EuroQol Month 72	0.22 Scores on a scale Standard Deviation 0.32	0.28 Scores on a scale Standard Deviation 0.35	0.23 Scores on a scale Standard Deviation 0.32	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) EuroQol Month 78	0.36 Scores on a scale Standard Deviation 0.37	0.10 Scores on a scale Standard Deviation 0.51	0.31 Scores on a scale Standard Deviation 0.40	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) EuroQol Month 84	0.27 Scores on a scale Standard Deviation 0.35	0.21 Scores on a scale Standard Deviation 0.43	0.27 Scores on a scale Standard Deviation 0.36	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) EuroQol Month 90	0.47 Scores on a scale Standard Deviation 0.32	0.84 Scores on a scale Standard Deviation 0	0.52 Scores on a scale Standard Deviation 0.32	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) EuroQol Month 96	0.09 Scores on a scale Standard Deviation 0.04	—	0.09 Scores on a scale Standard Deviation 0.04	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) WL: Physical Demands Month 6	-5.34 Scores on a scale Standard Deviation 39.81	-3.67 Scores on a scale Standard Deviation 38.17	-3.85 Scores on a scale Standard Deviation 38.33	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) WL: Physical Demands Month 12	-5.31 Scores on a scale Standard Deviation 37.81	-4.02 Scores on a scale Standard Deviation 39.25	-4.16 Scores on a scale Standard Deviation 39.08	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) WL: Physical Demands Month 18	-7.97 Scores on a scale Standard Deviation 35.46	-2.29 Scores on a scale Standard Deviation 37.48	-2.89 Scores on a scale Standard Deviation 37.29	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) WL: Physical Demands Month 24	-2.62 Scores on a scale Standard Deviation 36.05	-4.46 Scores on a scale Standard Deviation 37.54	-4.27 Scores on a scale Standard Deviation 37.36	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) WL: Physical Demands Month 30	-10.12 Scores on a scale Standard Deviation 37.17	-3.75 Scores on a scale Standard Deviation 37.67	-4.41 Scores on a scale Standard Deviation 37.63	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) WL: Physical Demands Month 36	-7.31 Scores on a scale Standard Deviation 34.69	-3.95 Scores on a scale Standard Deviation 39.58	-4.25 Scores on a scale Standard Deviation 39.14	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) WL: Physical Demands Month 42	-13.51 Scores on a scale Standard Deviation 33.91	-4.81 Scores on a scale Standard Deviation 38.98	-5.58 Scores on a scale Standard Deviation 38.58	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) WL: Physical Demands Month 48	-25.86 Scores on a scale Standard Deviation 34.47	0.73 Scores on a scale Standard Deviation 38.68	-2.76 Scores on a scale Standard Deviation 39.09	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) WL: Physical Demands Month 54	-39.17 Scores on a scale Standard Deviation 62.46	-13.27 Scores on a scale Standard Deviation 45.69	-15.63 Scores on a scale Standard Deviation 46.18	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) WL: Physical Demands Month 60	—	-27.78 Scores on a scale Standard Deviation 34.94	-27.78 Scores on a scale Standard Deviation 34.94	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) WL: Physical Demands Month 66	—	8.33 Scores on a scale Standard Deviation 0	8.33 Scores on a scale Standard Deviation 0	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) RA-HCRU Month 6	-2.01 Scores on a scale Standard Deviation 6.20	-2.08 Scores on a scale Standard Deviation 4.15	-2.07 Scores on a scale Standard Deviation 4.44	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) RA-HCRU Month 12	-2.41 Scores on a scale Standard Deviation 6.43	-2.26 Scores on a scale Standard Deviation 3.76	-2.28 Scores on a scale Standard Deviation 4.17	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) RA-HCRU Month 18	-1.88 Scores on a scale Standard Deviation 2.93	-2.24 Scores on a scale Standard Deviation 3.90	-2.19 Scores on a scale Standard Deviation 3.80	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) RA-HCRU Month 24	-2.03 Scores on a scale Standard Deviation 3.18	-2.22 Scores on a scale Standard Deviation 3.26	-2.19 Scores on a scale Standard Deviation 3.25	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) RA-HCRU Month 30	-1.67 Scores on a scale Standard Deviation 3.02	-2.16 Scores on a scale Standard Deviation 4.17	-2.10 Scores on a scale Standard Deviation 4.04	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) RA-HCRU Month 36	-2.38 Scores on a scale Standard Deviation 2.91	-2.32 Scores on a scale Standard Deviation 4.14	-2.33 Scores on a scale Standard Deviation 4.01	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) RA-HCRU Month 42	-1.68 Scores on a scale Standard Deviation 2.84	-2.18 Scores on a scale Standard Deviation 4.70	-2.11 Scores on a scale Standard Deviation 4.51	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) RA-HCRU Month 48	-1.88 Scores on a scale Standard Deviation 3.24	-2.15 Scores on a scale Standard Deviation 4.67	-2.12 Scores on a scale Standard Deviation 4.53	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) RA-HCRU Month 54	-2.00 Scores on a scale Standard Deviation 1.00	-2.59 Scores on a scale Standard Deviation 3.42	-2.55 Scores on a scale Standard Deviation 3.30	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) RA-HCRU Month 60	-2.00 Scores on a scale Standard Deviation 3.56	-2.88 Scores on a scale Standard Deviation 2.85	-2.85 Scores on a scale Standard Deviation 2.87	—	—	—
Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) RA-HCRU Month 72	—	-1.25 Scores on a scale Standard Deviation 6.70	-1.25 Scores on a scale Standard Deviation 6.70	—	—	—

SECONDARY outcome

Timeframe: Every 6 months until study completion

Population: The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.

Modified Total Sharp Score per visit. Baseline score was the last available assessment from the index study. The Modified Total Sharp Score measures disease progression; increased scores indicate disease progression. Score range 0 (normal) to 448 (worst possible total score). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.

TSS=Total Sharp Score

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=1123 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=3358 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib n=4481 Participants All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Initial Period: Preservation of Joint Structure in Participants Who Had Baseline Radiographs Obtained in Their Qualifying Index Study Modified TSS Baseline	20.55 Scores on a scale Standard Deviation 33.37	24.13 Scores on a scale Standard Deviation 43.57	23.84 Scores on a scale Standard Deviation 42.83	—	—	—
Initial Period: Preservation of Joint Structure in Participants Who Had Baseline Radiographs Obtained in Their Qualifying Index Study Modified TSS Month 6	22.58 Scores on a scale Standard Deviation 35.10	25.12 Scores on a scale Standard Deviation 44.42	24.91 Scores on a scale Standard Deviation 43.74	—	—	—
Initial Period: Preservation of Joint Structure in Participants Who Had Baseline Radiographs Obtained in Their Qualifying Index Study Modified TSS Month 12	21.26 Scores on a scale Standard Deviation 33.75	24.73 Scores on a scale Standard Deviation 44.08	24.44 Scores on a scale Standard Deviation 43.30	—	—	—
Initial Period: Preservation of Joint Structure in Participants Who Had Baseline Radiographs Obtained in Their Qualifying Index Study Modified TSS Month 24	22.07 Scores on a scale Standard Deviation 35.85	24.85 Scores on a scale Standard Deviation 43.21	24.61 Scores on a scale Standard Deviation 42.61	—	—	—
Initial Period: Preservation of Joint Structure in Participants Who Had Baseline Radiographs Obtained in Their Qualifying Index Study Modified TSS Month 36	25.88 Scores on a scale Standard Deviation 37.74	28.22 Scores on a scale Standard Deviation 44.95	28.02 Scores on a scale Standard Deviation 44.35	—	—	—

SECONDARY outcome

Timeframe: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

Population: Evaluable Immunogenicity Population

Number (%) of participants achieving a satisfactory humoral response to the pneumococcal vaccine as defined by ≥2-fold increase in antibody concentration from vaccine sub-study visit 2 (vaccination baseline) in ≥6 of 12 anti-pneumococcal antigens (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.

95% CI is based on Clopper-Pearson exact method for response rate.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=91 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=91 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib n=92 Participants All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 n=91 Participants Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Pneumococcal Vaccine as Defined by ≥ 2-fold Increase in Antibody Concentrations	18.7 Percent of participants Interval 11.3 to 28.2	38.5 Percent of participants Interval 28.4 to 49.2	75.0 Percent of participants Interval 64.9 to 83.4	84.6 Percent of participants Interval 75.5 to 91.3	—	—

SECONDARY outcome

Timeframe: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

Population: Evaluable Immunogenicity Population

Number of participants achieving a satisfactory humoral response to the seasonal influenza vaccine as defined by ≥4-fold increase in antibody titers from visit 2 (vaccination baseline) in ≥2 of 3 influenza antigens (HAI B, HAI H1N1, and HAI H3N2) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.

95% CI is based on Clopper-Pearson exact method for response rate.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=91 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=91 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib n=92 Participants All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 n=91 Participants Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Seasonal Influenza Vaccine as Defined by ≥ 4-fold Increase in Antibody Titers	31.9 Percent of participants Interval 22.5 to 42.5	53.8 Percent of participants Interval 43.1 to 64.4	66.3 Percent of participants Interval 55.7 to 75.8	63.7 Percent of participants Interval 53.0 to 73.6	—	—

SECONDARY outcome

Timeframe: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

Population: Evaluable Immunogenicity Population

Number (%) of participants achieving protective antibody titers to the seasonal influenza vaccine as measured by an HAI assay titer of ≥1:40 in ≥2 of 3 influenza antigens measured at vaccine sub-study visits 3 and 4.

The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.

95% CI is based on Clopper-Pearson exact method for response rate.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=91 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=91 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib n=92 Participants All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 n=91 Participants Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Vaccine Sub-study. Percentage of Participants Achieving Protective Antibody Titers to the Seasonal Influenza Vaccine as Measured by a Hemagglutination Inhibition (HI) Assay Titer of ≥ 1:40 in ≥ 2 of 3 Influenza Antigens at Vaccine Sub-study Visit 3 and 4	56.0 Percent of participants Interval 45.2 to 66.4	69.2 Percent of participants Interval 58.7 to 78.5	75.0 Percent of participants Interval 64.9 to 83.4	82.4 Percent of participants Interval 73.0 to 89.6	—	—

SECONDARY outcome

Timeframe: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

Population: Evaluable Immunogenicity Population

Number (%) of participants achieving a satisfactory humoral response to the pneumococcal vaccine as defined by ≥2-fold increase in antibody concentration from vaccine sub-study visit 2 (vaccination baseline) in ≥6 of 12 anti-pneumococcal antigens (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.

95% CI is based on Clopper-Pearson exact method for response rate.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=92 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=91 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 Serotype 1	75 Percent of participants Interval 64.9 to 83.4	82.4 Percent of participants Interval 73.0 to 89.6	—	—	—	—
Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 Serotype 3	53.3 Percent of participants Interval 42.6 to 63.7	71.4 Percent of participants Interval 61.0 to 80.4	—	—	—	—
Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 Serotype 4	76.1 Percent of participants Interval 66.1 to 84.4	76.9 Percent of participants Interval 66.9 to 85.1	—	—	—	—
Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 Serotype 5	42.4 Percent of participants Interval 32.1 to 53.1	49.5 Percent of participants Interval 38.8 to 60.1	—	—	—	—
Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 Serotype 6B	48.9 Percent of participants Interval 38.3 to 59.6	56 Percent of participants Interval 45.2 to 66.4	—	—	—	—
Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 Serotype 7F	71.7 Percent of participants Interval 61.4 to 80.6	78 Percent of participants Interval 68.1 to 86.0	—	—	—	—
Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 Serotype 9V	64.1 Percent of participants Interval 53.5 to 73.9	78 Percent of participants Interval 68.1 to 86.0	—	—	—	—
Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 Serotype 14	71.7 Percent of participants Interval 61.4 to 80.6	75.8 Percent of participants Interval 65.7 to 84.2	—	—	—	—
Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 Serotype 18C	73.9 Percent of participants Interval 63.7 to 82.5	83.5 Percent of participants Interval 74.3 to 90.5	—	—	—	—
Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 Serotype 19A	54.3 Percent of participants Interval 43.6 to 64.8	56.0 Percent of participants Interval 45.2 to 66.4	—	—	—	—
Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 Serotype 19F	60.9 Percent of participants Interval 50.1 to 70.9	71.4 Percent of participants Interval 61.0 to 80.4	—	—	—	—
Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 Serotype 23F	53.3 Percent of participants Interval 42.6 to 63.7	70.3 Percent of participants Interval 59.8 to 79.5	—	—	—	—

SECONDARY outcome

Timeframe: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

Population: Evaluable Immunogenicity Population

Number (%) of participants achieving a satisfactory humoral response to the seasonal influenza vaccine defined as ≥4-fold increase in antibody titers from visit 2 (vaccination baseline) in ≥2 of 3 influenza antigens (HAI B, HAI H1N1, and HAI H3N2).

The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.

95% CI is based on Clopper-Pearson exact method for response rate.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=92 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=91 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 3 Influenza Antigens as Defined by ≥ 4-fold Increase in Antibody Titers From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 Antigen B	45.7 Percent of participants Interval 35.2 to 56.4	51.6 Percent of participants Interval 40.9 to 62.3	—	—	—	—
Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 3 Influenza Antigens as Defined by ≥ 4-fold Increase in Antibody Titers From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 Antigen H1N1	71.7 Percent of participants Interval 61.4 to 80.6	63.7 Percent of participants Interval 53.0 to 73.6	—	—	—	—
Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 3 Influenza Antigens as Defined by ≥ 4-fold Increase in Antibody Titers From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 Antigen H3N2	66.3 Percent of participants Interval 55.7 to 75.8	74.7 Percent of participants Interval 64.5 to 83.3	—	—	—	—

SECONDARY outcome

Timeframe: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

Population: Evaluable Immunogenicity Population

Geometric Mean Fold Increase From Baseline of Pneumococcal Antigens Measured at Visit 4.

n was the number of participants with valid and determinate assay results for the specified serotype at the given visit.

The stated number of participants analyzed was the total number of participants. The actual number of participants analyzed for some serotypes varied, and is provided where it differed from the total number of participants.

Confidence Intervals (CIs) were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=92 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=91 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 Serotype 6B	2.32 Fold Change in Antibody Level Interval 1.98 to 2.73	3.06 Fold Change in Antibody Level Interval 2.53 to 3.69	—	—	—	—
Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 Serotype 7F	4.69 Fold Change in Antibody Level Interval 3.73 to 5.9	6.41 Fold Change in Antibody Level Interval 4.97 to 8.28	—	—	—	—
Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 Serotype 1	5.87 Fold Change in Antibody Level Interval 4.57 to 7.55	9.26 Fold Change in Antibody Level Interval 6.89 to 12.44	—	—	—	—
Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 Serotype 3	2.34 Fold Change in Antibody Level Interval 1.97 to 2.79	4.20 Fold Change in Antibody Level Interval 3.31 to 5.32	—	—	—	—
Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 Serotype 4	5.32 Fold Change in Antibody Level Interval 4.22 to 6.71	6.29 Fold Change in Antibody Level Interval 4.65 to 8.51	—	—	—	—
Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 Serotype 5	2.02 Fold Change in Antibody Level Interval 1.75 to 2.34	2.53 Fold Change in Antibody Level Interval 2.12 to 3.02	—	—	—	—
Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 Serotype 9V	3.17 Fold Change in Antibody Level Interval 2.7 to 3.72	4.39 Fold Change in Antibody Level Interval 3.62 to 5.34	—	—	—	—
Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 Serotype 14	5.23 Fold Change in Antibody Level Interval 4.0 to 6.86	7.34 Fold Change in Antibody Level Interval 5.5 to 9.79	—	—	—	—
Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 Serotype 18C	3.97 Fold Change in Antibody Level Interval 3.28 to 4.79	7.41 Fold Change in Antibody Level Interval 5.77 to 9.53	—	—	—	—
Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 Serotype 19A	2.33 Fold Change in Antibody Level Interval 1.99 to 2.72	2.93 Fold Change in Antibody Level Interval 2.46 to 3.5	—	—	—	—
Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 Serotype 19F	2.97 Fold Change in Antibody Level Interval 2.44 to 3.62	4.60 Fold Change in Antibody Level Interval 3.64 to 5.8	—	—	—	—
Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 Serotype 23F	2.74 Fold Change in Antibody Level Interval 2.27 to 3.32	4.54 Fold Change in Antibody Level Interval 3.58 to 5.75	—	—	—	—

SECONDARY outcome

Timeframe: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

Population: Evaluable Immunogenicity Population

Geometric Mean Fold Increase From Baseline of Influenza Antigens Measured at Visit 4.

n was the number of participants with valid and determinate assay results for the specified HAI strain at the given visit.

Confidence Intervals (CIs) were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=92 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=91 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Vaccine Sub-study. Fold Increase of Anti-influenza Antibody Levels to Each of the 3 Influenza Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 Antigen B	3.33 Fold Change in Antibody Level Interval 2.57 to 4.32	4.17 Fold Change in Antibody Level Interval 3.25 to 5.34	—	—	—	—
Vaccine Sub-study. Fold Increase of Anti-influenza Antibody Levels to Each of the 3 Influenza Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 Antigen H1N1	7.94 Fold Change in Antibody Level Interval 5.96 to 10.58	6.71 Fold Change in Antibody Level Interval 4.94 to 9.12	—	—	—	—
Vaccine Sub-study. Fold Increase of Anti-influenza Antibody Levels to Each of the 3 Influenza Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 Antigen H3N2	7.80 Fold Change in Antibody Level Interval 5.58 to 10.91	8.51 Fold Change in Antibody Level Interval 6.45 to 11.21	—	—	—	—

SECONDARY outcome

Timeframe: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

Population: Evaluable Immunogenicity Population

Mean pneumococcal concentrations (ug/mL) at vaccine baseline (visit 2) and post-vaccination visits (visits 3 and 4) by serotype. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed for each serotype varied, and is provided for each individually.

ug/mL=micrograms per milliliter

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=92 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=91 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib n=92 Participants All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 n=91 Participants Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 n=92 Participants Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 n=91 Participants Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Vaccine Sub-study. Concentrations of Anti-pneumococcal Antibodies at Vaccine Sub-study Visit 3 and 4 Serotype 9V	1.31 Concentration (ug/mL) Interval 1.08 to 1.6	1.12 Concentration (ug/mL) Interval 0.89 to 1.42	2.00 Concentration (ug/mL) Interval 1.64 to 2.44	2.26 Concentration (ug/mL) Interval 1.78 to 2.87	4.16 Concentration (ug/mL) Interval 3.29 to 5.27	4.80 Concentration (ug/mL) Interval 3.75 to 6.16
Vaccine Sub-study. Concentrations of Anti-pneumococcal Antibodies at Vaccine Sub-study Visit 3 and 4 Serotype 14	2.31 Concentration (ug/mL) Interval 1.79 to 2.98	2.05 Concentration (ug/mL) Interval 1.59 to 2.63	4.02 Concentration (ug/mL) Interval 3.04 to 5.32	5.03 Concentration (ug/mL) Interval 3.77 to 6.71	12.09 Concentration (ug/mL) Interval 8.76 to 16.69	15.01 Concentration (ug/mL) Interval 10.8 to 20.88
Vaccine Sub-study. Concentrations of Anti-pneumococcal Antibodies at Vaccine Sub-study Visit 3 and 4 Serotype 18C	1.08 Concentration (ug/mL) Interval 0.86 to 1.36	0.89 Concentration (ug/mL) Interval 0.7 to 1.14	1.81 Concentration (ug/mL) Interval 1.43 to 2.29	2.41 Concentration (ug/mL) Interval 1.82 to 3.18	4.27 Concentration (ug/mL) Interval 3.34 to 5.47	6.61 Concentration (ug/mL) Interval 5.01 to 8.74
Vaccine Sub-study. Concentrations of Anti-pneumococcal Antibodies at Vaccine Sub-study Visit 3 and 4 Serotype 19F	1.17 Concentration (ug/mL) Interval 0.92 to 1.5	1.18 Concentration (ug/mL) Interval 0.89 to 1.58	1.61 Concentration (ug/mL) Interval 1.25 to 2.08	2.17 Concentration (ug/mL) Interval 1.61 to 2.91	3.52 Concentration (ug/mL) Interval 2.6 to 4.76	5.47 Concentration (ug/mL) Interval 3.98 to 7.52
Vaccine Sub-study. Concentrations of Anti-pneumococcal Antibodies at Vaccine Sub-study Visit 3 and 4 Serotype 23F	1.25 Concentration (ug/mL) Interval 1.01 to 1.56	1.16 Concentration (ug/mL) Interval 0.93 to 1.44	1.80 Concentration (ug/mL) Interval 1.44 to 2.25	2.24 Concentration (ug/mL) Interval 1.75 to 2.88	3.44 Concentration (ug/mL) Interval 2.66 to 4.44	5.27 Concentration (ug/mL) Interval 3.96 to 7.02

SECONDARY outcome

Timeframe: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

Population: Evaluable Immunogenicity Population

Mean influenza antibody titers at visits 3 and 4.

Outcome measures

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=92 Participants Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=91 Participants Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib n=91 Participants All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Tofacitinib 10 mg BID Interrupted Visit 4 n=91 Participants Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization	Tofacitinib 10 mg BID Continuous Visit 4 n=92 Participants Participants receiving continuous tofacitinib treatment	Tofacitinib 10 mg BID Interrupted Visit 4 n=91 Participants Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
Vaccine Sub-study. Titers of Anti-influenza Antibodies at Vaccine Sub-study Visit 3 and 4 HAI B	11.43 Antibody Titer Interval 9.38 to 13.91	10.85 Antibody Titer Interval 8.9 to 13.22	23.29 Antibody Titer Interval 17.92 to 30.27	37.45 Antibody Titer Interval 28.17 to 49.78	38.06 Antibody Titer Interval 28.71 to 50.47	45.19 Antibody Titer Interval 35.01 to 58.34
Vaccine Sub-study. Titers of Anti-influenza Antibodies at Vaccine Sub-study Visit 3 and 4 HAI H1N1	15.14 Antibody Titer Interval 11.67 to 19.64	20.26 Antibody Titer Interval 14.86 to 27.62	52.75 Antibody Titer Interval 37.97 to 73.28	105.2 Antibody Titer Interval 70.76 to 156.5	120.2 Antibody Titer Interval 89.83 to 160.8	136.0 Antibody Titer Interval 97.67 to 189.4
Vaccine Sub-study. Titers of Anti-influenza Antibodies at Vaccine Sub-study Visit 3 and 4 HAI H3N2	18.18 Antibody Titer Interval 13.53 to 24.44	17.30 Antibody Titer Interval 12.98 to 23.07	55.07 Antibody Titer Interval 38.19 to 79.43	83.10 Antibody Titer Interval 57.38 to 120.4	141.8 Antibody Titer Interval 102.9 to 195.4	147.2 Antibody Titer Interval 107.8 to 201.0

Adverse Events

Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID)

Serious events: 346 serious events

Other events: 807 other events

Deaths: 25 deaths

Initial Period: Tofacitinib 10 mg BID

Serious events: 997 serious events

Other events: 2422 other events

Deaths: 30 deaths

Initial Period: All Tofacitinib

Serious events: 1343 serious events

Other events: 3229 other events

Deaths: 55 deaths

Extension Period: Tofacitinib 5 mg

Serious events: 5 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=1123 participants at risk Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=3358 participants at risk Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib n=4481 participants at risk All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Extension Period: Tofacitinib 5 mg n=48 participants at risk Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Blood and lymphatic system disorders Leukocytosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Blood and lymphatic system disorders Anaemia	0.36% 4/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.30% 10/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.31% 14/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Blood and lymphatic system disorders Leukopenia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Blood and lymphatic system disorders Mastocytosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Blood and lymphatic system disorders Pancytopenia	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Blood and lymphatic system disorders Paratracheal lymphadenopathy	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Acute myocardial infarction	0.36% 4/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.18% 8/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Angina pectoris	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Angina unstable	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.15% 5/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.18% 8/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Aortic valve incompetence	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Aortic valve stenosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Arrhythmia	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Arteriosclerosis coronary artery	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Atrial fibrillation	0.53% 6/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.42% 14/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.45% 20/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Atrial flutter	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Atrioventricular block complete	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Atrioventricular block second degree	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Bradycardia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Bundle branch block right	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Cardiac arrest	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Cardiac failure	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.15% 5/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.18% 8/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Cardiac failure congestive	0.36% 4/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.16% 7/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Cardiac tamponade	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Cardio-respiratory arrest	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Cardiogenic shock	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Cardiopulmonary failure	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Cardiovascular insufficiency	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Coronary artery disease	0.36% 4/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.33% 11/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.33% 15/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Coronary artery stenosis	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Coronary artery thrombosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Hypertensive heart disease	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Long QT syndrome	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Mitral valve incompetence	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Mitral valve stenosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Myocardial infarction	0.71% 8/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.39% 13/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.47% 21/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Myocardial ischaemia	0.36% 4/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.16% 7/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Palpitations	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Pericardial effusion	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Sinus node dysfunction	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Sinus tachycardia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Stress cardiomyopathy	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Supraventricular tachycardia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Tachycardia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Ventricular arrhythmia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Ventricular tachycardia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Wolff-Parkinson-White syndrome	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Congenital, familial and genetic disorders Developmental hip dysplasia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Congenital, familial and genetic disorders Tourette's disorder	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Ear and labyrinth disorders Acute vestibular syndrome	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Ear and labyrinth disorders Vertigo	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Ear and labyrinth disorders Vertigo positional	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Endocrine disorders Adrenal insufficiency	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Endocrine disorders Goitre	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.21% 7/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.22% 10/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Endocrine disorders Hyperparathyroidism primary	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Endocrine disorders Hyperthyroidism	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Eye disorders Cataract	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.24% 8/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.22% 10/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Eye disorders Glaucoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Eye disorders Keratitis interstitial	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Eye disorders Necrotising retinitis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Eye disorders Optic disc drusen	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Eye disorders Retinal artery occlusion	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Eye disorders Retinal detachment	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Eye disorders Ulcerative keratitis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Eye disorders Uveitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Eye disorders Visual acuity reduced	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Abdominal hernia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Abdominal incarcerated hernia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Abdominal pain upper	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Ascites	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Chronic gastritis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Colitis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.15% 5/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.13% 6/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Colitis ulcerative	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Crohn's disease	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Diarrhoea	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.24% 8/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.22% 10/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Diverticular perforation	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.15% 5/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.18% 8/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Diverticulum	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Duodenal polyp	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Dyspepsia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Enterocele	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Enterocolitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Secondary syphilis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Faecaloma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Fistula of small intestine	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Food poisoning	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Gastric disorder	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Gastric perforation	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Gastric polyps	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Gastric ulcer	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Sepsis	0.45% 5/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.24% 8/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.29% 13/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Gastritis	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.16% 7/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Gastritis erosive	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Haematemesis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Haematochezia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Haemorrhagic erosive gastritis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Haemorrhoids	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Hiatus hernia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Ileus	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Ileus paralytic	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Inguinal hernia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Large intestinal stenosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Large intestine perforation	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Large intestine polyp	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Melaena	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Mesenteric vein thrombosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Nausea	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Oesophageal spasm	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Pancreatitis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.11% 5/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Pancreatitis acute	0.36% 4/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.18% 8/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Rectal haemorrhage	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Rectal prolapse	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Tooth disorder	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Tooth impacted	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Umbilical hernia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Vomiting	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Abscess sterile	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Asthenia	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Chest discomfort	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Chest pain	0.45% 5/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.36% 12/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.38% 17/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Death	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Drug ineffective	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Fatigue	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Fibrosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Gait disturbance	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Hernia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Multiple organ dysfunction syndrome	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Non-cardiac chest pain	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Oedema	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Oedema peripheral	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Peripheral swelling	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Pyrexia	0.45% 5/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.15% 5/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.22% 10/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Sudden death	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Systemic inflammatory response syndrome	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Bile duct stone	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Biliary colic	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Cholangitis acute	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Cholangitis chronic	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Cholecystitis	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Cholecystitis acute	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.11% 5/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Cholecystitis chronic	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Cholelithiasis	0.89% 10/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.39% 13/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.51% 23/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Gallbladder disorder	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Gallbladder non-functioning	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Hepatic congestion	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Hepatic failure	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Hepatic steatosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Sepsis syndrome	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Hepatitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Hepatotoxicity	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Hypertransaminasaemia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Sphincter of Oddi dysfunction	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Immune system disorders Allergy to arthropod bite	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Immune system disorders Allergy to arthropod sting	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Immune system disorders Anaphylactic reaction	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Immune system disorders Anaphylactic shock	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Abdominal abscess	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Abdominal wall abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Abscess limb	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Abscess neck	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Anal abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Appendicitis	0.53% 6/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.33% 11/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.38% 17/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Appendicitis perforated	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Arthritis bacterial	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.11% 5/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Arthritis infective	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Atypical pneumonia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Bacteraemia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Bacterial pyelonephritis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Bartholin's abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Bone tuberculosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Bronchiolitis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Bronchitis	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.15% 5/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.18% 8/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Bursitis infective	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Cellulitis	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.42% 14/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.36% 16/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Cellulitis gangrenous	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Chronic sinusitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Chronic tonsillitis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Clostridial infection	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Clostridium difficile colitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Clostridium difficile infection	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Colonic abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Cytomegalovirus chorioretinitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Cytomegalovirus hepatitis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Dengue fever	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Device related infection	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Diabetic gangrene	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Diarrhoea infectious	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Disseminated tuberculosis	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.16% 7/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Diverticulitis	0.45% 5/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.36% 12/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.38% 17/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Encephalitis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Epstein-Barr virus infection	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Erysipelas	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Escherichia bacteraemia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Escherichia sepsis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Extradural abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Eye infection fungal	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Gastroenteritis	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.39% 13/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.33% 15/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Gastroenteritis viral	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Gastrointestinal viral infection	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Groin abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations H1N1 influenza	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations HIV infection	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Hepatitis A	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Hepatitis B	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Hepatitis C	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Hepatitis E	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Herpes dermatitis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Herpes simplex	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Herpes virus infection	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Herpes zoster	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.48% 16/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.40% 18/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Herpes zoster cutaneous disseminated	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Herpes zoster disseminated	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.15% 5/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.11% 5/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Herpes zoster oticus	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Incision site infection	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Infected seroma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Infected skin ulcer	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Infectious colitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Infectious mononucleosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Infective exacerbation of bronchiectasis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Infective spondylitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Influenza	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Joint abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Joint tuberculosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Lower respiratory tract infection	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Lower respiratory tract infection bacterial	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Lung infection	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Lyme disease	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Lymph node tuberculosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Meningitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Meningitis bacterial	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Meningitis cryptococcal	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Meningococcal bacteraemia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Meningoencephalitis bacterial	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Nasopharyngitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Necrotising fasciitis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Oesophageal candidiasis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Ophthalmic herpes simplex	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Osteomyelitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Otitis media	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pelvic inflammatory disease	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Periorbital cellulitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Perirectal abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Peritoneal tuberculosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Peritonitis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Peritonsillar abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pertussis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pharyngeal abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pneumonia	1.9% 21/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	2.1% 70/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	2.0% 91/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pneumonia bacterial	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pneumonia cryptococcal	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pneumonia cytomegaloviral	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pneumonia legionella	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pneumonia necrotising	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pneumonia pneumococcal	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pneumonia streptococcal	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Post procedural infection	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Postoperative abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Postoperative wound infection	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.15% 5/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.11% 5/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Primary syphilis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Psoas abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pulmonary sepsis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pulmonary tuberculosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.21% 7/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.18% 8/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pulpitis dental	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pyelonephritis	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.11% 5/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pyelonephritis acute	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.15% 5/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.13% 6/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pyoderma streptococcal	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pyometra	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Rectal abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Renal abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Renal cyst infection	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Respiratory tract infection	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.15% 5/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.11% 5/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Retinitis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Salpingo-oophoritis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Septic shock	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.16% 7/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Sinusitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Sinusitis aspergillus	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Sinusitis fungal	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Skin infection	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Splenic abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Staphylococcal infection	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Staphylococcal sepsis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Streptococcal infection	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Subcutaneous abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Superinfection	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Tonsillitis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Tooth abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Toxic shock syndrome	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Tuberculosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Tuberculosis of central nervous system	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Tubo-ovarian abscess	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Upper respiratory tract infection	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Upper respiratory tract infection bacterial	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Urinary tract infection	0.71% 8/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.42% 14/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.49% 22/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Urinary tract infection bacterial	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Urosepsis	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Varicella zoster virus infection	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Vestibular neuronitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Viral infection	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Wound infection	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Wound infection bacterial	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Wound infection staphylococcal	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Anastomotic ulcer	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Ankle fracture	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.21% 7/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.20% 9/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Concussion	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Contusion	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Dislocation of vertebra	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Exposure via father	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Fall	0.62% 7/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.27% 9/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.36% 16/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Femoral neck fracture	0.36% 4/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.16% 7/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Femur fracture	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.36% 12/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.31% 14/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Foetal exposure during pregnancy	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Foot fracture	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.11% 5/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Forearm fracture	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Fracture	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Fractured ischium	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Hip fracture	0.53% 6/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.18% 8/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Humerus fracture	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.33% 11/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.29% 13/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Incorrect dose administered	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Injury	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Joint dislocation	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.11% 5/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Joint dislocation postoperative	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Joint injury	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Laceration	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Ligament rupture	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Lower limb fracture	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Maternal exposure timing unspecified	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Meniscus injury	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Muscle injury	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Periprosthetic fracture	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Perirenal haematoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Post procedural oedema	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Postoperative hernia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Radius fracture	0.36% 4/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.16% 7/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.15% 5/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.11% 5/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.15% 5/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.11% 5/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Scapula fracture	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Soft tissue injury	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Tendon rupture	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.30% 10/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.27% 12/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.21% 7/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.16% 7/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Traumatic liver injury	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Twiddler's syndrome	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Ulna fracture	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Upper limb fracture	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.11% 5/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Wound	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Airway peak pressure increased	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations B-lymphocyte count increased	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Blood creatine phosphokinase increased	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations C-reactive protein increased	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Cardiac murmur	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Electrocardiogram T wave abnormal	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Electrocardiogram T wave inversion	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Electrocardiogram abnormal	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Haematocrit decreased	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Haemoglobin decreased	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Hepatic enzyme increased	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Human papilloma virus test positive	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Liver function test increased	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Metamyelocyte count increased	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Myelocyte count increased	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Red blood cell sedimentation rate increased	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Transaminases increased	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Troponin I increased	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Weight decreased	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Weight increased	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Dehydration	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.18% 6/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.20% 9/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Diabetes mellitus	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Hypoglycaemia unawareness	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Hypokalaemia	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Hypovolaemia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Metabolic syndrome	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Obesity	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Acquired claw toe	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.24% 8/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.20% 9/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Arthritis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.11% 5/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Atlantoaxial instability	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.36% 4/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.39% 13/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.38% 17/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Bone disorder	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Bursitis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Exostosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Extraskeletal ossification	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Finger deformity	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Foot deformity	0.45% 5/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.36% 12/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.38% 17/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Groin pain	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Hand deformity	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.33% 11/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.31% 14/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Joint contracture	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Joint destruction	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Kyphosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Ligament disorder	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.45% 5/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.20% 9/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Meniscal degeneration	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Myopathy	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.9% 21/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	1.9% 63/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	1.9% 84/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.15% 5/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.16% 7/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Pathological fracture	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Polyarthritis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Rheumatic disorder	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.98% 11/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.68% 23/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.76% 34/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Rheumatoid nodule	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.21% 7/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.16% 7/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.24% 8/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.20% 9/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Spondylitis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.24% 8/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.22% 10/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Synovial disorder	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Tendon calcification	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) 5q minus syndrome	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute promyelocytic leukaemia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of appendix	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of the cervix	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell small lymphocytic lymphoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.36% 12/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.33% 15/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign tracheal neoplasm	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.36% 4/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.36% 12/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.36% 16/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage 0	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Choroid plexus papilloma	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage I	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extranodal marginal zone B-cell lymphoma (MALT type)	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroadenoma of breast	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's sarcoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.11% 5/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.24% 8/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.25% 11/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant peritoneal neoplasm	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Marginal zone lymphoma stage II	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medullary thyroid cancer	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mucoepidermoid carcinoma	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nodular melanoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer metastatic	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian germ cell teratoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.21% 7/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.16% 7/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sebaceous carcinoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spindle cell sarcoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.30% 10/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.27% 12/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.16% 7/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the cervix	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the vulva	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Synovial sarcoma	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell lymphoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteral neoplasm	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.62% 7/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.42% 14/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.47% 21/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer stage 0	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Aphasia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Brain injury	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Brain stem infarction	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Carotid artery aneurysm	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Carotid artery stenosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Central nervous system lesion	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Cerebellar ataxia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Cerebral arteriosclerosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Cerebral haematoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Cerebral haemorrhage	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.11% 5/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Cerebral infarction	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Cerebrovascular accident	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.18% 6/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.18% 8/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Cervical cord compression	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Cervical myelopathy	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Cervical radiculopathy	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Dizziness	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Facial nerve disorder	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Facial paralysis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Haemorrhagic stroke	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Headache	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Hemianopia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Hemiparesis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Intensive care unit acquired weakness	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Intracranial aneurysm	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Intraventricular haemorrhage	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Ischaemic stroke	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Loss of consciousness	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Lumbar radiculopathy	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Lumbosacral radiculopathy	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Metabolic encephalopathy	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Migraine	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Monoplegia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Multiple sclerosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Myasthenia gravis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Myelopathy	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Nerve root compression	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Neuritis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Pachymeningitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Parkinson's disease	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Post herpetic neuralgia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Presyncope	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Quadriparesis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Radicular syndrome	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Radiculopathy	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Ruptured cerebral aneurysm	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Sciatica	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.27% 9/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.22% 10/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Seizure	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Sensory loss	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Serotonin syndrome	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Small fibre neuropathy	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Spinal claudication	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Spinal subdural haematoma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Spondylitic myelopathy	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Syncope	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.15% 5/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.13% 6/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Tension headache	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Transient ischaemic attack	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.33% 11/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.29% 13/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Vasculitis cerebral	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Pregnancy, puerperium and perinatal conditions Foetal death	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Pregnancy, puerperium and perinatal conditions Unintended pregnancy	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Product Issues Device dislocation	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Product Issues Device electrical impedance issue	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Product Issues Device loosening	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Psychiatric disorders Affective disorder	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Psychiatric disorders Alcoholism	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Psychiatric disorders Anxiety	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Psychiatric disorders Anxiety disorder	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Psychiatric disorders Completed suicide	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Psychiatric disorders Confusional state	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Psychiatric disorders Depression	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Psychiatric disorders Drug abuse	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Psychiatric disorders Post-traumatic stress disorder	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Psychiatric disorders Psychotic disorder due to a general medical condition	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Psychiatric disorders Restlessness	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Psychiatric disorders Stress	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Psychiatric disorders Suicidal ideation	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Acute kidney injury	0.53% 6/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.18% 6/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.27% 12/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Anuria	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Calculus bladder	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Calculus urinary	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Chronic kidney disease	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Haematuria	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Hydronephrosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Mixed incontinence	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Nephrolithiasis	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.15% 5/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.16% 7/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Obstructive uropathy	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Proteinuria	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Pyelocaliectasis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Renal colic	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Renal failure	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Renal impairment	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Ureteral necrosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Ureteric stenosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Ureterolithiasis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Urethral meatus stenosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Urinary incontinence	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Renal and urinary disorders Urinary retention	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Adenomyosis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Breast enlargement	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Breast hyperplasia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Breast mass	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Cystocele	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Endometrial dysplasia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Fallopian tube cyst	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Haemorrhagic ovarian cyst	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Menometrorrhagia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Metrorrhagia	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Ovarian cyst	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.24% 8/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.20% 9/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Rectocele	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Uterine polyp	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Uterine prolapse	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Uterovaginal prolapse	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Acute interstitial pneumonitis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Alveolitis allergic	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.45% 5/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.18% 6/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.25% 11/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.12% 4/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.13% 6/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 4/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract inflammation	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.48% 16/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.42% 19/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Respiration abnormal	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.45% 5/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.18% 8/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Skin and subcutaneous tissue disorders Actinic keratosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Skin and subcutaneous tissue disorders Panniculitis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Skin and subcutaneous tissue disorders Rash	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Skin and subcutaneous tissue disorders Scar pain	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Skin and subcutaneous tissue disorders Skin ulcer	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Social circumstances Activities of daily living impaired	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Social circumstances Physical abuse	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Surgical and medical procedures Arthrodesis	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Surgical and medical procedures Hip arthroplasty	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Surgical and medical procedures Knee arthroplasty	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Accelerated hypertension	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Aortic aneurysm	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.09% 3/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.11% 5/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Aortic dissection	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Aortic stenosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Arteriosclerosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Circulatory collapse	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Deep vein thrombosis	0.53% 6/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.27% 9/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.33% 15/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Extremity necrosis	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Haematoma	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Hypertension	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.21% 7/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.22% 10/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Hypertensive crisis	0.27% 3/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.24% 8/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.25% 11/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Hypotension	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Hypovolaemic shock	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Peripheral artery occlusion	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Peripheral venous disease	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.06% 2/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.04% 2/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Shock	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Thromboangiitis obliterans	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Thrombophlebitis	0.18% 2/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.03% 1/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.07% 3/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Varicose vein	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.15% 5/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.11% 5/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Venous thrombosis limb	0.09% 1/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.02% 1/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Herpes zoster 1	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	2.1% 1/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pneumonia 1	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	2.1% 1/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Humerus fracture 1	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	2.1% 1/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma 1	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	2.1% 1/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Psychiatric disorders Depression 1	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	2.1% 1/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.

Other adverse events

Measure	Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) n=1123 participants at risk Participants with non-zero average total daily dose across study \<15 were assigned to 5 mg BID.	Initial Period: Tofacitinib 10 mg BID n=3358 participants at risk Participants with average total daily dose across study \>=15 were assigned to 10 mg BID.	Initial Period: All Tofacitinib n=4481 participants at risk All participants treated with tofacitinib 5 mg BID and 10 mg BID groups in initial period.	Extension Period: Tofacitinib 5 mg n=48 participants at risk Participants who completed 2 years of lymphocyte assessment in Initial period and enrolled for Extension period received Tofacitinib (CP-690,550) 5 mg orally, twice daily up to 12 months.
Blood and lymphatic system disorders Anemia	5.7% 64/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	5.2% 176/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	5.4% 240/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Diarrhoea	6.4% 72/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	6.3% 213/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	6.4% 285/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Nausea	5.0% 56/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	5.2% 175/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	5.2% 231/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Bronchitis	12.6% 141/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	12.8% 430/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	12.7% 571/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Herpes zoster	10.4% 117/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	11.1% 373/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	10.9% 490/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Influenza	6.9% 78/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	5.9% 199/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	6.2% 277/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Nasopharyngitis	12.3% 138/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	15.4% 517/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	14.6% 655/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pharyngitis	5.2% 58/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	4.4% 148/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	4.6% 206/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Sinusitis	6.2% 70/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	7.1% 239/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	6.9% 309/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Upper respiratory tract infection	20.3% 228/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	18.3% 613/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	18.8% 841/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Urinary tract infection	14.3% 161/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	13.3% 447/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	13.6% 608/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Fall	5.7% 64/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	6.2% 209/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	6.1% 273/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Alanine aminotransferase increased	5.6% 63/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	3.6% 122/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	4.1% 185/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Blood creatine phosphokinase increased	8.1% 91/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	7.4% 247/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	7.5% 338/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Investigations Blood creatinine increased	5.3% 60/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	3.5% 116/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	3.9% 176/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Metabolism and nutrition disorders Hypercholesterolaemia	5.5% 62/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	4.6% 153/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	4.8% 215/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 87/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	7.9% 265/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	7.9% 352/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Back pain	9.4% 106/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	8.7% 291/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	8.9% 397/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	9.2% 103/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	8.7% 293/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	8.8% 396/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Headache	6.0% 67/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	6.0% 201/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	6.0% 268/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	5.8% 65/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	6.0% 202/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	6.0% 267/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Hypertension	12.4% 139/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	9.3% 311/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	10.0% 450/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Bronchitis 1	0.00% 0/1123 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/3358 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	0.00% 0/4481 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.	6.2% 3/48 • 114 months for Initial Period; 13 months for Extension Period The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the investigator is that the sponsor can review results communications at least 30 days prior to public release and can embargo communications regarding trial results for a period that is no more than an additional 60 days. Investigators will, on request, remove any previously undisclosed confidential information (other than the study results themselves) before disclosure.
• Publication restrictions are in place

Restriction type: OTHER