Trial Outcomes & Findings for The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone) (NCT NCT01106690)

NCT ID: NCT01106690

Last Updated: 2013-07-15

Results Overview

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 344 participants
• Primary outcome timeframe: Day 1 (Baseline) and Week 26
• Results posted on: 2013-07-15

Participant Flow

This study evaluated the efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin and pioglitazone. The study was conducted between 13 April 2010 and 20 November 2011 and recruited patients from 74 study centers in 11 countries worldwide.

344 patients were randomly allocated to the 3 treatment arms. 342 patients received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set (used for the Week 26 efficacy analysis) and safety analysis set (used for the Week 26 and Week 52 safety analyses).

Participant milestones

Measure	Placebo/Sitagliptin Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.	Canagliflozin 100 mg Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.	Canagliflozin 300 mg Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Core Period: Baseline to Week 26 STARTED	115	113	114
Core Period: Baseline to Week 26 COMPLETED	91	104	101
Core Period: Baseline to Week 26 NOT COMPLETED	24	9	13
Extension Period: Week 26 to Week 52 STARTED	90	103	96
Extension Period: Week 26 to Week 52 COMPLETED	78	96	89
Extension Period: Week 26 to Week 52 NOT COMPLETED	12	7	7

Reasons for withdrawal

Measure	Placebo/Sitagliptin Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.	Canagliflozin 100 mg Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.	Canagliflozin 300 mg Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Core Period: Baseline to Week 26 Adverse Event	6	1	4
Core Period: Baseline to Week 26 Lost to Follow-up	1	1	2
Core Period: Baseline to Week 26 Protocol Violation	1	0	0
Core Period: Baseline to Week 26 Withdrawal by Subject	4	1	0
Core Period: Baseline to Week 26 Creatinine or eGFR withdrawal criteria	0	3	1
Core Period: Baseline to Week 26 Noncompliance with study drug	0	1	0
Core Period: Baseline to Week 26 Unable to take rescue therapy	1	0	0
Core Period: Baseline to Week 26 Lack of efficacy on rescue therapy	1	0	0
Core Period: Baseline to Week 26 Other	10	2	6
Extension Period: Week 26 to Week 52 Adverse Event	1	1	0
Extension Period: Week 26 to Week 52 Withdrawal by Subject	1	0	0
Extension Period: Week 26 to Week 52 Physician Decision	0	2	2
Extension Period: Week 26 to Week 52 Noncompliance with study drug	0	0	1
Extension Period: Week 26 to Week 52 Unable to take rescue therapy	1	1	0
Extension Period: Week 26 to Week 52 Other	8	3	4
Extension Period: Week 26 to Week 52 Lost to Follow-up	1	0	0

Baseline Characteristics

The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone)

Baseline characteristics by cohort

Measure	Placebo/Sitagliptin n=115 Participants Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.	Canagliflozin 100 mg n=113 Participants Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.	Canagliflozin 300 mg n=114 Participants Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.	Total n=342 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	83 Participants n=5 Participants	83 Participants n=7 Participants	83 Participants n=5 Participants	249 Participants n=4 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants	30 Participants n=7 Participants	31 Participants n=5 Participants	93 Participants n=4 Participants
Age Continuous	58.3 years STANDARD_DEVIATION 9.56 • n=5 Participants	56.7 years STANDARD_DEVIATION 10.36 • n=7 Participants	57 years STANDARD_DEVIATION 10.19 • n=5 Participants	57.4 years STANDARD_DEVIATION 10.03 • n=4 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	36 Participants n=7 Participants	51 Participants n=5 Participants	126 Participants n=4 Participants
Sex: Female, Male Male	76 Participants n=5 Participants	77 Participants n=7 Participants	63 Participants n=5 Participants	216 Participants n=4 Participants
Region of Enrollment CANADA	24 participants n=5 Participants	22 participants n=7 Participants	21 participants n=5 Participants	67 participants n=4 Participants
Region of Enrollment FINLAND	7 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	13 participants n=4 Participants
Region of Enrollment FRANCE	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants
Region of Enrollment GERMANY	7 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants	19 participants n=4 Participants
Region of Enrollment GREECE	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment INDIA	10 participants n=5 Participants	10 participants n=7 Participants	5 participants n=5 Participants	25 participants n=4 Participants
Region of Enrollment MEXICO	7 participants n=5 Participants	3 participants n=7 Participants	11 participants n=5 Participants	21 participants n=4 Participants
Region of Enrollment SPAIN	8 participants n=5 Participants	5 participants n=7 Participants	2 participants n=5 Participants	15 participants n=4 Participants
Region of Enrollment THAILAND	5 participants n=5 Participants	8 participants n=7 Participants	4 participants n=5 Participants	17 participants n=4 Participants
Region of Enrollment UNITED KINGDOM	3 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants	8 participants n=4 Participants
Region of Enrollment UNITED STATES	43 participants n=5 Participants	55 participants n=7 Participants	56 participants n=5 Participants	154 participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 (Baseline) and Week 26

Population: Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

Outcome measures

Measure	Placebo/Sitagliptin n=114 Participants Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.	Canagliflozin 100 mg n=113 Participants Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.	Canagliflozin 300 mg n=112 Participants Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Change in HbA1c From Baseline to Week 26	-0.26 Percent Standard Error 0.069	-0.89 Percent Standard Error 0.069	-1.03 Percent Standard Error 0.070

SECONDARY outcome

Timeframe: Week 26

Population: Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.

The table below shows the percentage of patients with HbA1c<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.

Outcome measures

Measure	Placebo/Sitagliptin n=114 Participants Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.	Canagliflozin 100 mg n=113 Participants Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.	Canagliflozin 300 mg n=112 Participants Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Percentage of Patients With HbA1c <7% at Week 26	32.5 Percentage of patients	46.9 Percentage of patients	64.3 Percentage of patients

SECONDARY outcome

Timeframe: Day 1 (Baseline) and Week 26

Population: Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.

The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

Outcome measures

Measure	Placebo/Sitagliptin n=114 Participants Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.	Canagliflozin 100 mg n=113 Participants Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.	Canagliflozin 300 mg n=112 Participants Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26	2.54 mg/dL Standard Error 2.785	-26.8 mg/dL Standard Error 2.796	-33.2 mg/dL Standard Error 2.817

SECONDARY outcome

Timeframe: Day 1 (Baseline) and Week 26

Population: Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.

HOMA2-%B is a measure of beta cell function (the cells in the pancreas that produce and store insulin). The table below shows the least-squares (LS) mean change in HOMA2-%B from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

Outcome measures

Measure	Placebo/Sitagliptin n=100 Participants Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.	Canagliflozin 100 mg n=103 Participants Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.	Canagliflozin 300 mg n=105 Participants Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Change in Homeostasis Model Assessment (HOMA2-%B) From Baseline to Week 26	0.91 HOMA2-%B Standard Error 1.833	15.19 HOMA2-%B Standard Error 1.809	18.14 HOMA2-%B Standard Error 1.790

SECONDARY outcome

Timeframe: Day 1 (Baseline) and Week 26

Population: Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.

The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.

Outcome measures

Measure	Placebo/Sitagliptin n=114 Participants Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.	Canagliflozin 100 mg n=113 Participants Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.	Canagliflozin 300 mg n=112 Participants Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Percent Change in Body Weight From Baseline to Week 26	-0.1 Percent change Standard Error 0.3	-2.8 Percent change Standard Error 0.3	-3.8 Percent change Standard Error 0.3

SECONDARY outcome

Timeframe: Day 1 (Baseline) and Week 26

Population: Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.

The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

Outcome measures

Measure	Placebo/Sitagliptin n=114 Participants Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.	Canagliflozin 100 mg n=113 Participants Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.	Canagliflozin 300 mg n=112 Participants Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26	-1.24 mmHg Standard Error 1.033	-5.30 mmHg Standard Error 1.036	-4.70 mmHg Standard Error 1.044

SECONDARY outcome

Timeframe: Day 1 (Baseline) and Week 26

Population: Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.

The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.

Outcome measures

Measure	Placebo/Sitagliptin n=105 Participants Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.	Canagliflozin 100 mg n=108 Participants Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.	Canagliflozin 300 mg n=109 Participants Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Percent Change in Triglycerides From Baseline to Week 26	15.2 Percent change Standard Error 4.1	3.2 Percent change Standard Error 4.1	-1.7 Percent change Standard Error 4.1

SECONDARY outcome

Timeframe: Day 1 (Baseline) and Week 26

Population: Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.

The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.

Outcome measures

Measure	Placebo/Sitagliptin n=105 Participants Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.	Canagliflozin 100 mg n=107 Participants Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.	Canagliflozin 300 mg n=109 Participants Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26	2.4 Percent change Standard Error 1.4	7.2 Percent change Standard Error 1.3	8.9 Percent change Standard Error 1.3

Adverse Events

Placebo/Sitagliptin: Baseline to Week 26

Serious events: 5 serious events

Other events: 31 other events

Deaths: 0 deaths

Canagliflozin 100 mg: Baseline to Week 26

Serious events: 3 serious events

Other events: 35 other events

Deaths: 0 deaths

Canagliflozin 300 mg: Baseline to Week 26

Serious events: 4 serious events

Other events: 40 other events

Deaths: 0 deaths

Placebo/Sitagliptin: Baseline to Week 52

Serious events: 6 serious events

Other events: 49 other events

Deaths: 0 deaths

Canagliflozin 100 mg: Baseline to Week 52

Serious events: 8 serious events

Other events: 48 other events

Deaths: 0 deaths

Canagliflozin 300 mg: Baseline to Week 52

Serious events: 7 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo/Sitagliptin: Baseline to Week 26 n=115 participants at risk Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52. Data are presented for Baseline to Week 26.	Canagliflozin 100 mg: Baseline to Week 26 n=113 participants at risk Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 26.	Canagliflozin 300 mg: Baseline to Week 26 n=114 participants at risk Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 26.	Placebo/Sitagliptin: Baseline to Week 52 n=115 participants at risk Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52. Data are presented for Baseline to Week 52.	Canagliflozin 100 mg: Baseline to Week 52 n=113 participants at risk Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 52.	Canagliflozin 300 mg: Baseline to Week 52 n=114 participants at risk Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 52.
Cardiac disorders Acute coronary syndrome	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Gastrointestinal disorders Dyspepsia	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
General disorders Chest pain	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Infections and infestations Anal abscess	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Infections and infestations Escherichia bacteraemia	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Infections and infestations Gastrointestinal infection	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Infections and infestations Osteomyelitis	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Infections and infestations Sepsis syndrome	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Injury, poisoning and procedural complications Concussion	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Injury, poisoning and procedural complications Laceration	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Injury, poisoning and procedural complications Periprosthetic fracture	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Respiratory, thoracic and mediastinal disorders Restrictive pulmonary disease	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Vascular disorders Hypotension	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Infections and infestations Bacterial Sepsis	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Infections and infestations Bronchopneumonia	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Infections and infestations Cellulitis	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Investigations Arteriogram coronary	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Reproductive system and breast disorders Pelvic prolapse	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Nervous system disorders Cerebrovascular accident	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Nervous system disorders Dizziness postural	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.00% 0/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.

Other adverse events

Measure	Placebo/Sitagliptin: Baseline to Week 26 n=115 participants at risk Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52. Data are presented for Baseline to Week 26.	Canagliflozin 100 mg: Baseline to Week 26 n=113 participants at risk Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 26.	Canagliflozin 300 mg: Baseline to Week 26 n=114 participants at risk Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 26.	Placebo/Sitagliptin: Baseline to Week 52 n=115 participants at risk Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52. Data are presented for Baseline to Week 52.	Canagliflozin 100 mg: Baseline to Week 52 n=113 participants at risk Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 52.	Canagliflozin 300 mg: Baseline to Week 52 n=114 participants at risk Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 52.
Gastrointestinal disorders Diarrhoea	5.2% 6/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	3.5% 4/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	3.5% 4/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	6.1% 7/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	6.2% 7/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	5.3% 6/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Infections and infestations Nasopharyngitis	5.2% 6/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	5.3% 6/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	9.6% 11/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	11.3% 13/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	9.7% 11/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	13.2% 15/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Infections and infestations Upper respiratory tract infection	6.1% 7/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	8.0% 9/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	4.4% 5/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	7.8% 9/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	12.4% 14/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	7.0% 8/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Infections and infestations Urinary tract infection	5.2% 6/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	3.5% 4/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	3.5% 4/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	7.8% 9/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	4.4% 5/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	7.9% 9/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	2.7% 3/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	5.3% 6/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	2.7% 3/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	5.3% 6/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Metabolism and nutrition disorders Hypoglycaemia	1.7% 2/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	5.3% 6/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	2.6% 3/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	2.7% 3/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	4.4% 5/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Musculoskeletal and connective tissue disorders Arthralgia	1.7% 2/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	5.3% 6/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	2.6% 3/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	2.7% 3/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	7.9% 9/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Musculoskeletal and connective tissue disorders Back pain	2.6% 3/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	7.1% 8/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	4.4% 5/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	3.5% 4/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	8.8% 10/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	6.1% 7/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Renal and urinary disorders Pollakiuria	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	4.4% 5/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	6.1% 7/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.87% 1/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	5.3% 6/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	7.0% 8/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Respiratory, thoracic and mediastinal disorders Cough	5.2% 6/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	2.7% 3/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	6.1% 7/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	4.4% 5/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	1.8% 2/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
General disorders Oedema peripheral	1.7% 2/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	1.8% 2/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	3.5% 4/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	3.5% 4/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	1.8% 2/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	5.3% 6/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Nervous system disorders Headache	3.5% 4/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	2.7% 3/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	4.4% 5/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	4.3% 5/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	2.7% 3/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	5.3% 6/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.
Musculoskeletal and connective tissue disorders Muscle spasms	2.6% 3/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	0.88% 1/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	2.6% 3/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	5.2% 6/115 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	1.8% 2/113 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.	3.5% 4/114 • Adverse event data were collected for the duration of study (52 weeks). The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm either during the 26-week period or entire 52-week period.

Additional Information

Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise

Janssen Research & Development, LLC

Phone: 1-800-526-7736

Results disclosure agreements

• Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER