Trial Outcomes & Findings for A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus (NCT NCT00800176)

NCT ID: NCT00800176

Last Updated: 2020-11-18

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

394 participants

Primary outcome timeframe

Baseline, Week 4, Week 8 and Week 12

Results posted on

2020-11-18

Participant Flow

Screening period: Week 6 to 5 prior to randomization

As soon as the results of the screening tests were available, eligible patients could start the 4-week placebo run-in period (visit week -4). A diet and exercise plan was discussed based on the recommendations of the investigator. This plan was not to be changed during the study

Participant milestones

Participant milestones
Measure	Placebo During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	RO4998452 2.5mg During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	RO4998452 5mg During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.	RO4998452 10 mg During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	RO4998452 20mg During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.	RO4998452 40mg During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
Overall Study STARTED	66	66	65	66	64	67
Overall Study COMPLETED	57	60	65	62	60	62
Overall Study NOT COMPLETED	9	6	0	4	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	RO4998452 2.5mg During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	RO4998452 10 mg During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	RO4998452 20mg During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.	RO4998452 40mg During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
Overall Study Adverse Event	2	1	2	1	1
Overall Study Refused treatment	3	2	0	1	4
Overall Study Failure to return	3	3	2	0	0
Overall Study Other	1	0	0	2	0

Baseline Characteristics

A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	RO4998452 2.5 mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	RO4998452 5mg n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.	RO4998452 10mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	RO4998452 20mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.	RO4998452 40mg n=67 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.	Total n=394 Participants Total of all reporting groups
Age, Continuous	53.9 Years STANDARD_DEVIATION 11.12 • n=5 Participants	53.3 Years STANDARD_DEVIATION 10.86 • n=7 Participants	54.8 Years STANDARD_DEVIATION 10.53 • n=5 Participants	54.5 Years STANDARD_DEVIATION 10.7 • n=4 Participants	56.3 Years STANDARD_DEVIATION 9.79 • n=21 Participants	57.5 Years STANDARD_DEVIATION 9.31 • n=8 Participants	55.1 Years STANDARD_DEVIATION 10.34 • n=8 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	32 Participants n=7 Participants	34 Participants n=5 Participants	32 Participants n=4 Participants	21 Participants n=21 Participants	36 Participants n=8 Participants	185 Participants n=8 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	34 Participants n=7 Participants	31 Participants n=5 Participants	34 Participants n=4 Participants	43 Participants n=21 Participants	31 Participants n=8 Participants	209 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	42 Participants n=5 Participants	46 Participants n=7 Participants	41 Participants n=5 Participants	40 Participants n=4 Participants	45 Participants n=21 Participants	39 Participants n=8 Participants	253 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	20 Participants n=7 Participants	24 Participants n=5 Participants	26 Participants n=4 Participants	19 Participants n=21 Participants	28 Participants n=8 Participants	141 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	18 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	15 Participants n=4 Participants	13 Participants n=21 Participants	19 Participants n=8 Participants	93 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	6 Participants n=8 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants	46 Participants n=7 Participants	41 Participants n=5 Participants	40 Participants n=4 Participants	45 Participants n=21 Participants	39 Participants n=8 Participants	253 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	4 Participants n=21 Participants	9 Participants n=8 Participants	42 Participants n=8 Participants
Race/Ethnicity, Customized Ex-Japan	54 Participants n=5 Participants	55 Participants n=7 Participants	53 Participants n=5 Participants	54 Participants n=4 Participants	53 Participants n=21 Participants	54 Participants n=8 Participants	323 Participants n=8 Participants
Race/Ethnicity, Customized Japan	12 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	12 Participants n=4 Participants	11 Participants n=21 Participants	13 Participants n=8 Participants	71 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4, Week 8 and Week 12

Population: Full analysis set included all patients who were randomized, received at least one dose of study medication, and had an evaluable baseline and at least one evaluable post baseline measurement of HbA1c. If patient's HbA1c value at baseline visit was missing, latest screening HbA1c value was used as baseline. If patient received an incorrect dose of study medication at any time during study, patient was analyzed according to dose patient was randomized to, not dose patient received.

Outcome measures

Outcome measures
Measure	Placebo n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	RO4998452 2.5 mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	RO4998452 5mg n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.	RO4998452 10mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	RO4998452 20mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.	RO4998452 40mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
Absolute Change in HbA1c Baseline	7.872 Percentage Interval 7.695 to 8.049	7.939 Percentage Interval 7.829 to 8.118	8.006 Percentage Interval 7.823 to 8.183	7.998 Percentage Interval 7.823 to 8.174	7.919 Percentage Interval 7.74 to 8.097	7.933 Percentage Interval 7.758 to 8.109
Absolute Change in HbA1c Week 4	-0.238 Percentage Interval -0.341 to -0.135	-0.394 Percentage Interval -0.497 to -0.291	-0.460 Percentage Interval -0.561 to -0.358	-0.539 Percentage Interval -0.641 to -0.437	-0.516 Percentage Interval -0.619 to -0.413	-0.564 Percentage Interval -0.664 to -0.464
Absolute Change in HbA1c Week 8	-0.280 Percentage Interval -0.405 to -0.155	-0.468 Percentage Interval -0.594 to -0.342	-0.611 Percentage Interval -0.736 to -0.486	-0.694 Percentage Interval -0.84 to -0.549	-0.768 Percentage Interval -0.916 to -0.62	-0.832 Percentage Interval -0.976 to -0.688
Absolute Change in HbA1c Week 12	-0.269 Percentage Interval -0.415 to -0.123	-0.440 Percentage Interval -0.588 to -0.293	-0.617 Percentage Interval -0.763 to -0.471	-0.694 Percentage Interval -0.84 to -0.549	-0.768 Percentage Interval -0.916 to -0.62	-0.832 Percentage Interval -0.976 to -0.688

SECONDARY outcome

Timeframe: Baseline and Week 12

Outcome measures

Outcome measures
Measure	Placebo n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	RO4998452 2.5 mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	RO4998452 5mg n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.	RO4998452 10mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	RO4998452 20mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.	RO4998452 40mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
Change From Baseline in Fasting Plasma Glucose (mmol/L) Baseline	8.738 mmol/L Interval 8.312 to 9.164	8.917 mmol/L Interval 8.488 to 9.347	8.695 mmol/L Interval 8.269 to 9.121	8.824 mmol/L Interval 8.401 to 9.247	8.741 mmol/L Interval 8.311 to 9.17	8.992 mmol/L Interval 8.57 to 9.415
Change From Baseline in Fasting Plasma Glucose (mmol/L) Last Visit: Change from Baseline	-0.502 mmol/L Interval -0.854 to -0.149	-0.021 mmol/L Interval -0.376 to 0.335	-0.641 mmol/L Interval -0.993 to -0.288	-1.042 mmol/L Interval -1.395 to -0.69	-0.935 mmol/L Interval -1.294 to -0.577	-1.422 mmol/L Interval -1.771 to -1.073

SECONDARY outcome

Timeframe: Baseline and Week 12

Outcome measures

Outcome measures
Measure	Placebo n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	RO4998452 2.5 mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	RO4998452 5mg n=63 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.	RO4998452 10mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	RO4998452 20mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.	RO4998452 40mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
Change From Baseline in Mean Daily Glucose Concentration (mmol/L) Change from Baseline	9.655 mmol/L Interval 9.236 to 10.075	9.546 mmol/L Interval 9.123 to 9.968	9.750 mmol/L Interval 9.324 to 10.176	9.843 mmol/L Interval 9.427 to 10.259	9.614 mmol/L Interval 9.192 to 10.037	9.648 mmol/L Interval 9.232 to 10.064
Change From Baseline in Mean Daily Glucose Concentration (mmol/L) Last Visit: Absolute Change from Baseline	-0.278 mmol/L Interval -0.599 to 0.043	-0.556 mmol/L Interval -0.878 to -0.233	-0.800 mmol/L Interval -1.123 to -0.477	-1.055 mmol/L Interval -1.375 to -0.734	-0.882 mmol/L Interval -1.207 to -0.558	-1.298 mmol/L Interval -1.615 to -0.981

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Outcome measures

Outcome measures
Measure	Placebo n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	RO4998452 2.5 mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	RO4998452 5mg n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.	RO4998452 10mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	RO4998452 20mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.	RO4998452 40mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
Change From Baseline in Fructosamine Concentration (μmol/L) Baseline	293.292 μmol/L Interval 283.047 to 303.538	294.891 μmol/L Interval 284.566 to 305.216	292.600 μmol/L Interval 282.355 to 302.845	290.970 μmol/L Interval 280.802 to 301.137	292.672 μmol/L Interval 282.347 to 302.997	305.015 μmol/L Interval 294.848 to 315.182
Change From Baseline in Fructosamine Concentration (μmol/L) Last Visit: Absolute Change from Baseline	-0.368 μmol/L Interval -8.417 to 7.68	-11.202 μmol/L Interval -19.092 to -3.312	-12.992 μmol/L Interval -20.491 to -5.493	-16.712 μmol/L Interval -24.411 to -9.013	-18.758 μmol/L Interval -26.583 to -10.934	-20.619 μmol/L Interval -28.446 to -12.792

SECONDARY outcome

Timeframe: Baseline and Week 12

Outcome measures

Outcome measures
Measure	Placebo n=63 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	RO4998452 2.5 mg n=63 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	RO4998452 5mg n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.	RO4998452 10mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	RO4998452 20mg n=63 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.	RO4998452 40mg n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
Change From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L) Baseline	11.663 mmol/L Interval 11.119 to 12.207	11.661 mmol/L Interval 11.116 to 12.205	11.689 mmol/L Interval 11.153 to 12.225	11.432 mmol/L Interval 10.9 to 11.963	11.643 mmol/L Interval 11.099 to 12.187	12.032 mmol/L Interval 11.496 to 12.568
Change From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L) Last Visit: Absolute Change from Baseline	-0.655 mmol/L Interval -1.053 to -0.257	-1.692 mmol/L Interval -2.083 to -1.301	-2.146 mmol/L Interval -2.522 to -1.769	-2.347 mmol/L Interval -2.731 to -1.964	-2.443 mmol/L Interval -2.827 to -2.059	-2.884 mmol/L Interval -3.268 to -2.501

SECONDARY outcome

Timeframe: Baseline and Week 12

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	RO4998452 2.5 mg n=61 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	RO4998452 5mg n=62 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.	RO4998452 10mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	RO4998452 20mg n=61 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.	RO4998452 40mg n=63 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
Change From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L) Baseline	201.243 mmol/L Interval 169.516 to 232.97	202.269 mmol/L Interval 171.066 to 233.471	207.255 mmol/L Interval 176.305 to 238.204	223.964 mmol/L Interval 193.501 to 254.426	219.396 mmol/L Interval 188.194 to 250.599	189.286 mmol/L Interval 158.583 to 219.989
Change From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L) Last Visit: Absolute Change from Baseline	-8.909 mmol/L Interval -26.748 to 8.929	-46.108 mmol/L Interval -63.662 to -28.553	-39.409 mmol/L Interval -56.095 to -22.723	-68.881 mmol/L Interval -86.116 to -51.647	-67.373 mmol/L Interval -84.466 to -50.281	-58.053 mmol/L Interval -75.228 to -40.878

SECONDARY outcome

Timeframe: Baseline and Week 12

Outcome measures

Outcome measures
Measure	Placebo n=63 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	RO4998452 2.5 mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	RO4998452 5mg n=63 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.	RO4998452 10mg n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	RO4998452 20mg n=62 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.	RO4998452 40mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
Change From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L) Baseline	6.607 mmol/L Interval 2.098 to 11.116	8.472 mmol/L Interval 3.999 to 12.946	6.841 mmol/L Interval 2.332 to 11.35	11.659 mmol/L Interval 7.22 to 16.098	14.039 mmol/L Interval 9.494 to 18.585	10.395 mmol/L Interval 5.99 to 14.801
Change From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L) Last Visit: Absolute Change from Baseline	-1.282 mmol/L Interval -13.644 to 11.079	43.369 mmol/L Interval 31.519 to 55.219	52.396 mmol/L Interval 40.818 to 63.975	68.634 mmol/L Interval 56.957 to 80.311	62.610 mmol/L Interval 50.694 to 74.527	59.294 mmol/L Interval 47.55 to 71.038

SECONDARY outcome

Timeframe: Baseline and Week 12

Outcome measures

Outcome measures
Measure	Placebo n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	RO4998452 2.5 mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	RO4998452 5mg n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.	RO4998452 10mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	RO4998452 20mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.	RO4998452 40mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
Change From Baseline in Body Weight (kg) Baseline	83.965 kg Interval 79.691 to 88.238	85.455 kg Interval 81.148 to 89.762	82.149 kg Interval 77.876 to 86.423	83.411 kg Interval 79.169 to 87.652	84.914 kg Interval 80.607 to 89.221	81.568 kg Interval 77.327 to 85.809
Change From Baseline in Body Weight (kg) Last Visit: Absolute Change from Baseline	-0.741 kg Interval -1.218 to -0.265	-1.564 kg Interval -2.044 to -1.083	-1.853 kg Interval -2.332 to -1.375	-2.235 kg Interval -2.711 to -1.759	-2.551 kg Interval -3.032 to -2.07	-2.824 kg Interval -3.297 to -2.351

SECONDARY outcome

Timeframe: Baseline up to 12 weeks

Outcome measures

Outcome measures
Measure	Placebo n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	RO4998452 2.5 mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	RO4998452 5mg n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.	RO4998452 10mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	RO4998452 20mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.	RO4998452 40mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
Percentage of Participants Treated to Target HbA1c < 7%	13.8 Percentage Interval 6.5 to 24.7	17.2 Percentage Interval 8.9 to 28.7	23.1 Percentage Interval 13.5 to 35.2	24.2 Percentage Interval 14.5 to 36.4	34.4 Percentage Interval 22.9 to 47.3	40.9 Percentage Interval 29.0 to 53.7

SECONDARY outcome

Timeframe: Baseline up to 12 weeks

Outcome measures

Outcome measures
Measure	Placebo n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	RO4998452 2.5 mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	RO4998452 5mg n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.	RO4998452 10mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	RO4998452 20mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.	RO4998452 40mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
Percentage of Participants Treated to Target HbA1c < 6.5%	3.1 Percentage Interval 0.4 to 10.7	6.3 Percentage Interval 1.7 to 15.2	9.2 Percentage Interval 3.5 to 19.0	6.1 Percentage Interval 1.7 to 14.8	10.9 Percentage Interval 4.5 to 21.2	16.7 Percentage Interval 8.6 to 27.9

SECONDARY outcome

Timeframe: Baseline up to 12 weeks

Population: The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	RO4998452 2.5 mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	RO4998452 5mg n=65 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.	RO4998452 10mg n=66 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	RO4998452 20mg n=64 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.	RO4998452 40mg n=67 Participants During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
Percentage of Participants With at Least One Adverse Event	37.9 Percentage	36.4 Percentage	46.2 Percentage	37.9 Percentage	35.9 Percentage	46.3 Percentage

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

RO4998452 2.5mg

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

RO4998452 5mg

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

RO4998452 10mg

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

RO4998452 20mg

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

RO4998452 40mg

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=66 participants at risk During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	RO4998452 2.5mg n=66 participants at risk During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	RO4998452 5mg n=65 participants at risk During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.	RO4998452 10mg n=66 participants at risk During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	RO4998452 20mg n=64 participants at risk During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.	RO4998452 40mg n=67 participants at risk During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
Gastrointestinal disorders INGUINAL HERNIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Injury, poisoning and procedural complications ANIMAL BITE	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Nervous system disorders CEREBRAL HAEMORRHAGE	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.

Other adverse events

Other adverse events
Measure	Placebo n=66 participants at risk During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.	RO4998452 2.5mg n=66 participants at risk During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.	RO4998452 5mg n=65 participants at risk During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.	RO4998452 10mg n=66 participants at risk During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.	RO4998452 20mg n=64 participants at risk During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.	RO4998452 40mg n=67 participants at risk During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
Investigations URINE OUTPUT INCREASED	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations NASOPHARYNGITIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/66 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	6.1% 4/66 • Number of events 4 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/67 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations URINARY TRACT INFECTION	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.1% 2/65 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/66 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/67 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations PHARYNGITIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations BRONCHITIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations GASTROENTERITIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/67 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations ORAL HERPES	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations PYELONEPHRITIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations VULVOVAGINAL MYCOTIC INFECTION	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations CERVICITIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations DENGUE FEVER	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations FURUNCLE	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations GASTROENTERITIS VIRAL	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations GASTROINTESTINAL INFECTION	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations GENITAL INFECTION FUNGAL	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations GENITOURINARY TRACT INFECTION	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations INFLUENZA	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations OTITIS EXTERNA BACTERIAL	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations OTITIS MEDIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Investigations LYMPH NODE PALPABLE	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations PYELONEPHRITIS ACUTE	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations RESPIRATORY TRACT INFECTION	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations RHINITIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations SINUSITIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations TINEA PEDIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Infections and infestations VIRAL INFECTION	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Gastrointestinal disorders CONSTIPATION	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/66 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/67 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Gastrointestinal disorders NAUSEA	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/66 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Gastrointestinal disorders TOOTHACHE	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.1% 2/65 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/67 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Gastrointestinal disorders DIARRHOEA	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/66 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Gastrointestinal disorders FOOD POISONING	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Gastrointestinal disorders GASTRITIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Gastrointestinal disorders GINGIVAL PAIN	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Gastrointestinal disorders VOMITING	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/67 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Gastrointestinal disorders DENTAL CARIES	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Gastrointestinal disorders FLATULENCE	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Gastrointestinal disorders INGUINAL HERNIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Gastrointestinal disorders INTRA-ABDOMINAL HAEMATOMA	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Gastrointestinal disorders SALIVA ALTERED	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Nervous system disorders HEADACHE	3.0% 2/66 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	4.7% 3/64 • Number of events 3 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	4.5% 3/67 • Number of events 3 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Nervous system disorders DIZZINESS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/66 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/66 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.1% 2/64 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Nervous system disorders DIABETIC NEUROPATHY	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Nervous system disorders SINUS HEADACHE	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Nervous system disorders APHONIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Nervous system disorders BURNING SENSATION	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Nervous system disorders CEREBRAL HAEMORRHAGE	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Nervous system disorders FACIAL PALSY	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Nervous system disorders HYPERSOMNIA	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Nervous system disorders NEUROPATHY PERIPHERAL	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Nervous system disorders PARAESTHESIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Nervous system disorders SCIATICA	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Nervous system disorders SOMNOLENCE	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Musculoskeletal and connective tissue disorders BACK PAIN	3.0% 2/66 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/66 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Musculoskeletal and connective tissue disorders MUSCLE CONTRACTURE	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Musculoskeletal and connective tissue disorders OSTEOCHONDROSIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Metabolism and nutrition disorders HYPOGLYCAEMIA	3.0% 2/66 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/66 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Metabolism and nutrition disorders HYPERURICAEMIA	3.0% 2/66 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Metabolism and nutrition disorders HYPERCHOLESTEROLAEMIA	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Metabolism and nutrition disorders HYPERTRIGLYCERIDAEMIA	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Metabolism and nutrition disorders HYPERGLYCAEMIA	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Metabolism and nutrition disorders INCREASED APPETITE	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Metabolism and nutrition disorders POLYDIPSIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Investigations BLOOD FIBRINOGEN INCREASED	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Investigations ELECTROCARDIOGRAM T WAVE ABNORMAL	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Investigations BLOOD CREATININE INCREASED	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Investigations BLOOD UREA INCREASED	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Investigations ELECTROCARDIOGRAM QT PROLONGED	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Investigations ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Investigations ELECTROCARDIOGRAM T WAVE BIPHASIC	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Investigations HELICOBACTER PYLORI IDENTIFICATION TEST POSITIVE	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Investigations WEIGHT DECREASED	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Renal and urinary disorders POLLAKIURIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	4.5% 3/66 • Number of events 3 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/67 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Renal and urinary disorders HAEMATURIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Renal and urinary disorders MICTURITION URGENCY	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Renal and urinary disorders NOCTURIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Renal and urinary disorders POLYURIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Renal and urinary disorders RENAL COLIC	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Renal and urinary disorders RENAL FAILURE ACUTE	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Renal and urinary disorders RENAL IMPAIRMENT	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Cardiac disorders ATRIOVENTRICULAR BLOCK FIRST DEGREE	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Cardiac disorders SINUS BRADYCARDIA	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Cardiac disorders SINUS TACHYCARDIA	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Cardiac disorders ANGINA PECTORIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Cardiac disorders BUNDLE BRANCH BLOCK LEFT	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Cardiac disorders BUNDLE BRANCH BLOCK RIGHT	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Cardiac disorders CARDIAC FAILURE	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Cardiac disorders MYOCARDIAL INFARCTION	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Cardiac disorders PALPITATIONS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Cardiac disorders SUPRAVENTRICULAR EXTRASYSTOLES	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
General disorders HUNGER	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
General disorders THIRST	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
General disorders FATIGUE	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
General disorders OEDEMA PERIPHERAL	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
General disorders ASTHENIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
General disorders INFLUENZA LIKE ILLNESS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
General disorders MALAISE	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
General disorders VESSEL PUNCTURE SITE HAEMATOMA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Injury, poisoning and procedural complications EXCORIATION	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/66 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Injury, poisoning and procedural complications ANIMAL BITE	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Injury, poisoning and procedural complications EPICONDYLITIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Injury, poisoning and procedural complications FALL	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Injury, poisoning and procedural complications INJURY	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Injury, poisoning and procedural complications JOINT SPRAIN	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Injury, poisoning and procedural complications PERIORBITAL HAEMATOMA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Injury, poisoning and procedural complications THERMAL BURN	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Injury, poisoning and procedural complications WOUND	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Psychiatric disorders ANXIETY	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	3.0% 2/66 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Psychiatric disorders INSOMNIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Psychiatric disorders AGITATION	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Psychiatric disorders DEPRESSED MOOD	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Psychiatric disorders DEPRESSION	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Psychiatric disorders LIBIDO DECREASED	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Psychiatric disorders LOSS OF LIBIDO	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	3.0% 2/66 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Respiratory, thoracic and mediastinal disorders UPPER RESPIRATORY TRACT INFLAMMATION	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Eye disorders VISION BLURRED	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Eye disorders CONJUNCTIVITIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Eye disorders DIABETIC RETINOPATHY	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Eye disorders GLAUCOMA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Eye disorders OCULAR DISCOMFORT	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Eye disorders OCULAR HYPERAEMIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Eye disorders VISUAL ACUITY REDUCED	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Skin and subcutaneous tissue disorders DERMATITIS ALLERGIC	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Skin and subcutaneous tissue disorders ECZEMA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Skin and subcutaneous tissue disorders RASH ERYTHEMATOUS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Skin and subcutaneous tissue disorders RASH MACULAR	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Skin and subcutaneous tissue disorders RASH PRURITIC	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Skin and subcutaneous tissue disorders SKIN EROSION	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Skin and subcutaneous tissue disorders SKIN ULCER	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	4.5% 3/67 • Number of events 3 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	3.0% 2/66 • Number of events 2 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Reproductive system and breast disorders MENORRHAGIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Reproductive system and breast disorders METRORRHAGIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Reproductive system and breast disorders PRURITUS GENITAL	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Reproductive system and breast disorders VULVOVAGINAL PRURITUS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Vascular disorders HYPERTENSION	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Vascular disorders HOT FLUSH	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Vascular disorders HYPOTENSION	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.6% 1/64 • Number of events 11 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Congenital, familial and genetic disorders PHIMOSIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Congenital, familial and genetic disorders TYPE II HYPERLIPIDAEMIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Congenital, familial and genetic disorders TYPE IV HYPERLIPIDAEMIA	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/65 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Hepatobiliary disorders BILIARY COLIC	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Hepatobiliary disorders HEPATIC STEATOSIS	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Surgical and medical procedures DENTAL IMPLANTATION	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Surgical and medical procedures TOOTH EXTRACTION	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Endocrine disorders HYPOTHYROIDISM	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/67 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	1.5% 1/66 • Number of events 1 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/65 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/66 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/64 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.	0.00% 0/67 • Baseline up to 8 months The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.

Additional Information

Medical Communications

Hoffmann-La Roche

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Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
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Restriction type: OTHER