Trial Outcomes & Findings for Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps (NCT NCT00118365)

NCT ID: NCT00118365

Last Updated: 2015-01-22

Results Overview

Detection of any adenoma at the end of the study. This analysis is based on the participants who had the end-of-study colonscopy procedure done.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 375 participants
• Primary outcome timeframe: Up to 36 months
• Results posted on: 2015-01-22

Participant Flow

Participant milestones

Measure	Arm I (Eflornithine and Sulindac) Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies
Overall Study STARTED	191	184
Overall Study COMPLETED	132	124
Overall Study NOT COMPLETED	59	60

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps

Baseline characteristics by cohort

Measure	Arm I (Eflornithine and Sulindac) n=191 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=184 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Total n=375 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 8.6 • n=5 Participants	61 years STANDARD_DEVIATION 8.4 • n=7 Participants	60.5 years STANDARD_DEVIATION 8.40 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	46 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	147 Participants n=5 Participants	138 Participants n=7 Participants	285 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 36 months

Population: This analysis is based on the participants who had the end-of-study colonscopy procedure done.

Detection of any adenoma at the end of the study. This analysis is based on the participants who had the end-of-study colonscopy procedure done.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=138 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=129 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Detection of Any Adenoma at the End of the Study No	121 participants	76 participants	—	—
Detection of Any Adenoma at the End of the Study Yes	17 participants	53 participants	—	—

SECONDARY outcome

Timeframe: Up to 36 months

Population: This analysis is based on the participants who had the end-of-study colonscopy procedure done and their baseline PGE2 values are available. The low PGE2 is defined as the values that are below the median PGE2 value in the analysis cohort. The high PGE2 is defined as the values that are above the median PGE2 value in the analysis cohort.

This analysis is based on the participants who had the end-of-study colonscopy procedure done and their baseline PGE2 values are available. The low PGE2 is defined as the values that are below the median PGE2 value in the analysis cohort. The high PGE2 is defined as the values that are above the median PGE2 value in the analysis cohort.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=53 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=44 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline n=42 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline n=53 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment Yes	12 participants	3 participants	19 participants	21 participants
Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment No	41 participants	41 participants	23 participants	32 participants

SECONDARY outcome

Timeframe: Up 36 months

Population: In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset. The analysis cohort is based on the participants whose data are available and complete.

The low is defined as the values that are below the median putrescine level in the analysis cohort. The high is defined as the values that are above the median putrescine level in the analysis cohort.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=70 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=66 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline n=62 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline n=67 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Detection of Any Adenoma at the End of the Study Stratified by Baseline Putrescine and Treatment Yes	7 participants	10 participants	24 participants	31 participants
Detection of Any Adenoma at the End of the Study Stratified by Baseline Putrescine and Treatment No	63 participants	56 participants	38 participants	36 participants

SECONDARY outcome

Timeframe: Up 36 months

Population: In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset. The analysis cohort is based on the participants whose data are available and complete.

The low is defined as the ratios that are below the median spermidine-to-spermine ratio in the analysis cohort. The high is defined as the ratios that are above the median spermidine-to-spermine ratio in the analysis cohort.

In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset.

The analysis cohort is based on the participants whose data are available and complete.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=64 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=72 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline n=68 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline n=61 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Detection of Any Adenoma at the End of the Study Stratified by Baseline Spermidine-to-spermine Ratio and Treatment Yes	5 participants	12 participants	31 participants	24 participants
Detection of Any Adenoma at the End of the Study Stratified by Baseline Spermidine-to-spermine Ratio and Treatment No	59 participants	60 participants	37 participants	37 participants

SECONDARY outcome

Timeframe: Up to 36 months

Population: The analysis cohort is based on the participants whose data are available and complete.

PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=11 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=35 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline n=17 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline n=32 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Detection of Any Adenoma at the End of the Study Stratified by Prostaglandin E2 (PGE2) Response and Treatment Yes	1 participants	8 participants	4 participants	15 participants
Detection of Any Adenoma at the End of the Study Stratified by Prostaglandin E2 (PGE2) Response and Treatment No	10 participants	27 participants	13 participants	17 participants

SECONDARY outcome

Timeframe: Up to 36 months

Population: The analysis cohort is based on the participants whose data are available and complete.

Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=61 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=60 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline n=46 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline n=72 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Detection of Any Adenoma at the End of the Study Stratified by Putrescine Response and Treatment Yes	9 participants	7 participants	22 participants	28 participants
Detection of Any Adenoma at the End of the Study Stratified by Putrescine Response and Treatment No	52 participants	53 participants	24 participants	44 participants

SECONDARY outcome

Timeframe: Up to 36 months

Population: The analysis cohort is based on the participants whose data are available and complete.

Spermidine-to-spermine ratio responder = ratios at 36-month are decreased by >=30% from baseline Spermidine-to-spermine ratio nonresponder = ratios at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=83 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=38 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline n=41 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline n=77 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Detection of Any Adenoma at the End of the Study Stratified by Spermidine-to-spermine Ratio Response and Treatment Yes	8 participants	8 participants	17 participants	33 participants
Detection of Any Adenoma at the End of the Study Stratified by Spermidine-to-spermine Ratio Response and Treatment No	75 participants	30 participants	24 participants	44 participants

SECONDARY outcome

Timeframe: Up to 36 months

Participants reported at least 1 adverse event with a grade of 3 and above, regardless if the event is defined as serious per protocol or other.

Per protocol, not all grade 3 events are considered as serious events.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=191 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=184 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Adverse Events With a Grade of 3 and Above	46 participants	37 participants	—	—

SECONDARY outcome

Timeframe: Baseline

Population: The analysis cohort is based on the participants whose data are available and complete.

ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=101 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=125 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Baseline Putrescine by ODC Genotype	0.47 nmol/mg protein Interval 0.01 to 4.6	0.56 nmol/mg protein Interval 0.01 to 5.29	—	—

SECONDARY outcome

Timeframe: Baseline

Population: The analysis cohort is based on the participants whose data are available and complete.

ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=101 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=125 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Baseline Spermidine by ODC Genotype	1.99 nmol/mg protein Interval 0.76 to 9.18	2.17 nmol/mg protein Interval 1.05 to 8.97	—	—

SECONDARY outcome

Timeframe: Baseline

Population: The analysis cohort is based on the participants whose data are available and complete.

ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=101 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=125 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Baseline Spermine by ODC Genotype	6.82 nmol/mg protein Interval 2.29 to 19.86	7.29 nmol/mg protein Interval 2.72 to 22.85	—	—

SECONDARY outcome

Timeframe: At the end of the study

Population: The analysis cohort is based on the participants whose data are available and complete.

Putrescine responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) ≥ the threshold. Putrescine non-responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.

ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=58 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=40 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline n=43 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline n=49 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
At the End of the Study - Putrescine Response by ODC Genotype Responder	26 participants	21 participants	12 participants	12 participants
At the End of the Study - Putrescine Response by ODC Genotype Non-Responder	32 participants	19 participants	31 participants	37 participants

SECONDARY outcome

Timeframe: At the end of the study

Population: The analysis cohort is based on the participants whose data are available and complete.

Spermidine responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) ≥ the threshold. Spermidine non-responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.

ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=58 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=40 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline n=43 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline n=49 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
At the End of the Study - Spermidine Response by ODC Genotype Responder	25 participants	12 participants	15 participants	11 participants
At the End of the Study - Spermidine Response by ODC Genotype Non-Responder	32 participants	28 participants	28 participants	38 participants

SECONDARY outcome

Timeframe: At the end of the study

Population: The analysis cohort is based on the participants whose data are available and complete.

Spermine responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) ≥ the threshold. Spermine non-responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.

ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=58 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=40 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline n=43 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline n=49 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
At the End of the Study - Spermine Response by ODC Genotype Responder	7 participants	7 participants	18 participants	10 participants
At the End of the Study - Spermine Response by ODC Genotype Non-Responder	51 participants	33 participants	25 participants	39 participants

SECONDARY outcome

Timeframe: Up to 36 months

Population: The analysis cohort is based on the participants whose data are available and complete.

ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=64 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=42 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline n=44 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline n=53 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Number of Participants Have Adenoma Recurrence in Each ODC1 Genotytpe by Treatment Group	7 participants	9 participants	22 participants	18 participants

SECONDARY outcome

Timeframe: At the end of the study

Population: The analysis cohort is based on the participants whose data are available.

Apoptosis expression was assessed using cytoplasmic staining. The definitions for the category level for the Apoptosis are: 1. focal (less than 10% cells that are positively stained); 2. less than 50% cells are positively stained; 3. more than 50% cells are positively stained.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=12 adenoma Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=60 adenoma Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Biomarker in Adenoma: Apoptosis A pattern equal to normal mucosa	2 adenoma	4 adenoma	—	—
Biomarker in Adenoma: Apoptosis 1.focal (<10%)	7 adenoma	20 adenoma	—	—
Biomarker in Adenoma: Apoptosis 2.cyto less than 50%	1 adenoma	23 adenoma	—	—
Biomarker in Adenoma: Apoptosis 3.cyto more than 50%	2 adenoma	13 adenoma	—	—

SECONDARY outcome

Timeframe: At the end of the study

Population: The analysis cohort is based on the participants whose data are available.

Estimated mean percent of cells staining postivie for the Ki-67 based on the GEE approach with adjustment for covariates

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=11 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=40 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Biomarker in Adenoma - Ki-67	59.5 percentage of cells that are positive Interval 48.1 to 71.02	63.9 percentage of cells that are positive Interval 57.35 to 70.39	—	—

SECONDARY outcome

Timeframe: At the end of the study

Population: The analysis cohort is based on the participants whose data are available.

carcino-embryonic antigen (CEA) is adenocarcinoma tissue marker that is expressed during adenoma formation.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=12 Adenoma Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=66 Adenoma Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Biomarker in Adenoma: CEA A pattern equal to normal mucosa	1 Adenoma	5 Adenoma	—	—
Biomarker in Adenoma: CEA 1.<50% of cells showed staining	5 Adenoma	15 Adenoma	—	—
Biomarker in Adenoma: CEA 2.50-90% of cells showed staining	6 Adenoma	35 Adenoma	—	—
Biomarker in Adenoma: CEA 3.>90% of cells showed staining	0 Adenoma	9 Adenoma	—	—
Biomarker in Adenoma: CEA Insufficient tissue	0 Adenoma	2 Adenoma	—	—

SECONDARY outcome

Timeframe: At the end of the study

Population: The analysis cohort is based on the participants whose data are available.

sialyl-Tn (B72.3) is adenocarcinoma tissue marker that is expressed during adenoma formation.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=12 Adenoma Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=66 Adenoma Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Biomarker in Adenoma: Sialyl-TN (B72.3) a pattern equal to normal mucosa	3 Adenoma	11 Adenoma	—	—
Biomarker in Adenoma: Sialyl-TN (B72.3) 1.<10% of the cells in the adenoma showed staining	7 Adenoma	32 Adenoma	—	—
Biomarker in Adenoma: Sialyl-TN (B72.3) 2.10-50% cells showed staining	2 Adenoma	17 Adenoma	—	—
Biomarker in Adenoma: Sialyl-TN (B72.3) 3.>50% cells showed staining	0 Adenoma	5 Adenoma	—	—
Biomarker in Adenoma: Sialyl-TN (B72.3) Insufficient tissue	0 Adenoma	1 Adenoma	—	—

SECONDARY outcome

Timeframe: At the end of the study

Population: The analysis cohort is based on the participants whose data are available.

Estimated mean percent of cells staining postivie for p53 based on GEE approach with adjument for covariates.

Tumor protein p53, also known as p53, cellular tumor antigen p53, phosphoprotein p53, or tumor suppressor p53, is a protein that in humans is encoded by the TP53 gene.

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=11 Participants Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=40 Participants Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Biomarker in Adenoma - p53	75.6 percentage of cells that are positive Interval 51.1 to 100.09	70.3 percentage of cells that are positive Interval 61.86 to 78.69	—	—

SECONDARY outcome

Timeframe: At the end of the study, up to 3 years

Population: The analysis cohort is based on the participants whose data are available.

bcl-2 is the anti-apoptotic protein BCL2

Outcome measures

Measure	Arm I (Eflornithine and Sulindac) n=12 Adenoma Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=66 Adenoma Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies	Placebo + Low PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median	Placebo + High PGE2 at Baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
Biomarker in Adenoma: Bcl-2 A pattern equal to normal mucosa	4 Adenoma	17 Adenoma	—	—
Biomarker in Adenoma: Bcl-2 1.<10% of the cells in the adenoma showed staining	4 Adenoma	25 Adenoma	—	—
Biomarker in Adenoma: Bcl-2 2.10-50% cells showed staining	3 Adenoma	14 Adenoma	—	—
Biomarker in Adenoma: Bcl-2 3.>50% cells showed staining	1 Adenoma	8 Adenoma	—	—
Biomarker in Adenoma: Bcl-2 Insufficient tissue	0 Adenoma	2 Adenoma	—	—

Adverse Events

Arm I (Eflornithine and Sulindac)

Serious events: 41 serious events

Other events: 173 other events

Deaths: 0 deaths

Arm II (Placebo)

Serious events: 28 serious events

Other events: 154 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I (Eflornithine and Sulindac) n=191 participants at risk Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=184 participants at risk Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies
Reproductive system and breast disorders LEFT URETERAL STONES, OBSTRUCTING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders LUMBAR HERNIATED DISC AND LUMBAR RADICULOPATHY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders MALIGNANT EPITHELOID NEOPLASM	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ABDOMINAL PAIN MOST LIKELY SECONDARY TO ACUTE CHOLECYSTITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders ACUTE SHORTNESS OF BREATH R/T CHF, IMPROVED	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders ACUTE SHORTNESS OF BREATH; CAD; UNSTABLE ANGINA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders ANEURYSM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders ANGINA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders AORTIC STENOSIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders ARRYTHMIA SINUS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders BASAL CELL CARCINOMA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders BENIGN POSITIONAL VERTIGO	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders BIPOLAR, EXACERBATED	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders BLADDER PROLAPSE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders BROKEN RIGHT TIBIA UNDER KNEE D/T MVA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CARCINOMA PROSTATIC	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders CELLULITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders CELLULITIS OF RIGHT LEG	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders CEREBRAL INFARCTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CHEST PAIN	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CHEST PAIN AND PALPITATIONS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CHEST PAIN X 3 WKS, R/O CORONARY ARTERY DISEASE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Hepatobiliary disorders CHOLECYSTITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders COLITIS PSEUDOMEMBRANOUS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CONGESTIVE HEART FAILURE	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders COPD EXACERBATION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CORONARY ARTERY DISEASE	1.6% 3/191 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CORONARY ARTERY DISEASE POST NON-ST ELEVATION MI	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CORONARY ARTERY DISORDER	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders DEPRESSION SUICIDAL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders DISCHARGE SUMMARY 1/27/02 NEW ONSET ATRIAL FIBRILLATION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders DIVERTICULITIS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders DUCTAL LEFT BREAST CANCER	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders DYSPNEA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders FX (L) ELBOW	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Hepatobiliary disorders GALLSTONES, PANCREATITIS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GASTROINTESTINAL BLEEDING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GASTROINTESTINAL BLEEDING SECONDARY TO ACUTE GASTROENTERITIS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI BLEED R/T DIVERTICULA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders HEART DISEASE: A. CORONARY, B. NON-Q-WAVE INFARCTION, C. UNSTABLE ANGINA; CORONARY STENTING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders HOSPITALIZATION - OVERNIGHT OBSERVATION; LEFT KIDNEY BIOPSY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HOSPITALIZATION FOR PANCREATIC NEOPLASM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders HOSPITALIZATION UTI	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders HOSPITALIZATION VAGINAL BLEEDING TOTAL HYSTERECTOMY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders HOSPITALIZATION; APPENDICITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders HOSPITALIZATION; BENIGN PROSTATIC HYPERTROPHY; ADMITTED FOR TRANSURETHRAL RESECTION OF THE PROSTATE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders HOSPITALIZATION; FRACTURE OF LEFT ANKLE REQUIRING SURGICAL INTERVENTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders HOSPITALIZED FOR ELECTIVE BLADDER SURGERY TO EVALUATE INCONTINENCE AND BIOPSY POSSIBLE TUMOR.	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders INFARCT MYOCARDIAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders INTESTINAL ILEUS STATUS POST CHOLECYSTECTOMY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders JOINT DISORDER	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders KIDNEY CALCULUS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders LEFT LEG CELLULITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders MENTAL AND PHYSICAL BREAKDOWN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MVA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders MYOCARDIAL INFARCTION/CHEST PAIN, ABNORMAL CARDIAC ENZYMES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders NEPHROPATHY TOXIC	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OBSTRUCCTIVE JAUNDICE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders PAIN CHEST	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CANCER	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations PANCREATITIS	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Endocrine disorders PARATHYROID DISORDER	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders PNEUMONIA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders PNEUMONIA, SEPSIS SYNDROME, ACUTE RENAL FAILURE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders PNEUMONIA; POSSIBLE COPD EXACERBATION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PROBABLE RIGHT SUBCORTICAL INFARCT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders PROLAPSED CYSTOCELE; TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders PROSTATE CANCER	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PT WAS IN A MOTOR VEHICLE ACCIDENT…RECEIVED CONTUSIONS AND EXPERIENCED HEAD PAIN. PT WAS RESTRAINED.	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders PT. ADMITTED TO HOSPITAL FOR SPIGELIAN HERNIA REPAIR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders QUADRUPLE BYPASS SURGERY FOR CAD, UNSTABLE ANGINA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders R/O MI	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders RENAL CYST	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders RENAL FAILURE ACUTE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders RIGHT HIP PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders RIGHT KNEE PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders S/P LEFT TOTAL HIP ARTHROSCOPY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders SEIZURE ACTIVITY SECONDARY TO CEREBRAL ATROPHY OF RIGHT TEMPORAL LOBE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations SEPSIS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders STERNAL WOUND SURGICAL DEBRIDEMENT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations URINARY TRACT INFECTION, HYPERGLYCEMIA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations UTI WITH SEPSIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.

Other adverse events

Measure	Arm I (Eflornithine and Sulindac) n=191 participants at risk Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies	Arm II (Placebo) n=184 participants at risk Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies
Musculoskeletal and connective tissue disorders PAIN* BACK INTERMITTENT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* BACK LOWER LEFT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* BACK PAIN	2.1% 4/191 • Number of events 4 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* BACK PAIN WHILE EXERCISING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* BACK X2 EPISODES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* BACK, MUSCLE SPASM	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* BILATERAL KNEE SORENESS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* BILATERAL SHOULDER PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations 5 LBS X 2 WKS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders A-FIB	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ABDOMINAL PAIN	2.1% 4/191 • Number of events 6 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	2.7% 5/184 • Number of events 5 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ABDOMINAL PAIN ABD CRAMPING AND BLOAT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ABDOMINAL PAIN ABD. CRAMP AND CONSTIPATION	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ABDOMINAL PAIN ABDOMINAL CRAMPING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ABDOMINAL PAIN CRAMPING	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ABDOMINAL PAIN CRAMPS/ CONSTIPATION	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ABDOMINAL PAIN DIARRHEA X 1-2 DAILY, CRAMPING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ABDOMINAL PAIN DIARRHEA X 3-4 DAILY, CRAMPING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ABDOMINAL PAIN EPIGASTRIC PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ABDOMINAL PAIN LEFT SIDE	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ABDOMINAL PAIN LOWER ABDOMEN, INTERMITTENT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ABDOMINAL PAIN LOWER ABDOMINAL CRAMPING AFTER COLONOSCOPY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ABDOMINAL PAIN OCCASIONAL ABD CRAMP WITH LOOSE STOOL WHEN NERVIOUS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ABDOMINAL PAIN STOMACH CRAMPS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ABDOMINAL PAIN UPSET STOMACH	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders ABNORMAL PSA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations ABNORMAL X-RAY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ANKLE PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Metabolism and nutrition disorders ANOREXIA	4.2% 8/191 • Number of events 9 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.6% 3/184 • Number of events 6 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Metabolism and nutrition disorders ANOREXIA DECREASED APPETITE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Metabolism and nutrition disorders ANOREXIA LOSS OF APPETITE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders ANXIETY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	2.2% 4/184 • Number of events 4 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders ANXIETY AND DEPRESSION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders ANXIETY DEPRESSION	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders ANXIETY INCREASED ANXIERTY AND BOREDOM	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders ANXIETY MOOD SWINGS, HOT FLASHES, ANXIETY	0.52% 1/191 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Metabolism and nutrition disorders APPETITE LOSS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHIALGIA SHOULDER	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS ARTHRITIS FLARE UP - HANDS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS BACK PAIN WORSENING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS BILATERAL KNEE PAIN R/T	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS EXACERBATION OF GOUT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS GOUT, RIGHT FOOT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS HAND PAIN (ARTHRITIS) OR (FIBROMYALGIA EPISODE)	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS IN RIGHT KNEE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS LEFT HAND JOINT PAIN R/T ARTHRITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS LEFT KNEE/ LEFT WRIST	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS LEFT WRIST	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS NECK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS OSTEO	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS OSTEOARTHRITIS-LEFT KNEE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS OSTEOARTHRITIS-LEFT WRIST	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS R THUMB JOINT PAIN R/T	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS RIGHT ELBOW	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS THUMB PAIN - ARTHRITIS BOTH HANDS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders ARTHRITIS TOE PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders ASTHMA FLARE-UP	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders BACK PAIN (MOTRIN USE)	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders BACK PAIN, ON MOTRIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders BACK STRAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders BALANCE	2.1% 4/191 • Number of events 4 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.6% 3/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders BALANCE BALANCE DISTURBANCE	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders BALANCE BALANCE DISTURBANCE DUE TO B12 MALABSORPTION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders BALANCE DISTANCE DISTURBANCE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders BALANCE DISTURBANCE	2.1% 4/191 • Number of events 4 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders BASAL CELL SKIN LESION REMOVAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders BASAL CELL TAKEN FROM FACE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders BELLS PALSY SIDE WEAKNESS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders BIL LE EDEMA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders BIL SWOLLEN FEET AND ANKLES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders BIL. CATARACTS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders BLACK STOOLS (THINKS FROM MAALOX)	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders BLEEDING GUMS DURING DENTAL VISIT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders BLEEDING IN EYE FROM THORN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders BLEEDING RECTAL	3.7% 7/191 • Number of events 12 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	2.7% 5/184 • Number of events 6 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders BLEEDING RECTAL 4 EPISODES BRBPR	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders BLEEDING RECTAL BRB TOILET PAPER	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders BLEEDING RECTAL HEMORRHOIDS	2.6% 5/191 • Number of events 5 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders BLEEDING* BLOOD IN THE URINE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders BLEEDING* BLOOD IN URINE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.6% 3/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders BLEEDING* EAR CANALS, LEFT AND RIGHT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders BLEEDING* EPITAXIS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations BLEEDING* GUMS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders BLEEDING* HEMATOCHEZIA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders BLEEDING* HEMATURIA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders BLEEDING* HEMATURIA - TRACE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders BLEEDING* HEMORRHAGE HEMATURIA	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders BLEEDING* NOSE BLEED	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders BLEEDING* PENILE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders BLEEDING* PROLONGED MENSTRUAL BLEEDING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders BLEEDING* SHAVING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders BLEEDING* UPPER GI BLEED	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders BLEEDING* VAGINAL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders BLEEDING* VAGINAL BLEED	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders BLEEDING, RECTAL	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders BLOOD IN STOOL	2.1% 4/191 • Number of events 4 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders BLOOD IN STOOL /HEMORRHOID	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders BLOOD IN STOOL BURGUNDY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders BLOOD IN STOOL DIARRHEA, CRAMPING, BLACK STOOL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders BLOOD IN STOOL DX: COLITIS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders BLOOD IN STOOL OCCULT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders BLOOD IN STOOL SMALL DOT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders BLOOD IN URINE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders BLOOD WITH BM	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders BOWEL MOVEMENT REGULARITY CONTINUES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders BPH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders BROKE BACK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders BROKEN ANKLE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders BROKEN TOE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations BROKEN TOOTH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders BRONCHITIS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders BRUISING LEFT HIP AREA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders BX - BPH	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CAD	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* ALTERED LEFT VENTRICULAR DIASTOLIC FUNCTION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* ATRIAL FIBRILLATION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* CONGESTIVE HEART FAILURE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* DX -- POSSIBLE RETURN OF RENOVASCULAR HTN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* DX WITH CAD	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* FLUID IN LUNGS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* HEART ATTACK	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* HEART MURMUR	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* HEART PALPITATIONS AND HYPERTENSION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* LEFT BUNDLE BRANCH BLOCK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* MILD AORTIC SCLEROSIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* MYOCARDIAL INFARCTION BY EKG	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* NEAR FAINT EPISODES, DX HTN, ON DRUGS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* PALPITATION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* PALPITATIONS (PSVT)	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* TACHYCARDIA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* TACHYCARDIA EPISODES - INCREASED FREQUENCY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* UNSTABLE ANGINA, CHEST PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* VALVULAR HEART DISEASE - MILVAL VALVE REGURGITATION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* VASOVAGAL EPISODE	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CARDIAC* VASOVAGAL SYNCOPAL EPISODE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders CARPAL TUNNEL SYNDROM	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders CATARACT SURGERY RIGHT EYE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders CELLULITIS - LEFT BREAST WOUND - NON INFECTIOUS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders CELLULITIS LEF SIDE FACE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders CENTRAL NERVOUS SYSTEM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders CENTRAL NERVOUS SYSTEM DEPRESSION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders CENTRAL NERVOUS SYSTEM HEADACHE RELATED TO CHOCOLATE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders CENTRAL NERVOUS SYSTEM INCREASE IN SEIZURES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders CENTRAL NERVOUS SYSTEM MEMORY LOSS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders CENTRAL NERVOUS SYSTEM MEMORY LOSS INCREASED	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders CENTRAL NERVOUS SYSTEM MEMORY LOSS/FORGETFULNESS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders CENTRAL NERVOUS SYSTEM MEMORY PROBLEMS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders CHANGE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders CHANGE IN HEARING PER AUDIOGRAM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders CHANGE IN SIGNIFICANT OTHER'S PERCEPTION OF HEARING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CHEST PAIN RELATED TO 4/18 REPORT FOR HEART BURN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders CHEST PAIN WITH EXERTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders CN VIII	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders COLD	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders COLD SYMPTOMS	5.8% 11/191 • Number of events 13 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	4.9% 9/184 • Number of events 11 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders COLD SYMPTOMS COLD X3-4	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders COLD SYMPTOMS COUGH AND COLD SYMPTOMS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders COLD SYMPTOMS DX SINUS INFECTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders COLD SYMPTOMS HEAD	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders COLD SYMPTOMS HEAD COLD	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	3.3% 6/184 • Number of events 6 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders COLD SYMPTOMS NASAL CONGESTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders COLD SYMPTOMS POST NASAL DRIP	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders COLD SYMPTOMS SINUS DRAINAGE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders COLD SYMPTOMS SNIFFLES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders COLD SYMPTOMS SORE THROAT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders COLD SYMPTOMS WITH COUGH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders COLD WITH URI SX	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders COLD/SINUS/EAR CONGESTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders CONGESTION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders CONSTIPATION	3.1% 6/191 • Number of events 8 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	2.2% 4/184 • Number of events 7 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders CONSTIPATION CHRONIC	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders CONSTIPATION GETTING WORSE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders CONSTIPATION INCONTINENCE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders CONSTIPATION R/T IMMODIUM	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders COUGH*	3.1% 6/191 • Number of events 7 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	2.7% 5/184 • Number of events 8 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders COUGH* DRY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders CRAMPING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Injury, poisoning and procedural complications CUT SHIN = INFECTION (CELLULITIS)	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CYST. DERMAL ON BACK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations DECREASE HGB 5% FROM BASELINE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations DECREASE IN HGB	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders DECREASED PERIPHERAL REFLEXES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders DEPRESSION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 5 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders DEPRESSION, MOM'S DEATH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* 2 SPOTS ON SCALP	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* ACTINIC KERATOSES REMOVED X3	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* ACTINIC KERATOSIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* ANAL SKIN TAG REMOVED	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* BASAL CELL CARCINOMA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* BCC	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* BLACK SPOT CHANGES ON SCALP	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* BOIL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* BRUISES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* BRUISING INTERMITTENT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* DERMATITIS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* DERMATITIS/ EXACERBATION THUMBS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* DISCOVERY AND REMOVAL OF BENIGN SKIN LESION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* DRY SKIN, FEET	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* EXTREME RASH ON TRUNK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* FACIAL EDEMA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* FUNGAL INF.	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* IMPETIGO (NOSE)	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* MELANOMA UPPER ARM MOLE SKIN EXCISION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* PERIANA PRURITUS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* PIGMENTATION SLOW TO FILL IN ON SCRAPE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* PRURITUS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* R/O POSSIBLE SKIN CA SPOT SCHAGE COLOR AND SIZE, BX 2/12/04	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* RASH RIGHT ARM	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* REMOVAL SKIN CA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* ROSACEA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* ROSACEA FLARE-UP	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* SKIN - BUMP, RED LEFT UPPER MOUTH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* SKIN - LESION RIGHT EAR ANTIHELIX	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* SKIN LESION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* SKIN LESION ABOVE FOREHEAD	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* SKIN LESIONS (REMOVED)	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* SKIN RASH	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* SKIN ROSACEA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DERMATOLOGY* SKIN SENSITIVE TO SUN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Endocrine disorders DIABETES NEW ONSET	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders DIAPHORESIS ABDOMINAL DISCOMFORT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders DIARRHEA	16.2% 31/191 • Number of events 49 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	15.8% 29/184 • Number of events 47 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders DIARRHEA + ABDOMINAL CRAMPS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders DIARRHEA 2 EPISODES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders DIARRHEA 3 EPISODES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders DIARRHEA AFTER COLONOSCOPY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders DIARRHEA CONTINUED DIARRHEA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders DIARRHEA LOOSE STOOL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders DIARRHEA LOOSER STOOL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders DIARRHEA MILD	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders DIARRHEA OCCASIONAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders DIARRHEA X 1 RELATED TO FOOD	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders DIVERTICULITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders DIZZINESS	4.2% 8/191 • Number of events 11 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	4.3% 8/184 • Number of events 11 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders DIZZINESS AFT CERUMEN REMOVAL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders DIZZINESS FELL R/T LIGHT HEADED	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders DIZZINESS VERTIGO	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders DIZZINESS/VERTIGO	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders DIZZINESS/VERTIGO EPISODE LASTING LESS THAN 10 SEC	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations DROP HGB	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations DROP IN HGB	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders DRY EYE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders DX CHF	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders DX WITH EMPHYSEMA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders DYSPNEA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders DYSPNEA (SHORTNESS OF BREATH)	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders DYSPNEA ON EXERTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders EAR INFECTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders EARLY SATIETY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations ELECT. BALANCE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders ELEVATED BLOOD PRESSURE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations ELEVATED CREATININE BUN	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations ELEVATED LIVER ENZYMES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations ELEVATED PSA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations ELEVATED TRIGLYCERIDE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations ELEVATED TRIGLYCERIDES 571	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations ELEVATED TRIGLYCERIDES 779	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Endocrine disorders ENLARGED THYROID	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders EPIGASTRIC PAIN	4.2% 8/191 • Number of events 8 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	3.8% 7/184 • Number of events 8 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders EPIGASTRIC PAIN 2-3 EPISODES PER WEEK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders EPIGASTRIC PAIN GAS PAINS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders EPIGASTRIC PAIN GAS X 1 PER MONTH	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders EPIGASTRIC PAIN GASTRIC PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders EPIGASTRIC PAIN GERD	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders EPIGASTRIC PAIN GERD (INCREASE SYMPTOMS)	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders EPIGASTRIC PAIN GERD, WORSENED, EST. START 1970	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders EPIGASTRIC PAIN PAIN X 1	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders EPIGASTRIC PAIN RIGHT SIDE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders ERECTILE DYSFUNCTION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders ERECTILE DYSFUNTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders ERYTHORMATOUS PLAQUES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders EXACERBATION OF LEFT KNEE PAIN - ARTHRALGIA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) EXCISED MASS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FATIGUE	16.8% 32/191 • Number of events 34 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	9.2% 17/184 • Number of events 19 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FATIGUE* ALLERGY FATIGUE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FATIGUE* BILATERAL LEG FATIGUE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FATIGUE* DIAPHORESIS AFTER MEALS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FATIGUE* INCREASED	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FATIGUE* MILD	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FATIGUE* MILD DEPRESSION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FATIGUE* MUSCLE ACHES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FATIGUE* POSSIBLE VIRUS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FATIGUE* R/T MUSCLE WEAKNESS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FATIGUE* RELATED TO MUSCLE WEAKNESS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FATIGUE* SYNCOPE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FATIGUE* WEAKNESS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders FEELING HEATED AFTER TAKING MEDICATION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FEVER	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations FEVER BLISTERS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FEVER INTERMITTENT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FEVER SWEATS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FEVER X 2DAYS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FEVER X1	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Injury, poisoning and procedural complications FINGER LACERATION RIGHT HAND	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders FLATULENCE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FLU	3.7% 7/191 • Number of events 7 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.6% 3/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FLU ACHY, NAUSEA, HEADACHE, COUGH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FLU DIARRHEA N/V	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FLU FLU-LIKE SYMPTOMS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FLU INFECTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FLU S/S	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FLU SYMPTOMS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders FLU X5 DAYS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders FLU-LIKE SYNDROME	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Injury, poisoning and procedural complications FOOT CONTUSION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders FORHEAD LESION REMOVAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders FUZZY EYESIGHT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders FX RT GREAT TOE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GASTRIC REFLUX	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GASTRITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders GENITOURINARY - URINATING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders GENITOURINARY URINATING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI ABDOMINAL BLOATING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI BARRETT'S ESOPHAGUS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI BARRETT'S ESOPHAGUS/DYSPLASIA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI BLOATING	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI BLOATING / GAS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI BLOATING/FEELING OF INCOMPLETE EVACUATION, CONSISTENT WITH IBS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI CECUM BIOPSY: EROSIM WITH CHRONIC INFLAMMATION, NON-SPECIFIC	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI CONT. COLITIS SX	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI CONT. ESOPHAGEAL IRRITATION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI ESOPHAGEAL FULLNESS RELATED TO GASTRO CIRCLAGE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI HEARTBURN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.6% 3/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI HEARTBURN 1 - 2 EPISODES/WEEK	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI HEARTBURN 4 EPISODES WEEKLY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI HEARTBURN 5-6 EPISODES/WEEK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI HEARTBURN 5-6- EPISODES/WEEK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI HEARTBURN X9 EPISODES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI HEARTBURN, 1 EPISODE PER WEEK	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI INCREASE IN GERD SYMPTOMS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI INCREASED GERD SX	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI INFLAMMATION COLITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI PEPTIC ULCER DISEASE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI STOMACH CRAMPS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI UPPER GI PAIN/ACID REFLUX	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI UPSET	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI UPSET STOMACH	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI UPSET STOMACH X 2 EPISODES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GI UPSET STOMACH X3 EPISODES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders GLUCOSURIA	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders GOUT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders GROIN PULL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders GUM SORENESS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders H. PYLORI +, STOMACH UPSET	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders H.PYLORI +, DX IBS - CONSTIPATION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders HAND PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures HAND SURGERY - TRIGGER FINGER	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders HEAD CONGESTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders HEADACHE	9.9% 19/191 • Number of events 22 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	9.8% 18/184 • Number of events 26 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders HEADACHE INTERMITTENT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders HEADACHE NAUSEA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders HEADACHE PAIN 5 EPISODES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders HEADACHE PRESSURE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders HEADACHE SIDE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders HEADACHE SINUS PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders HEADACHE WITH NAUSEA AND VOMITING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders HEADACHE WITH NAUSEA AND VOMITTING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders HEADACHE WITH VISION INVOLVEMENT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders HEADACHE X1	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING	2.6% 5/191 • Number of events 5 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	2.7% 5/184 • Number of events 7 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING "CARBONIZATION SOUND" - LEFT EAR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING /INNER EAR - "STATIC NOISE" LEFT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING AUDIO CHANGE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING AUDIO CHANGE SUBCLINICAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING AUDIO SHOWS NO CHANGE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING AUDIOGRAM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING AUDIOGRAM CHANGE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING AUDIOGRAM GRADE 1 HEARING CHANGE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING AUDIOGRAM ONLY	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING AUDIOMETIC CHANGE, OFF STUDY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING AUDIOMETRIC CHANGE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING AUDIOMETRIC CHANGE BILATERAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING AUDIOMETRIC CHANGE LEFT EAR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING AUDIOMETRIC CHANGE RIGHT EAR	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING AUDIOMETRIC CHANGE RIGHT EAR/ OVERALL NO SIGNIFICANT CHANGE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING AUDITORY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING CHANGE	5.8% 11/191 • Number of events 13 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	3.3% 6/184 • Number of events 6 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING CHANGE AUDIOGRAM	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING CHANGE NOTED ON AUDIO	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING CHANGE PER AUDIOGRAM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING CHANGE-LEFT EAR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING CHANGE? PT NOT SURE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING DECREASE IN HEARING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING DECREASE IN HEARING ABILITY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING DECREASE LEFT>RIGHT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING DECREASED	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING DECREASED RIGHT EAR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING DIFFICULTY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING HEARING CHANGE	1.6% 3/191 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.6% 3/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING HEARING LOSS	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.6% 3/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING HEARING LOSS - SIGNIFICANT OTHER PERCEPTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING HEARING LOSS AUDIOMETRY ONLY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING HEARNING LOSS/ SUBCLINICAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING HEARS PULSE IN LEFT EAR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING HUSBAND THINKS POSSIBLE HEARING CHANGE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING INNER EAR	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING LOSS	1.6% 3/191 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING LOSS (SELF-PERCEPTION)	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING LOSS + PAIN, LEFT NECK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING LOSS - SIGNIFICANT OTHER PERCEPTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING LOSS IN LEFT EAR	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING LOSS IN LEFT EAR, AUDIO DONE 11-30-00	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING MILD LOSS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING MUFFLED	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING OTITIS MEDIA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING OTOTOXICITY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING OTOTOXICITY - AUDIOGRAM ONLY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING PLUGGED RIGHT EAR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING POSSIBLE CHANGE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING RIGHT EAR "PLUGGED" X2 EPISODES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING RIGHT EAR PAIN/PLUG	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING RIGHT EAR PAIN/PLUG, EUSTACHIAN TUBE DYSFUNCTION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING SELF PERCEPTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING SELF PERCEPTION, DIFFICULTY WITH DISCRIMINATION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING SLIGHT LOSS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders HEARING TINNITUS (HAS GOTTEN SLIGHTLY WORSE OVER LAST 2 MONTHS)	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders HEART DISEASE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders HEARTBURN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders HEMATARIA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders HEMATURIA-MICROSCOPIC	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders HEMIANOPSIA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders HEMMORRHOID	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders HEMOGLOBINURIA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders HEMORRHOIDS	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.6% 3/184 • Number of events 4 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders HEMORRHOIDS FLARE-UP	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures HERNIA REPAIR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations HERPES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders HIGH BLOOD PRESSURE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders HIP AREA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders HIP BURSITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders HIP PAIN	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Vascular disorders HOT FLASHES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders HTN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations HYPERGLICEMIA	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations HYPERGLYCEMIA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations HYPERKALEMIA	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders HYPERTENSION	3.1% 6/191 • Number of events 7 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	3.3% 6/184 • Number of events 7 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders HYPERTENSION /DIABETES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders HYPERTENSION MILD/MOD	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders HYPERTENSION RETURNED	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders HYPERTENSION SUSPECT OCULAR HYPERTENSION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders HYPERTENSION UNCONTROLLED	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders INCREASE "BURPING"	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders INCREASE BP WITH RINGING IN EARS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders INCREASE FLATULENCE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders INCREASE FREQ OF HEMORHOIDAL BLEEDING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders INCREASE STOOL FREQUENCY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders INCREASE STOOLING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations INCREASED ALKPHOSPHATASE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations INCREASED ALT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations INCREASED AST	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations INCREASED BILIRUBIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders INCREASED BOWEL MOVEMENTS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations INCREASED CREATININE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders INCREASED FATIGUE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders INCREASED FLATULENCE; ANAL INCONTINENCE	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders INCREASED FREQUENCY OF DROPPING ITEMS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations INCREASED HEMOGLOBIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations INCREASED LFTS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INCREASED ORAL HERPES OUTBREAKS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders INCREASED STOOLING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders INDIGESTION	2.1% 4/191 • Number of events 6 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.6% 3/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders INDIGESTION DYSPEPSIA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders INDIGESTION EPIGASTRIC PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders INDIGESTION HEART BURN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* BLADDER	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* BLADDER INFECTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* EAR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* ESOPHAGITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* EUSTACHIAN TUBES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* FUNGAL FINGERNAIL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* FUNGAL INFECTION FINGERNAILS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* FUNGAL, LEFT MIDDLE FINGER	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* INFECTED SCROTAL CYST	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* INSECT BITE RIGHT ANKLE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* LEFT INDEX FINGER	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* LEFT LOWER LEG AK SITE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* LEFT TESTICLE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* MIDDLE EAR-BLOCKED EUSTACHIAN TUBE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* PNEUMONIA POSS "SCAR" ON CXR	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* RIGHT BREAST	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* RIGHT CALF BITE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* RIGHT MIDDLE FINGER NAIL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* SINUS	1.6% 3/191 • Number of events 4 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* SINUS INFECTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* SKIN FUNGAL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* TOOTH	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* UPPER RESPIRATORY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* VAGINAL YEAST	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* WOUND/INFECTION LEFT LE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations INFECTION* YEAST	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders IRRITABILITY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders ITCHING AND RASH TO RECTUM	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders JOINT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders JOINT PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders KIDNEY PROBLEMS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders KIDNEY PROBLEMS/RENAL-OTHER	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders KIDNEY STONE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders KIDNEY STONES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders KNEE PAIN	1.0% 2/191 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS 10 % HGB DROP	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS 10% DROP HGB	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS 10% DROP HGB WITH DYSMENORRHEA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS 10% DROP IN HGB	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS ANEMIA	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS ANEMIA - DROP IN HGB	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS ANEMIA, MENSUS DISORDER	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS ANEMIA: IRON DEFICIENCY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS B-12 DEFICIENCY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS BLOOD GLUCOSE ELEVATED	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS DECREASE HGB GREATER THAN 10%	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS DECREASE IN HGB	2.1% 4/191 • Number of events 4 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	2.2% 4/184 • Number of events 4 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS DECREASED HBG 10% FROM BASELINE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS DECREASED HBG OF 10% BASELINE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS DECREASED HEMOGLOBIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS DECREASED HEMOGLOBIN >10%	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS DECREASED HEMOGLOBIN NOT GREATER THAN 10% BASELINE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS DECREASED HEMOGLOBIN, REDRAW 12/4/01	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS DECREASED HGB	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS DECREASED HGB GREATER THAN 10% BASELINE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS DECREASED HGB GREATER THAN 10% FROM BASELINE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS DECREASED HGB, 10% FROM BASELINE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS DECREASED HGB: CHRONIC	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS DECREASED NEUTROPHILS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS DECREASED WBC	2.1% 4/191 • Number of events 4 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS DROP IN HGB AND HEMATOCRIT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS ELEVATED ALKALINE PHOSPHATASE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS ELEVATED BILIRUBIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS ELEVATED PSA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS ENDOCRINE: ELEVATED BLOOD GLUCOSE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS HEMATURIA	1.6% 3/191 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS HGB DECREASE = 10%	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS HGB DECREASE GREATER THAN 10%	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS HGB DROP 10%	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS HIGH ALT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS HIGH AST	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS HIGH CHOLESTEROL LEVELS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS HYPERCHOLESTEREMIA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS HYPERKALEMIA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS HYPERLIPIDEMIA	1.6% 3/191 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS INCREASED ALKALINE PHOSPHATASE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS INCREASED CHOLESTEROL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS INCREASED GLUCOSE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS INCREASED HGB A1C	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS LOW BLOOD SUGAR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS LOW HEMOGLOBIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS LOW HEMOGLOBIN AFTER SURGERY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS LOW HGB	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS LOW HGB - 10% FROM BASELINE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.6% 3/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS LOW HGB = 10%	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS LOWER WBC	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS PROTEINURIA	0.52% 1/191 • Number of events 5 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS PSA ELEVATION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS PSA LEVELS INCREASED (5 TO 8 TO 11)	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS WHITE BLOOD CELL COUNT DECREASED	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LABS WHITE BLOOD CELLS COUNT DOWN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders LEFT EAR INFECTION, RINGING WITH FULLNESS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders LEFT FLANK PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders LEFT KIDNEY STONE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders LEFT KNEE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders LEG CRAMPS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders LEG PAIN	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders LEG PAIN (RELATED TO HERNIATED DISC)	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders LICHEN PLANUS MOUTH + TONGUE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders LLQ ABDOMINAL PAIN WITH BM	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders LOOSE STOOL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations LOW BLOOD COUNT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders LOW BONE DENSITY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders LOWBACK PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders LOWER BACK PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Vascular disorders LOWER LEG SWELLINGW	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders LOWERBACK PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders LOWGRADE FEVER	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Vascular disorders LYMPHADENITIS RIGT NECK	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MASS FOUND ON CRX	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders MORE FREQUENT HEADACHES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders MUCUS/COUGHING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MULTIPLE POLYPS (<4MM) IN FLEX SIGMOIDOSCOPY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* BODY ACHES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MULTIPLE POLYPS IN THE COLONOSCOPY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS IN BACK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL ACHE ARM LEFT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL ACHINESS, TIGHTNESS - KNEES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL ANKLE INJURY, LEFT, R/T MISSTEP	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL BACK PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL BACK SPASM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL BACK STRAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL BILATERAL LOWER EXTREMITY FATIGUE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL BILATERAL THIGH CRAMPS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL BUMP INTERIOR TO LEFT ELBOW	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CRAMPS THIGH RIGHT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CRAMPS THIGHS BILATERAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL FOOT PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MUSCULOSKELETAL GANGLION CYST	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL INCREASED BACK PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL L2, L3 DISKS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL LEFT HIP PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL LEFT INGUINAL HERNIA, RECURRENT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MUSCULOSKELETAL MIDDLE FINGER CYST	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL MINOR BACK PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL MUSCLE PAIN, RIGHT LEG	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL MUSCLE SORENESS - R FOREMARM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL MUSCLE WEAKNESS/SORENESS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL NECK PAIN FROM FALL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL OLECRANON BURSITIS/CELLULITIS/ELBOW SWELLING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN - BILATERAL KNEE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN - RIGHT KNEE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL RIGHT KNEE SWELLING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL RIGHT KNEE TORN MENISCUS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL RIGHT ROTATOR CUFF, PAIN JOINT FUNCTION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL SCIATICA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL SHOULDER PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL SHOULDER PAIN CONTINUES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL SPRAINED ANKLE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL TAILBONE INJURY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL THIGH CRAMPS BILATERAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL TORN ROTATOR CUFF, LEFT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL UNSTEADY GAIT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL VENTRAL HERNIA X 2	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders NAUSEA	8.4% 16/191 • Number of events 18 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	6.0% 11/184 • Number of events 16 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders NAUSEA 5 EPISODES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders NAUSEA AFTER COLONOSCOPY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders NAUSEA AND BELCHING	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders NAUSEA NAUSEA/DIARRHEA/HEADACHE	0.52% 1/191 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders NAUSEA POST SURGICAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders NAUSEA RELATED TO NEW MEDICINE GLUCOPHAGE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders NECK AND SHOULDER PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders NECK PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders NECK PAIN, INJURY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders NEUROLOGY - DIZZINESS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders NEUROPATHY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders NEUROPATHY/SENSORY; TINGLING IN FINGERS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders NOSEBLEED	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders NUMBNESS/TINGLING OF RIGHT ARM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OA PAIN (HIPS)	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders OCC. CHEST TIGHTNESS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OCCULAR MIGRAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OLECRANON BURSITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL HAD BUMP ON SURFACE OF TONGUE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL SORE NEAR RIGHT INCISOR	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL SORENESS, UPPER RIGHT GUM WHERE PREVIOUSLY BAD TOOTH REMOVED	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL SORES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* BLISTER ROOF OF MOUTH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* CANKER SORES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* CANKER SORES ON TONGUE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* CHAPPED LIPS	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* COLD SORES, LIPS	1.6% 3/191 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders ORAL* CONT. ESOPHAGEAL IRRITATION/SORE THROAT WITH DIFFICULTY SWALLOWING POSSIBLY DUE TO ROSACEA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* DIFFICULTY SWALLOWING POSSIBLY DUE TO ROSACEA MEDS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* DISCOLORING OF TEETH	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* DISCOMFORT MOUTH, POST DENTAL WORK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* DRY MOUTH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* DRY THROAT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* DRY THROAT/MOUTH	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* DYSGEUSIA/TASTE DISTURBANCE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* DYSPHAGIA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders PAIN* BREAST TENDERNESS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* EXACERBATION/ LICHEN PLANUS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* GINGIVITIS FROM TEETH SCALING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* GUM PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* HYPERTROPHY, LUMP LEFT UPPER GUM	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* INCREASED SALIVA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* INTERMITTENT ORAL ULCERS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* LESION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* LESION ON LOWER LIP	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* MOUTH DRYNESS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* MOUTH SORE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* MOUTH SORES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* PAIN - SOFT PALATE POST SURGICAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* PAIN IN MOUTH POST PERIODONTAL SURGERY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* PAIN RIGHT UPPER MOLAR	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* PRE-ABSCESS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* SORE GUM - RIGHT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* SORE THROAT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	2.2% 4/184 • Number of events 5 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* SORENESS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* THROAT DRYNESS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* THROAT IRRITATION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* TOOTH PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders ORAL* ULCERS	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations ORAL* YEAST INFECTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER CONJUNCTIVITIS, WITH OP EYE SURGERY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders OTHER* + + PITTING BILATERAL ANKLE EDEMA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* 1 CM LESION ON RT. HAND	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OTHER* 2 LUMPS IN GROIN AREA (SIZE 2 X 2 CM)	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* ABCESS OF FINGER	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* ABDOMINAL BLOATING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* ACTINIC KERATOSIS REMOVED	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OTHER* ADENOMA POLYP	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* ALLERGIC RHINITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* ALLERGIES	1.0% 2/191 • Number of events 5 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* ALLERGY PET	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* ALLERGY SYMPTOMS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.6% 3/184 • Number of events 5 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* ALTERED TASTE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* ALTERED TASTE CHOCOLATE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* ANAL FISTULA	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* ANAL FISTULA, SURG REPAIR	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* ARTHRALGIA LEFT ANKLE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* ARTHRALGIA LEFT ELBOW	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* ARTHRALGIA LEFT SHOULDER	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* ARTHRALGIA LEFT WRIST	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* ARTHRALGIA LOWER BACK	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* ARTHRALGIA NECK	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* BACK PAIN AND DIARRHEA	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* BACK STRAIN	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders OTHER* BAD COLD X 3 WKS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* BASAL CELL CARCINOMA LEFT CLAVICLE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* BASAL CELL CARCINOMA LEFT JAW	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders OTHER* BILATERAL FOOT EDEMA R>L	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* BILATERAL FOOT TINGLING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders OTHER* BILATERAL LOWER EXTREMEITY EDEMA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OTHER* BIOPSY OF SKIN NEOPLASM, ABD. CYST AND THIGH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OTHER* BLADDER POLYP	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER* BLEPHARITIS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* BLOATING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* BLOATING, HX IBS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* BLOODY MUCOUS/ EXPECTORATED	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* BODY ACHES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* BODY ACHES GENERAL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* BODY ODOR DIFFERENT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* BOIL ON COCCYX	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* BONE SPUR/HEEL PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures OTHER* BRACHY THERAPY FOR PROSTATE CA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures OTHER* BREAST BIOPSY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OTHER* BREAST LUMP (FNA NEG)	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* BROKEN RIGHT UPPER ARM AND RIGHT FOOT R/T FALL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* BURSITIS - SHOULDER	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* BURSITIS IN RIGHT SHOULDER	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* BURSITIS RIGHT SHOULDER	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* BURSITIS-ELBOW	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* CARPAL TUNNEL SYNDROME BILATERAL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* CELLULITIS RIGHT KNEE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures OTHER* CHEST X-RAY ABNORMAL, RIGHT UPPER LOBE LESION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders OTHER* CHILLS, JOINT PAIN, SKIN IS SENSITIVE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders OTHER* CLAUDICATION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* COCCYX INJURY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* COLD SORE (NOSE)	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER* CONJUNCTIVITIS (ALLERGIC)	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* COPD EXACERBATION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* CRAMPING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Injury, poisoning and procedural complications OTHER* CUTS TAKE LONGER TO HEAL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OTHER* CYST IN GROIN WITH INFECTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OTHER* CYST ON BACK, DRAINED 10/10/00	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders OTHER* DECREASED LIBIDO	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Endocrine disorders OTHER* DECREASED THYROID FUNCTION, THIN HAIR, DECREASED TEMP, DRY SKIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* DEGENERATIVE JOINT DISEASE-RIGHT GREAT TOE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* DEGENERATIVE JOINT DISEASE; LOW BACK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Metabolism and nutrition disorders OTHER* DEHYDRATION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders OTHER* DEPRESSION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders OTHER* DEPRESSION - RECURRANCE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders OTHER* DEPRESSIVE SX, RELATIONSHIP CONCERNS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Endocrine disorders OTHER* DIABETES	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Endocrine disorders OTHER* DIABETIC NEUROPATHY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* DIFFICULTY SWALLOWING(DYSPHAGIA)	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* DISCOMFORT - RIGHT LEG	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders OTHER* DISCOMFORT LEFT EAR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* DISCOMFORT LEFT KNEE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders OTHER* DISCOMFORT POST PROSTATE BIOPSY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER* DRY EYES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders OTHER* DX METRORRHAGIA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Endocrine disorders OTHER* DX OF DIABETES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* DYSGEUSIA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* DYSPEPSIA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* DYSPHAGIA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders OTHER* DYSPLASIA PROSTATE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders OTHER* EAR DISCHARGE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders OTHER* EAR PAIN AND PRESSURE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders OTHER* EDEMA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders OTHER* EDEMA LEFT EXTREMITY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders OTHER* ELEVATED BLOOD PRESSURE/ SINGLE EVENT 9/00	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders OTHER* ELEVATED BLOOD PRESSURE; SINGLE 9/00	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* EMPHYSEMA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Endocrine disorders OTHER* ENDOCRINE -- HOT FLASHES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders OTHER* ENLARGED PROSTATE, PT PLACED ON PROZOSIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER* EPISCLERITIS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders OTHER* ERECTILE DYSFUNCTION, INCREASED SEVERITY OVER TIME	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* ERODED ESOPHAGUS/GERD	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* ESOPHAGEAL SPASM	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* ESOPHAGEAL STRICTURE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* ESOPHAGITIS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures OTHER* F/U 6MO CT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders OTHER* FEELS "FUZZY" IN HER HEAD	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER* FLOATER D/T DIABETIC RETINOPATHY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* FOOD POISONING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* FOOD POISONING: DIARRHEA. VOMITTING	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* FORGETFULNESS, LOSS OF TRAIN OF THOUGHT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Hepatobiliary disorders OTHER* GALLSTONES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* GASTRITIS, DEHYDRATION, RESPIRATORY TRACT INFECTION, FATIGUE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders OTHER* GENERAL ACHES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders OTHER* GENERAL BODY ACHES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders OTHER* GENITOURINARY "TWINGE" RIGHT TESTICLE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders OTHER* GENITOURINARY BLADDER SPASMS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders OTHER* GENITOURINARY, LEFT TESTICLE TENDER/SWOLLEN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders OTHER* GENITOURINARY/ VAGINITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* GERD	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER* GLAUCOMA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER* GLAUCOMA INCREASED	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders OTHER* GRIEF/DEPRESSION FM. DEATH	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders OTHER* GU - URINARY FREQUENCY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders OTHER* GU BLADDER SPASMS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* HARDER STOOLS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders OTHER* HEAD GETS COLD	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* HEARTBURN	3.7% 7/191 • Number of events 15 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	3.8% 7/184 • Number of events 9 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* HEARTBURN 2X WEEKLY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* HEARTBURN 3 TIMES A WEEK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* HEARTBURN X 3 EPISODES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* HEARTBURN X5 EPISODES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* HEARTBURN, 3-4 EPISODES/WEEK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* HEARTBURN, INCREASE?	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* HEME + X3	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* HEMOPTISIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* HOT AND SWEATY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Vascular disorders OTHER* HOT FLASHES, STOPPED HRT MEDS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations OTHER* HSV OUTBREAK	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* HT OF GASTRIC ULCERS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders OTHER* HTN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders OTHER* HTN (R/T STRESS AND WEIGHT)	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders OTHER* IGA GLOMERULONEPHRITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders OTHER* IMPOTENCE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders OTHER* INCONTINENCE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders OTHER* INCREASE IN DEPRESSION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* INCREASE IN TREMORS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders OTHER* INCREASED DEPRESSION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* INCREASED GAS WITH EATING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders OTHER* INCREASED PSA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders OTHER* INCREASED STRESS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders OTHER* INCREASED URINARY URGENCY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders OTHER* INCREASING INCONTINENCE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* INFECTION SINUS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders OTHER* INSOMNIA	1.6% 3/191 • Number of events 7 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders OTHER* INSOMNIA - TROUBLE SLEEPING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders OTHER* INSOMNIA INCREASE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Psychiatric disorders OTHER* IRRITABILITY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* IRRITATED THROAT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER* ITCHY EYES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders OTHER* KIDNEY STONES	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* KNEE STRAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Injury, poisoning and procedural complications OTHER* LACERATION, ER VISIT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* LAPSES IN CONCENTRATION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* LEFT ARM FRACTURE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OTHER* LEFT BREAST NODULE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* LEFT FOOT ARCH BRUISE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders OTHER* LEFT NIPPLE IRRITATED	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OTHER* LESION ON RIGHT THIGH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders OTHER* LETHARGY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* LIGHTHEADEDNESS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* LOOSE SPHINCTER RECTURM-SEEPAGE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* LOOSE STOOL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders OTHER* LOWER EXTREMITY EDEMA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders OTHER* LOWER EXTREMITY EDEMA - BILATERAL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OTHER* LUMP IN RIGHT GROIN, LYMPHADENOPATHY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OTHER* LUNG CANCER LEFT HILAR MASS SQUAMOUS CELL LYMPH NODE THORAX	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Injury, poisoning and procedural complications OTHER* MECHANICAL FALL WITH LACERATION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders OTHER* MENOPAUSE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* MILD PARESTHESIA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* MILD PARESTHESIA, BILATERAL ARMS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* MODERATE PARESTHESIA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* MODERATE PARESTHESIA IN RIGHT HAND	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* MOUTH COLD SORE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* MUCLE PULLED BACK	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* NAIL AVULSION, LEFT HALLUX NAIL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* NASAL DISCHARGE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* NERVOUS REACTION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* NIGHT SWEATS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* NUMBNESS LEFT PINNA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* OCCASIONAL BRUISING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders OTHER* OCCASIONAL LOSS OF ERECTION DURING INTERCOURSE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER* OCULAR - DRY MACULAR DEGENERATION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER* OCULAR - INCREASE INTRAOCULAR PRESSURE LEFT EYE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER* OCULAR/VISUAL MYOPIA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* ORAL SORENESS; ABCESS LOWER GUM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* OSTEOPOROSIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* OSTEOPOROSIS-LEFT WRIST	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* PAIN-LEFT ANKLE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* PARESTHESIA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* PARESTHESIA GREAT TOE RIGHT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* PARESTHESIA TOES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* PARESTHESIA TOES LEFT FOOT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* PARESTHESIA-LEFT ARM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* PERIANAL ABSCESS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* PERIANAL SWELLING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Injury, poisoning and procedural complications OTHER* PHLEBITIS LEFT FOREARM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Injury, poisoning and procedural complications OTHER* PHLEBITIS SUPERFICIAL LEFT FOREARM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* PLANTAR FASCIITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* PLANTAR FASCIITIS LEFT FOOT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* POST NASAL DRIP	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OTHER* PROSTATE CANCER	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OTHER* PROSTATIC ADENOCARCINOMA DX 7/01/03 BY BX	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* PRURITIUS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* PRURITIUS LEGS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* PRURITIUS, HIPS AND BELLY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* PRURITUS, INTERMITTENT, BELLY, HIPS, LEGS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* PRURITUS, INTERMITTENT, HIPS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* RECTAL BOIL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* RECTAL MOISTNESS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* RECTAL URGENCY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* RECTOCELE, VAGINAL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* RED LINE ON TOE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER* REDDENED EYES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures OTHER* REMOVAL OF SHRAPNEL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER* RETINA EDEMA, POST OP	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER* RETINAL TEAR LEFT EYE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders OTHER* RIGHT EAR PRESSURE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER* RIGHT EYE BLURRINESS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* RIGHT GREAT TOE WITH REDDISH SPOT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* RIGHT INGUINAL HERNIA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures OTHER* ROOT CANAL X3	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* RUNNY NOSE	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* SCRATCHY THROAT/SNIFFLES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OTHER* SHADOW IN LEFT LUNG, POSS. BENIGN TUMOR OR SCAR TISSUE. CT 3/10/04	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* SINUS INFECTION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* SINUS PROBLEM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* SKIN LESION LEFT FOREARM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* SLEEP APNEA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders OTHER* SLEEPY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Endocrine disorders OTHER* SMALL GOITER	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* SNIFFLES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* SOB CHEST TIGHTNESS, POSSIBLE GERD SX	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* SORE SHOULDER RELATED TO PAST BREAK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* SORE THROAT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	2.2% 4/184 • Number of events 4 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Injury, poisoning and procedural complications OTHER* SPIDER BITE (LEG) SWELLING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* STIFF FINGERS RIGHT. GOLF?	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* STOMACH CRAMPING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* STRAIN LEFT ARM	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders OTHER* STRESS, INCREASED	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER* SUBORBITAL EDEMA, RIGHT EYE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* SYNCOPE X 1	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders OTHER* TEARY/WATERY EYES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders OTHER* TENDON, BRUISED RIGHT ELBOW	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* THROAT IRRITATION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* TINGLING LEFT FOOT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* TINGLING TONGUE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders OTHER* TURP	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders OTHER* ULCERATION, RT LOWER EXTREMITY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders OTHER* UNSTEADY GAIT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders OTHER* URGENCY TO URINATE WITH BURNING AT TIMES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders OTHER* URINARY RETENTION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders OTHER* URINARY URGENCY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders OTHER* URINATION PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Immune system disorders OTHER* URTICARIA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OTHER* UTERINE POLYP	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders OTHER* VAGINAL ITCHING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders OTHER* VERY LOOSE STOOL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 4 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders OTHER* VOICE CHANGE - HOARSENESS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations OTHER* WHITE BLOOD CELL COUNT INCREASE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders OTOTOXICITY* LEFT EAR	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders OTOTOXICITY* R/EAR CLOGGED	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders OTOTOXICITY* TINNITUS LEFT EAR	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders PAIN AND LOCAL SWELLING, UPPER LEFT MOLAR	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders PAIN FROM KIDNEY STONES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN IN LOWER CALF	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* "VAGUE PAIN" WEAKNESS LEFT LEG	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* ALL OVER BODY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* ANKLE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* ARTHRALAGIA LEFT HAND	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* BACK	2.6% 5/191 • Number of events 5 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 7 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* BACK INCREASING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* CERVICAL - NECK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders PAIN* CHEST	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders PAIN* CHEST DISCOMFORT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Cardiac disorders PAIN* CHEST; EXACERBATION OF PREVIOUS CONDITION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders PAIN* EAR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders PAIN* EAR ACHE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders PAIN* EAR PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* FINGER PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders PAIN* FLANK PAIN, KIDNEY STONES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* FOOT PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* FOOT PAIN/SORE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures PAIN* FROM SEED IMPLANT FOR PROSTATE CA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders PAIN* GAS	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* GENERAL MUSCLE/JOINT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* GREAT TOE RIGHT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* GREAT TOES PAINFUL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* GROIN PAIN/ PUBIC BONE WITH LONG SITTING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* HANDS JOINT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* HEADACHE SINUS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* HIPS/BACK	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* IN CHEST R/T FALL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* IN FRONT OF LEFT UPPER THIGH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* JOINTS INCREASING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* JOINTS OF LEFT SIDE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* KNEE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* KNEE LIGAMENT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* KNEE PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* LEFT ACHILLES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* LEFT ANKLE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* LEFT ARM	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* LEFT ARM W/TINGLING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* LEFT FOOT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* LEFT HAND	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* LEFT HEEL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* LEFT HEEL BONE SPUR	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* LEFT HIP	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.6% 3/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* LEFT KNEE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* LEFT LOWER EXTREMITY CLAUDICATION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* LEFT NECK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* LEFT SHOULDER	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders PAIN* LEFT TESTICLE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* LEFT THUMB	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* LEG CRAMPS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* LOW BACK	2.1% 4/191 • Number of events 4 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	2.2% 4/184 • Number of events 5 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* LOWER BACK STIFFNESS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* MILD BACK PAIN "BURNING"	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* MUSCLE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* MUSCLE ACHES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* MUSCLE STRAIN (PAIN) IN LOWER BACK (OCCASIONAL)	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* MUSCLE STRAIN/SPASM	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* MVA - CHEST WALL PN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* MVA BACK PN/LEG PN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* NECK	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* NECK & BACK	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* NECK & UPPER CHEST PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* NECK, INJURY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* PAIN IN LEFT LEG AND KNEE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders PAIN* PELVIC CRAMPING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 8 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures PAIN* POST - SURGICAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures PAIN* POST HERNIA REPAIR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures PAIN* POST ORAL SURGERY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures PAIN* POST ROOT CANAL	1.0% 2/191 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures PAIN* POST SURGICAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures PAIN* POST TOOTH EXTRACTION	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* PULLED MUSCLE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders PAIN* RECTAL PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RIGHT BACK PAIN, INJURY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders PAIN* RIGHT BREAST	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RIGHT BUTTOCKS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RIGHT FLANK	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RIGHT GREAT TOE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RIGHT HEEL	1.6% 3/191 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RIGHT HEEL - PLANTAR FASCIITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RIGHT HIP AND KNEE	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RIGHT KNEE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RIGHT KNEE - INCREASE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RIGHT LEG PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RIGHT LOWER BACK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RIGHT LOWER BACK AND LEFT KNEE PAIN	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RIGHT LOWER BACK PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RIGHT SHOULDER	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RIGHT SHOULDER BLADE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RIGHT SHOULDER PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RIGHT SIDED PAIN AFTER EXERCISE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RLQ	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RT LEG SECONDARY TO FALL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PAIN* RT. RING FINGER, RT PINKY NUMBNESS/TINGLING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* RUQ PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* SCIATICA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Injury, poisoning and procedural complications PAIN* SCORPION BITE RIGHT FOREARM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Injury, poisoning and procedural complications PAIN* SHIN LACERATION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* SHOULDERS	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* SORE KNEE	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* SORE LEFT BIG TOE - GOUT?	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* SORE LEFT SHOULDER	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* SORE ON THUMB	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* SORE RT. KNEE, INCREASED PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders PAIN* SORE THROAT	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* SPRAINED ANKLE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Injury, poisoning and procedural complications PAIN* STERNAL PAIN/BURNING SENSATION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* STIFF NECK R/T HEAD BUMP IN BATH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* STIFFNESS & PAIN IN WRIST	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders PAIN* STOMACH	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* TAILBONE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders PAIN* TESTICLE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders PAIN* TESTICULAR SORENESS & SWELLING	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders PAIN* TOOTH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN* UPPER RIGHT QUADRANT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders PAIN/MUSCULOSKELETAL/SOFT TISSUE; EXTREMITY - UPPER LEFT SHOULDER ROTATOR CUFF TEAR REAPAIR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PARKINSONS DISEASE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM*	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM* ARMS TINGLE/GO NUMB	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM* HAND TREMBLINGS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM* HAND TREMOR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM* MILD PARESTHESIA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM* MILD PARESTHESIA BOTH HANDS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM* NEURO SCIATIC RIGHT LEG	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM* NEURO SCIATICA RIGHT LEG	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM* OLD INJURY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM* PARESTHESIA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM* PARESTHESIA BILAT TINGLING IN SHOULDERS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM* PARESTHESIA L/HAND NUMBNESS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM* PARESTHESIA LEFT SHOULDER PINCHED NERVE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM* PERESTHESIA, FEET, INCREASED FROM BASELINE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM* RIGHT FOOT TOE NUMBNESS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM* RIGHT LEG NUMBNESS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM* SLIGHT TINGLING/NUMBNESS HANDS/WRIST	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM* SPINAL STENOSIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations POSSIBLE FUNGAL INFECTION (SCALP)	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders POSSIBLE RENAL CALCULUS (TOOK 1 VICODINE)	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders POST NASAL DRIP	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders PROCTALGIA FUGAX	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders PROTRUDING AND TENDER HEMORRHOIDS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders PSEDOTUMOR EYE WILL F/U IN 6 MONTHS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders RASH	2.1% 4/191 • Number of events 4 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders RASH ABDOMINAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders RASH BODY AND EXTREMITIES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders RASH BUMPS ON SKIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders RASH EXACERBATION OF SEASONAL ITCHY RASH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders RASH FACE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders RASH HANDS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders RASH ITCH	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders RASH RIGHT CHEEK	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders RASH RIGHT FOOTECZEMA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders RASH RIGHT FOREARM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders RASH RIGHT LEG	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders RASH SHINGLES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders RASH SKIN RIGHT UPPER ARM	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders RASH URTICARIA RIGHT BUTTOCK	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders REFLUX	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.6% 3/184 • Number of events 4 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders REFLUX ACID	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders REFLUX ACID REFLUX	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders REFLUX ACID REFLUX 2-3 EPISODES/WK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders REFLUX ACID REFLUX DAILY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders REFLUX GASTRIC	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders REFLUX GERD	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders REFLUX GERD EPISODE	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders REFLUX GERD EPISODIC	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders REFLUX GERD, INCREASED SEVERITY OF EPISODES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders REFLUX INCREASED GERD, NUMBER OF EPISODES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures RELEASE OF CARPAL TUNNEL IN RIGHT HAND	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures REMOVAL OF PINS FROM PRIOR BUNIONECTOMY RIGHT FOOT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures REMOVAL PRE-CAN SK.	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY ALLERGIC RHINITIS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY ALLERGIES/ASTHMA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY ASTHMA FLARE UP	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY ASTHMA FLARE-UP, WHEEZING, SOB	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY BRONCHIAL ASTHMA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY BRONCHITIS	3.1% 6/191 • Number of events 6 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.6% 3/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY CHEST COLD SX, DX WITH PNEUMONIA RIGHT LUNG	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY CHEST CRX, PNEUMONIA RIGHT LUNG	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY CHOKING ON SALIVA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY CHRONIC RHINITIS CONTINUES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY COLD	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY COLD SYMPTOMS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY COLD SYMPTOMS: NASAL DRAINAGE, CONGESTION, COUGH	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY COPD EXACERBATION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY COUGH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DIAPHRAGM DISCOMFORT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DX WITH BRONCHIAL PNEUMONIA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DYSPNEA ON EXERTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY INFECTION, BRONCHITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY PNEUMONIA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY RHINITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY SHORT OF BREATH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY SHORTNESS OF BREATH	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY SHORTNESS OF BREATH 2X	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY SINUS INFECTION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY SINUSITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY SOB 6 EPISODES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY SOB WITH EXERTION	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY SOB WITH HEAVY EXERCISE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY STUFFY NOSE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY UPPER RESPIRATORY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY UPPER, INFLUENZA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY UPPER, SINUS PROBLEM ALLERGY RELATED	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RESPIRATORY URI	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders RIGHT ANKLE PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders RIGHT EAR SENSORAL HEARING LOSS -- AGE RELATED PER ENT MD	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders RIGHT ELBOW TENDONITIS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders RIGHT RENAL CYST	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders RIGHT SIDE ABOVE EAR	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders RIGHT TELBOW TENDONITIS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders RINORRHEA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders ROSACASE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders RT ELBOW FX	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders SEASONAL ALLERGIES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Investigations SERUM GLUCOSE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders SEVERE BACK PAIN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Reproductive system and breast disorders SEXUAL DYSFUNCTION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders SHINGLES	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders SHORTNESS OF BREATH	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders SHOULDER PAIN OLD INJURY FLAIR UP	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders SIGNIFICANT OTHER PERCEPTION OF CHANGE IN HEARING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	4.7% 9/191 • Number of events 9 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION & ALLERGIES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION ALLERGIES	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION CONGESTION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION HEAD CONGESTION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION SINUS INFECTION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION SINUSITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders SINUS DISCOMFORT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders SINUS HEADACHE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders SINUS INFECTION	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.6% 3/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders SINUSITIS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders SKIN LESION REMOVED	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders SKIN RASH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders SLEEP APNEA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders SLIGHT QUEEZY STOMACH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders SMALL OUTBREAKS OF PUSTULES UNDER NOSTRILS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders SORE THROAT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders SORE THROAT, COUGH, BODY ACHES, 103 TEMP	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders SORE THROAT, MUCUS/COUGH	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders SPINNING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders SPRAINED ANKLE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Skin and subcutaneous tissue disorders SQUAMOUS CELL REMOVAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders STOMACH ACHE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders STOMACH FLU	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders STOMACH PAIN	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders STOMACH UPSET AND HEARTBURN	0.52% 1/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders STOMACH VIRUS (VIRAL GASTROECTERITIS)	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders STOOL* BLACK	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders STOOL* CLEAR RECTAL DISCHARGE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders STOOL* DISCOLORED	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders STOOL* HARD	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders STOOL* HIGHER FREQUENCY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders STOOL* LOOSE	1.0% 2/191 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders STOOL* LOOSE, 2-3 DAYS/WEEK	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders STOOL* LOOSER	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders STOOL* SOFT WITH ABDOMINAL CRAMPS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders STOOL* TARRY	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders STREP THROAT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders SUBCONJUNCTIVAL HEMORRHAGE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures SURGERY* CABG WOUNDS (CORONARY ARTERY BYPASS GRAFT)	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures SURGERY* CHOLESYSTECTOMY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures SURGERY* DEVIATED SEPTUM & UVULECTOMY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures SURGERY* GUM SURGERY OUT PT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures SURGERY* HERNIA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures SURGERY* POSS BASAL CELL SKIN CANCER	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures SURGERY* PROSTATE RESTRUCTURING-ELECTIVE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures SURGERY* RIGHT INGUINAL HERNIA REPAIR	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures SURGERY* ROTATOR CUFF REPAIR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Surgical and medical procedures SURGERY* TURP/HOSPITAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders SWELLING PERIPHERAL EDEMA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
General disorders SWOLLEN ANKLES (PERIPHERAL EDEMA)	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders TENDONITIS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders TINGLING BIL THIGH TO CALVES. OCCURS ~2X/MO	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders TINGLING IN FINGER TIPS (NEUROPATHYSENSORY)	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders TINNITUS	6.3% 12/191 • Number of events 12 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	4.3% 8/184 • Number of events 11 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders TINNITUS - SLIGHT INTERFERRENCE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders TINNITUS CHRONIC	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders TINNITUS INCREASE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders TINNITUS INCREASE, LEFT EAR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders TINNITUS INCREASED	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders TINNITUS INCREASED, LEFT EAR	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders TINNITUS LEFT EAR	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders TINNITUS MAY HAVE INCREASED	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders TINNITUS MILD INCREASE, AUDIO AT 6M	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders TINNITUS PRE-EXISTING - INCREASED	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders TINNITUS VERY SLIGHT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders TINNITUS X1 EPISODE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Ear and labyrinth disorders TINNITUS X4 EPISODES	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders TMJ	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Infections and infestations TOE INFECTION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders TOOTH ABCESS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders TOOTH INFECTION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders TOOTH INFECTION -> ROOT CANAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders UPPER HARD PALATE 1 CM ERYTHEMA W/ ULCER	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders UPPER RESPIRATORY INFECTION	1.0% 2/191 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders URI	2.6% 5/191 • Number of events 5 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	3.8% 7/184 • Number of events 8 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders URI CHEST CONGESTION/COUGH/PHLEGM	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 3 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders URI COUGH AND SORE CHEST	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders URI SINUS INFECTION/COUGH	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders URI UPPER RESPIRATORY INFECTION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders UTI	4.7% 9/191 • Number of events 9 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	3.8% 7/184 • Number of events 8 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders UTI (BACK PN)	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Renal and urinary disorders UTI UTI SX	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders VERTIGO	2.6% 5/191 • Number of events 5 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders VERTIGO POSITIONAL	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Nervous system disorders VERTIGO SPINNING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders VIRAL GASTROENTERITIS	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION BLURRED	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION BLURRED RIGH EYE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION BLURRED WHEN READING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION BLURRING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION CATARACT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION CATARACT LEFT EYE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION CATARACTS, "FLASHING LIGHT"	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION DISTURBANCE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION FLASHING LIGHTS - BILATERAL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION FLOATERS - LEFT EYE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION FLOATERS, RIGHT EYE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION GLAUCOMA	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION INCREASED INTRAOCULAR PRESSURE	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION LEFT EYE BLURRY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION MYOPIA, LACERATION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION RIGHT CATARACT	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Eye disorders VISION SUB-CONJUNCTIVAL HEMMORHAGE	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders VOMITING	4.7% 9/191 • Number of events 9 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	2.7% 5/184 • Number of events 8 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders VOMITING AND NAUSEA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders VOMITING NAUSEA AND VOMITING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Gastrointestinal disorders VOMITTING	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders WEAKNESS	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	1.1% 2/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders WEAKNESS LEFT HAND	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders WEAKNESS LOWER EXTREMITY	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders WEAKNESS NEW - LEFT ARM	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Musculoskeletal and connective tissue disorders WEAKNESS OVERALL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Metabolism and nutrition disorders WEIGHT LOSS	5.2% 10/191 • Number of events 13 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	2.7% 5/184 • Number of events 5 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Metabolism and nutrition disorders WEIGHT LOSS >5%	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Metabolism and nutrition disorders WEIGHT LOSS AND DIARRHEA	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Metabolism and nutrition disorders WEIGHT LOSS DIETING	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Metabolism and nutrition disorders WEIGHT LOSS DURING RUN-IN PERIOD	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Metabolism and nutrition disorders WEIGHT LOSS INTENTIONAL	3.7% 7/191 • Number of events 7 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	2.2% 4/184 • Number of events 5 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Metabolism and nutrition disorders WEIGHT LOSS ON DIET REGIMEN	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Metabolism and nutrition disorders WEIGHT LOSS PURPOSEFUL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Metabolism and nutrition disorders WEIGHT LOSS R/T ATKINS DIET (10 LBS)	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Respiratory, thoracic and mediastinal disorders WHEEZING W/ SWEATING SHORTNESS OF BREATH	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 2 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Injury, poisoning and procedural complications WOUND INFECT	0.52% 1/191 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.00% 0/184 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Injury, poisoning and procedural complications WOUND* FACIAL CUT FROM FALL	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Injury, poisoning and procedural complications WOUND* HEAD LACERATION	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
Injury, poisoning and procedural complications WOUND* HEAD LACERATION ON SCALP	0.00% 0/191 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.	0.54% 1/184 • Number of events 1 • The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.

Additional Information

Dr. Frank Meyskens, Jr.

University of California, Irvine

Phone: 714-456-6310

Email: flmeyske@uci.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60